ID

14202

Beschrijving

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

Trefwoorden

  1. 04-04-16 04-04-16 -
  2. 05-04-16 05-04-16 -
Houder van rechten

CC BY-NC 3.0

Geüploaded op

4 april 2016

DOI

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Licentie

Creative Commons BY-NC 3.0

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Eligibility Asthma NCT00163358

Eligibility Asthma NCT00163358

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

Criteria

clinical diagnosis of mild persistent asthma
Beschrijving

mild persistent asthma

Datatype

boolean

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

pre-treatment with sabas only

Datatype

boolean

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

fev1

Datatype

boolean

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

health status

Datatype

boolean

Alias
UMLS CUI [1]
C0018759
main exclusion criteria:
Beschrijving

exclusion criteria

Datatype

boolean

Alias
UMLS CUI [1]
C0680251
concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids
Beschrijving

comorbidity limiting use of inhaled steroids

Datatype

boolean

Alias
UMLS CUI [1,1]
C2065041
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
Beschrijving

copd or other lung diseases

Datatype

boolean

Alias
UMLS CUI [1]
C0024117
UMLS CUI [2]
C0024115
pregnancy
Beschrijving

pregnancy

Datatype

boolean

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

intention to become pregnant

Datatype

boolean

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

lactation

Datatype

boolean

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

lack of contraception

Datatype

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C0332197
current smokers ≥10 pack-years and ex-smokers with ≥10 pack-years
Beschrijving

smoking history

Datatype

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)
Datatype
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])
exclusion criteria
Item
main exclusion criteria:
boolean
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
C2065041 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
copd or other 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])
lactation
Item
breast feeding
boolean
C0006147 (UMLS CUI [1])
lack of 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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