Eligibility Asthma NCT00359073

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StudyEvent: Eligibility
1. Eligibility Asthma NCT00359073

Name

Typ

Description | Question | Decode (Coded Value)

Datatyp

Alias

Inclusion Criteria

Item Group

C1512693 (UMLS CUI)

mild persistent asthma

Item

a subject with mild persistent asthma is eligible for participation in the study if all of the following inclusion criteria apply:

boolean

C1960046 (UMLS CUI [1])

health status

Item

male or female with no health concerns that might affect the outcome of the study

boolean

C0018759 (UMLS CUI [1])

age

Item

age 18-65 range

boolean

C0001779 (UMLS CUI [1])

mild persistent asthma

Item

diagnosis of mild persistent asthma based on clinical findings such as cough, wheeze and shortness of breath

boolean

C1960046 (UMLS CUI [1])

history of asthma

Item

a history of asthma for at least six months prior to screening

boolean

C0262926 (UMLS CUI [1,1])
C0004096 (UMLS CUI [1,2])

fev1

Item

fev1> 80% of predicted

boolean

C0748133 (UMLS CUI [1])

allergy, prick skin test

Item

presence of allergy based on at least one positive prick skin test when tested with a standard panel of common allergens

boolean

C0430561 (UMLS CUI [1])
C0020517 (UMLS CUI [2])

ability to produce sputum

Item

ability to produce sputum when induced during the baseline assessments

boolean

C0038056 (UMLS CUI [1])

inhaled short acting b-agonist

Item

asthma medications consisting of only inhaled short acting b-agonist taken as needed

boolean

C2936789 (UMLS CUI [1])

reversible airway disease

Item

reversible airways disease as indicated by > 12% reversibility post b-agonist or

boolean

C0205343 (UMLS CUI [1,1])
C0699949 (UMLS CUI [1,2])
C2599594 (UMLS CUI [2])

methacholine hyperresponsiveness

Item

methacholine hyperresponsiveness (pc20 < 8 mg/ml)

boolean

C0430567 (UMLS CUI [1])

ability to give valid informed consent to participate by signing and dating a written consent form

Item

ability to give valid informed consent to participate by signing and dating a written consent form

boolean

C0021430 (UMLS CUI [1])

Exclusion Criteria

Item Group

C0680251 (UMLS CUI)

exclusion criteria

Item

a subject is not eligible to participate in this study if any of the following exclusion criteria apply:

boolean

C0680251 (UMLS CUI [1])

severe episodes of asthma

Item

history of severe episodes of asthma with respiratory infections

boolean

C0004096 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])

rv16 antibody

Item

screening serum rv16 antibody titer > 1

boolean

smoking history

Item

current smoker or has a smoking history exceeding 5 pack years

boolean

C1519384 (UMLS CUI [1])
C3241966 (UMLS CUI [2])

immunotherapy

Item

currently receiving immunotherapy

boolean

C0021083 (UMLS CUI [1])

participation status

Item

currently participating in another clinical trial or has participated in an investigational drug trial within one month of screening

boolean

C2348568 (UMLS CUI [1])

unable to comply

Item

unable, in the judgment of the investigator, to comply with directions and/or tolerate the procedures required for participation in this trial

boolean

C1321605 (UMLS CUI [1])

pregnancy or lactation or intention to become pregnant

Item

pregnant or breast-feeding or has a planned pregnancy during the course of the study

boolean

C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032961 (UMLS CUI [3,1])
C1283828 (UMLS CUI [3,2])

asthma controller

Item

regular use of an asthma controller such as montelukast or an inhaled corticosteroid.

boolean

C0004096 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])

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Eligibility Asthma NCT00359073