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24592

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Study ID: 100470 Clinical Study ID: SCO100470 Study Title: A multicentre, randomised, double-blind, parallel group, 24 week study to compare the effect of salmeterol/fluticasone propionate combination product 50/250mcg, with salmeterol 50mcg both delivered twice daily via DISKUS®/ACCUHALER® inhaler on lung function and dyspnoea in subjects with Chronic Obstructive Pulmonary Disease (COPD). Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor:GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone propionate/salmeterol Trade Name: Serevent Study Indication: Pulmonary Disease, Chronic Obstructive

Nyckelord

Versioner (4)
  1. 2017-07-27 2017-07-27 -
  2. 2017-07-27 2017-07-27 -
  3. 2017-07-27 2017-07-27 -
  4. 2017-08-08 2017-08-08 -
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8 augusti 2017

DOI

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Creative Commons BY-NC 3.0
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    visit 1 (medical evaluation) salmeterol/fluticasone propionate combination compared to salmeterol on COPD 100470

    Engelsk

    visit 1 (medical evaluation) salmeterol/fluticasone propionate combination compared to salmeterol on COPD 100470

    1 Formulär  
    Administrative Data
    Beskrivning

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Subject Identifier
    Beskrivning

    subject identifier

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Visit Date
    Beskrivning

    date of visit

    Datatyp

    date

    Alias
    UMLS CUI [1]
    C1320303
    DEMOGRAPHY
    Beskrivning

    DEMOGRAPHY

    Alias
    UMLS CUI-1
    C0011298
    Date of birth
    Beskrivning

    Date of birth

    Datatyp

    date

    Alias
    UMLS CUI [1]
    C0421451
    Sex
    Beskrivning

    Gender

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0079399
    Race
    Beskrivning

    Race

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0034510
    MEDICAL CONDITIONS
    Beskrivning

    MEDICAL CONDITIONS

    Alias
    UMLS CUI-1
    C0012634
    MedDRA System Organ Class
    Beskrivning

    MedDRA System Organ Class

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C2347091
    Current medical condition
    Beskrivning

    current medical condition

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0521116
    UMLS CUI [1,2]
    C0012634
    no medical condition
    Beskrivning

    medical condition

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0012634
    HISTORY OF TOBACCO USE
    Beskrivning

    HISTORY OF TOBACCO USE

    Alias
    UMLS CUI-1
    C0543414
    What is the subject’s history of tobacco use?
    Beskrivning

    tobacco use

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0543414
    if former smoker, when did the subjet last smoke?
    Beskrivning

    last smoke

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0543414
    UMLS CUI [1,2]
    C0011008
    Average number of cigarettes smoked per day
    Beskrivning

    cigarettes per day

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C3694146
    UMLS CUI [1,2]
    C1510992
    Number of years during which the subject has smoked?
    Beskrivning

    number of years smoking

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C0037369
    UMLS CUI [1,2]
    C0439234
    UMLS CUI [1,3]
    C0449788
    number of pack years?
    Beskrivning

    (Average number of cigarettes smoked per day/20) x number of years smoked

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C1277691
    UMLS CUI [1,2]
    C0449788
    COPD
    Beskrivning

    COPD

    Alias
    UMLS CUI-1
    C0024117
    DURATION OF COPD
    Beskrivning

    duration of COPD

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C0024117
    UMLS CUI [1,2]
    C0449238
    Number of exacerbations in the last 12 months that were managed without oral corticosteroids and/or antibiotics (not involving hospitalisation)
    Beskrivning

    number of exacerbations managed without drugs

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C0740304
    UMLS CUI [1,2]
    C0013227
    Number of exacerbations in the last 12 months that required oral corticosteroids and/or antibiotics (not involving hospitalisation)
    Beskrivning

    number of exacerbations requiring drugs

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C0740304
    UMLS CUI [1,2]
    C0013227
    Number of exacerbations in the last 12 months that required hopitalisation
    Beskrivning

    number of exacerbations requiring hospitalisation

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C0740304
    UMLS CUI [1,2]
    C0019993
    OROPHARYNGEAL CANDIDIASIS EXAMINATION
    Beskrivning

