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ID

41464

Beschreibung

Study ID: 111114 Clinical Study ID: 111114 Study Title: A Randomized, Double-Blind, Parallel-Group, 24-Week Study to Evaluate the Efficacy and Safety of ADVAIR™ DISKUS™ (Fluticasone Propionate/Salmeterol Combination Product 250/50mcg Inhalation Powder) BID Plus Spiriva HandiHaler (Tiotropium Bromide Inhalation Powder 18mcg) QD Versus Spiriva QD Plus Placebo DISKUS BID in Subjects with Chronic Obstructive Pulmonary Disease (COPD) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00784550 https://clinicaltrials.gov/ct2/show/NCT00784550 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: N/A Trade Name: Tiotropium Bromide, Fluticasone Propionate/Salmeterol Study Indication: Pulmonary Disease, Chronic Obstructive The purpose of the study is to determine the efficacy and safety of the combination of ADVAIR DISKUS® 250/50mcg (FLUTICASONE PROPIONATE/SALMETEROL COMBINATION PRODUCT) plus SPIRIVA® HANDIHALER® inhaler 18mcg (TIOTROPIUM) compared to SPIRIVA® HANDIHALER® inhaler 18mcg (TIOTROPIUM) in patients with COPD. There are a total of 6 visits: Screening (Visit 1), Randomization (Visit 2), and after 4 (Visit 3), 8 (Visit 4), 16 (Visit 5) and 24 (Visit 6) weeks of treatment. This form (Inform Screening) is to be filled out at the Screening (Visit 1).

Link

https://clinicaltrials.gov/ct2/show/NCT00784550

Stichworte

Versionen (1)
  1. 20.10.20 20.10.20 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

20. Oktober 2020

DOI

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Creative Commons BY-NC 4.0
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    Efficacy and Safety of ADVAIR DISKUS Plus Spiriva HandiHaler Versus Spiriva HandiHaler in COPD NCT00784550

    Englisch

    Inform Screening

    1 Formulare  
    1. StudyEvent: ODM
      1. Inform Screening
    Subject Identification
    Beschreibung

    Subject Identification

    Alias
    UMLS CUI-1
    C1269815
    Subject Initials
    Beschreibung

    This item is hidden to all users and will be auto populated by the system as "---"

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C1997894
    UMLS CUI [1,2]
    C2986440
    Date of birth
    Beschreibung

    Date of birth

    Datentyp

    date

    Alias
    UMLS CUI [1]
    C0421451
    Are you willing to tell us how you learned about this study?
    Beschreibung

    Are you willing to tell us how you learned about this study?

    Alias
    UMLS CUI-1
    C0242800
    Are you willing to tell us how you learned about this study?
    Beschreibung

    Are you willing to tell us how you learned about this study?

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0242800
    If yes, how did the subject initially hear about the study or how was the subject recruited into the study?
    Beschreibung

    Source of information

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0683836
    If Prior Clinic Patient, please specify
    Beschreibung

    Prior Clinic Patient

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0585862
    UMLS CUI [1,2]
    C0332152
    UMLS CUI [1,3]
    C2347804
    If introduced during study visit for study specific ailment, please insert study specific ailment.
    Beschreibung

    Prior Clinic Patient (Study specific ailment)

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0585862
    UMLS CUI [1,2]
    C0332152
    UMLS CUI [1,3]
    C2347804
    UMLS CUI [2,1]
    C0012634
    UMLS CUI [2,2]
    C2348235
    UMLS CUI [2,3]
    C0008976
    If Other prior clinic patient (not listed above), please specify
    Beschreibung

    Other Prior Clinic Patient

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0585862
    UMLS CUI [1,2]
    C0332152
    UMLS CUI [1,3]
    C2347804
    UMLS CUI [1,4]
    C0205394
    If Physician or Colleague Referral, please specify
    Beschreibung

    Physician or Colleague Referral

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C0583834
    If Other physician or colleague referral activity (not listed above), please specify
    Beschreibung

    Other Physician or Colleague Referral

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0583834
    UMLS CUI [1,2]
    C0205394
    If Word of Mouth, please specify
    Beschreibung

    Word of Mouth

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0034866
    UMLS CUI [1,2]
    C1705847
    UMLS CUI [1,3]
    C0031831
    If Other word of mouth method (not listed above), please specify
    Beschreibung

