ID

14223

Description

Efficacy and Safety of Roflumilast Taken in the Morning or Evening in Patients With Stable Asthma (12 to 70 y) (BY217/M2-015); ODM derived from: https://clinicaltrials.gov/show/NCT00163475

Link

https://clinicaltrials.gov/show/NCT00163475

Keywords

Versions (1)
  1. 4/5/16 4/5/16 -
Copyright Holder

CC BY-NC 3.0

Uploaded on

April 5, 2016

DOI

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License

Creative Commons BY-NC 3.0
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Eligibility Asthma NCT00163475

English

Eligibility Asthma NCT00163475

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00163475
Criteria
Description

Criteria

written informed consent
Description

written informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
diagnosis of persistent bronchial asthma (with reference to the global initiative for asthma guidelines 2002)
Description

persistent asthma

Data type

boolean

Alias
UMLS CUI [1]
C3266628
baseline fev1 50 - 85% in patients either untreated or receiving e.g. short-acting bronchodilators, dscg, nedocromil, anticholinergics, long-acting bronchodilators, theophylline/aminophylline, lipoxygenase inhibitors, leukotriene antagonists, alone or in combination
Description

fev1

Data type

boolean

Alias
UMLS CUI [1]
C0748133
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0004096
baseline fev1 60 - 90% in patients receiving not more than 500 mcg bdp-cfc (or equivalent) and/or in combination with any other asthma medication mentioned above
Description

fev1

Data type

boolean

Alias
UMLS CUI [1]
C0748133
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0004096
no change in the asthma treatment 4 weeks prior to baseline period
Description

no change in asthma treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0004096
UMLS CUI [1,3]
C0442739
UMLS CUI [1,4]
C0040223
patients who, with the exception of asthma, are in good health
Description

health status

Data type

boolean

Alias
UMLS CUI [1]
C0018759
Exclusion criteria
Description

Exclusion criteria

Alias
UMLS CUI-1
C0680251
poorly controlled asthma: requirement of a course of oral and/or parenteral glucocorticosteroids 4 weeks prior to the baseline, or admission to hospital for asthma (including treatment in an emergency room) 4 weeks prior to the baseline period, or asthma exacerbation in the last 4 weeks prior to baseline period
Description

poorly controlled asthma

Data type

boolean

Alias
UMLS CUI [1,1]
C0004096
UMLS CUI [1,2]
C3853134
UMLS CUI [2]
C0349790
UMLS CUI [3]
C0184666
UMLS CUI [4]
C0744425
patient using regularly >8 puffs/day rescue medication prior to baseline
Description

rescue medication

Data type

boolean

Alias
UMLS CUI [1]
C0013227
history of lower airway infection in the last 4 weeks prior to baseline period
Description

history of lower airway infection

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0458827
UMLS CUI [1,3]
C0040223
diagnosis of chronic obstructive pulmonary disease 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
heavy smoker: currently: >20 cigarettes/day and/or >10 pack years, ex-smoker: with a smoking history of ≥10 pack years
Description

smoking history

Data type

boolean

Alias
UMLS CUI [1,1]
C1519384
UMLS CUI [1,2]
C1277691
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]
C1254595
UMLS CUI [2]
C0009488
liver insufficiency (child pugh a or worse)
Description

liver insufficiency

Data type

boolean

Alias
UMLS CUI [1]
C1306571
active hepatitis
Description

active hepatitis

Data type

boolean

Alias
UMLS CUI [1,1]
C0205177
UMLS CUI [1,2]
C0019158
known infection with hiv
Description

hiv infection

Data type

boolean

Alias
UMLS CUI [1]
C0019682
diagnosis or history of cancer (other than basal cell carcinoma) or recurrence within 5 years prior to study start
Description

cancer

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0007117
UMLS CUI [3]
C0040223
alcohol and/or drug abuse
Description

alcohol and/or drug abuse

Data type

boolean

Alias
UMLS CUI [1]
C0038586
suspected hypersensitivity and/or contraindication to any ingredients of the study medication (roflumilast) or rescue medication
Description

hypersensitivity to study medication

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0965618
pregnancy or patient of childbearing potential who is not using reliable method of contraception
Description

pregnancy, childbearing potential, lack of contraception

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C3831118
UMLS CUI [3,1]
C0700589
UMLS CUI [3,2]
C0332197
patients not able to follow study procedures, e.g. due to language problems, psychological disorders
Description

compliance behavior

Data type

boolean

Alias
UMLS CUI [1]
C1321605
suspected inability or unwillingness to comply with the study procedures
Description

suspected inability or unwillingness to comply with the study procedures

Data type

boolean

Alias
UMLS CUI [1]
C1321605
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Similar models

