ID

14321

Description

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

Link

https://clinicaltrials.gov/show/NCT00382889

Keywords

  1. 4/11/16 4/11/16 -
Copyright Holder

CC BY-NC 3.0

Uploaded on

April 11, 2016

DOI

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License

Creative Commons BY-NC 3.0

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Eligibility Asthma NCT00382889

Eligibility Asthma NCT00382889

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

Inclusion Criteria

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

mild persistent asthma

Data type

boolean

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

fev1

Data type

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;
Description

fev1 reversibility, methacholine challenge

Data type

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;
Description

stable asthma

Data type

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
Description

Exclusion Criteria

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

copd

Data type

boolean

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

smoking history

Data type

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;
Description

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

Data type

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;
Description

asthma exacerbation

Data type

boolean

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

oral corticosteroids or hospitalisation for asthma

Data type

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;
Description

beclomethasone

Data type

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
Type
Description | Question | Decode (Coded Value)
Data type
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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