    Other Word of mouth

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0034866
    UMLS CUI [1,2]
    C1705847
    UMLS CUI [1,3]
    C0031831
    UMLS CUI [1,4]
    C0205394
    If Posters, Flyers or Brochures, please specify
    Beschreibung

    Posters, Flyers or Brochures

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0030258
    UMLS CUI [1,2]
    C0949214
    UMLS CUI [2,1]
    C0376675
    UMLS CUI [2,2]
    C0949214
    If Other poster, flyer, brochure display (not listed above), please specify
    Beschreibung

    Other Posters, Flyers or Brochures

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0030258
    UMLS CUI [1,2]
    C0949214
    UMLS CUI [1,3]
    C0205394
    UMLS CUI [2,1]
    C0376675
    UMLS CUI [2,2]
    C0949214
    UMLS CUI [2,3]
    C0205394
    If Community Outreach, please specify
    Beschreibung

    Community Outreach

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0033414
    UMLS CUI [1,2]
    C0008976
    UMLS CUI [1,3]
    C0009462
    UMLS CUI [1,4]
    C2347796
    If Other community outreach method (not listed above), please specify
    Beschreibung

    Other Community Outreach

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0033414
    UMLS CUI [1,2]
    C0008976
    UMLS CUI [1,3]
    C0009462
    UMLS CUI [1,4]
    C2347796
    UMLS CUI [1,5]
    C0205394
    If Internet/Website/Email please specify
    Beschreibung

    Internet/Website/Email

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0282111
    UMLS CUI [1,2]
    C0949214
    UMLS CUI [2,1]
    C2349146
    UMLS CUI [2,2]
    C0949214
    UMLS CUI [3,1]
    C0013849
    UMLS CUI [3,2]
    C0949214
    If Other internet/email method (not listed above), please specify
    Beschreibung

    Other Internet/Website/Email

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0282111
    UMLS CUI [1,2]
    C0949214
    UMLS CUI [1,3]
    C0205394
    UMLS CUI [2,1]
    C2349146
    UMLS CUI [2,2]
    C0949214
    UMLS CUI [2,3]
    C0205394
    UMLS CUI [3,1]
    C0013849
    UMLS CUI [3,2]
    C0949214
    UMLS CUI [3,3]
    C0205394
    If Local Advertising please specify
    Beschreibung

    Local Advertising

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0205276
    UMLS CUI [1,2]
    C0679720
    UMLS CUI [1,3]
    C0949214
    If Other local advertising (not listed above), please specify
    Beschreibung

    Other Local Advertising

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0205276
    UMLS CUI [1,2]
    C0679720
    UMLS CUI [1,3]
    C0949214
    UMLS CUI [1,4]
    C0205394
    If Central/National Media Campaign please specify
    Beschreibung

    Central/National Media Campaign

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0679720
    UMLS CUI [1,2]
    C0681788
    If Other national campaign (not listed above), please specify
    Beschreibung

    Other Central/National Media Campaign

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0679720
    UMLS CUI [1,2]
    C0681788
    UMLS CUI [1,3]
    C0205394
    If Other source of information, please specify
    Beschreibung

    Other source of information

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0683836
    UMLS CUI [1,2]
    C0205394
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    Ähnliche Modelle

