ID

41598

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 (Study Conclusion, Status of treatment blind, PGx research withdrawal of consent, Pregnancy information) is to be filled out at the End of the Study.

Link

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

Keywords

Versions (1)
  1. 11/19/20 11/19/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

November 19, 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

Study Conclusion, Status of treatment blind, PGx research withdrawal of consent, Pregnancy information

1 forms  
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject identification number
Description

Subject identification number

Data type

text

Alias
UMLS CUI [1]
C2348585
Date of visit/assessment
Description

Date of visit/assessment

Data type

date

Alias
UMLS CUI [1]
C1320303
UMLS CUI [2]
C2985720
Study Conclusion
Description

Study Conclusion

Alias
UMLS CUI-1
C1707478
UMLS CUI-2
C0008976
Date of subject completion or withdrawal
Description

Date of subject completion should be the date of the follow-up phone call. If follow-up phone call was not done, enter the last scheduled visit date or the Early Withdrawal date.

Data type

date

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C1549507
UMLS CUI [2,1]
C0422727
UMLS CUI [2,2]
C0011008
Was the patient withdrawn from the study?
Description

withdrawn from study

Data type

text

Alias
UMLS CUI [1]
C0422727
Primary reason for withdrawal
Description

If the subject is non-compliant, record as protocol deviation for reason of withdrawal.

Data type

integer

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0392360
If investigator discretion, specify
Description

Reason for withdrawal: investigator discretion, specify

Data type

text

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C0008961
UMLS CUI [1,4]
C0022423
UMLS CUI [1,5]
C2348235
Q1
Description

[hidden]

Data type

text

Q2
Description

[hidden]

Data type

text

Status of treatment: Blind
Description

Status of treatment: Blind

Alias
UMLS CUI-1
C0749659
UMLS CUI-2
C2347038
Was the treatment blind broken during the study?
Description

If yes, complete Non-Serious Adverse Event, Serious Adverse Event and/or Investigational Product form as appropriate.

Data type

text

Alias
UMLS CUI [1]
C3897431
If yes, complete Date blind broken
Description

Time blind broken is optional.

Data type

partialDatetime

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0011008
If yes, complete Reason blind broken
Description

Reason blind broken

Data type

text

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0392360
If yes and Other reason, specify
Description

Other reason blind broken

Data type

text

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C0205394
Pharmacogenetic Research Withdrawal of Consent
Description

Pharmacogenetic Research Withdrawal of Consent

Alias
UMLS CUI-1
C1707492
UMLS CUI-2
C2347500
UMLS CUI-3
C1948029
UMLS CUI-4
C0438730
Has the subject withdrawn consent for PGx research?
Description

Consent for pharmacogenetic research withdrawn

Data type

text

Alias
UMLS CUI [1,1]
C1707492
UMLS CUI [1,2]
C2347500
If yes, provide date informed consent was withdrawn
Description

Date informed consent withdrawn

Data type

date

Alias
UMLS CUI [1,1]
C1707492
UMLS CUI [1,2]
C2347500
UMLS CUI [1,3]
C0011008
Has a request been made for saliva sample destruction?
Description

Request for saliva sample destruction

Data type

text

Alias
UMLS CUI [1,1]
C1272683
UMLS CUI [1,2]
C1948029
UMLS CUI [1,3]
C0438730
If yes, check reason
Description

Reason for Request of Saliva Sample Destruction

Data type

text

Alias
UMLS CUI [1,1]
C0566251
UMLS CUI [1,2]
C1272683
UMLS CUI [1,3]
C1948029
UMLS CUI [1,4]
C0438730
It other reason, specify
Description

Other reason for request of saliva sample destruction

Data type

text

Alias
UMLS CUI [1,1]
C0566251
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C1272683
UMLS CUI [1,4]
C1948029
UMLS CUI [1,5]
C0438730
Pregnancy Information
Description

Pregnancy Information

Alias
UMLS CUI-1
C0032961
UMLS CUI-2
C1533716
Did the subject become pregnant during the study?
Description

If Yes, complete the paper Pregnancy Notification form.

