ID

14258

Description

Efficacy of Ciclesonide Versus Budesonide in Patients With Asthma (18 to 75 y) (BY9010/M1-137); ODM derived from: https://clinicaltrials.gov/show/NCT00163397

Link

https://clinicaltrials.gov/show/NCT00163397

Keywords

Versions (2)
  1. 4/4/16 4/4/16 -
  2. 4/5/16 4/5/16 -
Uploaded on

April 5, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Asthma NCT00163397

English

Eligibility Asthma NCT00163397

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00163397
Criteria
Description

Criteria

during the last 4 weeks prior to baseline, treatment with an inhaled steroid (dosage: up to 250 mcg fluticasone propionate or equivalent)
Description

inhaled steroid

Data type

boolean

Alias
UMLS CUI [1,1]
C2065041
UMLS CUI [1,2]
C0040223
fev1 80 - 105% of predicted
Description

fev1

Data type

boolean

Alias
UMLS CUI [1]
C0748133
healthy with the exception of asthma
Description

health status

Data type

boolean

Alias
UMLS CUI [1]
C0018759
written informed consent has been obtained
Description

written informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
outpatients
Description

outpatients

Data type

boolean

Alias
UMLS CUI [1]
C0029921
patients who have a history of persistent bronchial asthma for at least 6 months
Description

persistent asthma

Data type

boolean

Alias
UMLS CUI [1,1]
C3266628
UMLS CUI [1,2]
C0040223
Exclusion criteria
Description

Exclusion criteria

Alias
UMLS CUI-1
C0680251
concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids
Description

comorbidity limiting use of inhaled steroids

Data type

boolean

Alias
UMLS CUI [1,1]
C0586793
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
concomitant copd (i.e. chronic bronchitis or emphysema) and/or other relevant lung diseases causing alternating impairment in lung function
Description

copd or other relevant lung diseases

Data type

boolean

Alias
UMLS CUI [1,1]
C0024117
UMLS CUI [1,2]
C0024115
an asthma exacerbation or an infection of the lower airways prior to entry into the baseline period
Description

asthma exacerbation or infection of the lower airways

Data type

boolean

Alias
UMLS CUI [1]
C0349790
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C0458827
pregnancy
Description

pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
intention to become pregnant during the course of the study
Description

intention to become pregnant

Data type

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C1283828
breast feeding
Description

breast feeding

Data type

boolean

Alias
UMLS CUI [1]
C0006147
lack of safe contraception
Description

lack of safe contraception

Data type

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C0332197
patient is current smoker with 10 or more pack-years
Description

patient is current smoker with 10 or more pack-years

Data type

boolean

Alias
UMLS CUI [1,1]
C0543414
UMLS CUI [1,2]
C0040223
UMLS CUI [2]
C1277691
patient is ex-smoker with 10 or more pack-years
Description

patient is ex-smoker with 10 or more pack-years

Data type

boolean

Alias
UMLS CUI [1,1]
C0543414
UMLS CUI [1,2]
C0040223
UMLS CUI [2]
C1277691
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Similar models

Eligibility Asthma NCT00163397

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00163397
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
inhaled steroid
Item
during the last 4 weeks prior to baseline, treatment with an inhaled steroid (dosage: up to 250 mcg fluticasone propionate or equivalent)
boolean
C2065041 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
fev1
Item
fev1 80 - 105% of predicted
boolean
C0748133 (UMLS CUI [1])
health status
Item
healthy with the exception of asthma
boolean
C0018759 (UMLS CUI [1])
written informed consent
Item
written informed consent has been obtained
boolean
C0021430 (UMLS CUI [1])
outpatients
Item
outpatients
boolean
C0029921 (UMLS CUI [1])
persistent asthma
Item
patients who have a history of persistent bronchial asthma for at least 6 months
boolean
C3266628 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item Group
Exclusion criteria
C0680251 (UMLS CUI-1)
comorbidity limiting use of inhaled steroids
Item
concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids
boolean
C0586793 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
copd or other relevant lung diseases
Item
concomitant copd (i.e. chronic bronchitis or emphysema) and/or other relevant lung diseases causing alternating impairment in lung function
boolean
C0024117 (UMLS CUI [1,1])
C0024115 (UMLS CUI [1,2])
asthma exacerbation or infection of the lower airways
Item
an asthma exacerbation or an infection of the lower airways prior to entry into the baseline period
boolean
C0349790 (UMLS CUI [1])
C0009450 (UMLS CUI [2,1])
C0458827 (UMLS CUI [2,2])
pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])
intention to become pregnant
Item
intention to become pregnant during the course of the study
boolean
C0032961 (UMLS CUI [1,1])
C1283828 (UMLS CUI [1,2])
breast feeding
Item
breast feeding
boolean
C0006147 (UMLS CUI [1])
lack of safe contraception
Item
lack of safe contraception
boolean
C0700589 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
patient is current smoker with 10 or more pack-years
Item
patient is current smoker with 10 or more pack-years
boolean
C0543414 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C1277691 (UMLS CUI [2])
patient is ex-smoker with 10 or more pack-years
Item
patient is ex-smoker with 10 or more pack-years
boolean
C0543414 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C1277691 (UMLS CUI [2])
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