ID

14294

Description

Effect of Montelukast on Experimentally-Induced RV16 Infection in Asthma; ODM derived from: https://clinicaltrials.gov/show/NCT00359073

Link

https://clinicaltrials.gov/show/NCT00359073

Keywords

Versions (1)
  1. 4/7/16 4/7/16 -
Copyright Holder

CC BY-NC 3.0

Uploaded on

April 7, 2016

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Asthma NCT00359073

English

Eligibility Asthma NCT00359073

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00359073
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
a subject with mild persistent asthma is eligible for participation in the study if all of the following inclusion criteria apply:
Description

mild persistent asthma

Data type

boolean

Alias
UMLS CUI [1]
C1960046
male or female with no health concerns that might affect the outcome of the study
Description

health status

Data type

boolean

Alias
UMLS CUI [1]
C0018759
age 18-65 range
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
diagnosis of mild persistent asthma based on clinical findings such as cough, wheeze and shortness of breath
Description

mild persistent asthma

Data type

boolean

Alias
UMLS CUI [1]
C1960046
a history of asthma for at least six months prior to screening
Description

history of asthma

Data type

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0004096
fev1> 80% of predicted
Description

fev1

Data type

boolean

Alias
UMLS CUI [1]
C0748133
presence of allergy based on at least one positive prick skin test when tested with a standard panel of common allergens
Description

allergy, prick skin test

Data type

boolean

Alias
UMLS CUI [1]
C0430561
UMLS CUI [2]
C0020517
ability to produce sputum when induced during the baseline assessments
Description

ability to produce sputum

Data type

boolean

Alias
UMLS CUI [1]
C0038056
asthma medications consisting of only inhaled short acting b-agonist taken as needed
Description

inhaled short acting b-agonist

Data type

boolean

Alias
UMLS CUI [1]
C2936789
reversible airways disease as indicated by > 12% reversibility post b-agonist or
Description

reversible airway disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0205343
UMLS CUI [1,2]
C0699949
UMLS CUI [2]
C2599594
methacholine hyperresponsiveness (pc20 < 8 mg/ml)
Description

methacholine hyperresponsiveness

Data type

boolean

Alias
UMLS CUI [1]
C0430567
ability to give valid informed consent to participate by signing and dating a written consent form
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
a subject is not eligible to participate in this study if any of the following exclusion criteria apply:
Description

exclusion criteria

Data type

boolean

Alias
UMLS CUI [1]
C0680251
history of severe episodes of asthma with respiratory infections
Description

severe episodes of asthma

Data type

boolean

Alias
UMLS CUI [1,1]
C0004096
UMLS CUI [1,2]
C0205082
screening serum rv16 antibody titer > 1
Description

rv16 antibody

Data type

boolean

current smoker or has a smoking history exceeding 5 pack years
Description

smoking history

Data type

boolean

Alias
UMLS CUI [1]
C1519384
UMLS CUI [2]
C3241966
currently receiving immunotherapy
Description

immunotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0021083
currently participating in another clinical trial or has participated in an investigational drug trial within one month of screening
Description

participation status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
unable, in the judgment of the investigator, to comply with directions and/or tolerate the procedures required for participation in this trial
Description

unable to comply

Data type

boolean

Alias
UMLS CUI [1]
C1321605
pregnant or breast-feeding or has a planned pregnancy during the course of the study
Description

pregnancy or lactation or intention to become pregnant

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0032961
UMLS CUI [3,2]
C1283828
regular use of an asthma controller such as montelukast or an inhaled corticosteroid.
Description

asthma controller

Data type

boolean

Alias
UMLS CUI [1,1]
C0004096
UMLS CUI [1,2]
C0013227
Back to the top of the page

Similar models

Eligibility Asthma NCT00359073

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00359073
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
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])
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])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial