ID

14347

Description

Asthma Care With Alvesco® (Ciclesonide) in Primary Care in Adults - The ACCEPT-study (BY9010/CA-102); ODM derived from: https://clinicaltrials.gov/show/NCT00404547

Link

https://clinicaltrials.gov/show/NCT00404547

Keywords

Versions (1)
  1. 4/11/16 4/11/16 -
Copyright Holder

CC BY-NC 3.0

Uploaded on

April 11, 2016

DOI

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License

Creative Commons BY-NC 3.0
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Eligibility Asthma NCT00404547

English

Eligibility Asthma NCT00404547

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00404547
Criteria
Description

Criteria

written informed consent
Description

written informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
18 years or older with diagnosis of asthma for at least 6 months
Description

age and asthma

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0004096
clinically stable asthma at the time of study enrollment
Description

stable asthma

Data type

boolean

Alias
UMLS CUI [1,1]
C0004096
UMLS CUI [1,2]
C0205360
clinical requirements for treatment with ics as outlined in the canadian asthma consensus guidelines
Description

ics

Data type

boolean

Alias
UMLS CUI [1]
C3248292
if patients are currently on ics, the dose must be stable for 3 months and they must be willing to switch
Description

ics stable dose

Data type

boolean

Alias
UMLS CUI [1]
C3248292
UMLS CUI [2,1]
C0178602
UMLS CUI [2,2]
C0205360
main exclusion criteria:
Description

exclusion criteria

Data type

boolean

Alias
UMLS CUI [1]
C0680251
on combination therapy (ics + long acting beta-2-agonist) for asthma in the past 3 months or require combination therapy
Description

ics and long acting beta-2-agonist

Data type

boolean

Alias
UMLS CUI [1,1]
C3248292
UMLS CUI [1,2]
C1373132
UMLS CUI [1,3]
C0040223
severe asthma, one or more asthma exacerbations in the last 3 months requiring hospitalization or emergency room visit, or patients who have used systemic steroids more than 3 times in the past 6 months or who are currently using systemic steroids
Description

severe asthma

Data type

boolean

Alias
UMLS CUI [1]
C0581126
UMLS CUI [2]
C0349790
UMLS CUI [3]
C1527398
UMLS CUI [4]
C0019993
UMLS CUI [5]
C2825233
mild asthma requiring short acting beta-2-agonists only
Description

mild asthma requiring short acting beta-2-agonists only

Data type

boolean

Alias
UMLS CUI [1,1]
C0581124
UMLS CUI [1,2]
C2936789
patients with a contraindication to ics therapy
Description

contraindication to ics therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C3248292
any other disease or medical condition requiring further clinical evaluation, which in the opinion of the primary care practitioner may interfere with the clinical study or interfere with the diagnosis of asthma.
Description

comorbidity limiting study protocol

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
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 during the course of the study or lack of safe contraception in pre-menopausal women

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0700589
UMLS CUI [3]
C0006147
UMLS CUI [4,1]
C0032961
UMLS CUI [4,2]
C1283828
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Similar models

Eligibility Asthma NCT00404547

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00404547
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
written informed consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
age and asthma
Item
18 years or older with diagnosis of asthma for at least 6 months
boolean
C0001779 (UMLS CUI [1])
C0004096 (UMLS CUI [2])
stable asthma
Item
clinically stable asthma at the time of study enrollment
boolean
C0004096 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
ics
Item
clinical requirements for treatment with ics as outlined in the canadian asthma consensus guidelines
boolean
C3248292 (UMLS CUI [1])
ics stable dose
Item
if patients are currently on ics, the dose must be stable for 3 months and they must be willing to switch
boolean
C3248292 (UMLS CUI [1])
C0178602 (UMLS CUI [2,1])
C0205360 (UMLS CUI [2,2])
exclusion criteria
Item
main exclusion criteria:
boolean
C0680251 (UMLS CUI [1])
ics and long acting beta-2-agonist
Item
on combination therapy (ics + long acting beta-2-agonist) for asthma in the past 3 months or require combination therapy
boolean
C3248292 (UMLS CUI [1,1])
C1373132 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
severe asthma
Item
severe asthma, one or more asthma exacerbations in the last 3 months requiring hospitalization or emergency room visit, or patients who have used systemic steroids more than 3 times in the past 6 months or who are currently using systemic steroids
boolean
C0581126 (UMLS CUI [1])
C0349790 (UMLS CUI [2])
C1527398 (UMLS CUI [3])
C0019993 (UMLS CUI [4])
C2825233 (UMLS CUI [5])
mild asthma requiring short acting beta-2-agonists only
Item
mild asthma requiring short acting beta-2-agonists only
boolean
C0581124 (UMLS CUI [1,1])
C2936789 (UMLS CUI [1,2])
contraindication to ics therapy
Item
patients with a contraindication to ics therapy
boolean
C1301624 (UMLS CUI [1,1])
C3248292 (UMLS CUI [1,2])
comorbidity limiting study protocol
Item
any other disease or medical condition requiring further clinical evaluation, which in the opinion of the primary care practitioner may interfere with the clinical study or interfere with the diagnosis of asthma.
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
pregnancy, breast feeding, intention to become pregnant during the course of the study or lack of safe contraception in pre-menopausal women
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])
C0700589 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
C0032961 (UMLS CUI [4,1])
C1283828 (UMLS CUI [4,2])
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