ID

14345

Description

To Evaluate the Inflammatory Markers in Adult Patients With Asthma Associated With Allergic Rhinitis Receiving Montelukast Therapy (0476-366); ODM derived from: https://clinicaltrials.gov/show/NCT00398151

Link

https://clinicaltrials.gov/show/NCT00398151

Keywords

Versions (1)
  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 NCT00398151

English

Eligibility Asthma NCT00398151

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00398151
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
allergic rhinitis symptoms: sneezing, rhinorrhea, obstruction of the nasal passages, itchy nose and throat, and conjunctival
Description

allergic rhinitis symptoms

Data type

boolean

Alias
UMLS CUI [1,1]
C2607914
UMLS CUI [1,2]
C1457887
UMLS CUI [2]
C0037383
UMLS CUI [3]
C0027429
UMLS CUI [4]
C0850060
UMLS CUI [5]
C0700184
male or female outpatient 20 years of age and older
Description

outpatient, age

Data type

boolean

Alias
UMLS CUI [1]
C0029921
UMLS CUI [2]
C0001779
patients with the following signs and symptoms of asthma and allergic rhinitis: history of cough, wheezing, shortness of breath, positive methacholine bronchoprovocation test
Description

asthma and allergic rhinitis symptoms

Data type

boolean

Alias
UMLS CUI [1]
C0004096
UMLS CUI [2]
C2607914
UMLS CUI [3,1]
C0430567
UMLS CUI [3,2]
C1446409
UMLS CUI [4]
C0010200
UMLS CUI [5]
C0043144
UMLS CUI [6]
C0013404
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
active, acute or chronic, pulmonary disorder (besides asthma) documented by history, physical examination, or chest x-ray. history of anaphylactic or hypersensitive to study drug
Description

pulmonary disorder

Data type

boolean

Alias
UMLS CUI [1]
C1096000
requires oral, intravenous, or intramuscular corticosteroids on daily routine basis
Description

corticosteroids daily

Data type

boolean

Alias
UMLS CUI [1,1]
C0001617
UMLS CUI [1,2]
C0332173
started on immunotherapy within six months before the pre-study visit and/or the dose of immunotherapy is expected to change over the course of the study
Description

immunotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0021083
UMLS CUI [1,2]
C0040223
treated with montelukast within 3 months before enrollment
Description

montelukast

Data type

boolean

Alias
UMLS CUI [1]
C0298130
unable to perform acceptable, reproducible spirometry and peak flow measurement
Description

unable to perform acceptable, reproducible spirometry and peak flow measurement

Data type

boolean

Alias
UMLS CUI [1]
C1321605
UMLS CUI [2]
C0037981
UMLS CUI [3]
C0521299
unresolved symptoms and signs of an upper respiratory tract infection (uri) within 2 weeks prior to visit 1
Description

upper respiratory tract infection

Data type

boolean

Alias
UMLS CUI [1]
C0041912
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Similar models

Eligibility Asthma NCT00398151

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00398151
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
allergic rhinitis symptoms
Item
allergic rhinitis symptoms: sneezing, rhinorrhea, obstruction of the nasal passages, itchy nose and throat, and conjunctival
boolean
C2607914 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0037383 (UMLS CUI [2])
C0027429 (UMLS CUI [3])
C0850060 (UMLS CUI [4])
C0700184 (UMLS CUI [5])
outpatient, age
Item
male or female outpatient 20 years of age and older
boolean
C0029921 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
asthma and allergic rhinitis symptoms
Item
patients with the following signs and symptoms of asthma and allergic rhinitis: history of cough, wheezing, shortness of breath, positive methacholine bronchoprovocation test
boolean
C0004096 (UMLS CUI [1])
C2607914 (UMLS CUI [2])
C0430567 (UMLS CUI [3,1])
C1446409 (UMLS CUI [3,2])
C0010200 (UMLS CUI [4])
C0043144 (UMLS CUI [5])
C0013404 (UMLS CUI [6])
Item Group
C0680251 (UMLS CUI)
pulmonary disorder
Item
active, acute or chronic, pulmonary disorder (besides asthma) documented by history, physical examination, or chest x-ray. history of anaphylactic or hypersensitive to study drug
boolean
C1096000 (UMLS CUI [1])
corticosteroids daily
Item
requires oral, intravenous, or intramuscular corticosteroids on daily routine basis
boolean
C0001617 (UMLS CUI [1,1])
C0332173 (UMLS CUI [1,2])
immunotherapy
Item
started on immunotherapy within six months before the pre-study visit and/or the dose of immunotherapy is expected to change over the course of the study
boolean
C0021083 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
montelukast
Item
treated with montelukast within 3 months before enrollment
boolean
C0298130 (UMLS CUI [1])
unable to perform acceptable, reproducible spirometry and peak flow measurement
Item
unable to perform acceptable, reproducible spirometry and peak flow measurement
boolean
C1321605 (UMLS CUI [1])
C0037981 (UMLS CUI [2])
C0521299 (UMLS CUI [3])
upper respiratory tract infection
Item
unresolved symptoms and signs of an upper respiratory tract infection (uri) within 2 weeks prior to visit 1
boolean
C0041912 (UMLS CUI [1])
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