    OROPHARYNGEAL CANDIDIASIS EXAMINATION

    Alias
    UMLS CUI-1
    C0006849
    UMLS CUI-2
    C0582103
    Does the subject have clinical evidence of oropharyngeal candidiasis?
    Beskrivning

    clinical evidence of oropharyngeal candidiasis

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0006849
    UMLS CUI [1,2]
    C3887511
    Was a swab taken?
    Beskrivning

    Swab need only be taken if there is clinical evidence of oropharyngeal candidiasis

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0006849
    UMLS CUI [1,2]
    C0563454
    if a swab was taken, result of the swab?
    Beskrivning

    oropharyngeal candidiasis test result

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C0006849
    UMLS CUI [1,2]
    C0563454
    UMLS CUI [1,3]
    C1274040
    CHEST X-RAY
    Beskrivning

    CHEST X-RAY

    Alias
    UMLS CUI-1
    C0039985
    Has the subject had a chest X-ray within the last 3 months?
    Beskrivning

    chest X-ray within the last 3 months

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0039985
    UMLS CUI [1,2]
    C4086725
    if the patient had a chest x-ray in the last 3 months, record the date
    Beskrivning

    date of chest x-ray

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0039985
    UMLS CUI [1,2]
    C0011008
    if the patient had no chest x-ray in the last 3 months, perform one and record the date
    Beskrivning

    date of chest x-ray

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0039985
    UMLS CUI [1,2]
    C0011008
    Are there any chest abnormalities other than features of COPD?
    Beskrivning

    Review chest X-ray (performed within the last 3 months or performed at Visit 1)

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0497258
    MODIFIED MEDICAL RESEARCH COUNCIL DYSPNOEA SCALE
    Beskrivning

    MODIFIED MEDICAL RESEARCH COUNCIL DYSPNOEA SCALE

    Alias
    UMLS CUI-1
    C3826977
    Which ONE of these situations best applies to the subject?
    Beskrivning

    dyspnoea status

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C0013404
    UMLS CUI [1,2]
    C0449438
    12-LEAD ECG
    Beskrivning

    12-LEAD ECG

    Alias
    UMLS CUI-1
    C0430456
    Date of ECG
    Beskrivning

    date of ECG

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0013798
    UMLS CUI [1,2]
    C0011008
    Result of the ECG
    Beskrivning

    result of the ECG

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C1623258
    UMLS CUI [1,2]
    C0456984
    PULMONARY FUNCTION TESTING
    Beskrivning

    PULMONARY FUNCTION TESTING

    Alias
    UMLS CUI-1
    C0024119
    Did the subject take any bronchodilators prior to these lung function measurements?
    Beskrivning

    use of bronchodilatators before lung function measurement

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0006280
    UMLS CUI [1,2]
    C0332152
    UMLS CUI [1,3]
    C0024119
    pulmonary funtion testing: FEV1
    Beskrivning

    pulmonary funtion testing: FEV1

    Alias
    UMLS CUI-1
    C0748133
    Time of Assessment PreVENTOLIN
    Beskrivning

    time of assessment before Ventolin

    Datatyp

    time

    Alias
    UMLS CUI [1,1]
    C0033744
    UMLS CUI [1,2]
    C0040223
    UMLS CUI [1,3]
    C0220825
    Actual Measurement PreVENTOLIN
    Beskrivning

    Actual Measurement PreVENTOLIN = A

    Datatyp

    float

    Måttenheter
    • L
    Alias
    UMLS CUI [1,1]
    C0033744
    UMLS CUI [1,2]
    C0242485
    L
    Predicted Normal
    Beskrivning

    Predicted Normal= B

    Datatyp

    float

    Måttenheter
    • L
    Alias
    UMLS CUI [1,1]
    C0205307
    UMLS CUI [1,2]
    C0456984
    UMLS CUI [1,3]
    C0802965
    UMLS CUI [1,4]
    C0024119
    L
    % Predicted Normal
    Beskrivning

    % Predicted Normal= (C/B)x100 C= Actual Measurement 30 minutes PostVENTOLIN B= Predicted Normal

    Datatyp

    float

    Måttenheter
    • %
    Alias
    UMLS CUI [1]
    C2239179
    %
    Actual Measurement 30 minutes PostVENTOLIN
    Beskrivning

    Actual Measurement 30 minutes PostVENTOLIN= C

    Datatyp

    float

    Måttenheter
    • L
    Alias
    UMLS CUI [1,1]
    C0033744
    UMLS CUI [1,2]
    C0242485
    UMLS CUI [1,3]
    C1442458
    L
    % Reversibility
    Beskrivning

