ID

43550

Description

Study part: Visit V0 Screening visit. Effectiveness and tolerance of sublingual desensitization with LAIS grass tablets in Patients with an allergic rhinoconjunctivitis caused by grass pollen. A prospective, multi-center, doubleblind, randomized, placebo-controlled Phase III study. Principal Investigator Prof. Dr. med. Ralph Mösges.

Keywords

  1. 2/10/16 2/10/16 -
  2. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY-NC 3.0

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    Visit V0 LAIS grass tablets by allergic rhinoconjunctivitis EudraCT-Nr.2012-004916-79

    Visit V0 Screening visit

    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI-1
    C1512693
    Female or male patients between 18 and 75 years with at least 2 years known, induced by grass pollen allergic rhinitis and / or allergic rhinoconjunctivitis with or without controlled allergic asthma
    Description

    age; Allergic rhinoconjunctivitis; Allergic asthma

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    UMLS CUI [2]
    C0861154
    UMLS CUI [3]
    C0155877
    Clinical sensitization to grass pollen. Patients with sensitization to perennial allergens such as dust mites, cats, dogs may be included where such sensitization during the analysis period are not clinically relevant.
    Description

    sensitization; Perennial allergy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C3662483
    UMLS CUI [2]
    C2721639
    Reliability and ability of the patient to fill out the patient diary for self-assessment of symptoms and taking the anti symptomatic medication selbsständig
    Description

    compliance behavior; patient diary

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1321605
    UMLS CUI [2]
    C3890583
    Signed and dated informed consent of the patient
    Description

    informed consent

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI-1
    C0680251
    Simultaneous participation in other clinical trials
    Description

    Study Subject Participation Status

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2348568
    Previous immunotherapy with grass pollen allergen or cross-reacting allergen in the last 5 years
    Description

    immunotherapy; Grass pollen; allergen

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0021083
    UMLS CUI [2]
    C0440307
    UMLS CUI [3]
    C0002092
    Continuing immunotherapy for allergens
    Description

    immunotherapy; allergen

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0021083
    UMLS CUI [2]
    C0002092
    Patients who are in any sort of relationship or dependence on the sponsor and / or investigator
    Description

    investigator; relationship

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0008961
    UMLS CUI [2]
    C0439849
    Other reasons that according to the opinion of the investigator contraindicate an inclusion in the clinical trial (e.g, low reliability, inability of the patient to understand the study documents and instructions)
    Description

    compliance behavior limited

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1321605
    UMLS CUI [1,2]
    C0439801
    An existing or planned pregnancy, lactation and / or lack of adequate contraception
    Description

    contraception status

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0420837
    Mostly perennial allergic rhinitis
    Description

    perennial allergic rhinitis

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0035457
    Only partially controlled or non-controlled or predominantly perenniales Asthma
    Description

    Perennial allergy Asthma

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C2721639
    UMLS CUI [1,2]
    C0004096
    Chronic asthma or emphysema, in particular with an FEV1 <70% of the expected value
    Description

    comorbidity; asthma; emphysem

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0009488
    UMLS CUI [2]
    C0004096
    UMLS CUI [3]
    C0034067
    Chronic asthma or emphysema, in particular with an FEV1 <70% of the individual value
    Description

    comorbidity; asthma; emphysem

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0009488
    UMLS CUI [2]
    C0004096
    UMLS CUI [3]
    C0034067
    Infections in the oral cavity with severe symptoms
    Description

    infection oral cavity

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0009450
    UMLS CUI [1,2]
    C0226896
    Patients with hereditary problems of galactose intolerance, lactase deficiency, glucose galactose malabsorption
    Description

    Intolerance galactose

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1744706
    UMLS CUI [1,2]
    C0016945
    Patients with deformities of the nose and / or adenoids
    Description

    adenoid

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001428
    Active tuberculosis
    Description

    Active tuberculosis

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0151332
    General inflammatory / febrile and severe acute or chronic inflammatory diseases
    Description

    inflammatory disease

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1290884
    Immunodeficiencies (for example, also induced by immunosuppressants)
    Description

    Immunodeficiencies

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0596032
    Autoimmune diseases
    Description

    Autoimmune diseases

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0004364
    By a doctor diagnosed internal diseases (for example, the liver, spleen, nervous system, the thyroid gland and rheumatic disorders), which are due to an autoimmune mechanism.
    Description

    Autoimmune Diseases; internal disease

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0004364
    UMLS CUI [2]
    C0679231
    Malignant tumors
    Description

    Malignant tumors

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0006826
    Alcohol abuse, drugs or medication abuse
    Description

    Substance Use Disorder

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0038586
    Contraindication to epinephrine (e.g. in acute or chronic myocardial ischemia symptomatology, severe hypertension)
    Description

    Contraindication epinephrine

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0522473
    UMLS CUI [1,2]
    C0014563
    Completed or ongoing long-term treatment with sedatives, or psychoactive drugs
    Description

    sedatives

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0036557
    Patients being treated with contraindicated Drug
    Description

    Contraindicated drug

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C3845816
    Demographics
    Description

    Demographics

    Alias
    UMLS CUI-1
    C0011298
    Date of screening visit (= Day -28/ -3 of the study)
    Description

    visit date

    Data type

    date

    Alias
    UMLS CUI [1]
    C1320303
    Date on which informed consent is signed
    Description

    consent date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0021430
    UMLS CUI [1,2]
    C0011008
    Birth year
    Description

    birth year

    Data type

    partialDate

    Alias
    UMLS CUI [1]
    C2826771
    Gender
    Description

    gender

    Data type

    text

    Alias
    UMLS CUI [1]
    C0079399
    Ethnicity
    Description

    Ethnicity

    Data type

    text

    Alias
    UMLS CUI [1]
    C0015031
    If other, please mention
    Description

    other

    Data type

    text

    Alias
    UMLS CUI [1]
    C0205394
    Date of next Visit V1 (3 to 28 days after V0)
    Description

    visit date

    Data type

    date

    Alias
    UMLS CUI [1]
    C1320303
    Laboratory
    Description

    Laboratory

    Alias
    UMLS CUI-1
    C0022877
    Date of venipuncture for total and specific IgE
    Description

    venipuncture date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0600406
    UMLS CUI [1,2]
    C0011008
    Date of venipuncture for safety laboratory
    Description

    venipuncture date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0600406
    UMLS CUI [1,2]
    C0011008
    Does the patient have a safe contraception?
    Description

    contraception status

    Data type

    text

    Alias
    UMLS CUI [1]
    C0420837
    Pregnancy test date
    Description

    Exception to the pregnancy test: patients with hysterectomy or patients in postmenopause (since at least 1 year.)

