0 Ratings
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

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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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