ID

41464

Description

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

Keywords

Versions (1)
  1. 10/20/20 10/20/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

October 20, 2020

DOI

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License

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

English

Inform Screening

1 forms  
  1. StudyEvent: ODM
    1. Inform Screening
Subject Identification
Description

Subject Identification

Alias
UMLS CUI-1
C1269815
Subject Initials
Description

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

Data type

text

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

Date of birth

Data type

date

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

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?
Description

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

Data type

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?
Description

Source of information

Data type

text

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

Prior Clinic Patient

Data type

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.
Description

Prior Clinic Patient (Study specific ailment)

Data type

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
Description

Other Prior Clinic Patient

Data type

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
Description

Physician or Colleague Referral

Data type

integer

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

Other Physician or Colleague Referral

Data type

text

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

Word of Mouth

Data type

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
Description

Other Word of mouth

Data type

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
Description

Posters, Flyers or Brochures

Data type

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
Description

Other Posters, Flyers or Brochures

Data type

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
Description

Community Outreach

Data type

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
Description

Other Community Outreach

Data type

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
Description

Internet/Website/Email

Data type

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
Description

Other Internet/Website/Email

Data type

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
Description

Local Advertising

Data type

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
Description

Other Local Advertising

Data type

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
Description

Central/National Media Campaign

Data type

integer

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

Other Central/National Media Campaign

Data type

text

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

Other source of information

Data type

text

Alias
UMLS CUI [1,1]
C0683836
UMLS CUI [1,2]
C0205394
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Similar models

Inform Screening

1 forms
  1. StudyEvent: ODM
    1. Inform Screening
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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