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ID

14522

Description

Vitamin D for the Treatment of Severe Asthma; ODM derived from: https://clinicaltrials.gov/show/NCT00712205

Link

https://clinicaltrials.gov/show/NCT00712205

Keywords

  1. 4/19/16 4/19/16 -
Copyright Holder

CC BY-NC 3.0

Uploaded on

April 19, 2016

DOI

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License

Creative Commons BY-NC 3.0

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    Eligibility Asthma NCT00712205

    Eligibility Asthma NCT00712205

    1. StudyEvent: Eligibility
      1. Eligibility Asthma NCT00712205
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    20 outpatients of either sex,
    Description

    outpatients

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0029921
    ages ≥18 years, with a history of persistent asthma as defined by the american thoracic society (ats) will be eligible for entry into the study.
    Description

    age and persistent asthma

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    UMLS CUI [2]
    C3266628
    additionally, patients must have been previously treated with ics for at least 4 weeks at a stable dose equivalent to ≥400 ug/day beclomethasone dipropionate.
    Description

    ics treatment

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C3248292
    UMLS CUI [1,2]
    C0040223
    UMLS CUI [2]
    C0004906
    patients will be required to have a forced expiratory volume in 1 s (fev1) between 40-85% of predicted normal before the use of an inhaled bronchodilator and to demonstrate at least one of the following:
    Description

    pre-bronchodilator fev1

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C3172227
    an improvement in fev1 ≥ 12% and ≥ 200 ml within 15-30 min after inhalation of salbutamol 200-400 ug;
    Description

    post-bronchodilator fev1

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0748133
    UMLS CUI [1,2]
    C2599594
    UMLS CUI [1,3]
    C0001927
    airway hyperresponsiveness to methacholine causing a 20% decline in fev1 (pc20 fev1) at a concentration of < 16 mg/ml;
    Description

    methacholine challenge

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0430567
    UMLS CUI [1,2]
    C0748133
    diurnal peak expiratory flow (pef) variability of ≥ 15% during at least 3 of 7 days before randomization.
    Description

    pef variability

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0030735
    UMLS CUI [1,2]
    C2827666
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    patients with either an exacerbation of asthma or respiratory tract infection within 6 weeks or admission to a hospital for asthma within 6 weeks before the study will be excluded.
    Description

    asthma exacerbation or respiratory tract infection or hospitalization for asthma

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0349790
    UMLS CUI [2,1]
    C0009450
    UMLS CUI [2,2]
    C0458827
    UMLS CUI [3,1]
    C0019993
    UMLS CUI [3,2]
    C0004096
    UMLS CUI [4]
    C0040223
    also patients will not be eligible if they had > 3 nights with awakenings due to asthma that required treatment with short-acting betamimetics or had 3 days when they required > or = 12 puffs/d short-acting betamimetics during the 7days before the randomization visits.
    Description

    nighttime symptoms and beta-2 agonists

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1273489
    UMLS CUI [1,2]
    C0860510
    UMLS CUI [2]
    C1373132
    patients will also excluded if they use medications greater potency than inhaled steroid, e.g.not leukotriene inhibitors or anti-ige (xolair®).
    Description

    potency greater than inhaled steroid

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C2065041
    UMLS CUI [1,2]
    C0678792
    patients with chronic obstructive pulmonary disease and current or former smokers of >10 pack-years
    Description

    copd and smoking history

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0024117
    UMLS CUI [2]
    C1519384
    UMLS CUI [3]
    C1277691

    Similar models

    Eligibility Asthma NCT00712205

    1. StudyEvent: Eligibility
      1. Eligibility Asthma NCT00712205
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    outpatients
    Item
    20 outpatients of either sex,
    boolean
    C0029921 (UMLS CUI [1])
    age and persistent asthma
    Item
    ages ≥18 years, with a history of persistent asthma as defined by the american thoracic society (ats) will be eligible for entry into the study.
    boolean
    C0001779 (UMLS CUI [1])
    C3266628 (UMLS CUI [2])
    ics treatment
    Item
    additionally, patients must have been previously treated with ics for at least 4 weeks at a stable dose equivalent to ≥400 ug/day beclomethasone dipropionate.
    boolean
    C3248292 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    C0004906 (UMLS CUI [2])
    pre-bronchodilator fev1
    Item
    patients will be required to have a forced expiratory volume in 1 s (fev1) between 40-85% of predicted normal before the use of an inhaled bronchodilator and to demonstrate at least one of the following:
    boolean
    C3172227 (UMLS CUI [1])
    post-bronchodilator fev1
    Item
    an improvement in fev1 ≥ 12% and ≥ 200 ml within 15-30 min after inhalation of salbutamol 200-400 ug;
    boolean
    C0748133 (UMLS CUI [1,1])
    C2599594 (UMLS CUI [1,2])
    C0001927 (UMLS CUI [1,3])
    methacholine challenge
    Item
    airway hyperresponsiveness to methacholine causing a 20% decline in fev1 (pc20 fev1) at a concentration of < 16 mg/ml;
    boolean
    C0430567 (UMLS CUI [1,1])
    C0748133 (UMLS CUI [1,2])
    pef variability
    Item
    diurnal peak expiratory flow (pef) variability of ≥ 15% during at least 3 of 7 days before randomization.
    boolean
    C0030735 (UMLS CUI [1,1])
    C2827666 (UMLS CUI [1,2])
    Item Group
    C0680251 (UMLS CUI)
    asthma exacerbation or respiratory tract infection or hospitalization for asthma
    Item
    patients with either an exacerbation of asthma or respiratory tract infection within 6 weeks or admission to a hospital for asthma within 6 weeks before the study will be excluded.
    boolean
    C0349790 (UMLS CUI [1])
    C0009450 (UMLS CUI [2,1])
    C0458827 (UMLS CUI [2,2])
    C0019993 (UMLS CUI [3,1])
    C0004096 (UMLS CUI [3,2])
    C0040223 (UMLS CUI [4])
    nighttime symptoms and beta-2 agonists
    Item
    also patients will not be eligible if they had > 3 nights with awakenings due to asthma that required treatment with short-acting betamimetics or had 3 days when they required > or = 12 puffs/d short-acting betamimetics during the 7days before the randomization visits.
    boolean
    C1273489 (UMLS CUI [1,1])
    C0860510 (UMLS CUI [1,2])
    C1373132 (UMLS CUI [2])
    potency greater than inhaled steroid
    Item
    patients will also excluded if they use medications greater potency than inhaled steroid, e.g.not leukotriene inhibitors or anti-ige (xolair®).
    boolean
    C2065041 (UMLS CUI [1,1])
    C0678792 (UMLS CUI [1,2])
    copd and smoking history
    Item
    patients with chronic obstructive pulmonary disease and current or former smokers of >10 pack-years
    boolean
    C0024117 (UMLS CUI [1])
    C1519384 (UMLS CUI [2])
    C1277691 (UMLS CUI [3])

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