ID

14241

Description

Efficacy of Ciclesonide and Fluticasone Propionate in Adult Patients With Moderate and Severe Persistent Asthma (18 to 75 y) (BY9010/IT-101); ODM derived from: https://clinicaltrials.gov/show/NCT00163319

Link

https://clinicaltrials.gov/show/NCT00163319

Keywords

  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.

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 NCT00163319

Eligibility Asthma NCT00163319

  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00163319
Criteria
Description

Criteria

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

asthma

Data type

boolean

Alias
UMLS CUI [1,1]
C0004096
UMLS CUI [1,2]
C0040223
pre-treatment with cfc-beclomethasone dipropionate (cfc-bdp) ≥ 1000 mcg/day or equivalent and a long-acting beta agonist (laba) either in free or fixed combination
Description

cfc-beclomethasone dipropionate and a long-acting beta agonist

Data type

boolean

Alias
UMLS CUI [1]
C0004906
UMLS CUI [2]
C2936789
fev1 ≥ 80% 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 or contraindications for the use of labas
Description

comorbidity limiting inhaled steroids

Data type

boolean

Alias
UMLS CUI [1,1]
C2065041
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
UMLS CUI [2,1]
C2936789
UMLS CUI [2,2]
C0439801
UMLS CUI [2,3]
C0009488
copd
Description

copd

Data type

boolean

Alias
UMLS CUI [1]
C0024117
smoking with ≥10 pack-years
Description

pack years

Data type

boolean

Alias
UMLS CUI [1]
C1277691
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

Similar models

Eligibility Asthma NCT00163319

  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00163319
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 for at least 6 months
boolean
C0004096 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
cfc-beclomethasone dipropionate and a long-acting beta agonist
Item
pre-treatment with cfc-beclomethasone dipropionate (cfc-bdp) ≥ 1000 mcg/day or equivalent and a long-acting beta agonist (laba) either in free or fixed combination
boolean
C0004906 (UMLS CUI [1])
C2936789 (UMLS CUI [2])
fev1
Item
fev1 ≥ 80% of predicted
boolean
C0748133 (UMLS CUI [1])
Item Group
Exclusion criteria
C0680251 (UMLS CUI-1)
comorbidity limiting inhaled steroids
Item
concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids or contraindications for the use of labas
boolean
C2065041 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
C2936789 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
C0009488 (UMLS CUI [2,3])
copd
Item
copd
boolean
C0024117 (UMLS CUI [1])
pack years
Item
smoking with ≥10 pack-years
boolean
C1277691 (UMLS CUI [1])
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])

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

Fields marked with * are required.

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