0 Bedömningar
ID

26107

Beskrivning

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.

Nyckelord

Versioner (1)
  1. 2017-10-09 2017-10-09 -
Rättsinnehavare

Glaxo Smith Kline

Uppladdad den

9 oktober 2017

DOI

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Licens

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. End of Study Record

    Engelsk

    End of Study Record

    1 Formulär  
    1. StudyEvent: ODM
      1. End of Study Record
    End of Study Record
    Beskrivning

    End of Study Record

    Alias
    UMLS CUI-1
    C0008976 (Clinical Trials)
    SNOMED
    110465008
    LOINC
    LP231796-6
    UMLS CUI-2
    C0444930 (End)
    SNOMED
    261782000
    Subject number
    Beskrivning

    Subject number

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Date of subject completion or discontinuation from the study
    Beskrivning

    Date of subject completion or discontinuation from the study

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C2348577 (Subject Completed Participation in Study)
    UMLS CUI [1,2]
    C0011008 (Date in time)
    SNOMED
    410671006
    Time of subject completion or discontinuation from the study
    Beskrivning

    Time of subject completion or discontinuation from the study

    Datatyp

    time

    Alias
    UMLS CUI [1,1]
    C2348577 (Subject Completed Participation in Study)
    UMLS CUI [1,2]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    Did the subject become pregnant during the study?
    Beskrivning

    If YES, record details on PREGNANCY NOTIFICATION FORM.

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0032961 (Pregnancy)
    SNOMED
    289908002
    LOINC
    LP75920-6
    Did the subject discontinue the study prematurely?
    Beskrivning

    premature discontinuation of study

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0457454 (Discontinuation (procedure))
    UMLS CUI [1,2]
    C2348568 (Study Subject Participation Status)
    Primary reason for premature discontinuation
    Beskrivning

    premature discontinuation of study

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0457454 (Discontinuation (procedure))
    UMLS CUI [1,2]
    C2348568 (Study Subject Participation Status)
    Specify other reason for discontinuation
    Beskrivning

    Other reason for discontinuation

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0457454 (Discontinuation (procedure))
    UMLS CUI [1,2]
    C3840932 (Other Reason)
    LOINC
    LA6535-4
    Investigator Comment Log
    Beskrivning

    Investigator Comment Log

    Alias
    UMLS CUI-1
    C0008961 (Clinical Investigators)
    UMLS CUI-2
    C0947611 (Comment)
    LOINC
    LP72293-1
    Date of comment
    Beskrivning

    Date of comment

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0947611 (Comment)
    LOINC
    LP72293-1
    UMLS CUI [1,2]
    C0011008 (Date in time)
    SNOMED
    410671006
    CRF page number if applicable
    Beskrivning

    page number

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C1704732 (Page (document))
    Comment
    Beskrivning

    Comment

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0947611 (Comment)
    LOINC
    LP72293-1
    I confirm that I have carefully examined all entries on the Screening Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, correct as of the date below.
    Beskrivning

    Investigator's Statement

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0008961 (Clinical Investigators)
    UMLS CUI [1,2]
    C1710187 (Statement)
    Date of completion
    Beskrivning

    Date of completion

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0011008 (Date in time)
    SNOMED
    410671006
    UMLS CUI [1,2]
    C0850287 (document completion)
    Investigators signature
    Beskrivning

    Investigators signature

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C2346576 (Investigator Signature)
    Investigators name-print
    Beskrivning

    Investigators name

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C2826892 (Investigator Name)
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    Similar models

    End of Study Record

    1 Formulär
    1. StudyEvent: ODM
      1. End of Study Record
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    End of Study Record
    C0008976 (UMLS CUI-1)
    C0444930 (UMLS CUI-2)
    Subject number
    Item
    Subject number
    integer
    C2348585 (UMLS CUI [1])
    Date of subject completion or discontinuation from the study
    Item
    Date of subject completion or discontinuation from the study
    date
    C2348577 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Time of subject completion or discontinuation from the study
    Item
    Time of subject completion or discontinuation from the study
    time
    C2348577 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Item
    Did the subject become pregnant during the study?
    text
    C0032961 (UMLS CUI [1])
    Pregnancy
    Code List
    Did the subject become pregnant during the study?
    CL Item
    No (N)
    CL Item
    Not Applicable (not of childbearing potential or male) (X)
    CL Item
    Yes (Y)
    premature discontinuation of study
    Item
    Did the subject discontinue the study prematurely?
    boolean
    C0457454 (UMLS CUI [1,1])
    C2348568 (UMLS CUI [1,2])
    Item
    Primary reason for premature discontinuation
    text
    C0457454 (UMLS CUI [1,1])
    C2348568 (UMLS CUI [1,2])
    premature discontinuation of study
    Code List
    Primary reason for premature discontinuation
    CL Item
    Adverse event (A)
    CL Item
    Consent withdrawn (C)
    CL Item
    Lost to follow up (L)
    CL Item
    Protocol violation (P)
    CL Item
    Other (X)
    Other reason for discontinuation
    Item
    Specify other reason for discontinuation
    text
    C0457454 (UMLS CUI [1,1])
    C3840932 (UMLS CUI [1,2])
    Item Group
    Investigator Comment Log
    C0008961 (UMLS CUI-1)
    C0947611 (UMLS CUI-2)
    Date of comment
    Item
    Date of comment
    date
    C0947611 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    page number
    Item
    CRF page number if applicable
    integer
    C1704732 (UMLS CUI [1])
    Comment
    Item
    Comment
    text
    C0947611 (UMLS CUI [1])
    Investigator's Statement
    Item
    I confirm that I have carefully examined all entries on the Screening Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, correct as of the date below.
    boolean
    C0008961 (UMLS CUI [1,1])
    C1710187 (UMLS CUI [1,2])
    Date of completion
    Item
    Date of completion
    date
    C0011008 (UMLS CUI [1,1])
    C0850287 (UMLS CUI [1,2])
    Investigators signature
    Item
    Investigators signature
    text
    C2346576 (UMLS CUI [1])
    Investigators name
    Item
    Investigators name-print
    text
    C2826892 (UMLS CUI [1])
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