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0032976
    UMLS CUI [1,2]
    C0011008
    Pregnancy test result
    Description

    pregnancy test result

    Data type

    text

    Alias
    UMLS CUI [1]
    C0032976
    Physical examination
    Description

    Physical examination

    Alias
    UMLS CUI-1
    C0031809
    Weight
    Description

    Weight

    Data type

    float

    Measurement units
    • kg
    Alias
    UMLS CUI [1]
    C0005910
    kg
    Systolic blood pressure
    Description

    systolic blood pressure

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1]
    C0871470
    mmHg
    Diastolic blood pressure
    Description

    Diastolic blood pressure

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1]
    C0428883
    mmHg
    Heart rate
    Description

    Heart rate

    Data type

    integer

    Measurement units
    • 1/ min
    Alias
    UMLS CUI [1]
    C0018810
    1/ min
    Examination (Rhinoscope)
    Description

    Examination (Rhinoscope)

    Alias
    UMLS CUI-1
    C0582103
    UMLS CUI-2
    C0183044
    Edema
    Description

    Edema

    Data type

    text

    Alias
    UMLS CUI [1]
    C0013604
    Secretion
    Description

    Secretion

    Data type

    text

    Alias
    UMLS CUI [1]
    C1546724
    Redness
    Description

    Redness

    Data type

    text

    Alias
    UMLS CUI [1]
    C0332575
    History of allergies
    Description

    History of allergies

    Alias
    UMLS CUI-1
    C0489531
    Grass pollen
    Description

    If a clinically relevant sensitization to mainly co-seasonal or perennial co- allergens during the grass pollen season--> Exclusion of patients

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0440307
    Tree pollen
    Description

    tree pollen

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C3541399
    Atopic dermatitis
    Description

    Atopic dermatitis

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0011615
    Weed pollen
    Description

    weed pollen

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1328969
    Food allergies
    Description

    Food allergies

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0016470
    If yes, which?
    Description

    Food allergies

    Data type

    text

    Alias
    UMLS CUI [1]
    C0016470
    Other allergies
    Description

    allergy

    Data type

    text

    Alias
    UMLS CUI [1]
    C0020517
    Clinical symptoms
    Description

    Clinical symptoms

    Alias
    UMLS CUI-1
    C1457887
    Allergic rhinitis/ allergic rhinoconjunctivitis
    Description

    allergic rhinitis; allergic rhinoconjunctivitis

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2607914
    UMLS CUI [2]
    C0861154
    Allergic rhinitis/ allergic rhinoconjunctivitis
    Description

    allergic rhinitis; allergic rhinoconjunctivitis

    Data type

    text

    Alias
    UMLS CUI [1]
    C2607914
    UMLS CUI [2]
    C0861154
    Allergic rhinoconjunctivitis or allergic rhinitis since
    Description

    allergic rhinoconjunctivitis date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0861154
    UMLS CUI [1,2]
    C0011008
    Retrospective Rhinoconjunctivitis Total Symptom Score
    Description

    Retrospective Rhinoconjunctivitis Total Symptom Score

    Alias
    UMLS CUI-1
    C0449820
    UMLS CUI-2
    C0861155
    Sneezing
    Description

    Sneezing

    Data type

    text

    Alias
    UMLS CUI [1]
    C0037383
    Runny nose
    Description

    Rhinorrhea

    Data type

    text

    Alias
    UMLS CUI [1]
    C1260880
    Itching in the nose
    Description

    Nasal pruritus

    Data type

    text

    Alias
    UMLS CUI [1]
    C0850060
    Stuffy nose
    Description

    Nasal congestion

    Data type

    text

    Alias
    UMLS CUI [1]
    C0027424
    Watery eyes
    Description

    Watery eyes

    Data type

    text

    Alias
    UMLS CUI [1]
    C3257803
    Itching of eye
    Description

    Itching of eye

    Data type

    text

    Alias
    UMLS CUI [1]
    C0022281
    Summation (when total RTSS score is < 8, exclusion of patient)
    Description

    Summation

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0234108
    Concomitant medication
    Description

    Concomitant medication

    Alias
    UMLS CUI-1
    C2347852
    Concomitant medication
    Description

    Concomitant medication

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2347852
    Type of concomitant medication
    Description

    Concomitant medication

    Data type

    text

    Alias
    UMLS CUI [1]
    C2347852
    If other, please mention
    Description

    other

    Data type

    text

    Medical history
    Description

    Medical history

    Alias
    UMLS CUI-1
    C0262926
    Cardiovascular system
    Description

    cardiovascular system

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0007226
    Respiratory
    Description

    respiratory

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0035237
    Gastrointestinal Tract
    Description

    gastrointestinal tract

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0017189
    Eye
    Description

    Eye

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0015392
    Nose
    Description

    Nose

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0028429
    Ears
    Description

    Ears

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0013443
    Neck
    Description

    Neck

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0027530
    Skin
    Description

    Skin

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1123023
    Skin
    Description

    Skin

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1123023
    Endocrine / lymphatic system
    Description

    Endocrine system; lymphatic system

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0014130
    UMLS CUI [2]
    C0024235
    Muscle/ Skeleton
    Description

    muscle; skeleton

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0026845
    UMLS CUI [2]
    C0037253
    Nervous system
    Description

    Nervous system

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0027763
    Genitourinary
    Description

    genitourinary

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0042066
    Metabolic System
    Description

    Metabolic System

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0014136
    Comorbidity
    Description

    Comorbidity

    Data type

    text

    Alias
    UMLS CUI [1]
    C0009488
    Specification of comorbidity
    Description

    comorbidity

    Data type

    text

    Alias
    UMLS CUI [1]
    C0009488
    Retrospective registration of disease or surgical procedures on other organs within the last 10 years
    Description

    surgical procedures

    Data type

    text

    Alias
    UMLS CUI [1]
    C0543467
    If diagnosis, please describe
    Description

    Specification

    Data type

    text

    Skin prick test
    Description

    Skin prick test

    Alias
    UMLS CUI-1
    C0430561
    Size of wheal for grass pollen mixture (> = 3 mm)
    Description

    grass pollen

    Data type

    float

    Measurement units
    • mm
    Alias
    UMLS CUI [1]
    C0440307
    mm
    Size of wheal for histamine dihydrochloride (positive control 10 mg/ml) (>=3 mm)
    Description

    histamine dihydrochloride

    Data type

    float

    Measurement units
    • mm
    Alias
    UMLS CUI [1]
    C0543456
    mm
    Size of wheal for saline solution (< 2 mm)
    Description

    Saline Solution

    Data type

    float

    Measurement units
    • mm
    Alias
    UMLS CUI [1]
    C0036082
    mm
    Size of wheal for rye pollen
    Description

    rye pollen

    Data type

    float

    Measurement units
    • mm
    Alias
    UMLS CUI [1]
    C0440328
    mm
    Size of wheal for hazel pollen
    Description

    hazel pollen

    Data type

    float

    Measurement units
    • mm
    Alias
    UMLS CUI [1]
    C0440377
    mm
    Size of wheal for ambrosia pollen
    Description

    ambrosia pollen

    Data type

    float

    Measurement units
    • mm
    Alias
    UMLS CUI [1]
    C3495104
    mm
    Size of wheal for birch pollen
    Description

    Birch pollen

    Data type

    float

    Measurement units
    • mm
    Alias
    UMLS CUI [1]
    C4047367
    mm
    Size of wheal for mugwort pollen
    Description

    mugwort pollen

    Data type

    float

    Measurement units
    • mm
    Alias
    UMLS CUI [1]
    C3495107
    mm
    Size of wheal for house dust mite
    Description

    House dust mite

    Data type

    float

    Measurement units
    • mm
    Alias
    UMLS CUI [1]
    C3539110
    mm
    Size of wheal for cat hair
    Description

    cat hair

    Data type

    float

    Measurement units
    • mm
    Alias
    UMLS CUI [1]
    C0440419
    mm
    Size of wheal for dog hair
    Description

    dog hair

    Data type

    float

    Measurement units
    • mm
    Alias
    UMLS CUI [1]
    C0440417
    mm
    Size of wheal for alternaria
    Description

    Alternaria

    Data type

    float

    Measurement units
    • mm
    Alias
    UMLS CUI [1]
    C0002343
    mm
    Spirometry or Peak expiratory flow measurement (For asthmatics)
    Description

    Spirometry or Peak expiratory flow measurement (For asthmatics)

    Alias
    UMLS CUI-1
    C0037981
    UMLS CUI-2
    C0521299
    FEV1 (age-appropriate standard value)
    Description