    Inform Screening

    1 Formulare
    1. StudyEvent: ODM
      1. Inform Screening
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    Subject Identification
    C1269815 (UMLS CUI-1)
    Subject Initials
    Item
    Subject Initials
    text
    C1997894 (UMLS CUI [1,1])
    C2986440 (UMLS CUI [1,2])
    Date of birth
    Item
    Date of birth
    date
    C0421451 (UMLS CUI [1])
    Item Group
    Are you willing to tell us how you learned about this study?
    C0242800 (UMLS CUI-1)
    Are you willing to tell us how you learned about this study?
    Item
    Are you willing to tell us how you learned about this study?
    boolean
    C0242800 (UMLS CUI [1])
    Item
    If yes, how did the subject initially hear about the study or how was the subject recruited into the study?
    text
    C0683836 (UMLS CUI [1])
    Source of information
    Code List
    If yes, how did the subject initially hear about the study or how was the subject recruited into the study?
    CL Item
    Prior Clinical Patient (1)
    CL Item
    Physician or Colleague Referral (2)
    CL Item
    Word of mouth (3)
    CL Item
    Posters, Flyers or Brochures (4)
    CL Item
    Community Outreach (5)
    CL Item
    Internet/Website/Email (6)
    CL Item
    Local Advertising (PLACED BY SITE) (7)
    CL Item
    Central/National Media Campaign (PLACED BY GSK) (8)
    CL Item
    Call Centre (Organized by GSK) (9)
    CL Item
    Other (OT)
    Item
    If Prior Clinic Patient, please specify
    integer
    C0585862 (UMLS CUI [1,1])
    C0332152 (UMLS CUI [1,2])
    C2347804 (UMLS CUI [1,3])
    Prior Clinic Patient
    Code List
    If Prior Clinic Patient, please specify
    CL Item
    Chart review, mailed a letter/postcard to potential subjects (101)
    CL Item
    Chart review, contacted potential subjects by phone (102)
    CL Item
    Introduced study during office visit for other medical reason (104)
    CL Item
    Subject from feeder study into long-term extension study (105)
    CL Item
    Introduced study during office visit for [insert study specific ailment] (103)
    CL Item
    Other physician or colleague referral (not listed above) (199)
    Prior Clinic Patient (Study specific ailment)
    Item
    If introduced during study visit for study specific ailment, please insert study specific ailment.
    text
    C0585862 (UMLS CUI [1,1])
    C0332152 (UMLS CUI [1,2])
    C2347804 (UMLS CUI [1,3])
    C0012634 (UMLS CUI [2,1])
    C2348235 (UMLS CUI [2,2])
    C0008976 (UMLS CUI [2,3])
    Other Prior Clinic Patient
    Item
    If Other prior clinic patient (not listed above), please specify
    text
    C0585862 (UMLS CUI [1,1])
    C0332152 (UMLS CUI [1,2])
    C2347804 (UMLS CUI [1,3])
    C0205394 (UMLS CUI [1,4])
    Item
    If Physician or Colleague Referral, please specify
    integer
    C0583834 (UMLS CUI [1])
    Physician or Colleague Referral
    Code List
    If Physician or Colleague Referral, please specify
    CL Item
    Mailed letters to referring physicians about study (201)
    CL Item
    Calls to referring physicians about study (202)
    CL Item
    Presentations about study to referring physicians (203)
    CL Item
    Other physician or colleague referral activity (not listed above) (299)
    Other Physician or Colleague Referral
    Item
    If Other physician or colleague referral activity (not listed above), please specify
    text
    C0583834 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    Item
    If Word of Mouth, please specify
    integer
    C0034866 (UMLS CUI [1,1])
    C1705847 (UMLS CUI [1,2])
    C0031831 (UMLS CUI [1,3])
    Word of Mouth
    Code List
    If Word of Mouth, please specify
    CL Item
    subject heard about study from current/past study participant (301)
    CL Item
    subject heard about study from friend or family member (302)
    CL Item
    subject heard about study from disease or support group (303)
    CL Item
    Other word of mouth method (not listed above) (399)
    Other Word of mouth
    Item
    If Other word of mouth method (not listed above), please specify
    text
    C0034866 (UMLS CUI [1,1])
    C1705847 (UMLS CUI [1,2])
    C0031831 (UMLS CUI [1,3])
    C0205394 (UMLS CUI [1,4])
    Item
    If Posters, Flyers or Brochures, please specify
    integer
    C0030258 (UMLS CUI [1,1])