Data type

text

Alias
UMLS CUI [1]
C3828490
Signatures
Description

Signatures

Alias
UMLS CUI-1
C1519316
By my dated signature below, I, [First Name] [Last Name], verify that all case report form pages accurately display the results of the examinations, tests, evaluations, and treatments performed on this patient. Pursuant to section 11.199 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature is to be the legally binding equivalent of my handwritten signature.
Description

CRB Electronic Signature Affidavit

Data type

text

Alias
UMLS CUI [1]
C2346576
Date of signature
Description

CRB Electronic Signature Affidavit Date

Data type

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
Name of Investigator (CRB)
Description

[First Name] [Last Name]

Data type

text

Alias
UMLS CUI [1]
C2826892
By my dated signature below, I, [First Name] [Last Name], verify that all case report form pages accurately display the results of the examinations, tests, evaluations, and treatments noted within. Pursuant to section 11.199 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature is to be the legally binding equivalent of my handwritten signature.
Description

CRF Electronic Signature Affidavit

Data type

text

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C1516308
Date of signature
Description

CRF Electronic Signature Affidavit Date

Data type

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C1516308
UMLS CUI [1,3]
C0011008
Name of Investigator (CRF)
Description

[First Name] [Last Name]

Data type

text

Alias
UMLS CUI [1,1]
C2826892
UMLS CUI [1,2]
C1516308
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Similar models

Study Conclusion, Status of treatment blind, PGx research withdrawal of consent, Pregnancy information

