ID

14248

Description

Efficacy of Ciclesonide Versus Fluticasone Propionate in Patients With Mild to Moderate Asthma (12 to 75 y) (BY9010/M1-142); ODM derived from: https://clinicaltrials.gov/show/NCT00163423

Link

https://clinicaltrials.gov/show/NCT00163423

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 NCT00163423

English

Eligibility Asthma NCT00163423

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00163423
Criteria
Description

Criteria

outpatients
Description

outpatients

Data type

boolean

Alias
UMLS CUI [1]
C0029921
written informed consent
Description

written informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
history of bronchial asthma for at least 6 months
Description

history of asthma

Data type

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0004096
UMLS CUI [2]
C0040223
good health with the exception of asthma
Description

health status

Data type

boolean

Alias
UMLS CUI [1]
C0018759
treated with inhaled steroids with a maximum daily constant dosage of 250 mcg fluticasone propionate or equivalent
Description

inhaled steroids

Data type

boolean

Alias
UMLS CUI [1,1]
C2065041
UMLS CUI [1,2]
C2348070
fev1 80 - 105% of predicted
Description

fev1

Data type

boolean

Alias
UMLS CUI [1]
C0748133
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
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]
C0024117
UMLS CUI [2]
C0024115
current smoking with more than 10 pack-years
Description

current smoker

Data type

boolean

Alias
UMLS CUI [1]
C3241966
UMLS CUI [2]
C1277691
previous smoking with more than 10 pack-years
Description

smoking history

Data type

boolean

Alias
UMLS CUI [1,1]
C1519384
UMLS CUI [1,2]
C1277691
use of systemic steroids 4 weeks (injectable depot steroids 6 weeks) before entry into the baseline period, or more than 2 times
Description

systemic steroids

Data type

boolean

Alias
UMLS CUI [1,1]
C2825233
UMLS CUI [1,2]
C0040223
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
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Similar models

Eligibility Asthma NCT00163423

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00163423
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
outpatients
Item
outpatients
boolean
C0029921 (UMLS CUI [1])
written informed consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
history of asthma
Item
history of bronchial asthma for at least 6 months
boolean
C0262926 (UMLS CUI [1,1])
C0004096 (UMLS CUI [1,2])
C0040223 (UMLS CUI [2])
health status
Item
good health with the exception of asthma
boolean
C0018759 (UMLS CUI [1])
inhaled steroids
Item
treated with inhaled steroids with a maximum daily constant dosage of 250 mcg fluticasone propionate or equivalent
boolean
C2065041 (UMLS CUI [1,1])
C2348070 (UMLS CUI [1,2])
fev1
Item
fev1 80 - 105% of predicted
boolean
C0748133 (UMLS CUI [1])
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
copd (i.e. chronic bronchitis or emphysema) and/or other relevant lung diseases causing alternating impairment in lung function
boolean
C0024117 (UMLS CUI [1])
C0024115 (UMLS CUI [2])
current smoker
Item
current smoking with more than 10 pack-years
boolean
C3241966 (UMLS CUI [1])
C1277691 (UMLS CUI [2])
smoking history
Item
previous smoking with more than 10 pack-years
boolean
C1519384 (UMLS CUI [1,1])
C1277691 (UMLS CUI [1,2])
systemic steroids
Item
use of systemic steroids 4 weeks (injectable depot steroids 6 weeks) before entry into the baseline period, or more than 2 times
boolean
C2825233 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
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])
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