0 Ratings

ID

12758

Description

A 3-week Study Investigating Patient Use and Functionality of Formoterol in a Novel Inhalation Device in Patients With Asthma; ODM derived from: https://clinicaltrials.gov/show/NCT00130351

Link

https://clinicaltrials.gov/show/NCT00130351

Keywords

  1. 12/21/15 12/21/15 -
Uploaded on

December 21, 2015

DOI

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License

Creative Commons BY 4.0

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    Eligibility Asthma NCT00130351

    Eligibility Asthma NCT00130351

    1. StudyEvent: Eligibility
      1. Eligibility Asthma NCT00130351
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    patients who are capable of understanding the directions for device usage, evaluating device function and completing the patient diary
    Description

    compliance

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1321605
    patients who have a current diagnosis of asthma
    Description

    asthma

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0004096
    patients who have a documented forced expiratory volume at 1 second (fev1) reversibility of at least 12% over baseline value following administration of a bronchodilator (i.e. "historical" reversibility) or demonstrate a >12% increase in fev1 over their baseline value within 30 minutes after inhalation of up to 360 µg (4 puffs) of albuterol at visit 1. the administration of albuterol for the reversibility test must be within 30 minutes after baseline spirometry.
    Description

    Forced expiratory volume in 1 second finding; Bronchodilator Agents

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0429706
    UMLS CUI [2]
    C0006280
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    patients who were enrolled in study cfor258f2304 or cfor258f2306, or who have any experience using the certihaler® device.
    Description

    Study Subject Participation Status

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2348568
    qtc above 450 milliseconds for males and 470 milliseconds for females, or any findings on the screening electrocardiogram (ecg) that in the opinion of the investigator would present a safety hazard for continuation in the study
    Description

    Compliance behavior Limited Comorbidity

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1321605
    UMLS CUI [1,2]
    C0439801
    UMLS CUI [1,3]
    C0009488
    patients who have a known history of untoward reactions to sympathomimetic amines or to inhaled medications or to any of the individual components in those therapies
    Description

    hypersensitivity sympathomimetic amines

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C0002509
    other protocol-defined inclusion and exclusion criteria apply
    Description

    Study Subject Participation Status

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2348568

    Similar models

    Eligibility Asthma NCT00130351

    1. StudyEvent: Eligibility
      1. Eligibility Asthma NCT00130351
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    compliance
    Item
    patients who are capable of understanding the directions for device usage, evaluating device function and completing the patient diary
    boolean
    C1321605 (UMLS CUI [1])
    asthma
    Item
    patients who have a current diagnosis of asthma
    boolean
    C0004096 (UMLS CUI [1])
    Forced expiratory volume in 1 second finding; Bronchodilator Agents
    Item
    patients who have a documented forced expiratory volume at 1 second (fev1) reversibility of at least 12% over baseline value following administration of a bronchodilator (i.e. "historical" reversibility) or demonstrate a >12% increase in fev1 over their baseline value within 30 minutes after inhalation of up to 360 µg (4 puffs) of albuterol at visit 1. the administration of albuterol for the reversibility test must be within 30 minutes after baseline spirometry.
    boolean
    C0429706 (UMLS CUI [1])
    C0006280 (UMLS CUI [2])
    Item Group
    C0680251 (UMLS CUI)
    Study Subject Participation Status
    Item
    patients who were enrolled in study cfor258f2304 or cfor258f2306, or who have any experience using the certihaler® device.
    boolean
    C2348568 (UMLS CUI [1])
    Compliance behavior Limited Comorbidity
    Item
    qtc above 450 milliseconds for males and 470 milliseconds for females, or any findings on the screening electrocardiogram (ecg) that in the opinion of the investigator would present a safety hazard for continuation in the study
    boolean
    C1321605 (UMLS CUI [1,1])
    C0439801 (UMLS CUI [1,2])
    C0009488 (UMLS CUI [1,3])
    hypersensitivity sympathomimetic amines
    Item
    patients who have a known history of untoward reactions to sympathomimetic amines or to inhaled medications or to any of the individual components in those therapies
    boolean
    C0020517 (UMLS CUI [1,1])
    C0002509 (UMLS CUI [1,2])
    Study Subject Participation Status
    Item
    other protocol-defined inclusion and exclusion criteria apply
    boolean
    C2348568 (UMLS CUI [1])

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