ID

14242

Description

Efficacy of Ciclesonide on Small Airways in Patients With Stable Asthma (18 to 60 y) (BY9010/M1-131); ODM derived from: https://clinicaltrials.gov/show/NCT00163345

Link

https://clinicaltrials.gov/show/NCT00163345

Keywords

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

April 5, 2016

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Asthma NCT00163345

English

Eligibility Asthma NCT00163345

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00163345
Criteria
Description

Criteria

written informed consent
Description

written informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
history of bronchial asthma
Description

asthma

Data type

boolean

Alias
UMLS CUI [1]
C0004096
fev1 more than or equal to 60% of predicted
Description

fev1

Data type

boolean

Alias
UMLS CUI [1]
C0748133
stable asthma
Description

stable asthma

Data type

boolean

Alias
UMLS CUI [1,1]
C0004096
UMLS CUI [1,2]
C0205360
patients who are in 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, diseases expected to interfere with the outcome of the study, or diseases which are contraindications for the use of ics
Description

comorbidity limiting study protocol

Data type

boolean

Alias
UMLS CUI [1,1]
C2348563
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
use of ics 4 weeks before entry into the baseline period
Description

ics

Data type

boolean

Alias
UMLS CUI [1,1]
C3248292
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
use of other drugs not allowed
Description

other drugs

Data type

boolean

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0013227
current smokers and ex-smokers with more than or equal to 10 pack-years
Description

smoker

Data type

boolean

Alias
UMLS CUI [1,1]
C0543414
UMLS CUI [1,2]
C0040223
UMLS CUI [2]
C1277691
Back to the top of the page

Similar models

Eligibility Asthma NCT00163345

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00163345
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
written informed consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
asthma
Item
history of bronchial asthma
boolean
C0004096 (UMLS CUI [1])
fev1
Item
fev1 more than or equal to 60% of predicted
boolean
C0748133 (UMLS CUI [1])
stable asthma
Item
stable asthma
boolean
C0004096 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
health status
Item
patients who are in good health with the exception of asthma
boolean
C0018759 (UMLS CUI [1])
Item Group
Exclusion criteria
C0680251 (UMLS CUI-1)
comorbidity limiting study protocol
Item
concomitant severe diseases, diseases expected to interfere with the outcome of the study, or diseases which are contraindications for the use of ics
boolean
C2348563 (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])
ics
Item
use of ics 4 weeks before entry into the baseline period
boolean
C3248292 (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])
other drugs
Item
use of other drugs not allowed
boolean
C0205394 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
smoker
Item
current smokers and ex-smokers with more than or equal to 10 pack-years
boolean
C0543414 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C1277691 (UMLS CUI [2])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial