ID

14224

Beschrijving

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

Trefwoorden

  1. 05-04-16 05-04-16 -
Houder van rechten

CC BY-NC 3.0

Geüploaded op

5 april 2016

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY-NC 3.0

Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Eligibility Asthma NCT00163527

Eligibility Asthma NCT00163527

  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00163527
Criteria
Beschrijving

Criteria

written informed consent
Beschrijving

written informed consent

Datatype

boolean

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

persistent asthma

Datatype

boolean

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

bdp-cfc

Datatype

boolean

fev1 between 60 and 90% predicted at visit 1
Beschrijving

fev1

Datatype

boolean

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

no change in asthma treatment

Datatype

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0004096
UMLS CUI [1,3]
C0442739
UMLS CUI [1,4]
C0040223
Exclusion criteria
Beschrijving

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
Beschrijving

poorly controlled asthma

Datatype

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
Beschrijving

seasonal asthma

Datatype

boolean

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

lower airway infection

Datatype

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)
Beschrijving

copd or other relevant lung diseases

Datatype

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
Beschrijving

smoking history

Datatype

boolean

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

relief medication

Datatype

boolean

Alias
UMLS CUI [1]
C0013227
clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation
Beschrijving

abnormal laboratory values

Datatype

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
Beschrijving

cancer history

Datatype

boolean

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

nyha

Datatype

boolean

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

hypersensitivity to any ingredients of the study medication

Datatype

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
Beschrijving

substance use disorder

Datatype

boolean

Alias
UMLS CUI [1]
C0038586
pregnancy or women of childbearing potential who are not using a reliable method of contraception
Beschrijving

pregnancy, childbearing potential, lack of contraception

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C3831118
UMLS CUI [3,1]
C0700589
UMLS CUI [3,2]
C0332197

Similar models

Eligibility Asthma NCT00163527

  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00163527
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

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