ID

13530

Descripción

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

Palabras clave

  1. 13/2/16 13/2/16 -
Subido en

13 de febrero de 2016

DOI

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Licencia

Creative Commons BY 4.0

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Eligibility Asthma NCT01202084

Eligibility Asthma NCT01202084

  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT01202084
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
sign the icf
Descripción

Consent Forms

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0009797
age ≥ 12 years
Descripción

age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
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
Descripción

persistent asthma

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3266628
current use of inhaled corticosteroid (beclomethasone dipropionate dose of up to 1000
Descripción

Steroid therapy Inhales drugs

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0149783
UMLS CUI [1,2]
C0556393
µg), associated or not with long-term β2-adrenergic agents and breakthrough medication (salbutamol or equivalent)
Descripción

Adrenergic beta-2 Receptor Agonists

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2936789
initial fev1 of at least 40% of the predicted normal value
Descripción

fev1

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0802965
serum cortisol assessment within normal values.
Descripción

Serum cortisol measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0236396
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
use of oral or parenteral corticosteroid within the 3 months prior to study beginning
Descripción

corticosteroid; Drug Administration Routes

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001617
UMLS CUI [2]
C0013153
requirement of admission due to asthma within the 3 months prior to study beginning
Descripción

hospitalization

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019993
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
Descripción

smoking

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1519384
presence of severe co-morbidities, such as cardiovascular, renal, liver, neurological, neoplastic, hematological, infectious, dermatological, neurological, psychiatric or chronic respiratory disease other than asthma
Descripción

comorbidity; Cardiovascular Diseases

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2]
C0007222
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
Descripción

Study Subject Participation Status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
intolerance or allergy to any of the components of the drugs assessed in the study
Descripción

hypersensitivity drug

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013227
pregnancy or lactation
Descripción

pregnancy; lactation

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
chronic use of β-blocker medications, per routine oral or intravenous route, or also as ophthalmic solutions
Descripción

beta blockers

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0304516

Similar models

Eligibility Asthma NCT01202084

  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT01202084
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
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])
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])
Item Group
C0680251 (UMLS CUI)
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])
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])
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])
pregnancy; lactation
Item
pregnancy or lactation
boolean
C0032961 (UMLS CUI [1])
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])

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