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ID

14290

Beschreibung

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

Stichworte

  1. 07.04.16 07.04.16 -
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CC BY-NC 3.0

Hochgeladen am

7. April 2016

DOI

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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
    Beschreibung

    Inclusion Criteria

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

    age

    Datentyp

    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.
    Beschreibung

    smoking history

    Datentyp

    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
    Beschreibung

    mild to moderate, stable, allergic asthma

    Datentyp

    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
    Beschreibung

    episodic wheeze and shortness of breath

    Datentyp

    boolean

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

    inhaled short-acting bronchodilator

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0578554
    Exclusion Criteria
    Beschreibung

    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
    Beschreibung

    comorbidity

    Datentyp

    boolean

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

    hypersensitivity to corticosteroids

    Datentyp

    boolean

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

    abnormal chest x-ray

    Datentyp

    boolean

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

    pregnancy or lactation

    Datentyp

    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.
    Beschreibung

    corticosteroid use

    Datentyp

    boolean

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

    asthma-related medications

    Datentyp

    boolean

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

    Ähnliche Modelle

    Eligibility Asthma NCT00327808

    1. StudyEvent: Eligibility
      1. Eligibility Asthma NCT00327808
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    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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