0 Ratings
ID

41658

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 (Subject Diary) is to be filled out by study participant between Visit 1 (Screening) and Visit 2 (Randomization), between Visit 2 (Randomization) and Visit 3, between Visit 3 and Visit 4, between Visit 4 and Visit 5 and between Visit 5 and Visit 6. Daily Diary Instructions: Reminders: (for patient) - Bring this Diary and all study medication to each clinic visit. - Do not take any new medications without first contacting the study doctor. - Do not write your name or initials anywhere on this diary. (paper-pen specific) - Withhold albuterol for at least 6 hours prior to your next clinic visit. If you have taken albuterol within 6 hours prior to a visit, contact the clinic to reschedule the visit. - Complete the Medical Problems/Medications Taken Worksheet if you experience any medical problems and take medication(s) for the problem(s). - Withhold your morning dose of blinded study medication prior to the next clinic visit. IF you have taken your morning dose of blinded study medication prior to a visit contact the clinic to reschedule the visit. (NOT applicable for Subject Diary 1) - Record all medical problems which may have occurred on that date, AND all medication(s) you (the subject) took on that date to treat the problem. General rules for Diary completion: - Print neatly using only black or blue ink. Do NOT use pencil. (paper-pen specific) - Draw one line through any changes or mistakes and re-enter the correct information above/beside. (paper-pen specific) - DO NOT use correction fluid or tape. (paper-pen specific) Record the following information in this diary every day. 1. Date. Record dates in DD MMM YY format (for example: 15. OCT 08). 2. Daily Albuterol Use. If you required rescue albuterol for COPD symptoms during the last 24 hour period, record the total number of puffs administered. If none, enter zero (0). 3. Daily Albuterol Nebel Use. If you required rescue albuterol nebulas for COPD symptoms during the last 24 hour period, record the total number of nebulas administered. If none, enter zero (0). 4.1. Morning (AM) Study Medication Taken. Each morning (approximately 6:00-9:00 AM) take 1 inhalation from the SPIRIVA HANDIHALER Device. Record the total number of inhalations of open-blind study medication you took each day from the SPIRIVA HANDIHALER Device. (applicable only for Subject Diary 1) 4.2. Morning (AM) and Evening (PM) Study Medication Taken. Each morning (approximately 6:00-9:00 AM) take 1 inhalation from the DISKUS followed by 1 inhalation from the SPIRIVA HANDIHALER Device. Each evening (approximately 6:00-9:00 PM) approximately 12 hours after the morning dosing with the DISKUS, take 1 inhalation from the DISKUS. Record the total number of inhalations of double-blind study medication you took each day from the DISKUS and the total number of inhalations of open-blind study medication you took each day from the SPIRIVA HANDIHALER Device. (applicable for Subject Diaries 2-5) 5. Medical Problems/Medications Taken Worksheet. Record all medical problems which may have occurred on that date, AND all medication(s) you took on that date to treat the problem on the separate Medical Problems/Medication Taken Worksheet page. Do not include study-related medications.

Link

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

Keywords

Versions (3)
  1. 12/1/20 12/1/20 -
  2. 12/5/20 12/5/20 -
  3. 12/5/20 12/5/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

December 5, 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

    Subject Diary

    1 forms  
    1. StudyEvent: ODM
      1. Subject Diary
    Administrative Data
    Description

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    Subject identification number
    Description

    Subject identification number

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Date of next visit
    Description

    Date of next visit

    Data type

    date

    Alias
    UMLS CUI [1]
    C2735342 (Date next clinic visit)
    LOINC
    LP96939-1
    Diary type
    Description

    Diary type

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C3890583 (Subject Diary)
    UMLS CUI [1,2]
    C0332307 (Type - attribute)
    SNOMED
    261664005
    Study Contact Name
    Description

    Study Contact Name

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0337611 (contact person)
    SNOMED
    70862002
    UMLS CUI [1,2]
    C0008976 (Clinical Trials)
    SNOMED
    110465008
    LOINC
    LP231796-6
    Study site telephone number
    Description