    FEV1

    Data type

    float

    Alias
    UMLS CUI [1]
    C0748133
    FEV1
    Description

    FEV1

    Data type

    float

    Alias
    UMLS CUI [1]
    C0748133
    FEV1/ Standard value (If FEV1 < 70% of age appropriate standard value, exclusion)
    Description

    Ratio; FEV1; standard value

    Data type

    integer

    Measurement units
    • %
    Alias
    UMLS CUI [1]
    C0456603
    UMLS CUI [2]
    C0588029
    UMLS CUI [3]
    C1442989
    %
    PEF 1
    Description

    Peak expiratory flow measurement

    Data type

    integer

    Measurement units
    • l/min
    Alias
    UMLS CUI [1]
    C0521299
    l/min
    PEF 2
    Description

    Peak expiratory flow measurement

    Data type

    integer

    Measurement units
    • l/ min
    Alias
    UMLS CUI [1]
    C0521299
    l/ min
    PEF 3
    Description

    Peak expiratory flow measurement

    Data type

    integer

    Measurement units
    • l/ min
    Alias
    UMLS CUI [1]
    C0521299
    l/ min
    Best PEF
    Description

    Peak expiratory flow measurement

    Data type

    integer

    Measurement units
    • l/ min
    Alias
    UMLS CUI [1]
    C0521299
    l/ min
    Optimum individual value PEF (If FEV1 < 70% of optimum individual value, exclusion)
    Description

    Peak expiratory flow measurement

    Data type

    integer

    Measurement units
    • l/ min
    Alias
    UMLS CUI [1]
    C0521299
    l/ min
    Conjunctival provocation testing
    Description

    Conjunctival provocation testing

    Alias
    UMLS CUI-1
    C0430565
    Conjunctival provocation test result 1
    Description

    Conjunctival provocation testing

    Data type

    text

    Alias
    UMLS CUI [1]
    C0430565
    Conjunctival provocation test result 2 (to be carried out only when test 1 outcome is negative)
    Description

    Conjunctival provocation testing

    Data type

    text

    Alias
    UMLS CUI [1]
    C0430565
    Conjunctival provocation test result 3 (to be carried out only when test 2 outcome is negative)
    Description

    Conjunctival provocation testing

    Data type

    text

    Alias
    UMLS CUI [1]
    C0430565
    Allergen concentration at which the test outcome is positive
    Description

    concentration allergen

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1446561
    UMLS CUI [1,2]
    C0002092
    The outcome for all tests is negative
    Description

    Conjunctival provocation testing

    Data type

    boolean

    Allergy diagnostics
    Description

    Allergy diagnostics

    Alias
    UMLS CUI-1
    C0086143
    UMLS CUI-2
    C0020517
    Total Immunoglobulin E
    Description

    Immunoglobulin E

    Data type

    float

    Measurement units
    • kU/l
    Alias
    UMLS CUI [1]
    C0202086
    kU/l
    Immunoglobulin IgG4
    Description

    Immunoglobulin G4

    Data type

    float

    Measurement units
    • kU/l
    Alias
    UMLS CUI [1]
    C0020860
    kU/l
    Grass (Phleum pratense) Phl p 1
    Description

    Immunoglobulin; Grass pollen

    Data type

    float

    Measurement units
    • kU/l
    Alias
    UMLS CUI [1]
    C0021027
    UMLS CUI [2]
    C0440307
    kU/l
    RAST class for grass Phl p 1
    Description

    Radioallergosorbent Test

    Data type

    text

    Alias
    UMLS CUI [1]
    C0034554
    Grass (Phleum pratense) Phl p5b
    Description

    Immunoglobulin; Grass pollen

    Data type

    float

    Measurement units
    • kU/l
    Alias
    UMLS CUI [1]
    C0021027
    UMLS CUI [2]
    C0440307
    kU/l
    RAST class for grass Phl p5b
    Description

    Radioallergosorbent Test

    Data type

    text

    Alias
    UMLS CUI [1]
    C0034554
    Grass (Phleum pratense) Phl p 7
    Description

    Immunoglobulin; Grass pollen

    Data type

    float

    Measurement units
    • kU/l
    Alias
    UMLS CUI [1]
    C0021027
    UMLS CUI [2]
    C0440307
    kU/l
    RAST class for grass Phl p7
    Description

    Radioallergosorbent Test

    Data type

    text

    Alias
    UMLS CUI [1]
    C0034554
    Grass (Phleum pratense) Phl p 12
    Description

    Immunoglobulin; Grass pollen

    Data type

    float

    Measurement units
    • kU/l
    Alias
    UMLS CUI [1]
    C0021027
    UMLS CUI [2]
    C0440307
    kU/l
    RAST class for grass Phl p 12
    Description

    Radioallergosorbent Test

    Data type

    text

    Alias
    UMLS CUI [1]
    C0034554
    Birch Bet v 1
    Description

    Birch antigen

    Data type

    float

    Measurement units
    • kU/l
    Alias
    UMLS CUI [1]
    C1527024
    kU/l
    RAST class for birch Bet v1
    Description

    Radioallergosorbent Test

    Data type

    text

    Alias
    UMLS CUI [1]
    C0034554
    Mugwort Art v1
    Description

    Immunoglobulin Mugwort

    Data type

    float

    Measurement units
    • kU/l
    Alias
    UMLS CUI [1,1]
    C0021027
    UMLS CUI [1,2]
    C0348066
    kU/l
    RAST class for mugwort Art v1
    Description

    Radioallergosorbent Test

    Data type

    text

    Alias
    UMLS CUI [1]
    C0034554
    Ambrosia Amb a1
    Description

    Immunoglobulin ambrosia

    Data type

    float

    Measurement units
    • kU/l
    Alias
    UMLS CUI [1,1]
    C0021027
    UMLS CUI [1,2]
    C0331432
    kU/l
    RAST class for ambrosia Amb a1
    Description

    Radioallergosorbent Test

    Data type

    text

    Alias
    UMLS CUI [1]
    C0034554
    D. pteronyssinus Der p1
    Description

    Immunoglobulin Dermatophagoides pteronyssinus

    Data type

    float

    Measurement units
    • kU/l
    Alias
    UMLS CUI [1,1]
    C0021027
    UMLS CUI [1,2]
    C1122992
    kU/l
    RAST class for D. pteronyssinus Der p1
    Description

    Radioallergosorbent Test

    Data type

    text

    Alias
    UMLS CUI [1]
    C0034554
    D. farinae Der p2
    Description

    Immunoglobulin Dermatophagoides farinae

    Data type

    float

    Measurement units
    • kU/l
    Alias
    UMLS CUI [1,1]
    C0021027
    UMLS CUI [1,2]
    C0323677
    kU/l
    RAST class for D. farinae
    Description

    Radioallergosorbent Test

    Data type

    text

    Alias
    UMLS CUI [1]
    C0034554
    Dog Can f1
    Description

    Dog antigen

    Data type

    float

    Measurement units
    • kU/l
    Alias
    UMLS CUI [1]
    C1443014
    kU/l
    RAST class for dog Can f1
    Description

    Radioallergosorbent Test

    Data type

    text

    Alias
    UMLS CUI [1]
    C0034554
    Cat Fel d1
    Description

    Cat hair antigen

    Data type

    float

    Measurement units
    • kU/l
    Alias
    UMLS CUI [1]
    C1443200
    kU/l
    RAST class for cat Fel d1
    Description

    Radioallergosorbent Test

    Data type

    text

    Alias
    UMLS CUI [1]
    C0034554
    Alternaria Alt a1
    Description

    Immunoglobulin Alternaria

    Data type

    float

    Measurement units
    • kU/l
    Alias
    UMLS CUI [1,1]
    C0021027
    UMLS CUI [1,2]
    C0002343
    kU/l
    RAST class for Alternaria Alt a1
    Description