    C0949214 (UMLS CUI [1,2])
    C0376675 (UMLS CUI [2,1])
    C0949214 (UMLS CUI [2,2])
    Posters, Flyers or Brochures
    Code List
    If Posters, Flyers or Brochures, please specify
    CL Item
    Displayed in our clinic (401)
    CL Item
    Information at day care (402)
    CL Item
    University/school posting (403)
    CL Item
    Church posting (404)
    CL Item
    Other poster, flyer, brochure display (not listed above) (499)
    Other Posters, Flyers or Brochures
    Item
    If Other poster, flyer, brochure display (not listed above), please specify
    text
    C0030258 (UMLS CUI [1,1])
    C0949214 (UMLS CUI [1,2])
    C0205394 (UMLS CUI [1,3])
    C0376675 (UMLS CUI [2,1])
    C0949214 (UMLS CUI [2,2])
    C0205394 (UMLS CUI [2,3])
    Item
    If Community Outreach, please specify
    integer
    C0033414 (UMLS CUI [1,1])
    C0008976 (UMLS CUI [1,2])
    C0009462 (UMLS CUI [1,3])
    C2347796 (UMLS CUI [1,4])
    Community Outreach
    Code List
    If Community Outreach, please specify
    CL Item
    Screening day/event (501)
    CL Item
    Health fair (502)
    CL Item
    Pharmacy programme (503)
    CL Item
    Other community outreach method (not listed above) (599)
    Other Community Outreach
    Item
    If Other community outreach method (not listed above), please specify
    text
    C0033414 (UMLS CUI [1,1])
    C0008976 (UMLS CUI [1,2])
    C0009462 (UMLS CUI [1,3])
    C2347796 (UMLS CUI [1,4])
    C0205394 (UMLS CUI [1,5])
    Item
    If Internet/Website/Email please specify
    integer
    C0282111 (UMLS CUI [1,1])
    C0949214 (UMLS CUI [1,2])
    C2349146 (UMLS CUI [2,1])
    C0949214 (UMLS CUI [2,2])
    C0013849 (UMLS CUI [3,1])
    C0949214 (UMLS CUI [3,2])
    Internet/Website/Email
    Code List
    If Internet/Website/Email please specify
    CL Item
    Acurian (601)
    CL Item
    Veritas Medicine (602)
    CL Item
    Harris Interactive (603)
    CL Item
    www.emergingmed.com (604)
    CL Item
    www.clinicaltrials.gov (605)
    CL Item
    www.centrewatch.com (606)
    CL Item
    Study specific website (ex:www.OApainstudy.com) (607)
    CL Item
    Other internet/email method (not listed above) (699)
    Other Internet/Website/Email
    Item
    If Other internet/email method (not listed above), please specify
    text
    C0282111 (UMLS CUI [1,1])
    C0949214 (UMLS CUI [1,2])
    C0205394 (UMLS CUI [1,3])
    C2349146 (UMLS CUI [2,1])
    C0949214 (UMLS CUI [2,2])
    C0205394 (UMLS CUI [2,3])
    C0013849 (UMLS CUI [3,1])
    C0949214 (UMLS CUI [3,2])
    C0205394 (UMLS CUI [3,3])
    Item
    If Local Advertising please specify
    integer
    C0205276 (UMLS CUI [1,1])
    C0679720 (UMLS CUI [1,2])
    C0949214 (UMLS CUI [1,3])
    Local Advertising
    Code List
    If Local Advertising please specify
    CL Item
    Local newspaper advertisement (701)
    CL Item
    Local radio advertisement (702)
    CL Item
    Local television advertisement (703)
    CL Item
    Local direct mail campaign (704)
    CL Item
    Other local advertising (not listed above) (799)
    Other Local Advertising
    Item
    If Other local advertising (not listed above), please specify
    text
    C0205276 (UMLS CUI [1,1])
    C0679720 (UMLS CUI [1,2])
    C0949214 (UMLS CUI [1,3])
    C0205394 (UMLS CUI [1,4])
    Item
    If Central/National Media Campaign please specify
    integer
    C0679720 (UMLS CUI [1,1])
    C0681788 (UMLS CUI [1,2])
    Central/National Media Campaign
    Code List
    If Central/National Media Campaign please specify
    CL Item
    National newspaper advertisement (801)
    CL Item
    National radio advertisement (802)
    CL Item
    National television advertisement (803)
    CL Item
    National magazine campaign (804)
    CL Item
    National coupon advertisement (805)
    CL Item
    National direct mail campaign (806)
    CL Item
    Other national campaign (not listed above) (899)
    Other Central/National Media Campaign
    Item
    If Other national campaign (not listed above), please specify
    text
    C0679720 (UMLS CUI [1,1])
    C0681788 (UMLS CUI [1,2])
    C0205394 (UMLS CUI [1,3])
    Other source of information
    Item
    If Other source of information, please specify
    text
    C0683836 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
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