    Study site telephone number

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1515258 (Telephone Number)
    SNOMED
    734005006
    LOINC
    LP6871-0
    UMLS CUI [1,2]
    C2825164 (Study Site)
    Subject Daily Diary
    Description

    Subject Daily Diary

    Alias
    UMLS CUI-1
    C3890583 (Subject Diary)
    UMLS CUI-2
    C0332173 (Daily)
    SNOMED
    69620002
    LOINC
    LA14799-3
    Date of assessment
    Description

    Date of assessment

    Data type

    date

    Alias
    UMLS CUI [1]
    C2985720 (Assessment Date)
    Number of puffs of rescue albuterol taken during the last 24 hours
    Description

    Number of puffs of rescue albuterol taken during the last 24 hours

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0884980 (rescue remedy)
    UMLS CUI [1,2]
    C0001927 (albuterol)
    SNOMED
    372897005
    UMLS CUI [1,3]
    C1533107 (Puff unit dose)
    SNOMED
    415215001
    UMLS CUI [1,4]
    C1442770 (24 Hours)
    LOINC
    LP6924-7
    Number of rescue albuterol nebules used during the last 24 hours
    Description

    Number of rescue albuterol nebules used during the last 24 hours

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0884980 (rescue remedy)
    UMLS CUI [1,2]
    C0001927 (albuterol)
    SNOMED
    372897005
    UMLS CUI [1,3]
    C2347333 (Nebule Dosing Unit)
    UMLS CUI [1,4]
    C1442770 (24 Hours)
    LOINC
    LP6924-7
    Number of inhalations of open-label SPIRIVA HANDIHALER study medication taken during the last 24 hours (AM dosing only)
    Description

    Number of inhalations of open-label SPIRIVA HANDIHALER study medication taken during the last 24 hours

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0001559 (Inhalation Drug Administration)
    SNOMED
    243132000
    UMLS CUI [1,2]
    C1705566 (Count Dosing Unit)
    UMLS CUI [1,3]
    C1442770 (24 Hours)
    LOINC
    LP6924-7
    UMLS CUI [1,4]
    C1306772 (tiotropium bromide)
    SNOMED
    425812008
    Number of inhalations of double-blind DISKUS study medication taken during the last 24 hours (AM and PM dosing)
    Description

    NOT applicable for Subject Diary 1 (between Visit 1 and Visit 2)

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0001559 (Inhalation Drug Administration)
    SNOMED
    243132000
    UMLS CUI [1,2]
    C1705566 (Count Dosing Unit)
    UMLS CUI [1,3]
    C1442770 (24 Hours)
    LOINC
    LP6924-7
    UMLS CUI [1,4]
    C0304229 (Experimental drug)
    Medical Problems/Medication taken
    Description

    Medical Problems/Medication taken

    Alias
    UMLS CUI-1
    C1254481 (Patient Problem)
    UMLS CUI-2
    C3890583 (Subject Diary)
    UMLS CUI-3
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    Medical Problem
    Description

    Medical Problem

    Data type

    text

    Alias
    UMLS CUI [1]
    C3540840 (Sign or Symptom)
    UMLS CUI [2]
    C0012634 (Disease)
    SNOMED
    64572001
    LOINC
    LP21006-9
    Date Medical Problem Started
    Description

    Date Medical Problem Started

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C3540840 (Sign or Symptom)
    UMLS CUI [1,2]
    C0808070 (Start Date)
    UMLS CUI [2,1]
    C0012634 (Disease)
    SNOMED
    64572001
    LOINC
    LP21006-9
    UMLS CUI [2,2]
    C0808070 (Start Date)
    Date Medical Problem Stopped
    Description

