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ID

14320

Beskrivning

As Needed Beclomethasone/Salbutamol Combination in Single Inhaler for Mild Persistent Asthma; ODM derived from: https://clinicaltrials.gov/show/NCT00382889

Länk

https://clinicaltrials.gov/show/NCT00382889

Nyckelord

  1. 2016-04-11 2016-04-11 -
Uppladdad den

11 april 2016

DOI

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Licens

Creative Commons BY 4.0

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    Eligibility Asthma NCT00382889

    Eligibility Asthma NCT00382889

    1. StudyEvent: Eligibility
      1. Eligibility Asthma NCT00382889
    Inclusion Criteria
    Beskrivning

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    clinical diagnosis of mild persistent asthma as defined by nhlbi/who 97; for at least 6 months;
    Beskrivning

    mild persistent asthma

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1960046
    UMLS CUI [2]
    C0040223
    fev1 ³ 75% of predicted normal value;
    Beskrivning

    fev1

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0748133
    positive response to the reversibility test to b2 agonist, defined as an increase > 12% in the fev1 measured 30 minutes following 2 puffs (2x100mg) of inhaled salbutamol spray, or positive methacholine challenge (pc20<8mg/ml or pd20<1 mg) within the previous 6 months;
    Beskrivning

    fev1 reversibility, methacholine challenge

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0748133
    UMLS CUI [1,2]
    C0001927
    UMLS CUI [2]
    C0430567
    stable asthma. asthma is defined stable if none of the following occurred during the last 14 days of the run-in period: diurnal variation of more than 20% in pef on 2 consecutive days; use of four or more inhalations of b2 agonist per day on two consecutive days; need the use of oral corticosteroids;
    Beskrivning

    stable asthma

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0004096
    UMLS CUI [1,2]
    C0205360
    UMLS CUI [2]
    C0521299
    UMLS CUI [3,1]
    C2936789
    UMLS CUI [3,2]
    C3476109
    UMLS CUI [4]
    C0001617
    Exclusion Criteria
    Beskrivning

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    copd as defined by the ers – consensus statement;
    Beskrivning

    copd

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0024117
    patients with more than 10 packs/year of cigarettes history and current smokers;
    Beskrivning

    smoking history

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1519384
    UMLS CUI [1,2]
    C1277691
    history of near fatal asthma and/or admission in intensive care unit because of asthma;
    Beskrivning

    near fatal asthma and/or admission in intensive care unit because of asthma

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0004096
    UMLS CUI [1,2]
    C2826244
    UMLS CUI [1,3]
    C1302234
    UMLS CUI [2,1]
    C0021708
    UMLS CUI [2,2]
    C0004096
    one severe exacerbation during the run-in period;
    Beskrivning

    asthma exacerbation

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0349790
    three or more courses of oral corticosteroids or hospitalisation for asthma during the previous 1 year;
    Beskrivning

    oral corticosteroids or hospitalisation for asthma

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0001617
    UMLS CUI [2]
    C0019993
    patients treated with more than 500 mcg/day of beclomethasone or equivalent for more than 6 months in the previous last year;
    Beskrivning

    beclomethasone

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C2065042
    UMLS CUI [1,2]
    C0040223

    Similar models

    Eligibility Asthma NCT00382889

    1. StudyEvent: Eligibility
      1. Eligibility Asthma NCT00382889
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    C1512693 (UMLS CUI)
    mild persistent asthma
    Item
    clinical diagnosis of mild persistent asthma as defined by nhlbi/who 97; for at least 6 months;
    boolean
    C1960046 (UMLS CUI [1])
    C0040223 (UMLS CUI [2])
    fev1
    Item
    fev1 ³ 75% of predicted normal value;
    boolean
    C0748133 (UMLS CUI [1])
    fev1 reversibility, methacholine challenge
    Item
    positive response to the reversibility test to b2 agonist, defined as an increase > 12% in the fev1 measured 30 minutes following 2 puffs (2x100mg) of inhaled salbutamol spray, or positive methacholine challenge (pc20<8mg/ml or pd20<1 mg) within the previous 6 months;
    boolean
    C0748133 (UMLS CUI [1,1])
    C0001927 (UMLS CUI [1,2])
    C0430567 (UMLS CUI [2])
    stable asthma
    Item
    stable asthma. asthma is defined stable if none of the following occurred during the last 14 days of the run-in period: diurnal variation of more than 20% in pef on 2 consecutive days; use of four or more inhalations of b2 agonist per day on two consecutive days; need the use of oral corticosteroids;
    boolean
    C0004096 (UMLS CUI [1,1])
    C0205360 (UMLS CUI [1,2])
    C0521299 (UMLS CUI [2])
    C2936789 (UMLS CUI [3,1])
    C3476109 (UMLS CUI [3,2])
    C0001617 (UMLS CUI [4])
    Item Group
    C0680251 (UMLS CUI)
    copd
    Item
    copd as defined by the ers – consensus statement;
    boolean
    C0024117 (UMLS CUI [1])
    smoking history
    Item
    patients with more than 10 packs/year of cigarettes history and current smokers;
    boolean
    C1519384 (UMLS CUI [1,1])
    C1277691 (UMLS CUI [1,2])
    near fatal asthma and/or admission in intensive care unit because of asthma
    Item
    history of near fatal asthma and/or admission in intensive care unit because of asthma;
    boolean
    C0004096 (UMLS CUI [1,1])
    C2826244 (UMLS CUI [1,2])
    C1302234 (UMLS CUI [1,3])
    C0021708 (UMLS CUI [2,1])
    C0004096 (UMLS CUI [2,2])
    asthma exacerbation
    Item
    one severe exacerbation during the run-in period;
    boolean
    C0349790 (UMLS CUI [1])
    oral corticosteroids or hospitalisation for asthma
    Item
    three or more courses of oral corticosteroids or hospitalisation for asthma during the previous 1 year;
    boolean
    C0001617 (UMLS CUI [1])
    C0019993 (UMLS CUI [2])
    beclomethasone
    Item
    patients treated with more than 500 mcg/day of beclomethasone or equivalent for more than 6 months in the previous last year;
    boolean
    C2065042 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])

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