ID

14484

Description

A Comparison of Symbicort® Single Inhaler Therapy and Conventional Best Practice for the Treatment of Persistent Asthma; ODM derived from: https://clinicaltrials.gov/show/NCT00628758

Link

https://clinicaltrials.gov/show/NCT00628758

Keywords

Versions (1)
  1. 4/18/16 4/18/16 -
Copyright Holder

CC BY-NC 3.0

Uploaded on

April 18, 2016

DOI

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License

Creative Commons BY-NC 3.0
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Eligibility Asthma NCT00628758

English

Eligibility Asthma NCT00628758

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00628758
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
signed informed consent form. if the patient cannot read and write, verbal consent from the patient is required.
Description

informed consent form

Data type

boolean

Alias
UMLS CUI [1]
C0021430
ability to read and write in turkish
Description

turkish literacy

Data type

boolean

Alias
UMLS CUI [1,1]
C0023864
UMLS CUI [1,2]
C0041402
female or male outpatients aged 18 years
Description

outpatients aged 18 years

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0029921
minimum of 3 months history of asthma, diagnosed according to the american thoracic society (ats) definition
Description

history of asthma

Data type

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0004096
UMLS CUI [1,3]
C0040223
prescribed inhaled glucocorticosteroid (gcs) at a dose of 320mg/day and within the approved label for the relevant drug during the last 3 months prior to visit 1
Description

ics

Data type

boolean

Alias
UMLS CUI [1,1]
C3248292
UMLS CUI [1,2]
C0040223
either: daily maintenance treatment with both inhaled gcs and long-acting b2-agonist (laba) or daily treatment with inhaled gcs alone (i.e. without laba); and a history of suboptimal asthma control the month prior to enrollment as judged by the investigator; and use of 3 peak expiratory flow inhalations ofas needed medication for symptom relief during the last 7 days before enrollment
Description

asthma treatment

Data type

boolean

Alias
UMLS CUI [1]
C2065041
UMLS CUI [2]
C0040223
UMLS CUI [3]
C1373132
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous treatment with symbicort single inhaler therapy
Description

symbicort

Data type

boolean

Alias
UMLS CUI [1,1]
C1121854
UMLS CUI [1,2]
C1514463
use of any b-blocking agent, including eye drops
Description

adrenergic beta-antagonists

Data type

boolean

Alias
UMLS CUI [1]
C0001645
use of oral gcs as maintenance treatment
Description

oral corticosteroid

Data type

boolean

Alias
UMLS CUI [1]
C0001617
known or suspected hypersensitivity to study therapy or excipients
Description

hypersensitivity to study therapy or excipients

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0304229
a history of smoking 10 pack years
Description

smoking history

Data type

boolean

Alias
UMLS CUI [1]
C1519384
UMLS CUI [2]
C1277691
pregnancy, breast-feeding or planned pregnancy during the study. fertile women not using acceptable contraceptive measures, as judged by the investigator
Description

pregnancy lactation intention to become pregnant

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C3831118
UMLS CUI [3]
C0700589
UMLS CUI [4]
C0006147
UMLS CUI [5,1]
C0032961
UMLS CUI [5,2]
C1283828
any significant disease or disorder, which, in the opinion of the investigator, may put the patient at risk because of participating in the study
Description

comorbidity limiting participation

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
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Similar models

Eligibility Asthma NCT00628758

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00628758
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
informed consent form
Item
signed informed consent form. if the patient cannot read and write, verbal consent from the patient is required.
boolean
C0021430 (UMLS CUI [1])
turkish literacy
Item
ability to read and write in turkish
boolean
C0023864 (UMLS CUI [1,1])
C0041402 (UMLS CUI [1,2])
outpatients aged 18 years
Item
female or male outpatients aged 18 years
boolean
C0001779 (UMLS CUI [1])
C0029921 (UMLS CUI [2])
history of asthma
Item
minimum of 3 months history of asthma, diagnosed according to the american thoracic society (ats) definition
boolean
C0262926 (UMLS CUI [1,1])
C0004096 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
ics
Item
prescribed inhaled glucocorticosteroid (gcs) at a dose of 320mg/day and within the approved label for the relevant drug during the last 3 months prior to visit 1
boolean
C3248292 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
asthma treatment
Item
either: daily maintenance treatment with both inhaled gcs and long-acting b2-agonist (laba) or daily treatment with inhaled gcs alone (i.e. without laba); and a history of suboptimal asthma control the month prior to enrollment as judged by the investigator; and use of 3 peak expiratory flow inhalations ofas needed medication for symptom relief during the last 7 days before enrollment
boolean
C2065041 (UMLS CUI [1])
C0040223 (UMLS CUI [2])
C1373132 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
symbicort
Item
previous treatment with symbicort single inhaler therapy
boolean
C1121854 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
adrenergic beta-antagonists
Item
use of any b-blocking agent, including eye drops
boolean
C0001645 (UMLS CUI [1])
oral corticosteroid
Item
use of oral gcs as maintenance treatment
boolean
C0001617 (UMLS CUI [1])
hypersensitivity to study therapy or excipients
Item
known or suspected hypersensitivity to study therapy or excipients
boolean
C0020517 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
smoking history
Item
a history of smoking 10 pack years
boolean
C1519384 (UMLS CUI [1])
C1277691 (UMLS CUI [2])
pregnancy lactation intention to become pregnant
Item
pregnancy, breast-feeding or planned pregnancy during the study. fertile women not using acceptable contraceptive measures, as judged by the investigator
boolean
C0032961 (UMLS CUI [1])
C3831118 (UMLS CUI [2])
C0700589 (UMLS CUI [3])
C0006147 (UMLS CUI [4])
C0032961 (UMLS CUI [5,1])
C1283828 (UMLS CUI [5,2])
comorbidity limiting participation
Item
any significant disease or disorder, which, in the opinion of the investigator, may put the patient at risk because of participating in the study
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
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