ID

14401

Description

Effect of Inhaled Ciclesonide in Adult Patients With Asthma (BY9010/M1-125); ODM derived from: https://clinicaltrials.gov/show/NCT00546520

Link

https://clinicaltrials.gov/show/NCT00546520

Keywords

Versions (1)
  1. 4/13/16 4/13/16 -
Copyright Holder

CC BY-NC 3.0

Uploaded on

April 13, 2016

DOI

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License

Creative Commons BY-NC 3.0
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Eligibility Asthma NCT00546520

English

Eligibility Asthma NCT00546520

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00546520
Criteria
Description

Criteria

out-patients
Description

outpatients

Data type

boolean

Alias
UMLS CUI [1]
C0029921
written informed consent
Description

written informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
history of atopic disease
Description

atopy

Data type

boolean

Alias
UMLS CUI [1]
C0392707
history of perennial bronchial asthma for at least 6 months as defined by ats criteria
Description

perennial asthma

Data type

boolean

Alias
UMLS CUI [1,1]
C0004096
UMLS CUI [1,2]
C0040223
current use of only inhaled short acting beta-2-agonist as required (for at least 4 weeks prior to baseline period b0)
Description

short acting beta-2-agonist

Data type

boolean

Alias
UMLS CUI [1]
C2936789
stable asthma, i.e. no exacerbation or relevant respiratory tract infection within 2 months prior to study start
Description

stable asthma

Data type

boolean

Alias
UMLS CUI [1,1]
C0004096
UMLS CUI [1,2]
C0205360
fev1 ≥ 70% predicted
Description

fev1

Data type

boolean

Alias
UMLS CUI [1]
C0748133
hyperreactivity to amp (pc20fev1 < 25 mg/ml)
Description

hyperreactivity to amp

Data type

boolean

Alias
UMLS CUI [1]
C0020517
good health with the exception of asthma
Description

good health with the exception of asthma

Data type

boolean

Alias
UMLS CUI [1,1]
C0018759
UMLS CUI [1,2]
C0205170
UMLS CUI [2]
C0004096
non-smokers as well as ex-smokers with either = 10 pack-years or more than 6 months of smoking abstinence
Description

smoking history

Data type

boolean

Alias
UMLS CUI [1]
C1519384
UMLS CUI [2]
C1277691
UMLS CUI [3]
C0337672
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 (e.g. lung tuberculosis)
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
clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation
Description

abnormal laboratory values

Data type

boolean

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C0009488
use of systemic steroids 4 weeks (injectable depot steroids 6 weeks) 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
pregnancy or intention to become pregnant during the course of the study, breast feeding, lack of safe contraception in heterosexually active female patients of child-bearing potential, or postmenopausal for less than one year
Description

pregnancy or intention to become pregnant or lactation or lack of safe contraception

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C0032961
UMLS CUI [2,2]
C1283828
UMLS CUI [3,1]
C0700589
UMLS CUI [3,2]
C0332197
UMLS CUI [4]
C0006147
UMLS CUI [5]
C3831118
UMLS CUI [6]
C0232970
copd (i.e. chronic bronchitis or emphysema) and/or other relevant lung diseases
Description

copd or other relevant lung diseases

Data type

boolean

Alias
UMLS CUI [1]
C0024117
UMLS CUI [2]
C0024115
known or suspected hypersensitivity to inhaled steroids or to the other excipients of the metered dose inhalers
Description

hypersensitivity to inhaled steroids

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C2065041
immunotherapy within one month prior to b0 and/or during the entire study duration
Description

immunotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0021083
UMLS CUI [1,2]
C0040223
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Similar models

Eligibility Asthma NCT00546520

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00546520
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
outpatients
Item
out-patients
boolean
C0029921 (UMLS CUI [1])
written informed consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
atopy
Item
history of atopic disease
boolean
C0392707 (UMLS CUI [1])
perennial asthma
Item
history of perennial bronchial asthma for at least 6 months as defined by ats criteria
boolean
C0004096 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
short acting beta-2-agonist
Item
current use of only inhaled short acting beta-2-agonist as required (for at least 4 weeks prior to baseline period b0)
boolean
C2936789 (UMLS CUI [1])
stable asthma
Item
stable asthma, i.e. no exacerbation or relevant respiratory tract infection within 2 months prior to study start
boolean
C0004096 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
fev1
Item
fev1 ≥ 70% predicted
boolean
C0748133 (UMLS CUI [1])
hyperreactivity to amp
Item
hyperreactivity to amp (pc20fev1 < 25 mg/ml)
boolean
C0020517 (UMLS CUI [1])
good health with the exception of asthma
Item
good health with the exception of asthma
boolean
C0018759 (UMLS CUI [1,1])
C0205170 (UMLS CUI [1,2])
C0004096 (UMLS CUI [2])
smoking history
Item
non-smokers as well as ex-smokers with either = 10 pack-years or more than 6 months of smoking abstinence
boolean
C1519384 (UMLS CUI [1])
C1277691 (UMLS CUI [2])
C0337672 (UMLS CUI [3])
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 (e.g. lung tuberculosis)
boolean
C0586793 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
abnormal laboratory values
Item
clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation
boolean
C1254595 (UMLS CUI [1,1])
C0009488 (UMLS CUI [1,2])
systemic steroids
Item
use of systemic steroids 4 weeks (injectable depot steroids 6 weeks) 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])
pregnancy or intention to become pregnant or lactation or lack of safe contraception
Item
pregnancy or intention to become pregnant during the course of the study, breast feeding, lack of safe contraception in heterosexually active female patients of child-bearing potential, or postmenopausal for less than one year
boolean
C0032961 (UMLS CUI [1])
C0032961 (UMLS CUI [2,1])
C1283828 (UMLS CUI [2,2])
C0700589 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0006147 (UMLS CUI [4])
C3831118 (UMLS CUI [5])
C0232970 (UMLS CUI [6])
copd or other relevant lung diseases
Item
copd (i.e. chronic bronchitis or emphysema) and/or other relevant lung diseases
boolean
C0024117 (UMLS CUI [1])
C0024115 (UMLS CUI [2])
hypersensitivity to inhaled steroids
Item
known or suspected hypersensitivity to inhaled steroids or to the other excipients of the metered dose inhalers
boolean
C0020517 (UMLS CUI [1,1])
C2065041 (UMLS CUI [1,2])
immunotherapy
Item
immunotherapy within one month prior to b0 and/or during the entire study duration
boolean
C0021083 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
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