    % Reversibility= ((C-A)/B) x100 Actual Measurement PreVENTOLIN = A Predicted Normal= B Actual Measurement 30 minutes PostVENTOLIN= C

    Datatyp

    float

    Måttenheter
    • %
    Alias
    UMLS CUI [1]
    C3830088
    %
    pulmonary function testing: FVC
    Beskrivning

    pulmonary function testing: FVC

    Alias
    UMLS CUI-1
    C3714541
    Actual Measurement PreVENTOLIN
    Beskrivning

    Actual Measurement PreVENTOLIN = A

    Datatyp

    float

    Måttenheter
    • L
    Alias
    UMLS CUI [1,1]
    C0033744
    UMLS CUI [1,2]
    C0242485
    L
    Actual Measurement 30 minutes PostVENTOLIN
    Beskrivning

    Actual Measurement 30 minutes PostVENTOLIN= C

    Datatyp

    float

    Måttenheter
    • L
    Alias
    UMLS CUI [1,1]
    C0033744
    UMLS CUI [1,2]
    C0242485
    UMLS CUI [1,3]
    C1442458
    L
    pulmonary function testing: FEV1 /FVC ratio
    Beskrivning

    pulmonary function testing: FEV1 /FVC ratio

    Alias
    UMLS CUI-1
    C0429745
    Actual Measurement PreVENTOLIN
    Beskrivning

    Actual Measurement PreVENTOLIN = A

    Datatyp

    float

    Måttenheter
    • L
    Alias
    UMLS CUI [1,1]
    C0033744
    UMLS CUI [1,2]
    C0242485
    L
    Actual Measurement 30 minutes PostVENTOLIN
    Beskrivning

    Actual Measurement 30 minutes PostVENTOLIN= C

    Datatyp

    float

    Måttenheter
    • L
    Alias
    UMLS CUI [1,1]
    C0033744
    UMLS CUI [1,2]
    C0242485
    UMLS CUI [1,3]
    C1442458
    L
    FAT FREE MASS
    Beskrivning

    FAT FREE MASS

    Alias
    UMLS CUI-1
    C0424679
    Serial number
    Beskrivning

    serial number

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C2348188
    Test number
    Beskrivning

    testing number

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C0039593
    UMLS CUI [1,2]
    C0237753
    Subject’s height at time of measurement
    Beskrivning

    height

    Datatyp

    integer

    Måttenheter
    • cm
    Alias
    UMLS CUI [1]
    C0005890
    cm
    Subject’s weight at time of measurement
    Beskrivning

    weight

    Datatyp

    float

    Måttenheter
    • kg
    Alias
    UMLS CUI [1]
    C0005910
    kg
    Fat Free Mass (Lean Muscle Mass including Muscle, Water, and Bone)
    Beskrivning

    fat free mass

    Datatyp

    float

    Måttenheter
    • kg
    Alias
    UMLS CUI [1]
    C0424679
    kg
    Impedance (The resistance)
    Beskrivning

    impedance

    Datatyp

    integer

    Måttenheter
    • ohm
    Alias
    UMLS CUI [1]
    C0162537
    ohm
    CENTRAL LABORATORY - BLOOD
    Beskrivning

    CENTRAL LABORATORY - BLOOD

    Alias
    UMLS CUI-1
    C0018941
    Date sample taken
    Beskrivning

    blood sample taken

    Datatyp

    date

    Alias
    UMLS CUI [1]
    C1277698
    ST. GEORGE’S RESPIRATORY QUESTIONNAIRE
    Beskrivning

    ST. GEORGE’S RESPIRATORY QUESTIONNAIRE

    Alias
    UMLS CUI-1
    C0451500
    Confirm the SGRQ has been completed by the subject
    Beskrivning

    St George's hospital respiratory questionnaire

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0451500
    BASELINE DYSPNOEA INDEX (BDI)
    Beskrivning

    BASELINE DYSPNOEA INDEX (BDI)

    Alias
    UMLS CUI-1
    C1511069
    Confirm the BDI instrument has been signed and dated
    Beskrivning

    BDI instrument signed and dated

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1511069
    UMLS CUI [1,2]
    C1519316
    UMLS CUI [1,3]
    C0011008
    Tillbaka till toppen

