ID

14224

Description

Efficacy and Safety of Oral Roflumilast Taken With Low Dose Inhaled Corticosteroids in Patients With Asthma (12 to 70 y) (BY217/M2-013); ODM derived from: https://clinicaltrials.gov/show/NCT00163527

Link

https://clinicaltrials.gov/show/NCT00163527

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 NCT00163527

English

Eligibility Asthma NCT00163527

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00163527
Criteria
Description

Criteria

written informed consent
Description

written informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
diagnosis of persistent chronic bronchial asthma, according to global initiative for asthma (gina) guidelines
Description

persistent asthma

Data type

boolean

Alias
UMLS CUI [1]
C3266628
the patient has been receiving bdp - cfc ≤1000 mcg per day or equivalent for the previous four weeks
Description

bdp-cfc

Data type

boolean

fev1 between 60 and 90% predicted at visit 1
Description

fev1

Data type

boolean

Alias
UMLS CUI [1]
C0748133
no change in asthma treatment within 4 weeks prior to visit 1
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
Exclusion criteria
Description

Exclusion criteria

Alias
UMLS CUI-1
C0680251
patients with poorly controlled asthma defined as requiring a course of oral or parenteral corticosteroids, admission to hospital for asthma (including treatment in an emergency room), or exacerbation of asthma in the four weeks prior to visit 1
Description

poorly controlled asthma

Data type

boolean

Alias
UMLS CUI [1,1]
C3853134
UMLS CUI [1,2]
C0004096
UMLS CUI [2]
C0349790
UMLS CUI [3]
C0184666
UMLS CUI [4]
C0744425
patients who suffer from seasonal asthma alone or patients who are likely to have a major exacerbation of their asthma due to seasonal effects during the study run-in or treatment period
Description

seasonal asthma

Data type

boolean

Alias
UMLS CUI [1]
C0004096
UMLS CUI [2]
C0349790
a history of lower airway infection in the four weeks prior to visit 1
Description

lower airway infection

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0458827
UMLS CUI [1,3]
C0040223
a diagnosis of chronic obstructive pulmonary disease (copd) and/or other relevant lung disease (e.g. cystic fibrosis, bronchiectasis)
Description

copd or other relevant lung diseases

Data type

boolean

Alias
UMLS CUI [1,1]
C0024117
UMLS CUI [1,2]
C0024115
heavy smoker currently smoking >20 cigarettes per day and/or >10 pack years or the patient is an ex-smoker who has smoked >10 pack years
Description

smoking history

Data type

boolean

Alias
UMLS CUI [1,1]
C1519384
UMLS CUI [1,2]
C1277691
patients using >8 puffs/day relief medication regularly prior to visit 1
Description

relief medication

Data type

boolean

Alias
UMLS CUI [1]
C0013227
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
a diagnosis, treatment or remission of any cancer (other than basal cell carcinoma) within two years prior to visit 1
Description

cancer history

Data type

boolean

Alias
UMLS CUI [1]
C1512706
UMLS CUI [2]
C0007117
patients with chronic heart failure class iii or iv (new york heart association)
Description

nyha

Data type

boolean

Alias
UMLS CUI [1]
C1275491
suspected hypersensitivity and/or contraindication to any ingredients of the study medication (roflumilast, bdp, or salbutamol)
Description

hypersensitivity to any ingredients of the study medication

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0965618
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0001927
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0004906
a history of alcoholism or substance abuse within the 12 months prior to visit 1
Description

substance use disorder

Data type

boolean

Alias
UMLS CUI [1]
C0038586
pregnancy or women of childbearing potential who are not using a 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
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Similar models

Eligibility Asthma NCT00163527

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00163527
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 chronic bronchial asthma, according to global initiative for asthma (gina) guidelines
boolean
C3266628 (UMLS CUI [1])
bdp-cfc
Item
the patient has been receiving bdp - cfc ≤1000 mcg per day or equivalent for the previous four weeks
boolean
fev1
Item
fev1 between 60 and 90% predicted at visit 1
boolean
C0748133 (UMLS CUI [1])
no change in asthma treatment
Item
no change in asthma treatment within 4 weeks prior to visit 1
boolean
C0013227 (UMLS CUI [1,1])
C0004096 (UMLS CUI [1,2])
C0442739 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item Group
C0680251 (UMLS CUI-1)
poorly controlled asthma
Item
patients with poorly controlled asthma defined as requiring a course of oral or parenteral corticosteroids, admission to hospital for asthma (including treatment in an emergency room), or exacerbation of asthma in the four weeks prior to visit 1
boolean
C3853134 (UMLS CUI [1,1])
C0004096 (UMLS CUI [1,2])
C0349790 (UMLS CUI [2])
C0184666 (UMLS CUI [3])
C0744425 (UMLS CUI [4])
seasonal asthma
Item
patients who suffer from seasonal asthma alone or patients who are likely to have a major exacerbation of their asthma due to seasonal effects during the study run-in or treatment period
boolean
C0004096 (UMLS CUI [1])
C0349790 (UMLS CUI [2])
lower airway infection
Item
a history of lower airway infection in the four weeks prior to visit 1
boolean
C0009450 (UMLS CUI [1,1])
C0458827 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
copd or other relevant lung diseases
Item
a diagnosis of chronic obstructive pulmonary disease (copd) and/or other relevant lung disease (e.g. cystic fibrosis, bronchiectasis)
boolean
C0024117 (UMLS CUI [1,1])
C0024115 (UMLS CUI [1,2])
smoking history
Item
heavy smoker currently smoking >20 cigarettes per day and/or >10 pack years or the patient is an ex-smoker who has smoked >10 pack years
boolean
C1519384 (UMLS CUI [1,1])
C1277691 (UMLS CUI [1,2])
relief medication
Item
patients using >8 puffs/day relief medication regularly prior to visit 1
boolean
C0013227 (UMLS CUI [1])
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])
cancer history
Item
a diagnosis, treatment or remission of any cancer (other than basal cell carcinoma) within two years prior to visit 1
boolean
C1512706 (UMLS CUI [1])
C0007117 (UMLS CUI [2])
nyha
Item
patients with chronic heart failure class iii or iv (new york heart association)
boolean
C1275491 (UMLS CUI [1])
hypersensitivity to any ingredients of the study medication
Item
suspected hypersensitivity and/or contraindication to any ingredients of the study medication (roflumilast, bdp, or salbutamol)
boolean
C0020517 (UMLS CUI [1,1])
C0965618 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0001927 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0004906 (UMLS CUI [3,2])
substance use disorder
Item
a history of alcoholism or substance abuse within the 12 months prior to visit 1
boolean
C0038586 (UMLS CUI [1])
pregnancy, childbearing potential, lack of contraception
Item
pregnancy or women of childbearing potential who are not using a reliable method of contraception
boolean
C0032961 (UMLS CUI [1])
C3831118 (UMLS CUI [2])
C0700589 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
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