0 Ratings
ID

25967

Description

Randomised, open label, two period, crossover study to compare the steroid systemic exposure of Fluticasone Propionate (FP) from FP/Salmeterol (SALM) (500/50) DISKUS and Budesonide (BUD) from BUD/formoterol (FOR).(200/6) Turbuhaler in patients with severe Chronic Obstructive Pulmonary Disease. Primary objective:To compare the exposure of the inhaled steroid fluticasone propionate (FP) and budesonide following repeat dosing with SERETIDE DISKUS (500/50) one inhalation twice daily (b.i.d.) when compared with Symbicort Turbuhaler (200/6) two inhalations b.i.d. in a severe chronic pulmonary obstructive disease (COPD) population. Secondary objectives:To compare the pharmacokinetics of FP and budesonide following repeat dosing with SERETIDE DISKUS (500/50) one inhalation b.i.d. when compared with Symbicort Turbuhaler (200/6) two inhalations b.i.d. in a severe COPD population and to explore further the pharmacokinetics of FP and budesonide.

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Versions (2)
  1. 10/2/17 10/2/17 -
  2. 10/2/17 10/2/17 -
Copyright Holder

Glaxo Smith Kline

Uploaded on

October 2, 2017

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License

Creative Commons BY-NC 3.0
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    GSK Study ID 100807 Fluticasone Propionate from SERETIDE™ (500/50) DISKUS™ and Budesonide from Symbicort (200/6) Turbuhaler in patients with severe Chronic Obstructive Pulmonary Disease. Main CRF (Follow-up)

    English

    Main CRF (Follow-up)

    1 forms  
    1. StudyEvent: ODM
      1. Main CRF (Follow-up)
    Compliance Restrictions/ Concomitant Medications and Adverse Event Enquiry Worksheet
    Description

    Compliance Restrictions/ Concomitant Medications and Adverse Event Enquiry Worksheet

    Alias
    UMLS CUI-1
    C1321605
    UMLS CUI-2
    C0021822
    UMLS CUI-4
    C2347852
    UMLS CUI-5
    C0021822
    UMLS CUI-7
    C0877248
    UMLS CUI-8
    C0021822
    Subject number
    Description

    Subject number

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Investigator number
    Description

    Investigator Identifier

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2826689
    Treatment Number
    Description

    Treatment Number

    Data type

    text

    Alias
    UMLS CUI [1]
    C1522541
    Date of assessment
    Description

    day month year

    Data type

    date

    Alias
    UMLS CUI [1]
    C2985720
    Did the subject comply with the Requirements and Restrictions as listed in the protocol as appropriate thus far?
    Description

    Compliance behavior

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1321605
    Is the subject aware of any forthcoming requirements?
    Description

    Compliance behavior limited

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1321605
    UMLS CUI [1,2]
    C0439801
    Comments
    Description

    Comments

    Data type

    text

    Alias
    UMLS CUI [1]
    C0947611
    Has the subject used any concomitant medications?
    Description

    If YES, record on CONCOMITANT MEDICATIONS page(s).

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2347852
    Has there been any change in the state of the subject's health?
    Description

    If YES record any adverse events as per protocol.

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0018759
    UMLS CUI [1,2]
    C0392747
    Pregnancy Test Worksheet
    Description

    Pregnancy Test Worksheet

    Alias
    UMLS CUI-1
    C0032976
    Date sample taken
    Description

    Specimen collection

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0200345
    UMLS CUI [1,2]
    C0038577
    Is a pregnancy test applicable?
    Description

    pregnancy test

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0032976
    If YES, was pregnancy test performed?
    Description

    pregnancy test

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0032976
    Pregnancy test result, tick one
    Description

    If positive, complete PREGNANCY NOTIFICATION FORM.

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0032976
    UMLS CUI [1,2]
    C1274040
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    Similar models

    Main CRF (Follow-up)

    1 forms
    1. StudyEvent: ODM
      1. Main CRF (Follow-up)
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Compliance Restrictions/ Concomitant Medications and Adverse Event Enquiry Worksheet
    C1321605 (UMLS CUI-1)
    C0021822 (UMLS CUI-2)
    C2347852 (UMLS CUI-4)
    C0021822 (UMLS CUI-5)
    C0877248 (UMLS CUI-7)
    C0021822 (UMLS CUI-8)
    Subject number
    Item
    Subject number
    integer
    C2348585 (UMLS CUI [1])
    Investigator Identifier
    Item
    Investigator number
    integer
    C2826689 (UMLS CUI [1])
    Treatment Number
    Item
    Treatment Number
    text
    C1522541 (UMLS CUI [1])
    Date of assessment
    Item
    Date of assessment
    date
    C2985720 (UMLS CUI [1])
    Compliance behavior
    Item
    Did the subject comply with the Requirements and Restrictions as listed in the protocol as appropriate thus far?
    boolean
    C1321605 (UMLS CUI [1])
    Compliance behavior limited
    Item
    Is the subject aware of any forthcoming requirements?
    boolean
    C1321605 (UMLS CUI [1,1])
    C0439801 (UMLS CUI [1,2])
    Comments
    Item
    Comments
    text
    C0947611 (UMLS CUI [1])
    Concomitant medications
    Item
    Has the subject used any concomitant medications?
    boolean
    C2347852 (UMLS CUI [1])
    Health status change
    Item
    Has there been any change in the state of the subject's health?
    boolean
    C0018759 (UMLS CUI [1,1])
    C0392747 (UMLS CUI [1,2])
    Item Group
    Pregnancy Test Worksheet
    C0032976 (UMLS CUI-1)
    Specimen collection
    Item
    Date sample taken
    date
    C0200345 (UMLS CUI [1,1])
    C0038577 (UMLS CUI [1,2])
    pregnancy test
    Item
    Is a pregnancy test applicable?
    boolean
    C0032976 (UMLS CUI [1])
    pregnancy test
    Item
    If YES, was pregnancy test performed?
    boolean
    C0032976 (UMLS CUI [1])
    Item
    Pregnancy test result, tick one
    text
    C0032976 (UMLS CUI [1,1])
    C1274040 (UMLS CUI [1,2])
    Pregnancy Test Result
    Code List
    Pregnancy test result, tick one
    CL Item
    negative (N)
    CL Item
    positive (P)
    Back to the top of the page 

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