ID

14286

Description

Responsiveness of Lower Airways in Adult Patients (18-60 Years) With Stable Asthma After Treatment With Ciclesonide and Fluticasone Propionate (BY9010/NL-101); ODM derived from: https://clinicaltrials.gov/show/NCT00306163

Link

https://clinicaltrials.gov/show/NCT00306163

Keywords

Versions (1)
  1. 4/7/16 4/7/16 -
Copyright Holder

CC BY-NC 3.0

Uploaded on

April 7, 2016

DOI

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License

Creative Commons BY-NC 3.0
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Eligibility Asthma NCT00306163

English

Eligibility Asthma NCT00306163

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00306163
Criteria
Description

Criteria

history of bronchial asthma
Description

history of bronchial asthma

Data type

boolean

Alias
UMLS CUI [1]
C0004096
fev1 > 1.20 l
Description

fev1

Data type

boolean

Alias
UMLS CUI [1]
C0748133
positive skin prick test
Description

positive skin prick test

Data type

boolean

Alias
UMLS CUI [1]
C0430561
not more than 500 mcg/day fluticasone propionate or equivalent for at least 28 days prior to baseline visit
Description

fluticasone propionate

Data type

boolean

Alias
UMLS CUI [1,1]
C0117996
UMLS CUI [1,2]
C0040223
main exclusion criteria:
Description

exclusion criteria

Data type

boolean

Alias
UMLS CUI [1]
C0680251
clinically relevant abnormal laboratory values
Description

clinically relevant abnormal laboratory values

Data type

boolean

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C2826293
concomitant severe diseases, diseases expected to interfere with the outcome of the study and diseases which are contra-indications for the use of inhaled steroids
Description

concomitant severe diseases, diseases expected to interfere with the outcome of the study and diseases which are contra-indications for the use of inhaled steroids

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
UMLS CUI [2,1]
C0586793
UMLS CUI [2,2]
C0439801
UMLS CUI [2,3]
C0009488
chronic obstructive pulmonary disease (copd) and /or other relevant lung diseases
Description

copd or other relevant lung diseases

Data type

boolean

Alias
UMLS CUI [1,1]
C0024117
UMLS CUI [1,2]
C0024115
one asthma exacerbation within 2 months or more than 3 exacerbations within the last year prior to baseline visit
Description

asthma exacerbation

Data type

boolean

Alias
UMLS CUI [1,1]
C0349790
UMLS CUI [1,2]
C0040223
current smokers or ex-smokers with more than 10 pack years, or having smoked within 1 year prior to baseline visit
Description

smoking history

Data type

boolean

Alias
UMLS CUI [1]
C1519384
UMLS CUI [2]
C1277691
positive response to saline challenge at baseline visits
Description

saline challenge

Data type

boolean

positive bronchial hyperresponsiveness
Description

bronchial hyperresponsiveness

Data type

boolean

Alias
UMLS CUI [1]
C0085129
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Similar models

Eligibility Asthma NCT00306163

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00306163
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
history of bronchial asthma
Item
history of bronchial asthma
boolean
C0004096 (UMLS CUI [1])
fev1
Item
fev1 > 1.20 l
boolean
C0748133 (UMLS CUI [1])
positive skin prick test
Item
positive skin prick test
boolean
C0430561 (UMLS CUI [1])
fluticasone propionate
Item
not more than 500 mcg/day fluticasone propionate or equivalent for at least 28 days prior to baseline visit
boolean
C0117996 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
exclusion criteria
Item
main exclusion criteria:
boolean
C0680251 (UMLS CUI [1])
clinically relevant abnormal laboratory values
Item
clinically relevant abnormal laboratory values
boolean
C1254595 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
concomitant severe diseases, diseases expected to interfere with the outcome of the study and diseases which are contra-indications for the use of inhaled steroids
Item
concomitant severe diseases, diseases expected to interfere with the outcome of the study and diseases which are contra-indications for the use of inhaled steroids
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
C0586793 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
C0009488 (UMLS CUI [2,3])
copd or other relevant lung diseases
Item
chronic obstructive pulmonary disease (copd) and /or other relevant lung diseases
boolean
C0024117 (UMLS CUI [1,1])
C0024115 (UMLS CUI [1,2])
asthma exacerbation
Item
one asthma exacerbation within 2 months or more than 3 exacerbations within the last year prior to baseline visit
boolean
C0349790 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
smoking history
Item
current smokers or ex-smokers with more than 10 pack years, or having smoked within 1 year prior to baseline visit
boolean
C1519384 (UMLS CUI [1])
C1277691 (UMLS CUI [2])
saline challenge
Item
positive response to saline challenge at baseline visits
boolean
bronchial hyperresponsiveness
Item
positive bronchial hyperresponsiveness
boolean
C0085129 (UMLS CUI [1])
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