    Similar models

    visit 1 (medical evaluation) salmeterol/fluticasone propionate combination compared to salmeterol on COPD 100470

    1 Formulär
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    subject identifier
    Item
    Subject Identifier
    integer
    C2348585 (UMLS CUI [1])
    date of visit
    Item
    Visit Date
    date
    C1320303 (UMLS CUI [1])
    Item Group
    DEMOGRAPHY
    C0011298 (UMLS CUI-1)
    Date of birth
    Item
    Date of birth
    date
    C0421451 (UMLS CUI [1])
    Item
    Sex
    text
    C0079399 (UMLS CUI [1])
    Gender
    Code List
    Sex
    CL Item
    Female (F)
    CL Item
    Male (M)
    Item
    Race
    text
    C0034510 (UMLS CUI [1])
    Race
    Code List
    Race
    CL Item
    Arabic/North African (2)
    (Comment:en)
    CL Item
    Black (3)
    (Comment:en)
    CL Item
    East & South East Asian (4)
    (Comment:en)
    CL Item
    other (z)
    (Comment:en)
    CL Item
    South Asian (6)
    (Comment:en)
    CL Item
    White/Caucasian (7)
    (Comment:en)
    Item Group
    MEDICAL CONDITIONS
    C0012634 (UMLS CUI-1)
    Item
    MedDRA System Organ Class
    integer
    C2347091 (UMLS CUI [1])
    MedDRA System Organ Class
    Code List
    MedDRA System Organ Class
    CL Item
    Blood and lymphatic system disorders (1)
    CL Item
    Cardiac disorders (2)
    CL Item
    Ear and labyrinth disorders (3)
    CL Item
    Endocrine disorders (4)
    CL Item
    Eye disorders (5)
    CL Item
    Gastrointestinal disorders (6)
    CL Item
    Hepatobiliary disorders (7)
    CL Item
    Immune system disorders (8)
    CL Item
    Metabolism and nutrition disorders (9)
    CL Item
    Musculoskeletal and connective tissue disorders (10)
    CL Item
    Neoplasms benign, malignant and unspecified (including cysts and polyps) (11)
    CL Item
    Nervous system disorders (12)
    CL Item
    Psychiatric disorders (13)
    CL Item
    Renal and urinary disorders (14)
    CL Item
    Reproductive system and breast disorders (15)
    CL Item
    Respiratory, thoracic and mediastinal disorders (16)
    CL Item
    Skin and subcutaneous tissue disorders (17)
    CL Item
    Vascular disorders (18)
    CL Item
    Infections and infestations (19)
    CL Item
    Congenital, familial and genetic disorders (20)
    current medical condition
    Item
    Current medical condition
    boolean
    C0521116 (UMLS CUI [1,1])
    C0012634 (UMLS CUI [1,2])
    medical condition
    Item
    no medical condition
    boolean
    C0012634 (UMLS CUI [1])
    Item Group
    HISTORY OF TOBACCO USE
    C0543414 (UMLS CUI-1)
    Item
    What is the subject’s history of tobacco use?
    integer
    C0543414 (UMLS CUI [1])
    tobacco use
    Code List
    What is the subject’s history of tobacco use?
    CL Item
    current smoker (2)
    (Comment:en)
    CL Item
    former smoker (3)
    (Comment:en)
    last smoke
    Item
    if former smoker, when did the subjet last smoke?
    date
    C0543414 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    cigarettes per day
    Item
    Average number of cigarettes smoked per day
    integer
    C3694146 (UMLS CUI [1,1])
    C1510992 (UMLS CUI [1,2])
    number of years smoking
    Item
    Number of years during which the subject has smoked?
    integer
    C0037369 (UMLS CUI [1,1])
    C0439234 (UMLS CUI [1,2])
    C0449788 (UMLS CUI [1,3])
    number of pack years
    Item
    number of pack years?
    integer
    C1277691 (UMLS CUI [1,1])
    C0449788 (UMLS CUI [1,2])
    Item Group
    COPD
    C0024117 (UMLS CUI-1)
    Item
    DURATION OF COPD
    integer
    C0024117 (UMLS CUI [1,1])
    C0449238 (UMLS CUI [1,2])
    duration of COPD
    Code List
    DURATION OF COPD
    CL Item
    < 5 years  (9)
    CL Item
    ≥ 5 years to < 10 years (11)
    CL Item
    ≥ 10 years to < 15 years (13)
    CL Item
    ≥ 15 years to < 20 years (15)
    CL Item
    ≥ 20 years to < 25 years  (17)
    CL Item