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject identification number
Item
Subject identification number
text
C2348585 (UMLS CUI [1])
Date of visit/assessment
Item
Date of visit/assessment
date
C1320303 (UMLS CUI [1])
C2985720 (UMLS CUI [2])
Item Group
Study Conclusion
C1707478 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
Date of subject completion or withdrawal
Item
Date of subject completion or withdrawal
date
C0008976 (UMLS CUI [1,1])
C1549507 (UMLS CUI [1,2])
C0422727 (UMLS CUI [2,1])
C0011008 (UMLS CUI [2,2])
Item
Was the patient withdrawn from the study?
text
C0422727 (UMLS CUI [1])
withdrawn from study
Code List
Was the patient withdrawn from the study?
CL Item
No (N)
CL Item
Yes, complete primary reason for withdrawal (Y)
Item
Primary reason for withdrawal
integer
C0422727 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
undefined item
Code List
Primary reason for withdrawal
CL Item
Adverse Event (record details on the Non-Serious Adverse Events or Serious Adverse Events from as appropriate) (1)
CL Item
Lack of efficacy (2)
CL Item
Protocol deviation (3)
CL Item
Lost to follow-up (6)
CL Item
Investigator discretion, specify (Select this reason if none of the other primary reasons are appropriate) (7)
CL Item
Withdrew consent (8)
Reason for withdrawal: investigator discretion, specify
Item
If investigator discretion, specify
text
C0422727 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0008961 (UMLS CUI [1,3])
C0022423 (UMLS CUI [1,4])
C2348235 (UMLS CUI [1,5])
Item
Q1
text
Q1
Code List
Q1
CL Item
Yes (Y)
CL Item
No (N)
Item
Q2
text
Q1
Code List
Q2
CL Item
PF_SC_LOST (?)
CL Item
PF_SC_DEATH (?)
CL Item
PF_SC_SPONSORDECISION (?)
CL Item
PF_SC_PHYSICIANDECISION (?)
CL Item
PF_SC_PATIENTDECISION (?)
CL Item
PF_SC_AE (?)
CL Item
PF_SC_ALE (?)
CL Item
PF_SC_CRITERIA (?)
CL Item
PF_SC_OTHER (?)
Item Group
Status of treatment: Blind
C0749659 (UMLS CUI-1)
C2347038 (UMLS CUI-2)
Item
Was the treatment blind broken during the study?
text
C3897431 (UMLS CUI [1])
Treatment blind broken during study
Code List
Was the treatment blind broken during the study?
CL Item
No (N)
CL Item
Yes, complete date and reason (Y)
Date blind broken
Item
If yes, complete Date blind broken
partialDatetime
C3897431 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
If yes, complete Reason blind broken
text
C3897431 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Reason blind broken
Code List
If yes, complete Reason blind broken
CL Item
Medical emergency requiring identification of investigational product for further treatment (1)
CL Item
Other, specify (Z)
Other reason blind broken
Item
If yes and Other reason, specify
text
C3897431 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Item Group
Pharmacogenetic Research Withdrawal of Consent
C1707492 (UMLS CUI-1)
C2347500 (UMLS CUI-2)
C1948029 (UMLS CUI-3)
C0438730 (UMLS CUI-4)
Item
Has the subject withdrawn consent for PGx research?
text
C1707492 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
Consent for pharmacogenetic research withdrawn
Code List
Has the subject withdrawn consent for PGx research?
CL Item
No (N)
CL Item
Yes, provide date (Y)
Date informed consent withdrawn
Item
If yes, provide date informed consent was withdrawn
date
C1707492 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
Has a request been made for saliva sample destruction?
text
C1272683 (UMLS CUI [1,1])
C1948029 (UMLS CUI [1,2])
C0438730 (UMLS CUI [1,3])
Request for saliva sample destruction
Code List
Has a request been made for saliva sample destruction?
CL Item
No (N)
CL Item
Yes, check reason (Y)
Item
If yes, check reason
text
C0566251 (UMLS CUI [1,1])
C1272683 (UMLS CUI [1,2])
C1948029 (UMLS CUI [1,3])
C0438730 (UMLS CUI [1,4])
Reason for Request of Saliva Sample Destruction
Code List
If yes, check reason
CL Item
Subject withdrew consent for PGx (3)
CL Item
Other, specify (Z)
Other reason for request of saliva sample destruction
Item
It other reason, specify
text
C0566251 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C1272683 (UMLS CUI [1,3])
C1948029 (UMLS CUI [1,4])
C0438730 (UMLS CUI [1,5])
Item Group
Pregnancy Information
C0032961 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
Item
Did the subject become pregnant during the study?
text
C3828490 (UMLS CUI [1])
Pregnancy during study
Code List
Did the subject become pregnant during the study?
CL Item
No (N)
CL Item
Yes (Y)
Item Group
Signatures
C1519316 (UMLS CUI-1)
CRB Electronic Signature Affidavit
Item
By my dated signature below, I, [First Name] [Last Name], verify that all case report form pages accurately display the results of the examinations, tests, evaluations, and treatments performed on this patient. Pursuant to section 11.199 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature is to be the legally binding equivalent of my handwritten signature.
text
C2346576 (UMLS CUI [1])
CRB Electronic Signature Affidavit Date
Item
Date of signature
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Name of Investigator (CRB)
Item
Name of Investigator (CRB)
text
C2826892 (UMLS CUI [1])
CRF Electronic Signature Affidavit
Item
By my dated signature below, I, [First Name] [Last Name], verify that all case report form pages accurately display the results of the examinations, tests, evaluations, and treatments noted within. Pursuant to section 11.199 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature is to be the legally binding equivalent of my handwritten signature.
text
C2346576 (UMLS CUI [1,1])
C1516308 (UMLS CUI [1,2])
CRF Electronic Signature Affidavit Date
Item
Date of signature
date
C2346576 (UMLS CUI [1,1])
C1516308 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Name of Investigator (CRF)
Item
Name of Investigator (CRF)
text
C2826892 (UMLS CUI [1,1])
C1516308 (UMLS CUI [1,2])
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