ID

14290

Descrição

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

Palavras-chave

  1. 07/04/2016 07/04/2016 -
Titular dos direitos

CC BY-NC 3.0

Transferido a

7 de abril de 2016

DOI

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Licença

Creative Commons BY-NC 3.0

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Eligibility Asthma NCT00327808

Eligibility Asthma NCT00327808

  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00327808
Inclusion Criteria
Descrição

Inclusion Criteria

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

age

Tipo de dados

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.
Descrição

smoking history

Tipo de dados

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
Descrição

mild to moderate, stable, allergic asthma

Tipo de dados

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
Descrição

episodic wheeze and shortness of breath

Tipo de dados

boolean

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

inhaled short-acting bronchodilator

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0578554
Exclusion Criteria
Descrição

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
Descrição

comorbidity

Tipo de dados

boolean

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

hypersensitivity to corticosteroids

Tipo de dados

boolean

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

abnormal chest x-ray

Tipo de dados

boolean

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

pregnancy or lactation

Tipo de dados

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.
Descrição

corticosteroid use

Tipo de dados

boolean

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

asthma-related medications

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0004096

Similar models

Eligibility Asthma NCT00327808

  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00327808
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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])

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