    ≥ 25 years (18)
    number of exacerbations managed without drugs
    Item
    Number of exacerbations in the last 12 months that were managed without oral corticosteroids and/or antibiotics (not involving hospitalisation)
    integer
    C0740304 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    number of exacerbations requiring drugs
    Item
    Number of exacerbations in the last 12 months that required oral corticosteroids and/or antibiotics (not involving hospitalisation)
    integer
    C0740304 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    number of exacerbations requiring hospitalisation
    Item
    Number of exacerbations in the last 12 months that required hopitalisation
    integer
    C0740304 (UMLS CUI [1,1])
    C0019993 (UMLS CUI [1,2])
    Item Group
    OROPHARYNGEAL CANDIDIASIS EXAMINATION
    C0006849 (UMLS CUI-1)
    C0582103 (UMLS CUI-2)
    Item
    Does the subject have clinical evidence of oropharyngeal candidiasis?
    text
    C0006849 (UMLS CUI [1,1])
    C3887511 (UMLS CUI [1,2])
    clinical evidence of oropharyngeal candidiasis
    Code List
    Does the subject have clinical evidence of oropharyngeal candidiasis?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item
    Was a swab taken?
    text
    C0006849 (UMLS CUI [1,1])
    C0563454 (UMLS CUI [1,2])
    taking of a swab
    Code List
    Was a swab taken?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item
    if a swab was taken, result of the swab?
    integer
    C0006849 (UMLS CUI [1,1])
    C0563454 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    oropharyngeal candidiasis test result
    Code List
    if a swab was taken, result of the swab?
    CL Item
    Negative (1)
    CL Item
    Positive (2)
    CL Item
    Not available (4)
    Item Group
    CHEST X-RAY
    C0039985 (UMLS CUI-1)
    Item
    Has the subject had a chest X-ray within the last 3 months?
    text
    C0039985 (UMLS CUI [1,1])
    C4086725 (UMLS CUI [1,2])
    chest X-ray within the last 3 months
    Code List
    Has the subject had a chest X-ray within the last 3 months?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    date of chest x-ray
    Item
    if the patient had a chest x-ray in the last 3 months, record the date
    date
    C0039985 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    date of chest x-ray
    Item
    if the patient had no chest x-ray in the last 3 months, perform one and record the date
    date
    C0039985 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item
    Are there any chest abnormalities other than features of COPD?
    text
    C0497258 (UMLS CUI [1])
    chest abnormalities
    Code List
    Are there any chest abnormalities other than features of COPD?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item Group
    MODIFIED MEDICAL RESEARCH COUNCIL DYSPNOEA SCALE
    C3826977 (UMLS CUI-1)
    Item
    Which ONE of these situations best applies to the subject?
    integer
    C0013404 (UMLS CUI [1,1])
    C0449438 (UMLS CUI [1,2])
    dyspnoea status
    Code List
    Which ONE of these situations best applies to the subject?
    CL Item
    Not troubled with breathlessness except with strenuous exercise (0)
    CL Item
    Troubled by shortness of breath when hurrying on the level or walking up a slight hill (1)
    CL Item
    Walks slower than people of the same age on the level because of breathlessness or has to stop for (2)
    CL Item
    breath when walking at own pace on the level (4)
    CL Item
    Stops to breathe after walking about 100 yards (100 meters) or after a few minutes on the level (3)
    CL Item
    Too breathless to leave the house or breathless when dressing or undressing (4)
    Item Group
    12-LEAD ECG
    C0430456 (UMLS CUI-1)
    date of ECG
    Item
    Date of ECG
    date
    C0013798 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item
    Result of the ECG
    integer
    C1623258 (UMLS CUI [1,1])
