Eligibility Asthma NCT00546520

1 Formulários

StudyEvent: Eligibility
1. Eligibility Asthma NCT00546520

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de dados

Alias

Criteria

Item Group

outpatients

Item

out-patients

boolean

C0029921 (UMLS CUI [1])

written informed consent

Item

written informed consent

boolean

C0021430 (UMLS CUI [1])

atopy

Item

history of atopic disease

boolean

C0392707 (UMLS CUI [1])

perennial asthma

Item

history of perennial bronchial asthma for at least 6 months as defined by ats criteria

boolean

C0004096 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])

short acting beta-2-agonist

Item

current use of only inhaled short acting beta-2-agonist as required (for at least 4 weeks prior to baseline period b0)

boolean

C2936789 (UMLS CUI [1])

stable asthma

Item

stable asthma, i.e. no exacerbation or relevant respiratory tract infection within 2 months prior to study start

boolean

C0004096 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])

fev1

Item

fev1 ≥ 70% predicted

boolean

C0748133 (UMLS CUI [1])

hyperreactivity to amp

Item

hyperreactivity to amp (pc20fev1 < 25 mg/ml)

boolean

C0020517 (UMLS CUI [1])

good health with the exception of asthma

Item

good health with the exception of asthma

boolean

C0018759 (UMLS CUI [1,1])
C0205170 (UMLS CUI [1,2])
C0004096 (UMLS CUI [2])

smoking history

Item

non-smokers as well as ex-smokers with either = 10 pack-years or more than 6 months of smoking abstinence

boolean

C1519384 (UMLS CUI [1])
C1277691 (UMLS CUI [2])
C0337672 (UMLS CUI [3])

exclusion criteria

Item

main exclusion criteria:

boolean

C0680251 (UMLS CUI [1])

comorbidity limiting use of inhaled steroids

Item

concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids (e.g. lung tuberculosis)

boolean

C0586793 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])

abnormal laboratory values

Item

clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation

boolean

C1254595 (UMLS CUI [1,1])
C0009488 (UMLS CUI [1,2])

systemic steroids

Item

use of systemic steroids 4 weeks (injectable depot steroids 6 weeks) before entry into the baseline period, or more than 3 times during the last 6 months

boolean

C2825233 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])

pregnancy or intention to become pregnant or lactation or lack of safe contraception

Item

pregnancy or intention to become pregnant during the course of the study, breast feeding, lack of safe contraception in heterosexually active female patients of child-bearing potential, or postmenopausal for less than one year

boolean

C0032961 (UMLS CUI [1])
C0032961 (UMLS CUI [2,1])
C1283828 (UMLS CUI [2,2])
C0700589 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0006147 (UMLS CUI [4])
C3831118 (UMLS CUI [5])
C0232970 (UMLS CUI [6])

copd or other relevant lung diseases

Item

copd (i.e. chronic bronchitis or emphysema) and/or other relevant lung diseases

boolean

C0024117 (UMLS CUI [1])
C0024115 (UMLS CUI [2])

hypersensitivity to inhaled steroids

Item

known or suspected hypersensitivity to inhaled steroids or to the other excipients of the metered dose inhalers

boolean

C0020517 (UMLS CUI [1,1])
C2065041 (UMLS CUI [1,2])

immunotherapy

Item

immunotherapy within one month prior to b0 and/or during the entire study duration

boolean

C0021083 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])

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Eligibility Asthma NCT00546520