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Eligibility Asthma, Bronchial NCT00385593

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
minimum of 3 months history of asthma, diagnosed according to the american thoracic society (ats) definition (9).
Description

Asthma

Data type

boolean

Alias
UMLS CUI [1]
C0004096
prescribed inhaled gcs at a dose of 400μg/day of budesonide (or equivalents)and within the approved label for the relevant drug during the last 3 months prior to visit 1.
Description

Glucocorticoids Inhalation | Budesonide

Data type

boolean

Alias
UMLS CUI [1,1]
C0017710
UMLS CUI [1,2]
C0205535
UMLS CUI [2]
C0054201
either daily maintenance treatment with both inhaled gcs and laba or daily treatment with inhaled gcs alone (i.e. without laba)
Description

Glucocorticoids Inhalation | Adrenergic beta-2 Receptor Agonists

Data type

boolean

Alias
UMLS CUI [1,1]
C0017710
UMLS CUI [1,2]
C0205535
UMLS CUI [2]
C2936789
a history of suboptimal asthma control the month prior to enrolment as judged by the investigator
Description

Asthma control suboptimal

Data type

boolean

Alias
UMLS CUI [1,1]
C0004096
UMLS CUI [1,2]
C0243148
UMLS CUI [1,3]
C2984009
use of ≥3 inhalations of as needed medication for symptom relief during the last 7 days before enrolment
Description

Inhalation Pharmaceutical Preparations | Symptom relieving factors

Data type

boolean

Alias
UMLS CUI [1,1]
C0205535
UMLS CUI [1,2]
C0013227
UMLS CUI [2]
C0436323
Exclusion Criteria
Description

Exclusion Criteria

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

Prior Therapy Symbicort Inhaler

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C1121854
UMLS CUI [1,3]
C0021461
use of any b-blocking agent, including eye-drops and oral gcs as maintenance treatment.
Description

Adrenergic beta-Antagonists | Eye Drops | Glucocorticoids Oral

Data type

boolean

Alias
UMLS CUI [1]
C0001645
UMLS CUI [2]
C0015399
UMLS CUI [3,1]
C0017710
UMLS CUI [3,2]
C1527415
known or suspected hypersensitivity to study therapy or excipients.
Description

Hypersensitivity Study Therapeutic procedure | Hypersensitivity Pharmaceutical Excipient

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C2603343
UMLS CUI [1,3]
C0087111
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0015237
a history of smoking ≥ 10 pack years.
Description

smoking cigarettes: ____ pack-years history

Data type

boolean

Alias
UMLS CUI [1]
C2230126
asthma exacerbation requiring change in asthma treatment during the last 14 days prior to or at visit 1.
Description

Exacerbation of asthma | Therapy change Asthma

Data type

boolean

Alias
UMLS CUI [1]
C0349790
UMLS CUI [2,1]
C3665894
UMLS CUI [2,2]
C0004096
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Similar models

Eligibility Asthma, Bronchial NCT00385593

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Asthma
Item
minimum of 3 months history of asthma, diagnosed according to the american thoracic society (ats) definition (9).
boolean
C0004096 (UMLS CUI [1])
Glucocorticoids Inhalation | Budesonide
Item
prescribed inhaled gcs at a dose of 400μg/day of budesonide (or equivalents)and within the approved label for the relevant drug during the last 3 months prior to visit 1.
boolean
C0017710 (UMLS CUI [1,1])
C0205535 (UMLS CUI [1,2])
C0054201 (UMLS CUI [2])
Glucocorticoids Inhalation | Adrenergic beta-2 Receptor Agonists
Item
either daily maintenance treatment with both inhaled gcs and laba or daily treatment with inhaled gcs alone (i.e. without laba)
boolean
C0017710 (UMLS CUI [1,1])
C0205535 (UMLS CUI [1,2])
C2936789 (UMLS CUI [2])
Asthma control suboptimal
Item
a history of suboptimal asthma control the month prior to enrolment as judged by the investigator
boolean
C0004096 (UMLS CUI [1,1])
C0243148 (UMLS CUI [1,2])
C2984009 (UMLS CUI [1,3])
Inhalation Pharmaceutical Preparations | Symptom relieving factors
Item
use of ≥3 inhalations of as needed medication for symptom relief during the last 7 days before enrolment
boolean
C0205535 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0436323 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Prior Therapy Symbicort Inhaler
Item
previous treatment with symbicort single inhaler;
boolean
C1514463 (UMLS CUI [1,1])
C1121854 (UMLS CUI [1,2])
C0021461 (UMLS CUI [1,3])
Adrenergic beta-Antagonists | Eye Drops | Glucocorticoids Oral
Item
use of any b-blocking agent, including eye-drops and oral gcs as maintenance treatment.
boolean
C0001645 (UMLS CUI [1])
C0015399 (UMLS CUI [2])
C0017710 (UMLS CUI [3,1])
C1527415 (UMLS CUI [3,2])
Hypersensitivity Study Therapeutic procedure | Hypersensitivity Pharmaceutical Excipient
Item
known or suspected hypersensitivity to study therapy or excipients.
boolean
C0020517 (UMLS CUI [1,1])
C2603343 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C0020517 (UMLS CUI [2,1])
C0015237 (UMLS CUI [2,2])
smoking cigarettes: ____ pack-years history
Item
a history of smoking ≥ 10 pack years.
boolean
C2230126 (UMLS CUI [1])
Exacerbation of asthma | Therapy change Asthma
Item
asthma exacerbation requiring change in asthma treatment during the last 14 days prior to or at visit 1.
boolean
C0349790 (UMLS CUI [1])
C3665894 (UMLS CUI [2,1])
C0004096 (UMLS CUI [2,2])
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