ID

14290

Description

Inhaled TPI-1020 Versus Inhaled Budesonide in Smokers With Mild Reversible Asthma; ODM derived from: https://clinicaltrials.gov/show/NCT00327808

Link

https://clinicaltrials.gov/show/NCT00327808

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 NCT00327808

English

Eligibility Asthma NCT00327808

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00327808
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
males or females 18 through 65 years of age.
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
smoking history of more than 5 pack/years but less than 25 pack/years and who have no desire to quit smoking despite physician's advice and who currently smoke at least 5 cigarettes per day.
Description

smoking history

Data type

boolean

Alias
UMLS CUI [1]
C1519384
UMLS CUI [2]
C1277691
mild to moderate, stable, allergic asthma as defined by american thoracic society (ats) criteria 1
Description

mild to moderate, stable, allergic asthma

Data type

boolean

Alias
UMLS CUI [1,1]
C0155877
UMLS CUI [1,2]
C1299392
UMLS CUI [1,3]
C0004096
history of episodic wheeze and shortness of breath
Description

episodic wheeze and shortness of breath

Data type

boolean

Alias
UMLS CUI [1]
C0043144
UMLS CUI [2]
C0013404
subjects currently and only receiving inhaled short-acting bronchodilator treatment for asthma.
Description

inhaled short-acting bronchodilator

Data type

boolean

Alias
UMLS CUI [1]
C0578554
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
history or symptoms of significant autoimmune, hematological, or neurological disease, including transient ischemic attack (tia), stroke, seizure disorder, or behavioural disturbances that are judged clinically significant by the investigator
Description

comorbidity

Data type

boolean

Alias
UMLS CUI [1]
C0009488
history of serious adverse reaction or hypersensitivity to corticosteroids
Description

hypersensitivity to corticosteroids

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0001617
abnormal chest x-ray that is judged clinically significant
Description

abnormal chest x-ray

Data type

boolean

Alias
UMLS CUI [1]
C0436503
pregnant or lactating or have positive plasma pregnancy test
Description

pregnancy or lactation

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032976
use of oral/parenteral/inhaled corticosteroids within the last 28 days or injectable depot corticosteroids within the last 6 weeks.
Description

corticosteroid use

Data type

boolean

Alias
UMLS CUI [1]
C0239126
use of any other asthma-related medications within 1 month of screening
Description

asthma-related medications

Data type

boolean

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

Similar models

Eligibility Asthma NCT00327808

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00327808
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
age
Item
males or females 18 through 65 years of age.
boolean
C0001779 (UMLS CUI [1])
smoking history
Item
smoking history of more than 5 pack/years but less than 25 pack/years and who have no desire to quit smoking despite physician's advice and who currently smoke at least 5 cigarettes per day.
boolean
C1519384 (UMLS CUI [1])
C1277691 (UMLS CUI [2])
mild to moderate, stable, allergic asthma
Item
mild to moderate, stable, allergic asthma as defined by american thoracic society (ats) criteria 1
boolean
C0155877 (UMLS CUI [1,1])
C1299392 (UMLS CUI [1,2])
C0004096 (UMLS CUI [1,3])
episodic wheeze and shortness of breath
Item
history of episodic wheeze and shortness of breath
boolean
C0043144 (UMLS CUI [1])
C0013404 (UMLS CUI [2])
inhaled short-acting bronchodilator
Item
subjects currently and only receiving inhaled short-acting bronchodilator treatment for asthma.
boolean
C0578554 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
comorbidity
Item
history or symptoms of significant autoimmune, hematological, or neurological disease, including transient ischemic attack (tia), stroke, seizure disorder, or behavioural disturbances that are judged clinically significant by the investigator
boolean
C0009488 (UMLS CUI [1])
hypersensitivity to corticosteroids
Item
history of serious adverse reaction or hypersensitivity to corticosteroids
boolean
C0020517 (UMLS CUI [1,1])
C0001617 (UMLS CUI [1,2])
abnormal chest x-ray
Item
abnormal chest x-ray that is judged clinically significant
boolean
C0436503 (UMLS CUI [1])
pregnancy or lactation
Item
pregnant or lactating or have positive plasma pregnancy test
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032976 (UMLS CUI [3])
corticosteroid use
Item
use of oral/parenteral/inhaled corticosteroids within the last 28 days or injectable depot corticosteroids within the last 6 weeks.
boolean
C0239126 (UMLS CUI [1])
asthma-related medications
Item
use of any other asthma-related medications within 1 month of screening
boolean
C0013227 (UMLS CUI [1,1])
C0004096 (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