    Radioallergosorbent Test

    Data type

    text

    Alias
    UMLS CUI [1]
    C0034554
    Hematology
    Description

    Hematology

    Alias
    UMLS CUI-1
    C0474523
    Hemoglobin
    Description

    Hemoglobin

    Data type

    float

    Measurement units
    • mmol/l
    Alias
    UMLS CUI [1]
    C0019046
    mmol/l
    Erythrocyte
    Description

    Erythrocyte

    Data type

    float

    Measurement units
    • /pl
    Alias
    UMLS CUI [1]
    C0014772
    /pl
    Thrombocyte
    Description

    Thrombocyte

    Data type

    float

    Measurement units
    • /nl
    Alias
    UMLS CUI [1]
    C0005821
    /nl
    Leucocyte (total)
    Description

    Leucocyte (total)

    Data type

    float

    Measurement units
    • /nl
    Alias
    UMLS CUI [1]
    C0023508
    /nl
    Hematocrit
    Description

    Hematocrit

    Data type

    float

    Measurement units
    • l/l
    Alias
    UMLS CUI [1]
    C0518014
    l/l
    Biochemistry
    Description

    Biochemistry

    Alias
    UMLS CUI-1
    C0005477
    Bilirubin (total)
    Description

    Bilirubin

    Data type

    float

    Measurement units
    • μmol/l
    Alias
    UMLS CUI [1]
    C1278039
    μmol/l
    SGPT- Serum Glutamate pyruvate transaminase
    Description

    Glutamate pyruvate transaminase

    Data type

    float

    Measurement units
    • U/l
    U/l
    Alkaline phosphatase
    Description

    alkaline phosphatase

    Data type

    float

    Measurement units
    • U/l
    Alias
    UMLS CUI [1]
    C0201850
    U/l
    Glucose
    Description

    Glucose

    Data type

    float

    Measurement units
    • mmol/l
    Alias
    UMLS CUI [1]
    C0202042
    mmol/l
    Creatinine
    Description

    Creatinine

    Data type

    float

    Measurement units
    • μmol/l
    Alias
    UMLS CUI [1]
    C0201976
    μmol/l
    SGOT- Aspartate aminotransferase measurement
    Description

    Aspartate aminotransferase measurement

    Data type

    float

    Measurement units
    • U/l
    Alias
    UMLS CUI [1]
    C0201899
    U/l
    CRP C reactive protein
    Description

    C reactive protein

    Data type

    float

    Measurement units
    • mg/l
    Alias
    UMLS CUI [1]
    C0201657
    mg/l
    Gamma-glutamyl transpeptidase
    Description

    Gamma-glutamyl transpeptidase

    Data type

    float

    Measurement units
    • U/l
    Alias
    UMLS CUI [1]
    C1883012
    U/l
    Inclusion Criteria (Part 2)
    Description

    Inclusion Criteria (Part 2)

    Alias
    UMLS CUI-1
    C1512693
    the occurrence of the majority of the corresponding clinical symptoms during the grass pollen season
    Description

    The positive clinical case history to grass pollen is evidenced by

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C0440307
    Patients should not suffer from typical symptoms caused by co-allergens during the grass pollen season (for example, patients with sensitization to animal fur / - dandruff are not be exposed)
    Description

    The positive clinical case history to grass pollen is evidenced by

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C3662483
    the positive skin prick test (wheal size> = 3 mm, negative control <2 mm)
    Description

    The positive clinical case history to grass pollen is evidenced by

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0430561
    The results in the skin prick test for co-seasonal and most of the perennial co-allergenic are smaller than the skin prick test result for Grass pollen
    Description

    The positive clinical case history to grass pollen is evidenced by

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2721639
    a positive reaction in the conjunctival Provocation test (CPT) with one of the three dilutions of grass allergy solution
    Description

    The positive clinical case history to grass pollen is evidenced by

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0430565
    Retrospective Total symptom score (RRTSS) during the previous grass pollen season is greater than or equal to 8
    Description

    The positive clinical case history to grass pollen is evidenced by

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0449820
    UMLS CUI [1,2]
    C0861155
    Planned antiallergic or antiasthmatic treatment with the following medicines: local treatment with levocabastine (eye), loratadine (oral), beclomethasone (nasal) or inhaled corticosteroid with a long-acting beta-2 agonists
    Description

    The positive clinical case history to grass pollen is evidenced by

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1535925
    Specific IgE reactivity to grass pollen: CAP RAST results for Phl p 1 or Phl p5b> = class 2 (0.70 kU / l) and CAP-RAST results for Phl p 1 or Phl p5b> CAP-RAST results for Phl p 7 or Phl p 12
    Description

    The positive clinical case history to grass pollen is evidenced by

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0202086
    The specific IgE values for predominantly perennial co- allergy (animal hair / - dandruff, dust mites) or for the predominantly co-seasonal allergen Alternaria must be less than the sIgE results for grass pollen allergens (Phl p 1 or Phl p5b). The difference must be at least a CAP RAAST class (> = 1).
    Description

    The positive clinical case history to grass pollen is evidenced by

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0202086
    UMLS CUI [2]
    C1387134

    Similar models

    Visit V0 Screening visit

    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Inclusion Criteria
    C1512693 (UMLS CUI-1)
    age; Allergic rhinoconjunctivitis; Allergic asthma
    Item
    Female or male patients between 18 and 75 years with at least 2 years known, induced by grass pollen allergic rhinitis and / or allergic rhinoconjunctivitis with or without controlled allergic asthma
    boolean
    C0001779 (UMLS CUI [1])
    C0861154 (UMLS CUI [2])
    C0155877 (UMLS CUI [3])
    sensitization; Perennial allergy
    Item
    Clinical sensitization to grass pollen. Patients with sensitization to perennial allergens such as dust mites, cats, dogs may be included where such sensitization during the analysis period are not clinically relevant.
    boolean
    C3662483 (UMLS CUI [1])
    C2721639 (UMLS CUI [2])
    compliance behavior; patient diary
    Item
    Reliability and ability of the patient to fill out the patient diary for self-assessment of symptoms and taking the anti symptomatic medication selbsständig
    boolean
    C1321605 (UMLS CUI [1])
    C3890583 (UMLS CUI [2])
    informed consent
    Item
    Signed and dated informed consent of the patient
    boolean
    C0021430 (UMLS CUI [1])
    Item Group
    Exclusion Criteria
    C0680251 (UMLS CUI-1)
    Study Subject Participation Status
    Item
    Simultaneous participation in other clinical trials
    boolean
    C2348568 (UMLS CUI [1])
    immunotherapy; Grass pollen; allergen
    Item
    Previous immunotherapy with grass pollen allergen or cross-reacting allergen in the last 5 years
    boolean
    C0021083 (UMLS CUI [1])
    C0440307 (UMLS CUI [2])
    C0002092 (UMLS CUI [3])
    immunotherapy; allergen
    Item
    Continuing immunotherapy for allergens
    boolean
    C0021083 (UMLS CUI [1])
    C0002092 (UMLS CUI [2])
    investigator; relationship
    Item
    Patients who are in any sort of relationship or dependence on the sponsor and / or investigator
    boolean
    C0008961 (UMLS CUI [1])
    C0439849 (UMLS CUI [2])
    compliance behavior limited
    Item
    Other reasons that according to the opinion of the investigator contraindicate an inclusion in the clinical trial (e.g, low reliability, inability of the patient to understand the study documents and instructions)
    boolean
    C1321605 (UMLS CUI [1,1])
    C0439801 (UMLS CUI [1,2])
    contraception status
    Item
    An existing or planned pregnancy, lactation and / or lack of adequate contraception
    boolean
    C0420837 (UMLS CUI [1])
    perennial allergic rhinitis
    Item
    Mostly perennial allergic rhinitis
    boolean
    C0035457 (UMLS CUI [1])
    Perennial allergy Asthma
    Item
    Only partially controlled or non-controlled or predominantly perenniales Asthma
    boolean
    C2721639 (UMLS CUI [1,1])
    C0004096 (UMLS CUI [1,2])
    comorbidity; asthma; emphysem
    Item
    Chronic asthma or emphysema, in particular with an FEV1 <70% of the expected value
    boolean
    C0009488 (UMLS CUI [1])
    C0004096 (UMLS CUI [2])
    C0034067 (UMLS CUI [3])
    comorbidity; asthma; emphysem
    Item
    Chronic asthma or emphysema, in particular with an FEV1 <70% of the individual value
    boolean
    C0009488 (UMLS CUI [1])
    C0004096 (UMLS CUI [2])
    C0034067 (UMLS CUI [3])
    infection oral cavity
    Item
    Infections in the oral cavity with severe symptoms
    boolean
    C0009450 (UMLS CUI [1,1])
    C0226896 (UMLS CUI [1,2])
    Intolerance galactose
    Item
    Patients with hereditary problems of galactose intolerance, lactase deficiency, glucose galactose malabsorption
    boolean
    C1744706 (UMLS CUI [1,1])
    C0016945 (UMLS CUI [1,2])
    adenoid
    Item
    Patients with deformities of the nose and / or adenoids
    boolean
    C0001428 (UMLS CUI [1])
    Active tuberculosis
    Item
    Active tuberculosis
    boolean
    C0151332 (UMLS CUI [1])
    inflammatory disease
    Item
    General inflammatory / febrile and severe acute or chronic inflammatory diseases
    boolean
    C1290884 (UMLS CUI [1])
    Immunodeficiencies
    Item
    Immunodeficiencies (for example, also induced by immunosuppressants)
    boolean
    C0596032 (UMLS CUI [1])
    Autoimmune diseases
    Item
    Autoimmune diseases
    boolean
    C0004364 (UMLS CUI [1])
    Autoimmune Diseases; internal disease
    Item
    By a doctor diagnosed internal diseases (for example, the liver, spleen, nervous system, the thyroid gland and rheumatic disorders), which are due to an autoimmune mechanism.
    boolean
    C0004364 (UMLS CUI [1])
    C0679231 (UMLS CUI [2])
    Malignant tumors
    Item
    Malignant tumors
    boolean
    C0006826 (UMLS CUI [1])
    Substance Use Disorder
    Item
    Alcohol abuse, drugs or medication abuse
    boolean
    C0038586 (UMLS CUI [1])
    Contraindication epinephrine
    Item
    Contraindication to epinephrine (e.g. in acute or chronic myocardial ischemia symptomatology, severe hypertension)
    boolean
    C0522473 (UMLS CUI [1,1])
    C0014563 (UMLS CUI [1,2])
    sedatives
    Item
    Completed or ongoing long-term treatment with sedatives, or psychoactive drugs
    boolean
    C0036557 (UMLS CUI [1])
    Contraindicated drug
    Item
    Patients being treated with contraindicated Drug
    boolean
    C3845816 (UMLS CUI [1])
    Item Group
    Demographics
    C0011298 (UMLS CUI-1)
    visit date
    Item
    Date of screening visit (= Day -28/ -3 of the study)
    date
    C1320303 (UMLS CUI [1])
    consent date
    Item
    Date on which informed consent is signed
    date
    C0021430 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    birth year
    Item
    Birth year
    partialDate
    C2826771 (UMLS CUI [1])
    Item
    Gender
    text
    C0079399 (UMLS CUI [1])
    Code List
    Gender
    CL Item
    male (1)
    CL Item
    female (2)
    Item
    Ethnicity
    text
    C0015031 (UMLS CUI [1])
    Code List
    Ethnicity
    CL Item
    caucasian (1)
    CL Item
    asian (2)
    CL Item
    negroid (3)
    CL Item
    other (4)
    other
    Item
    If other, please mention
    text
    C0205394 (UMLS CUI [1])
    visit date
    Item
    Date of next Visit V1 (3 to 28 days after V0)
    date
    C1320303 (UMLS CUI [1])
    Item Group
    Laboratory
    C0022877 (UMLS CUI-1)
    venipuncture date
    Item
    Date of venipuncture for total and specific IgE
    date
    C0600406 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    venipuncture date
    Item
    Date of venipuncture for safety laboratory
    date
    C0600406 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item
    Does the patient have a safe contraception?
    text
    C0420837 (UMLS CUI [1])
    Code List
    Does the patient have a safe contraception?
    CL Item
    no, then exclusion (1)
    CL Item
    yes, according to Supplement "Recognised methods of reliable contraception" (2)
    CL Item
