ID

14290

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT00327808

Nyckelord

  1. 2016-04-07 2016-04-07 -
Rättsinnehavare

CC BY-NC 3.0

Uppladdad den

7 april 2016

DOI

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Licens

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
Beskrivning

Inclusion Criteria

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

age

Datatyp

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.
Beskrivning

smoking history

Datatyp

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
Beskrivning

mild to moderate, stable, allergic asthma

Datatyp

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
Beskrivning

episodic wheeze and shortness of breath

Datatyp

boolean

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

inhaled short-acting bronchodilator

Datatyp

boolean

Alias
UMLS CUI [1]
C0578554
Exclusion Criteria
Beskrivning

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
Beskrivning

comorbidity

Datatyp

boolean

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

hypersensitivity to corticosteroids

Datatyp

boolean

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

abnormal chest x-ray

Datatyp

boolean

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

pregnancy or lactation

Datatyp

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.
Beskrivning

corticosteroid use

Datatyp

boolean

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

asthma-related medications

Datatyp

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
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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