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ID
13530
Description
A Study Comparative of Formoterol/Fluticasone Foraseq® and Fluticasone in Asthma Patients; ODM derived from: https://clinicaltrials.gov/show/NCT01202084
Link
https://clinicaltrials.gov/show/NCT01202084
Keywords
Versions (1)
- 2/13/16 2/13/16 -
Uploaded on
February 13, 2016
DOI
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License
Creative Commons BY 4.0
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Eligibility Asthma NCT01202084
Eligibility Asthma NCT01202084
- StudyEvent: Eligibility
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Eligibility Asthma NCT01202084
- StudyEvent: Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Consent Forms
Item
sign the icf
boolean
C0009797 (UMLS CUI [1])
age
Item
age ≥ 12 years
boolean
C0001779 (UMLS CUI [1])
persistent asthma
Item
persistent asthma diagnosis, as per the gina classification (www.ginasthma.com),18 with symptoms for at least 6 months and clinically stable for at least 1 month, with the acq-745 test (see appendix c) ≤ 3.0
boolean
C3266628 (UMLS CUI [1])
Steroid therapy Inhales drugs
Item
current use of inhaled corticosteroid (beclomethasone dipropionate dose of up to 1000
boolean
C0149783 (UMLS CUI [1,1])
C0556393 (UMLS CUI [1,2])
C0556393 (UMLS CUI [1,2])
Adrenergic beta-2 Receptor Agonists
Item
µg), associated or not with long-term β2-adrenergic agents and breakthrough medication (salbutamol or equivalent)
boolean
C2936789 (UMLS CUI [1])
fev1
Item
initial fev1 of at least 40% of the predicted normal value
boolean
C0802965 (UMLS CUI [1])
Serum cortisol measurement
Item
serum cortisol assessment within normal values.
boolean
C0236396 (UMLS CUI [1])
corticosteroid; Drug Administration Routes
Item
use of oral or parenteral corticosteroid within the 3 months prior to study beginning
boolean
C0001617 (UMLS CUI [1])
C0013153 (UMLS CUI [2])
C0013153 (UMLS CUI [2])
hospitalization
Item
requirement of admission due to asthma within the 3 months prior to study beginning
boolean
C0019993 (UMLS CUI [1])
smoking
Item
presence of active smoking, defined as the use of cigarette, pipe, cigar or any form of smoking at any amount within the last 3 months
boolean
C1519384 (UMLS CUI [1])
comorbidity; Cardiovascular Diseases
Item
presence of severe co-morbidities, such as cardiovascular, renal, liver, neurological, neoplastic, hematological, infectious, dermatological, neurological, psychiatric or chronic respiratory disease other than asthma
boolean
C0009488 (UMLS CUI [1])
C0007222 (UMLS CUI [2])
C0007222 (UMLS CUI [2])
Study Subject Participation Status
Item
recent (< 6 months) or predicted participation during this study in other clinical studies involving drugs of any nature or in studies of any form of intervention for treating asthma
boolean
C2348568 (UMLS CUI [1])
hypersensitivity drug
Item
intolerance or allergy to any of the components of the drugs assessed in the study
boolean
C0020517 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
pregnancy; lactation
Item
pregnancy or lactation
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0006147 (UMLS CUI [2])
beta blockers
Item
chronic use of β-blocker medications, per routine oral or intravenous route, or also as ophthalmic solutions
boolean
C0304516 (UMLS CUI [1])