Eligibility Asthma NCT00163475

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00163475
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
written informed consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
persistent asthma
Item
diagnosis of persistent bronchial asthma (with reference to the global initiative for asthma guidelines 2002)
boolean
C3266628 (UMLS CUI [1])
fev1
Item
baseline fev1 50 - 85% in patients either untreated or receiving e.g. short-acting bronchodilators, dscg, nedocromil, anticholinergics, long-acting bronchodilators, theophylline/aminophylline, lipoxygenase inhibitors, leukotriene antagonists, alone or in combination
boolean
C0748133 (UMLS CUI [1])
C0013227 (UMLS CUI [2,1])
C0004096 (UMLS CUI [2,2])
fev1
Item
baseline fev1 60 - 90% in patients receiving not more than 500 mcg bdp-cfc (or equivalent) and/or in combination with any other asthma medication mentioned above
boolean
C0748133 (UMLS CUI [1])
C0013227 (UMLS CUI [2,1])
C0004096 (UMLS CUI [2,2])
no change in asthma treatment
Item
no change in the asthma treatment 4 weeks prior to baseline period
boolean
C0013227 (UMLS CUI [1,1])
C0004096 (UMLS CUI [1,2])
C0442739 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
health status
Item
patients who, with the exception of asthma, are in good health
boolean
C0018759 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI-1)
poorly controlled asthma
Item
poorly controlled asthma: requirement of a course of oral and/or parenteral glucocorticosteroids 4 weeks prior to the baseline, or admission to hospital for asthma (including treatment in an emergency room) 4 weeks prior to the baseline period, or asthma exacerbation in the last 4 weeks prior to baseline period
boolean
C0004096 (UMLS CUI [1,1])
C3853134 (UMLS CUI [1,2])
C0349790 (UMLS CUI [2])
C0184666 (UMLS CUI [3])
C0744425 (UMLS CUI [4])
rescue medication
Item
patient using regularly >8 puffs/day rescue medication prior to baseline
boolean
C0013227 (UMLS CUI [1])
history of lower airway infection
Item
history of lower airway infection in the last 4 weeks prior to baseline period
boolean
C0009450 (UMLS CUI [1,1])
C0458827 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
copd or other relevant lung diseases
Item
diagnosis of chronic obstructive pulmonary disease and/or other relevant lung diseases
boolean
C0024117 (UMLS CUI [1,1])
C0024115 (UMLS CUI [1,2])
smoking history
Item
heavy smoker: currently: >20 cigarettes/day and/or >10 pack years, ex-smoker: with a smoking history of ≥10 pack years
boolean
C1519384 (UMLS CUI [1,1])
C1277691 (UMLS CUI [1,2])
abnormal laboratory values
Item
clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation
boolean
C1254595 (UMLS CUI [1])
C0009488 (UMLS CUI [2])
liver insufficiency
Item
liver insufficiency (child pugh a or worse)
boolean
C1306571 (UMLS CUI [1])
active hepatitis
Item
active hepatitis
boolean
C0205177 (UMLS CUI [1,1])
C0019158 (UMLS CUI [1,2])
hiv infection
Item
known infection with hiv
boolean
C0019682 (UMLS CUI [1])
cancer
Item
diagnosis or history of cancer (other than basal cell carcinoma) or recurrence within 5 years prior to study start
boolean
C0006826 (UMLS CUI [1])
C0007117 (UMLS CUI [2])
C0040223 (UMLS CUI [3])
alcohol and/or drug abuse
Item
alcohol and/or drug abuse
boolean
C0038586 (UMLS CUI [1])
hypersensitivity to study medication
Item
suspected hypersensitivity and/or contraindication to any ingredients of the study medication (roflumilast) or rescue medication
boolean
C0020517 (UMLS CUI [1,1])
C0965618 (UMLS CUI [1,2])
pregnancy, childbearing potential, lack of contraception
Item
pregnancy or patient of childbearing potential who is not using reliable method of contraception
boolean
C0032961 (UMLS CUI [1])
C3831118 (UMLS CUI [2])
C0700589 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
compliance behavior
Item
patients not able to follow study procedures, e.g. due to language problems, psychological disorders
boolean
C1321605 (UMLS CUI [1])
suspected inability or unwillingness to comply with the study procedures
Item
suspected inability or unwillingness to comply with the study procedures
boolean
C1321605 (UMLS CUI [1])
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