ID

14285

Description

Effect of Ciclesonide on Quality of Life in Patients With Moderate Persistent Asthma (21 to 65 y) (BY9010/AR-101); ODM derived from: https://clinicaltrials.gov/show/NCT00305461

Link

https://clinicaltrials.gov/show/NCT00305461

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 NCT00305461

English

Eligibility Asthma NCT00305461

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00305461
Criteria
Description

Criteria

written informed consent
Description

written informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
good health with the exception of asthma
Description

good health

Data type

boolean

Alias
UMLS CUI [1,1]
C0018759
UMLS CUI [1,2]
C0205170
clinical diagnosis of moderate persistent asthma during the last 6 months prior to visit b0
Description

moderate persistent asthma

Data type

boolean

Alias
UMLS CUI [1]
C1960047
pre-treatment with inhaled corticosteroids dose equivalent to 250 - 500 mcg bdp / day at stable dosing during the last 4 weeks prior to visit b0, concomitant or not to short-acting beta2-agonists treatment as rescue medication
Description

pre-treatment

Data type

boolean

Alias
UMLS CUI [1]
C2065041
UMLS CUI [2]
C2936789
fev1 ≥ 70% and ≤ 90% predicted measured at least 4 h after the last use of rescue medication at visit b0
Description

fev1

Data type

boolean

Alias
UMLS CUI [1]
C0748133
reversibility ≥ 12% and ≥ 200 ml in b0, b0 or t0, after inhalation of 400 mcg of salbutamol
Description

fev1 reversibility

Data type

boolean

Alias
UMLS CUI [1]
C0748133
UMLS CUI [2]
C0001927
patients compliant to recommended pre-treatment
Description

compliance

Data type

boolean

Alias
UMLS CUI [1]
C1321605
main exclusion criteria:
Description

exclusion criteria

Data type

boolean

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
chronic obstructive pulmonary disease (copd)
Description

copd

Data type

boolean

Alias
UMLS CUI [1]
C0024117
hospitalization within previous four weeks from baseline
Description

hospitalization

Data type

boolean

Alias
UMLS CUI [1,1]
C0019993
UMLS CUI [1,2]
C0040223
hospitalization due to asthma within the last twelve months
Description

hospitalization due to asthma

Data type

boolean

Alias
UMLS CUI [1,1]
C0019993
UMLS CUI [1,2]
C0004096
UMLS CUI [1,3]
C0040223
asthma exacerbation within two months previous to baseline
Description

asthma exacerbation

Data type

boolean

Alias
UMLS CUI [1,1]
C0349790
UMLS CUI [1,2]
C0040223
history of almost fatal asthma at any moment
Description

fatal asthma

Data type

boolean

Alias
UMLS CUI [1,1]
C0004096
UMLS CUI [1,2]
C2826244
UMLS CUI [1,3]
C1302234
pregnancy, breast feeding, intention to become pregnant during the course of the study or lack of safe contraception in pre-menopausal women
Description

pregnancy, breast feeding, intention to become pregnant or lack of safe contraception

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0032961
UMLS CUI [3,2]
C1283828
UMLS CUI [4,1]
C0700589
UMLS CUI [4,2]
C0332197
exacerbation of asthma within 2 months prior to entry into the baseline period
Description

exacerbation of asthma

Data type

boolean

Alias
UMLS CUI [1,1]
C0349790
UMLS CUI [1,2]
C0040223
use of systemic steroids up to 2 months (injectable depot steroids 6 months) before entry into the baseline period, or more than 3 times during the last 6 months
Description

systemic steroids

Data type

boolean

Alias
UMLS CUI [1,1]
C2825233
UMLS CUI [1,2]
C0040223
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Similar models

Eligibility Asthma NCT00305461

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00305461
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
written informed consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
good health
Item
good health with the exception of asthma
boolean
C0018759 (UMLS CUI [1,1])
C0205170 (UMLS CUI [1,2])
moderate persistent asthma
Item
clinical diagnosis of moderate persistent asthma during the last 6 months prior to visit b0
boolean
C1960047 (UMLS CUI [1])
pre-treatment
Item
pre-treatment with inhaled corticosteroids dose equivalent to 250 - 500 mcg bdp / day at stable dosing during the last 4 weeks prior to visit b0, concomitant or not to short-acting beta2-agonists treatment as rescue medication
boolean
C2065041 (UMLS CUI [1])
C2936789 (UMLS CUI [2])
fev1
Item
fev1 ≥ 70% and ≤ 90% predicted measured at least 4 h after the last use of rescue medication at visit b0
boolean
C0748133 (UMLS CUI [1])
fev1 reversibility
Item
reversibility ≥ 12% and ≥ 200 ml in b0, b0 or t0, after inhalation of 400 mcg of salbutamol
boolean
C0748133 (UMLS CUI [1])
C0001927 (UMLS CUI [2])
compliance
Item
patients compliant to recommended pre-treatment
boolean
C1321605 (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
C0586793 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
copd
Item
chronic obstructive pulmonary disease (copd)
boolean
C0024117 (UMLS CUI [1])
hospitalization
Item
hospitalization within previous four weeks from baseline
boolean
C0019993 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
hospitalization due to asthma
Item
hospitalization due to asthma within the last twelve months
boolean
C0019993 (UMLS CUI [1,1])
C0004096 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
asthma exacerbation
Item
asthma exacerbation within two months previous to baseline
boolean
C0349790 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
fatal asthma
Item
history of almost fatal asthma at any moment
boolean
C0004096 (UMLS CUI [1,1])
C2826244 (UMLS CUI [1,2])
C1302234 (UMLS CUI [1,3])
pregnancy, breast feeding, intention to become pregnant or lack of safe contraception
Item
pregnancy, breast feeding, intention to become pregnant during the course of the study or lack of safe contraception in pre-menopausal women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032961 (UMLS CUI [3,1])
C1283828 (UMLS CUI [3,2])
C0700589 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
exacerbation of asthma
Item
exacerbation of asthma within 2 months prior to entry into the baseline period
boolean
C0349790 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
systemic steroids
Item
use of systemic steroids up to 2 months (injectable depot steroids 6 months) before entry into the baseline period, or more than 3 times during the last 6 months
boolean
C2825233 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
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