ID

14346

Description

Efficacy and Safety of Single Doses of Indacaterol Delivered Via a Single Dose Dry Powder Inhaler (SDDPI) Compared to Placebo in Patients With Persistent Asthma; ODM derived from: https://clinicaltrials.gov/show/NCT00403637

Link

https://clinicaltrials.gov/show/NCT00403637

Keywords

  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 NCT00403637

Eligibility Asthma NCT00403637

  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00403637
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
males and females 12 - 75 years of age with a diagnosis of persistent asthma
Description

age and persistent asthma

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C3266628
daily treatment with a bronchodilator and daily dose of at least 100 µg beclomethasone dipropionate or equivalent
Description

bronchodilator daily treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C0578554
UMLS CUI [1,2]
C0332173
UMLS CUI [2]
C0004906
fev1 at visit 1 at least 50% of the predicted normal value
Description

fev1

Data type

boolean

Alias
UMLS CUI [1]
C0748133
fev1 reversibility at least 15%
Description

fev1 reversibility

Data type

boolean

Alias
UMLS CUI [1,1]
C0748133
UMLS CUI [1,2]
C0449261
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
use of tobacco products within 6 months prior to visit 1 or a smoking history of more than 10 pack years
Description

smoking history

Data type

boolean

Alias
UMLS CUI [1,1]
C1519384
UMLS CUI [1,2]
C1277691
chronic obstructive pulmonary disease (copd)
Description

copd

Data type

boolean

Alias
UMLS CUI [1]
C0024117
seasonal allergy where asthma is likely to deteriorate during the period of the study
Description

seasonal allergy

Data type

boolean

Alias
UMLS CUI [1]
C0018621
emergency room treatment for an acute asthma attack within the previous 6 weeks or hospitalized within the previous 6 months
Description

emergency room treatment for an acute asthma attack within the previous 6 weeks or hospitalized within the previous 6 months

Data type

boolean

Alias
UMLS CUI [1,1]
C2065341
UMLS CUI [1,2]
C0004096
UMLS CUI [2]
C0019993
a respiratory tract infection within the previous 6 weeks other protocol-defined exclusion criteria may apply
Description

respiratory tract infection

Data type

boolean

Alias
UMLS CUI [1,1]
C0035243
UMLS CUI [1,2]
C0040223

Similar models

Eligibility Asthma NCT00403637

  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00403637
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
age and persistent asthma
Item
males and females 12 - 75 years of age with a diagnosis of persistent asthma
boolean
C0001779 (UMLS CUI [1])
C3266628 (UMLS CUI [2])
bronchodilator daily treatment
Item
daily treatment with a bronchodilator and daily dose of at least 100 µg beclomethasone dipropionate or equivalent
boolean
C0578554 (UMLS CUI [1,1])
C0332173 (UMLS CUI [1,2])
C0004906 (UMLS CUI [2])
fev1
Item
fev1 at visit 1 at least 50% of the predicted normal value
boolean
C0748133 (UMLS CUI [1])
fev1 reversibility
Item
fev1 reversibility at least 15%
boolean
C0748133 (UMLS CUI [1,1])
C0449261 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
smoking history
Item
use of tobacco products within 6 months prior to visit 1 or a smoking history of more than 10 pack years
boolean
C1519384 (UMLS CUI [1,1])
C1277691 (UMLS CUI [1,2])
copd
Item
chronic obstructive pulmonary disease (copd)
boolean
C0024117 (UMLS CUI [1])
seasonal allergy
Item
seasonal allergy where asthma is likely to deteriorate during the period of the study
boolean
C0018621 (UMLS CUI [1])
emergency room treatment for an acute asthma attack within the previous 6 weeks or hospitalized within the previous 6 months
Item
emergency room treatment for an acute asthma attack within the previous 6 weeks or hospitalized within the previous 6 months
boolean
C2065341 (UMLS CUI [1,1])
C0004096 (UMLS CUI [1,2])
C0019993 (UMLS CUI [2])
respiratory tract infection
Item
a respiratory tract infection within the previous 6 weeks other protocol-defined exclusion criteria may apply
boolean
C0035243 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])

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