    yes, other reasons for a safe contraception (3)
    pregnancy test date
    Item
    Pregnancy test date
    date
    C0032976 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item
    Pregnancy test result
    text
    C0032976 (UMLS CUI [1])
    Code List
    Pregnancy test result
    CL Item
    positive, exclusion (1)
    CL Item
    negative (2)
    Item Group
    Physical examination
    C0031809 (UMLS CUI-1)
    Weight
    Item
    Weight
    float
    C0005910 (UMLS CUI [1])
    systolic blood pressure
    Item
    Systolic blood pressure
    integer
    C0871470 (UMLS CUI [1])
    Diastolic blood pressure
    Item
    Diastolic blood pressure
    integer
    C0428883 (UMLS CUI [1])
    Heart rate
    Item
    Heart rate
    integer
    C0018810 (UMLS CUI [1])
    Item Group
    Examination (Rhinoscope)
    C0582103 (UMLS CUI-1)
    C0183044 (UMLS CUI-2)
    Item
    Edema
    text
    C0013604 (UMLS CUI [1])
    Code List
    Edema
    CL Item
    no (1)
    CL Item
    slight (2)
    CL Item
    medium (3)
    CL Item
    strong (4)
    Item
    Secretion
    text
    C1546724 (UMLS CUI [1])
    Code List
    Secretion
    CL Item
    no (1)
    CL Item
    slight (2)
    CL Item
    medium (3)
    CL Item
    strong (4)
    Item
    Redness
    text
    C0332575 (UMLS CUI [1])
    Code List
    Redness
    CL Item
    no (1)
    CL Item
    slight (2)
    CL Item
    medium (3)
    CL Item
    strong (4)
    Item Group
    History of allergies
    C0489531 (UMLS CUI-1)
    grass pollen
    Item
    Grass pollen
    boolean
    C0440307 (UMLS CUI [1])
    tree pollen
    Item
    Tree pollen
    boolean
    C3541399 (UMLS CUI [1])
    Atopic dermatitis
    Item
    Atopic dermatitis
    boolean
    C0011615 (UMLS CUI [1])
    weed pollen
    Item
    Weed pollen
    boolean
    C1328969 (UMLS CUI [1])
    Food allergies
    Item
    Food allergies
    boolean
    C0016470 (UMLS CUI [1])
    Food allergies
    Item
    If yes, which?
    text
    C0016470 (UMLS CUI [1])
    allergy
    Item
    Other allergies
    text
    C0020517 (UMLS CUI [1])
    Item Group
    Clinical symptoms
    C1457887 (UMLS CUI-1)
    allergic rhinitis; allergic rhinoconjunctivitis
    Item
    Allergic rhinitis/ allergic rhinoconjunctivitis
    boolean
    C2607914 (UMLS CUI [1])
    C0861154 (UMLS CUI [2])
    Item
    Allergic rhinitis/ allergic rhinoconjunctivitis
    text
    C2607914 (UMLS CUI [1])
    C0861154 (UMLS CUI [2])
    Code List
    Allergic rhinitis/ allergic rhinoconjunctivitis
    CL Item
    seasonal (1)
    CL Item
    predominantly perennial, then exclusion (2)
    allergic rhinoconjunctivitis date
    Item
    Allergic rhinoconjunctivitis or allergic rhinitis since
    date
    C0861154 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item Group
    Retrospective Rhinoconjunctivitis Total Symptom Score
    C0449820 (UMLS CUI-1)
    C0861155 (UMLS CUI-2)
    Item
    Sneezing
    text
    C0037383 (UMLS CUI [1])
    Code List
    Sneezing
    CL Item
    no symptoms 0 (1)
    CL Item
    slight symptoms 1 (2)
    CL Item
    moderate symptoms 2 (3)
    CL Item
    strong symptoms 3 (4)
    Item
    Runny nose
    text
    C1260880 (UMLS CUI [1])
    Code List
    Runny nose
    CL Item
    no symptoms 0 (1)
    CL Item
    slight symptoms 1 (2)
    CL Item
    moderate symptoms 2 (3)
    CL Item
    strong symptoms 3 (4)
    Item
    Itching in the nose
    text
    C0850060 (UMLS CUI [1])
    Code List
    Itching in the nose
    CL Item
    no symptoms 0 (1)
    CL Item
    slight symptoms 1 (2)
    CL Item
    moderate symptoms 2 (3)
    CL Item
    strong symptoms 3 (4)
    Item
    Stuffy nose
    text
    C0027424 (UMLS CUI [1])
    Code List
    Stuffy nose
    CL Item
    no symptoms 0 (1)
    CL Item
    slight symptoms 1 (2)
    CL Item
    moderate symptoms 2 (3)
    CL Item
    strong symptoms 3 (4)
    Item
    Watery eyes
    text
    C3257803 (UMLS CUI [1])
    Code List
    Watery eyes
    CL Item
    no symptoms 0 (1)
    CL Item
    slight symptoms 1 (2)
    CL Item
    moderate symptoms 2 (3)
    CL Item
    strong symptoms 3 (4)
    Item
    Itching of eye
    text
    C0022281 (UMLS CUI [1])
    Code List
    Itching of eye
    CL Item
    no symptoms 0 (1)
    CL Item
    slight symptoms 1 (2)
    CL Item
    moderate symptoms 2 (3)
    CL Item
    strong symptoms 3 (4)
    Summation
    Item
    Summation (when total RTSS score is < 8, exclusion of patient)
    integer
    C0234108 (UMLS CUI [1])
    Item Group
    Concomitant medication
    C2347852 (UMLS CUI-1)
    Concomitant medication
    Item
    Concomitant medication
    boolean
    C2347852 (UMLS CUI [1])
    Item
    Type of concomitant medication
    text
    C2347852 (UMLS CUI [1])
    Code List
    Type of concomitant medication
    CL Item
    contraindicated drugs (1)
    CL Item
    other medicines (2)
    other
    Item
    If other, please mention
    text
    Item Group
    Medical history
    C0262926 (UMLS CUI-1)
    cardiovascular system
    Item
    Cardiovascular system
    boolean
    C0007226 (UMLS CUI [1])
    respiratory
    Item
    Respiratory
    boolean
    C0035237 (UMLS CUI [1])
    gastrointestinal tract
    Item
    Gastrointestinal Tract
    boolean
    C0017189 (UMLS CUI [1])
    Eye
    Item
    Eye
    boolean
    C0015392 (UMLS CUI [1])
    Nose
    Item
    Nose
    boolean
    C0028429 (UMLS CUI [1])
    Ears
    Item
    Ears
    boolean
    C0013443 (UMLS CUI [1])
    Neck
    Item
    Neck
    boolean
    C0027530 (UMLS CUI [1])
    Skin
    Item
    Skin
    boolean
    C1123023 (UMLS CUI [1])
    Skin
    Item
    Skin
    boolean
    C1123023 (UMLS CUI [1])
    Endocrine system; lymphatic system
    Item
    Endocrine / lymphatic system
    boolean
    C0014130 (UMLS CUI [1])
    C0024235 (UMLS CUI [2])
    muscle; skeleton
    Item
    Muscle/ Skeleton
    boolean
    C0026845 (UMLS CUI [1])
    C0037253 (UMLS CUI [2])
    Nervous system
    Item
    Nervous system
    boolean
    C0027763 (UMLS CUI [1])
    genitourinary
    Item
    Genitourinary
    boolean
    C0042066 (UMLS CUI [1])
    Metabolic System
    Item
    Metabolic System
    boolean
    C0014136 (UMLS CUI [1])
    Item
    Comorbidity
    text
    C0009488 (UMLS CUI [1])
    Code List
    Comorbidity
    CL Item
    no (1)
    CL Item
    yes, please match with exclusion criteria and specify (2)
    comorbidity
    Item
    Specification of comorbidity
    text
    C0009488 (UMLS CUI [1])
    surgical procedures
    Item
    Retrospective registration of disease or surgical procedures on other organs within the last 10 years
    text
    C0543467 (UMLS CUI [1])
    Specification
    Item
    If diagnosis, please describe
    text
    Item Group
    Skin prick test
    C0430561 (UMLS CUI-1)
    grass pollen
    Item
    Size of wheal for grass pollen mixture (> = 3 mm)
    float
    C0440307 (UMLS CUI [1])
