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ID

14273

Description

Asthma Intervention Research 2 (AIR2) Trial; ODM derived from: https://clinicaltrials.gov/show/NCT00231114

Link

https://clinicaltrials.gov/show/NCT00231114

Keywords

Versions (1)
  1. 07/04/2016 07/04/2016 -
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CC BY-NC 3.0

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7 avril 2016

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Creative Commons BY-NC 3.0
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    Eligibility Asthma NCT00231114

    English

    Eligibility Asthma NCT00231114

    1 forms  
    1. StudyEvent: Eligibility
      1. Eligibility Asthma NCT00231114
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693 (Inclusion)
    subject is an adult between the ages of 18 to 65 years.
    Description

    age

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001779 (Age)
    SNOMED
    424144002
    LOINC
    LP28815-6
    subject has asthma and is taking regular maintenance medication that includes inhaled corticosteroid (ics) and long acting ß2-agonist (laba).
    Description

    asthma, inhaled corticosteroid (ics) and long acting ß2-agonist (laba)

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0004096 (Asthma)
    SNOMED
    195967001
    LOINC
    MTHU020815
    UMLS CUI [2]
    C3248292 (Inhaled corticosteroids prescribed (Asthma))
    UMLS CUI [3,1]
    C2936789 (Adrenergic beta-2 Receptor Agonists)
    UMLS CUI [3,2]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    subject has a pre-bronchodilator forced expiratory volume in one second (fev1) of greater than or equal to 60% of predicted after medication stabilization during the baseline period.
    Description

    pre-bronchodilator fev1

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C3172227 (Pre-bronchodilator forced expiratory volume in 1 second attempt:Find:Pt:^Patient:Nom:PhenX)
    LOINC
    64026-8
    subject has a pc20 < 8 mg/ml per methacholine inhalation test using standardized methods. pc20 is a provocative concentration of provocholine® (a brand of methacholine chloride) resulting in a drop of fev1 of 20% or more from baseline.
    Description

    pc20

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1714620 (Volume expired during 1.0 s of forced expiration^pre dose methacholine:Vol:Pt:Respiratory system:Qn)
    LOINC
    43253-4
    subject has at least two days of asthma symptoms during the 4-weeks of the baseline diary period.
    Description

    asthma symptom frequency

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0004096 (Asthma)
    SNOMED
    195967001
    LOINC
    MTHU020815
    UMLS CUI [1,2]
    C1457887 (Symptoms)
    LOINC
    MTHU021540
    UMLS CUI [1,3]
    C0439603 (Frequencies (time pattern))
    SNOMED
    272123002
    LOINC
    LP130485-8
    subject is a non-smoker for 1 year or greater (if former smoker, less than 10 pack years total smoking history).
    Description

    smoking history

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1519384 (Tobacco Smoking History)
    UMLS CUI [2]
    C1277691 (Pack years)
    SNOMED
    315609007
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251 (Exclusion Criteria)
    subject has a post-bronchodilator fev1 of less than 65%.
    Description

    post-bronchodilator fev1

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0748133 (PULMONARY FUNCTION TEST FEV1)
    UMLS CUI [1,2]
    C2599594 (post bronchodilator)
    LOINC
    LP71934-1
    subject has 3 or more hospitalizations for exacerbations of asthma in the previous year; or a history of life-threatening asthma, defined by past intubations for asthma, or icu admission for asthma within the prior 24 months.
    Description

    hospitalizations for exacerbations of asthma

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0019993 (Hospitalization)
    SNOMED
    394656005
    LOINC
    LA15417-1
    UMLS CUI [2]
    C0349790 (Exacerbation of asthma)
    SNOMED
    281239006
    UMLS CUI [3,1]
    C0004096 (Asthma)
    SNOMED
    195967001
    LOINC
    MTHU020815
    UMLS CUI [3,2]
    C2826244 (Life Threatening)
    subject has a history of recurrent lower respiratory tract infections requiring antibiotics (more than 3 in the past 12 months).
    Description

    recurrent lower respiratory tract infections

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0149725 (Lower respiratory tract infection)
    SNOMED
    50417007
    UMLS CUI [1,2]
    C2945760 (Recurrent)
    SNOMED
    255227004
    UMLS CUI [2,1]
    C1514873 (Requirement)
    UMLS CUI [2,2]
    C0003232 (Antibiotics)
    SNOMED
    255631004
    LOINC
    LP31426-7
    subject has a history of recurrent oral steroid use for asthma (4 or more pulses of oral steroids in the past 12 months).
    Description

    recurrent oral steroid use

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0574135 (Oral steroid therapy)
    SNOMED
    297280007
    UMLS CUI [1,2]
    C2945760 (Recurrent)
    SNOMED
    255227004
    subject has a known sensitivity to medications required to perform bronchoscopy (such as lidocaine, atropine and benzodiazepines).
    Description

    sensitivity to medications required to perform bronchoscopy

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517 (Hypersensitivity)
    SNOMED
    421961002
    LOINC
    LP20697-6
    UMLS CUI [1,2]
    C0023660 (lidocaine)
    SNOMED
    82573000
    UMLS CUI [1,3]
    C0004259 (atropine)
    SNOMED
    73949004
    UMLS CUI [1,4]
    C0005064 (Benzodiazepines)
    LOINC
    LP15014-1
    subject has known systemic hypersensitivity or contraindication to methacholine chloride or other parasympathomimetic agents.
    Description

    hypersensitivity or contraindication to methacholine chloride or other parasympathomimetic agents

