ID

12913

Description

Pediatric Asthma Study Using Stepwise Treatment With Two Food And Drug Administration Approved Asthma Medications; ODM derived from: https://clinicaltrials.gov/show/NCT00158834

Link

https://clinicaltrials.gov/show/NCT00158834

Keywords

  1. 1/6/16 1/6/16 -
Copyright Holder

CC BY-NC 3.0

Uploaded on

January 6, 2016

DOI

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License

Creative Commons BY-NC 3.0

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Eligibility Asthma NCT00158834

Eligibility Asthma NCT00158834

  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00158834
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
children with a documented history of asthma.
Description

asthma

Data type

boolean

Alias
UMLS CUI [1]
C0004096
using inhaled steroids from 100 mcg up to 500 mcg twice daily for at least 1 month before study start.
Description

inhaled steroids

Data type

boolean

Alias
UMLS CUI [1]
C2065041
must be able to perform reproducible lung function tests.
Description

lung function tests

Data type

boolean

Alias
UMLS CUI [1]
C0024119
must have a positive rast or skin prick test.
Description

RAST or skin prick test

Data type

boolean

Alias
UMLS CUI [1]
C0034554
UMLS CUI [2]
C0430561
during the treatment period, the patient has to be hyperreactive (defined as pd20 methacholine < 150 mcg) and/or have a cumulative symptom score of 14 based on the daily record card filled in during the last 2 weeks of the run-in period.
Description

Hyperreactivity

Data type

boolean

Alias
UMLS CUI [1]
C1096470
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of an acute upper or lower respiratory tract infection, middle ear, or sinus infection 4 weeks prior to visit 1.
Description

Infection

Data type

boolean

Alias
UMLS CUI [1]
C0009450
admitted to hospital due to a respiratory disease 4 weeks prior to visit 1.
Description

respiratory disease

Data type

boolean

Alias
UMLS CUI [1]
C0035204
received oral corticosteroids within 4 weeks prior to visit 1.
Description

oral corticosteroids

Data type

boolean

Alias
UMLS CUI [1]
C0001617
existence of any disorder that affects growth.
Description

disorder that affects growth

Data type

boolean

Alias
UMLS CUI [1]
C0009488
clinical or laboratory evidence of a serious systemic disease, or suspected hypersensitivity to corticosteroids, lactose or short/long acting b2-agonists.
Description

Comorbidity

Data type

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0001617
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0022949
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C2936789

Similar models

Eligibility Asthma NCT00158834

  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00158834
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
asthma
Item
children with a documented history of asthma.
boolean
C0004096 (UMLS CUI [1])
inhaled steroids
Item
using inhaled steroids from 100 mcg up to 500 mcg twice daily for at least 1 month before study start.
boolean
C2065041 (UMLS CUI [1])
lung function tests
Item
must be able to perform reproducible lung function tests.
boolean
C0024119 (UMLS CUI [1])
RAST or skin prick test
Item
must have a positive rast or skin prick test.
boolean
C0034554 (UMLS CUI [1])
C0430561 (UMLS CUI [2])
Hyperreactivity
Item
during the treatment period, the patient has to be hyperreactive (defined as pd20 methacholine < 150 mcg) and/or have a cumulative symptom score of 14 based on the daily record card filled in during the last 2 weeks of the run-in period.
boolean
C1096470 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Infection
Item
history of an acute upper or lower respiratory tract infection, middle ear, or sinus infection 4 weeks prior to visit 1.
boolean
C0009450 (UMLS CUI [1])
respiratory disease
Item
admitted to hospital due to a respiratory disease 4 weeks prior to visit 1.
boolean
C0035204 (UMLS CUI [1])
oral corticosteroids
Item
received oral corticosteroids within 4 weeks prior to visit 1.
boolean
C0001617 (UMLS CUI [1])
disorder that affects growth
Item
existence of any disorder that affects growth.
boolean
C0009488 (UMLS CUI [1])
Comorbidity
Item
clinical or laboratory evidence of a serious systemic disease, or suspected hypersensitivity to corticosteroids, lactose or short/long acting b2-agonists.
boolean
C0009488 (UMLS CUI [1])
C0020517 (UMLS CUI [2,1])
C0001617 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0022949 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C2936789 (UMLS CUI [4,2])

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