    C0456984 (UMLS CUI [1,2])
    result of the ECG
    Code List
    Result of the ECG
    CL Item
    Normal (1)
    CL Item
    Abnormal - not clinically significant (2)
    CL Item
    Abnormal - clinically significant (3)
    Item Group
    PULMONARY FUNCTION TESTING
    C0024119 (UMLS CUI-1)
    Item
    Did the subject take any bronchodilators prior to these lung function measurements?
    text
    C0006280 (UMLS CUI [1,1])
    C0332152 (UMLS CUI [1,2])
    C0024119 (UMLS CUI [1,3])
    use of bronchodilatators before lung function measurement
    Code List
    Did the subject take any bronchodilators prior to these lung function measurements?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item Group
    pulmonary funtion testing: FEV1
    C0748133 (UMLS CUI-1)
    time of assessment before Ventolin
    Item
    Time of Assessment PreVENTOLIN
    time
    C0033744 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    C0220825 (UMLS CUI [1,3])
    measurement before Ventolin
    Item
    Actual Measurement PreVENTOLIN
    float
    C0033744 (UMLS CUI [1,1])
    C0242485 (UMLS CUI [1,2])
    predicted normal FEV1
    Item
    Predicted Normal
    float
    C0205307 (UMLS CUI [1,1])
    C0456984 (UMLS CUI [1,2])
    C0802965 (UMLS CUI [1,3])
    C0024119 (UMLS CUI [1,4])
    percent predicted normal
    Item
    % Predicted Normal
    float
    C2239179 (UMLS CUI [1])
    measurement 30 minutes after Ventolin
    Item
    Actual Measurement 30 minutes PostVENTOLIN
    float
    C0033744 (UMLS CUI [1,1])
    C0242485 (UMLS CUI [1,2])
    C1442458 (UMLS CUI [1,3])
    FEV1 Reversibility
    Item
    % Reversibility
    float
    C3830088 (UMLS CUI [1])
    Item Group
    pulmonary function testing: FVC
    C3714541 (UMLS CUI-1)
    measurement before Ventolin
    Item
    Actual Measurement PreVENTOLIN
    float
    C0033744 (UMLS CUI [1,1])
    C0242485 (UMLS CUI [1,2])
    measurement 30 minutes after Ventolin
    Item
    Actual Measurement 30 minutes PostVENTOLIN
    float
    C0033744 (UMLS CUI [1,1])
    C0242485 (UMLS CUI [1,2])
    C1442458 (UMLS CUI [1,3])
    Item Group
    pulmonary function testing: FEV1 /FVC ratio
    C0429745 (UMLS CUI-1)
    measurement before Ventolin
    Item
    Actual Measurement PreVENTOLIN
    float
    C0033744 (UMLS CUI [1,1])
    C0242485 (UMLS CUI [1,2])
    measurement 30 minutes after Ventolin
    Item
    Actual Measurement 30 minutes PostVENTOLIN
    float
    C0033744 (UMLS CUI [1,1])
    C0242485 (UMLS CUI [1,2])
    C1442458 (UMLS CUI [1,3])
    Item Group
    FAT FREE MASS
    C0424679 (UMLS CUI-1)
    serial number
    Item
    Serial number
    integer
    C2348188 (UMLS CUI [1])
    testing number
    Item
    Test number
    integer
    C0039593 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    height
    Item
    Subject’s height at time of measurement
    integer
    C0005890 (UMLS CUI [1])
    weight
    Item
    Subject’s weight at time of measurement
    float
    C0005910 (UMLS CUI [1])
    fat free mass
    Item
    Fat Free Mass (Lean Muscle Mass including Muscle, Water, and Bone)
    float
    C0424679 (UMLS CUI [1])
    impedance
    Item
    Impedance (The resistance)
    integer
    C0162537 (UMLS CUI [1])
    Item Group
    CENTRAL LABORATORY - BLOOD
    C0018941 (UMLS CUI-1)
    blood sample taken
    Item
    Date sample taken
    date
    C1277698 (UMLS CUI [1])
    Item Group
    ST. GEORGE’S RESPIRATORY QUESTIONNAIRE
    C0451500 (UMLS CUI-1)
    St George's hospital respiratory questionnaire
    Item
    Confirm the SGRQ has been completed by the subject
    boolean
    C0451500 (UMLS CUI [1])
    Item Group
    BASELINE DYSPNOEA INDEX (BDI)
    C1511069 (UMLS CUI-1)
    BDI instrument signed and dated
    Item
    Confirm the BDI instrument has been signed and dated
    boolean
    C1511069 (UMLS CUI [1,1])
    C1519316 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
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