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517 (Hypersensitivity)
    SNOMED
    421961002
    LOINC
    LP20697-6
    UMLS CUI [1,2]
    C0079829 (methacholine chloride)
    SNOMED
    109196007
    UMLS CUI [2,1]
    C0020517 (Hypersensitivity)
    SNOMED
    421961002
    LOINC
    LP20697-6
    UMLS CUI [2,2]
    C0030512 (Parasympathomimetic Agents)
    SNOMED
    19581007
    subject has other medical criteria.
    Description

    other medical criteria

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0009488 (Comorbidity)
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    Similar models

    Eligibility Asthma NCT00231114

    1 forms
    1. StudyEvent: Eligibility
      1. Eligibility Asthma NCT00231114
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    age
    Item
    subject is an adult between the ages of 18 to 65 years.
    boolean
    C0001779 (UMLS CUI [1])
    asthma, inhaled corticosteroid (ics) and long acting ß2-agonist (laba)
    Item
    subject has asthma and is taking regular maintenance medication that includes inhaled corticosteroid (ics) and long acting ß2-agonist (laba).
    boolean
    C0004096 (UMLS CUI [1])
    C3248292 (UMLS CUI [2])
    C2936789 (UMLS CUI [3,1])
    C0040223 (UMLS CUI [3,2])
    pre-bronchodilator fev1
    Item
    subject has a pre-bronchodilator forced expiratory volume in one second (fev1) of greater than or equal to 60% of predicted after medication stabilization during the baseline period.
    boolean
    C3172227 (UMLS CUI [1])
    pc20
    Item
    subject has a pc20 < 8 mg/ml per methacholine inhalation test using standardized methods. pc20 is a provocative concentration of provocholine® (a brand of methacholine chloride) resulting in a drop of fev1 of 20% or more from baseline.
    boolean
    C1714620 (UMLS CUI [1])
    asthma symptom frequency
    Item
    subject has at least two days of asthma symptoms during the 4-weeks of the baseline diary period.
    boolean
    C0004096 (UMLS CUI [1,1])
    C1457887 (UMLS CUI [1,2])
    C0439603 (UMLS CUI [1,3])
    smoking history
    Item
    subject is a non-smoker for 1 year or greater (if former smoker, less than 10 pack years total smoking history).
    boolean
    C1519384 (UMLS CUI [1])
    C1277691 (UMLS CUI [2])
    Item Group
    C0680251 (UMLS CUI)
    post-bronchodilator fev1
    Item
    subject has a post-bronchodilator fev1 of less than 65%.
    boolean
    C0748133 (UMLS CUI [1,1])
    C2599594 (UMLS CUI [1,2])
    hospitalizations for exacerbations of asthma
    Item
    subject has 3 or more hospitalizations for exacerbations of asthma in the previous year; or a history of life-threatening asthma, defined by past intubations for asthma, or icu admission for asthma within the prior 24 months.
    boolean
    C0019993 (UMLS CUI [1])
    C0349790 (UMLS CUI [2])
    C0004096 (UMLS CUI [3,1])
    C2826244 (UMLS CUI [3,2])
    recurrent lower respiratory tract infections
    Item
    subject has a history of recurrent lower respiratory tract infections requiring antibiotics (more than 3 in the past 12 months).
    boolean
    C0149725 (UMLS CUI [1,1])
    C2945760 (UMLS CUI [1,2])
    C1514873 (UMLS CUI [2,1])
    C0003232 (UMLS CUI [2,2])
    recurrent oral steroid use
    Item
    subject has a history of recurrent oral steroid use for asthma (4 or more pulses of oral steroids in the past 12 months).
    boolean
    C0574135 (UMLS CUI [1,1])
    C2945760 (UMLS CUI [1,2])
    sensitivity to medications required to perform bronchoscopy
    Item
    subject has a known sensitivity to medications required to perform bronchoscopy (such as lidocaine, atropine and benzodiazepines).
    boolean
    C0020517 (UMLS CUI [1,1])
    C0023660 (UMLS CUI [1,2])
    C0004259 (UMLS CUI [1,3])
    C0005064 (UMLS CUI [1,4])
    hypersensitivity or contraindication to methacholine chloride or other parasympathomimetic agents
    Item
    subject has known systemic hypersensitivity or contraindication to methacholine chloride or other parasympathomimetic agents.
    boolean
    C0020517 (UMLS CUI [1,1])
    C0079829 (UMLS CUI [1,2])
    C0020517 (UMLS CUI [2,1])
    C0030512 (UMLS CUI [2,2])
    other medical criteria
    Item
    subject has other medical criteria.
    boolean
    C0009488 (UMLS CUI [1])
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