ID

14361

Description

Efficacy and Tolerability of Beclometasone/Formoterol Single Inhaler in Patients With Moderate to Severe Persistent Asthma; ODM derived from: https://clinicaltrials.gov/show/NCT00476268

Link

https://clinicaltrials.gov/show/NCT00476268

Keywords

Versions (1)
  1. 4/12/16 4/12/16 -
Copyright Holder

CC BY-NC 3.0

Uploaded on

April 12, 2016

DOI

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License

Creative Commons BY-NC 3.0
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Eligibility Asthma NCT00476268

English

Eligibility Asthma NCT00476268

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00476268
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
clinical diagnosis of moderate to severe persistent asthma (according to gina 2002 guidelines)
Description

moderate to severe persistent asthma

Data type

boolean

Alias
UMLS CUI [1]
C1960047
UMLS CUI [2]
C1960048
fev1 > 40% and < 80% of predicted normal post-bronchodilator (and at least 0.7 l absolute value)
Description

post-bronchodilator fev1

Data type

boolean

Alias
UMLS CUI [1,1]
C0748133
UMLS CUI [1,2]
C2599594
patients already treated for at least 2 months with an association of inhaled corticosteroids plus laba at doses of:
Description

inhaled corticosteroids plus laba

Data type

boolean

Alias
UMLS CUI [1]
C2065041
UMLS CUI [2]
C1373132
750 - 1000 µg beclomethasone dipropionate or equivalent (icss) 24 µg formoterol or 100 µg salmeterol (labas)
Description

beclomethasone dipropionate formoterol salmeterol

Data type

boolean

Alias
UMLS CUI [1]
C0004906
UMLS CUI [2]
C0060657
UMLS CUI [3]
C0073992
or patients naïve of laba already treated for at least 2 months with inhaled corticosteroids (doses as above) associated with a daily use of saba and/or with clinical symptoms > 3 times in the week prior to inclusion
Description

naive of laba inhaled corticosteroids

Data type

boolean

Alias
UMLS CUI [1]
C0919936
UMLS CUI [2]
C2065041
a documented positive response to the reversibility test.
Description

reversibility test

Data type

boolean

Alias
UMLS CUI [1]
C1272658
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant or lactating females or women of childbearing potential without any efficient contraception.
Description

pregnancy or lactation

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C3831118
UMLS CUI [4,1]
C0700589
UMLS CUI [4,2]
C0332197
heavy smokers defined as smoking for > 10 pack years.
Description

smoking history

Data type

boolean

Alias
UMLS CUI [1,1]
C1519384
UMLS CUI [1,2]
C1277691
evidence of asthma exacerbation causing an hospitalisation or requiring treatment with oral/parenteral corticosteroids or evidence of symptomatic airways infection in the 4 weeks prior to inclusion (3 months for slow-release corticosteroids).
Description

asthma exacerbation

Data type

boolean

Alias
UMLS CUI [1,1]
C0349790
UMLS CUI [1,2]
C0040223
UMLS CUI [2]
C4039704
UMLS CUI [3]
C0019993
UMLS CUI [4,1]
C0035243
UMLS CUI [4,2]
C0040223
seasonal asthma or asthma occurring only during episodic exposure to an allergen or occupational chemical sensitizer.
Description

seasonal asthma or allergic asthma

Data type

boolean

Alias
UMLS CUI [1]
C2919352
UMLS CUI [2]
C0155877
clinically significant or unstable concomitant diseases, including clinically significant laboratory abnormalities.
Description

comorbidity

Data type

boolean

Alias
UMLS CUI [1]
C0009488
patients with an abnormal qtc interval value in the ecg test, defined as > 450 msec in males or > 470 msec in females.
Description

qtc interval

Data type

boolean

Alias
UMLS CUI [1]
C0489625
evidence of asthma worsening during the week preceding randomisation (e.g. pef variability > 30% during 2 consecutive days, saba use > 8 puffs/day during 2 consecutive days, nocturnal awakenings due to asthma symptoms during 3 consecutive days
Description

asthma worsening

Data type

boolean

Alias
UMLS CUI [1,1]
C0004096
UMLS CUI [1,2]
C1457868
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Similar models

Eligibility Asthma NCT00476268

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00476268
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
moderate to severe persistent asthma
Item
clinical diagnosis of moderate to severe persistent asthma (according to gina 2002 guidelines)
boolean
C1960047 (UMLS CUI [1])
C1960048 (UMLS CUI [2])
post-bronchodilator fev1
Item
fev1 > 40% and < 80% of predicted normal post-bronchodilator (and at least 0.7 l absolute value)
boolean
C0748133 (UMLS CUI [1,1])
C2599594 (UMLS CUI [1,2])
inhaled corticosteroids plus laba
Item
patients already treated for at least 2 months with an association of inhaled corticosteroids plus laba at doses of:
boolean
C2065041 (UMLS CUI [1])
C1373132 (UMLS CUI [2])
beclomethasone dipropionate formoterol salmeterol
Item
750 - 1000 µg beclomethasone dipropionate or equivalent (icss) 24 µg formoterol or 100 µg salmeterol (labas)
boolean
C0004906 (UMLS CUI [1])
C0060657 (UMLS CUI [2])
C0073992 (UMLS CUI [3])
naive of laba inhaled corticosteroids
Item
or patients naïve of laba already treated for at least 2 months with inhaled corticosteroids (doses as above) associated with a daily use of saba and/or with clinical symptoms > 3 times in the week prior to inclusion
boolean
C0919936 (UMLS CUI [1])
C2065041 (UMLS CUI [2])
reversibility test
Item
a documented positive response to the reversibility test.
boolean
C1272658 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
pregnancy or lactation
Item
pregnant or lactating females or women of childbearing potential without any efficient contraception.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3])
C0700589 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
smoking history
Item
heavy smokers defined as smoking for > 10 pack years.
boolean
C1519384 (UMLS CUI [1,1])
C1277691 (UMLS CUI [1,2])
asthma exacerbation
Item
evidence of asthma exacerbation causing an hospitalisation or requiring treatment with oral/parenteral corticosteroids or evidence of symptomatic airways infection in the 4 weeks prior to inclusion (3 months for slow-release corticosteroids).
boolean
C0349790 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C4039704 (UMLS CUI [2])
C0019993 (UMLS CUI [3])
C0035243 (UMLS CUI [4,1])
C0040223 (UMLS CUI [4,2])
seasonal asthma or allergic asthma
Item
seasonal asthma or asthma occurring only during episodic exposure to an allergen or occupational chemical sensitizer.
boolean
C2919352 (UMLS CUI [1])
C0155877 (UMLS CUI [2])
comorbidity
Item
clinically significant or unstable concomitant diseases, including clinically significant laboratory abnormalities.
boolean
C0009488 (UMLS CUI [1])
qtc interval
Item
patients with an abnormal qtc interval value in the ecg test, defined as > 450 msec in males or > 470 msec in females.
boolean
C0489625 (UMLS CUI [1])
asthma worsening
Item
evidence of asthma worsening during the week preceding randomisation (e.g. pef variability > 30% during 2 consecutive days, saba use > 8 puffs/day during 2 consecutive days, nocturnal awakenings due to asthma symptoms during 3 consecutive days
boolean
C0004096 (UMLS CUI [1,1])
C1457868 (UMLS CUI [1,2])
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