ID

14244

Description

Efficacy of Ciclesonide vs Fixed Combination of Fluticasone Propionate/Salmeterol vs Placebo in Patients With Mild Persistent Asthma (12 to 75 y) (BY9010/M1-132); ODM derived from: https://clinicaltrials.gov/show/NCT00163358

Link

https://clinicaltrials.gov/show/NCT00163358

Keywords

  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 NCT00163358

Eligibility Asthma NCT00163358

  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00163358
Criteria
Description

Criteria

clinical diagnosis of mild persistent asthma
Description

mild persistent asthma

Data type

boolean

Alias
UMLS CUI [1]
C1960046
pre-treatment with sabas only
Description

pre-treatment with sabas only

Data type

boolean

Alias
UMLS CUI [1,1]
C1882440
UMLS CUI [1,2]
C2936789
fev1 ≥80% predicted
Description

fev1

Data type

boolean

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

health status

Data type

boolean

Alias
UMLS CUI [1]
C0018759
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 (chronic bronchitis or emphysema) and/or other relevant lung diseases causing alternating impairment in pulmonary function
Description

copd or other relevant lung diseases

Data type

boolean

Alias
UMLS CUI [1]
C0024117
UMLS CUI [2]
C0024115
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
current smokers ≥10 pack-years and ex-smokers with ≥10 pack-years
Description

smoking history

Data type

boolean

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

Similar models

Eligibility Asthma NCT00163358

  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00163358
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
mild persistent asthma
Item
clinical diagnosis of mild persistent asthma
boolean
C1960046 (UMLS CUI [1])
pre-treatment with sabas only
Item
pre-treatment with sabas only
boolean
C1882440 (UMLS CUI [1,1])
C2936789 (UMLS CUI [1,2])
fev1
Item
fev1 ≥80% predicted
boolean
C0748133 (UMLS CUI [1])
health status
Item
good health with the exception of asthma
boolean
C0018759 (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 (chronic bronchitis or emphysema) and/or other relevant lung diseases causing alternating impairment in pulmonary function
boolean
C0024117 (UMLS CUI [1])
C0024115 (UMLS CUI [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])
smoking history
Item
current smokers ≥10 pack-years and ex-smokers with ≥10 pack-years
boolean
C0543414 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C1277691 (UMLS CUI [2])

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