    histamine dihydrochloride
    Item
    Size of wheal for histamine dihydrochloride (positive control 10 mg/ml) (>=3 mm)
    float
    C0543456 (UMLS CUI [1])
    Saline Solution
    Item
    Size of wheal for saline solution (< 2 mm)
    float
    C0036082 (UMLS CUI [1])
    rye pollen
    Item
    Size of wheal for rye pollen
    float
    C0440328 (UMLS CUI [1])
    hazel pollen
    Item
    Size of wheal for hazel pollen
    float
    C0440377 (UMLS CUI [1])
    ambrosia pollen
    Item
    Size of wheal for ambrosia pollen
    float
    C3495104 (UMLS CUI [1])
    Birch pollen
    Item
    Size of wheal for birch pollen
    float
    C4047367 (UMLS CUI [1])
    mugwort pollen
    Item
    Size of wheal for mugwort pollen
    float
    C3495107 (UMLS CUI [1])
    House dust mite
    Item
    Size of wheal for house dust mite
    float
    C3539110 (UMLS CUI [1])
    cat hair
    Item
    Size of wheal for cat hair
    float
    C0440419 (UMLS CUI [1])
    dog hair
    Item
    Size of wheal for dog hair
    float
    C0440417 (UMLS CUI [1])
    Alternaria
    Item
    Size of wheal for alternaria
    float
    C0002343 (UMLS CUI [1])
    Item Group
    Spirometry or Peak expiratory flow measurement (For asthmatics)
    C0037981 (UMLS CUI-1)
    C0521299 (UMLS CUI-2)
    FEV1
    Item
    FEV1 (age-appropriate standard value)
    float
    C0748133 (UMLS CUI [1])
    FEV1
    Item
    FEV1
    float
    C0748133 (UMLS CUI [1])
    Ratio; FEV1; standard value
    Item
    FEV1/ Standard value (If FEV1 < 70% of age appropriate standard value, exclusion)
    integer
    C0456603 (UMLS CUI [1])
    C0588029 (UMLS CUI [2])
    C1442989 (UMLS CUI [3])
    Peak expiratory flow measurement
    Item
    PEF 1
    integer
    C0521299 (UMLS CUI [1])
    Peak expiratory flow measurement
    Item
    PEF 2
    integer
    C0521299 (UMLS CUI [1])
    Peak expiratory flow measurement
    Item
    PEF 3
    integer
    C0521299 (UMLS CUI [1])
    Peak expiratory flow measurement
    Item
    Best PEF
    integer
    C0521299 (UMLS CUI [1])
    Peak expiratory flow measurement
    Item
    Optimum individual value PEF (If FEV1 < 70% of optimum individual value, exclusion)
    integer
    C0521299 (UMLS CUI [1])
    Item Group
    Conjunctival provocation testing
    C0430565 (UMLS CUI-1)
    Item
    Conjunctival provocation test result 1
    text
    C0430565 (UMLS CUI [1])
    Code List
    Conjunctival provocation test result 1
    CL Item
    positive (1)
    CL Item
    negative (2)
    Item
    Conjunctival provocation test result 2 (to be carried out only when test 1 outcome is negative)
    text
    C0430565 (UMLS CUI [1])
    Code List
    Conjunctival provocation test result 2 (to be carried out only when test 1 outcome is negative)
    CL Item
    positive (1)
    CL Item
    negative (2)
    Item
    Conjunctival provocation test result 3 (to be carried out only when test 2 outcome is negative)
    text
    C0430565 (UMLS CUI [1])
    Code List
    Conjunctival provocation test result 3 (to be carried out only when test 2 outcome is negative)
    CL Item
    positive (1)
    CL Item
    negative (2)
    Item
    Allergen concentration at which the test outcome is positive
    text
    C1446561 (UMLS CUI [1,1])
    C0002092 (UMLS CUI [1,2])
    Code List
    Allergen concentration at which the test outcome is positive
    CL Item
    100 SQ- E/ ml (1)
    CL Item
    1000 SQ-E/ ml (2)
    CL Item
    10000 SQ-E/ ml (3)
    Conjunctival provocation testing
    Item
    The outcome for all tests is negative
    boolean
    Item Group
    Allergy diagnostics
    C0086143 (UMLS CUI-1)
    C0020517 (UMLS CUI-2)
    Immunoglobulin E
    Item
    Total Immunoglobulin E
    float
    C0202086 (UMLS CUI [1])
    Immunoglobulin G4
    Item
    Immunoglobulin IgG4
    float
    C0020860 (UMLS CUI [1])
    Immunoglobulin; Grass pollen
    Item
    Grass (Phleum pratense) Phl p 1
    float
    C0021027 (UMLS CUI [1])
    C0440307 (UMLS CUI [2])
    Item
    RAST class for grass Phl p 1
    text
    C0034554 (UMLS CUI [1])
    Code List
    RAST class for grass Phl p 1
    CL Item
    Class 0 (< 0.35) (1)
    CL Item
    Class 1 (0.35- 0.69) (2)
    CL Item
    Class 2 (0.70-3.49) (3)
    CL Item
    Class 3 (3.50-17.49) (4)
    CL Item
    Class 4 (17.50-49.99) (5)
    CL Item
    Class 5 (50-100) (6)
    CL Item
    Class 6 (> 100) (7)
    Immunoglobulin; Grass pollen
    Item
    Grass (Phleum pratense) Phl p5b
    float
    C0021027 (UMLS CUI [1])
    C0440307 (UMLS CUI [2])
    Item
    RAST class for grass Phl p5b
    text
    C0034554 (UMLS CUI [1])
    Code List
    RAST class for grass Phl p5b
    CL Item
    Class 0 (< 0.35) (1)
    CL Item
    Class 1 (0.35- 0.69) (2)
    CL Item
    Class 2 (0.70-3.49) (3)
    CL Item
    Class 3 (3.50-17.49) (4)
    CL Item
    Class 4 (17.50-49.99) (5)
    CL Item
    Class 5 (50-100) (6)
    CL Item
    Class 6 (> 100) (7)
    Immunoglobulin; Grass pollen
    Item
    Grass (Phleum pratense) Phl p 7
    float
    C0021027 (UMLS CUI [1])
    C0440307 (UMLS CUI [2])
    Item
    RAST class for grass Phl p7
    text
    C0034554 (UMLS CUI [1])
    Code List
    RAST class for grass Phl p7
    CL Item
    Class 0 (< 0.35) (1)
    CL Item
    Class 1 (0.35- 0.69) (2)
    CL Item
    Class 2 (0.70-3.49) (3)
    CL Item
    Class 3 (3.50-17.49) (4)
    CL Item
    Class 4 (17.50-49.99) (5)
    CL Item
    Class 5 (50-100) (6)
    CL Item
    Class 6 (> 100) (7)
    Immunoglobulin; Grass pollen
    Item
    Grass (Phleum pratense) Phl p 12
    float
    C0021027 (UMLS CUI [1])
    C0440307 (UMLS CUI [2])
    Item
    RAST class for grass Phl p 12
    text
    C0034554 (UMLS CUI [1])
    Code List
    RAST class for grass Phl p 12
    CL Item
    Class 0 (< 0.35) (1)
    CL Item
    Class 1 (0.35- 0.69) (2)
    CL Item
    Class 2 (0.70-3.49) (3)
    CL Item
    Class 3 (3.50-17.49) (4)
    CL Item
    Class 4 (17.50-49.99) (5)
    CL Item
    Class 5 (50-100) (6)
    CL Item
    Class 6 (> 100) (7)
    Birch antigen
    Item
    Birch Bet v 1
    float
    C1527024 (UMLS CUI [1])
    Item
    RAST class for birch Bet v1
    text
    C0034554 (UMLS CUI [1])
    Code List
    RAST class for birch Bet v1
    CL Item
    Class 0 (< 0.35) (1)
    CL Item
    Class 1 (0.35- 0.69) (2)
    CL Item
    Class 2 (0.70-3.49) (3)
    CL Item
    Class 3 (3.50-17.49) (4)
    CL Item
    Class 4 (17.50-49.99) (5)
    CL Item
    Class 5 (50-100) (6)
    CL Item
    Class 6 (> 100) (7)
    Immunoglobulin Mugwort
    Item
    Mugwort Art v1
    float
    C0021027 (UMLS CUI [1,1])
    C0348066 (UMLS CUI [1,2])
    Item
    RAST class for mugwort Art v1
    text
    C0034554 (UMLS CUI [1])
    Code List
    RAST class for mugwort Art v1
    CL Item
    Class 0 (< 0.35) (1)
    CL Item
    Class 1 (0.35- 0.69) (2)
    CL Item
    Class 2 (0.70-3.49) (3)
    CL Item
    Class 3 (3.50-17.49) (4)
    CL Item
    Class 4 (17.50-49.99) (5)
    CL Item
    Class 5 (50-100) (6)
    CL Item
    Class 6 (> 100) (7)
    Immunoglobulin ambrosia
    Item
    Ambrosia Amb a1
    float
    C0021027 (UMLS CUI [1,1])
    C0331432 (UMLS CUI [1,2])
    Item
    RAST class for ambrosia Amb a1
    text
    C0034554 (UMLS CUI [1])
    Code List
    RAST class for ambrosia Amb a1
    CL Item
    Class 0 (< 0.35) (1)
    CL Item
    Class 1 (0.35- 0.69) (2)
    CL Item
    Class 2 (0.70-3.49) (3)
    CL Item
    Class 3 (3.50-17.49) (4)
    CL Item
    Class 4 (17.50-49.99) (5)
    CL Item
    Class 5 (50-100) (6)
    CL Item
    Class 6 (> 100) (7)
    Immunoglobulin Dermatophagoides pteronyssinus
    Item
    D. pteronyssinus Der p1
    float
    C0021027 (UMLS CUI [1,1])
    C1122992 (UMLS CUI [1,2])
    Item
    RAST class for D. pteronyssinus Der p1
    text
    C0034554 (UMLS CUI [1])
    Code List
    RAST class for D. pteronyssinus Der p1
    CL Item
    Class 0 (< 0.35) (1)
    CL Item
    Class 1 (0.35- 0.69) (2)
    CL Item
    Class 2 (0.70-3.49) (3)
    CL Item
    Class 3 (3.50-17.49) (4)
    CL Item
    Class 4 (17.50-49.99) (5)
    CL Item
    Class 5 (50-100) (6)
    CL Item
    Class 6 (> 100) (7)
    Immunoglobulin Dermatophagoides farinae
    Item
    D. farinae Der p2
    float
    C0021027 (UMLS CUI [1,1])
    C0323677 (UMLS CUI [1,2])
    Item
    RAST class for D. farinae
    text
    C0034554 (UMLS CUI [1])
    Code List
    RAST class for D. farinae
    CL Item
    Class 0 (< 0.35) (1)
    CL Item
    Class 1 (0.35- 0.69) (2)
    CL Item
    Class 2 (0.70-3.49) (3)
    CL Item
    Class 3 (3.50-17.49) (4)
    CL Item
    Class 4 (17.50-49.99) (5)
    CL Item
    Class 5 (50-100) (6)
    CL Item
    Class 6 (> 100) (7)
    Dog antigen
    Item
    Dog Can f1
    float
    C1443014 (UMLS CUI [1])
    Item
    RAST class for dog Can f1
    text
    C0034554 (UMLS CUI [1])
    Code List
    RAST class for dog Can f1
    CL Item
    Class 0 (< 0.35) (1)
    CL Item
    Class 1 (0.35- 0.69) (2)
    CL Item
    Class 2 (0.70-3.49) (3)
    CL Item
    Class 3 (3.50-17.49) (4)
    CL Item
    Class 4 (17.50-49.99) (5)
    CL Item
    Class 5 (50-100) (6)
    CL Item
    Class 6 (> 100) (7)
    Cat hair antigen
    Item
    Cat Fel d1
    float
    C1443200 (UMLS CUI [1])
    Item
    RAST class for cat Fel d1
    text
    C0034554 (UMLS CUI [1])
    Code List
    RAST class for cat Fel d1
    CL Item
    Class 0 (< 0.35) (1)
    CL Item
    Class 1 (0.35- 0.69) (2)
    CL Item
    Class 2 (0.70-3.49) (3)
    CL Item
    Class 3 (3.50-17.49) (4)
    CL Item
    Class 4 (17.50-49.99) (5)
    CL Item
    Class 5 (50-100) (6)
    CL Item
    Class 6 (> 100) (7)
    Immunoglobulin Alternaria
    Item
    Alternaria Alt a1
    float
    C0021027 (UMLS CUI [1,1])
    C0002343 (UMLS CUI [1,2])
    Item
    RAST class for Alternaria Alt a1
    text
    C0034554 (UMLS CUI [1])
    Code List
    RAST class for Alternaria Alt a1
    CL Item
    Class 0 (< 0.35) (1)
    CL Item
    Class 1 (0.35- 0.69) (2)
    CL Item
    Class 2 (0.70-3.49) (3)
    CL Item
    Class 3 (3.50-17.49) (4)
    CL Item
    Class 4 (17.50-49.99) (5)
    CL Item
    Class 5 (50-100) (6)
    CL Item
    Class 6 (> 100) (7)
    Item Group
    Hematology
    C0474523 (UMLS CUI-1)
    Hemoglobin
    Item
    Hemoglobin
    float
    C0019046 (UMLS CUI [1])
    Erythrocyte
    Item
    Erythrocyte
    float
    C0014772 (UMLS CUI [1])
    Thrombocyte
    Item
    Thrombocyte
    float
    C0005821 (UMLS CUI [1])
    Leucocyte (total)
    Item
    Leucocyte (total)
    float
    C0023508 (UMLS CUI [1])
    Hematocrit
    Item
    Hematocrit
    float
    C0518014 (UMLS CUI [1])
    Item Group
    Biochemistry
    C0005477 (UMLS CUI-1)
    Bilirubin
    Item
    Bilirubin (total)
    float
    C1278039 (UMLS CUI [1])
    Glutamate pyruvate transaminase
    Item
    SGPT- Serum Glutamate pyruvate transaminase
    float
    alkaline phosphatase
    Item
    Alkaline phosphatase
    float
    C0201850 (UMLS CUI [1])
    Glucose
    Item
    Glucose
    float
    C0202042 (UMLS CUI [1])
    Creatinine
    Item
    Creatinine
    float
    C0201976 (UMLS CUI [1])
    Aspartate aminotransferase measurement
    Item
    SGOT- Aspartate aminotransferase measurement
    float
    C0201899 (UMLS CUI [1])
    C reactive protein
    Item
    CRP C reactive protein
    float
    C0201657 (UMLS CUI [1])
    Gamma-glutamyl transpeptidase
    Item
    Gamma-glutamyl transpeptidase
    float
    C1883012 (UMLS CUI [1])
    Item Group
    Inclusion Criteria (Part 2)
    C1512693 (UMLS CUI-1)
    allergy grass pollen
    Item
    the occurrence of the majority of the corresponding clinical symptoms during the grass pollen season
    boolean
    C0020517 (UMLS CUI [1,1])
    C0440307 (UMLS CUI [1,2])
    sensitization
    Item
    Patients should not suffer from typical symptoms caused by co-allergens during the grass pollen season (for example, patients with sensitization to animal fur / - dandruff are not be exposed)
    boolean
    C3662483 (UMLS CUI [1])
    skin prick test
    Item
    the positive skin prick test (wheal size> = 3 mm, negative control <2 mm)
    boolean
    C0430561 (UMLS CUI [1])
    perennial allergy
    Item
    The results in the skin prick test for co-seasonal and most of the perennial co-allergenic are smaller than the skin prick test result for Grass pollen
    boolean
    C2721639 (UMLS CUI [1])
    conjunctival Provocation test
    Item
    a positive reaction in the conjunctival Provocation test (CPT) with one of the three dilutions of grass allergy solution
    boolean
    C0430565 (UMLS CUI [1])
    Score Rhinoconjunctivitis
    Item
    Retrospective Total symptom score (RRTSS) during the previous grass pollen season is greater than or equal to 8
    boolean
    C0449820 (UMLS CUI [1,1])
    C0861155 (UMLS CUI [1,2])
    Antiallergic therapy
    Item
    Planned antiallergic or antiasthmatic treatment with the following medicines: local treatment with levocabastine (eye), loratadine (oral), beclomethasone (nasal) or inhaled corticosteroid with a long-acting beta-2 agonists
    boolean
    C1535925 (UMLS CUI [1])
    immunoglobulin E
    Item
    Specific IgE reactivity to grass pollen: CAP RAST results for Phl p 1 or Phl p5b> = class 2 (0.70 kU / l) and CAP-RAST results for Phl p 1 or Phl p5b> CAP-RAST results for Phl p 7 or Phl p 12
    boolean
    C0202086 (UMLS CUI [1])
    immunoglobulin E; Grass allergy
    Item
    The specific IgE values for predominantly perennial co- allergy (animal hair / - dandruff, dust mites) or for the predominantly co-seasonal allergen Alternaria must be less than the sIgE results for grass pollen allergens (Phl p 1 or Phl p5b). The difference must be at least a CAP RAAST class (> = 1).
    boolean
    C0202086 (UMLS CUI [1])
    C1387134 (UMLS CUI [2])

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