    Date Medical Problem Stopped

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C3540840 (Sign or Symptom)
    UMLS CUI [1,2]
    C0806020 (End date)
    SNOMED
    454551000124105
    LOINC
    MTHU008302
    UMLS CUI [2,1]
    C0012634 (Disease)
    SNOMED
    64572001
    LOINC
    LP21006-9
    UMLS CUI [2,2]
    C0806020 (End date)
    SNOMED
    454551000124105
    LOINC
    MTHU008302
    Medication(s) Taken for Medical Problem
    Description

    Medication(s) Taken for Medical Problem

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C3540840 (Sign or Symptom)
    UMLS CUI [1,2]
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    UMLS CUI [2,1]
    C0012634 (Disease)
    SNOMED
    64572001
    LOINC
    LP21006-9
    UMLS CUI [2,2]
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    Date Medication Started
    Description

    Date Medication Started

    Data type

    date

    Alias
    UMLS CUI [1]
    C3173309 (Date treatment or therapy started)
    LOINC
    LP262646-5
    Date Medication Stopped
    Description

    Date Medication Stopped

    Data type

    date

    Alias
    UMLS CUI [1]
    C1531784 (Date treatment stopped)
    SNOMED
    413947000
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    Similar models

    Subject Diary

    1 forms
    1. StudyEvent: ODM
      1. Subject Diary
    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 next visit
    Item
    Date of next visit
    date
    C2735342 (UMLS CUI [1])
    Item
    Diary type
    text
    C3890583 (UMLS CUI [1,1])
    C0332307 (UMLS CUI [1,2])
    Diary type
    Code List
    Diary type
    CL Item
    Subject diary 1 (between Visit 1 and Visit 2) (1)
    CL Item
    Subject diary 2 (between Visit 2 and Visit 3) (2)
    CL Item
    Subject diary 3 (between Visit 3 and Visit 4) (3)
    CL Item
    Subject diary 4 (between Visit 4 and Visit 5) (4)
    CL Item
    Subject diary 5 (between Visit 5 and Visit 6) (5)
    Study Contact Name
    Item
    Study Contact Name
    text
    C0337611 (UMLS CUI [1,1])
    C0008976 (UMLS CUI [1,2])
    Study site telephone number
    Item
    Study site telephone number
    integer
    C1515258 (UMLS CUI [1,1])
    C2825164 (UMLS CUI [1,2])
    Item Group
    Subject Daily Diary
    C3890583 (UMLS CUI-1)
    C0332173 (UMLS CUI-2)
    Date of assessment
    Item
    Date of assessment
    date
    C2985720 (UMLS CUI [1])
    Number of puffs of rescue albuterol taken during the last 24 hours
    Item
    Number of puffs of rescue albuterol taken during the last 24 hours
    integer
    C0884980 (UMLS CUI [1,1])
    C0001927 (UMLS CUI [1,2])
    C1533107 (UMLS CUI [1,3])
    C1442770 (UMLS CUI [1,4])
    Number of rescue albuterol nebules used during the last 24 hours
    Item
    Number of rescue albuterol nebules used during the last 24 hours
    integer
    C0884980 (UMLS CUI [1,1])
    C0001927 (UMLS CUI [1,2])
    C2347333 (UMLS CUI [1,3])
    C1442770 (UMLS CUI [1,4])
    Number of inhalations of open-label SPIRIVA HANDIHALER study medication taken during the last 24 hours
    Item
    Number of inhalations of open-label SPIRIVA HANDIHALER study medication taken during the last 24 hours (AM dosing only)
    integer
    C0001559 (UMLS CUI [1,1])
    C1705566 (UMLS CUI [1,2])
    C1442770 (UMLS CUI [1,3])
    C1306772 (UMLS CUI [1,4])
    Number of inhalations of double-blind DISKUS study medication taken during the last 24 hours
    Item
    Number of inhalations of double-blind DISKUS study medication taken during the last 24 hours (AM and PM dosing)
    integer
    C0001559 (UMLS CUI [1,1])
    C1705566 (UMLS CUI [1,2])
    C1442770 (UMLS CUI [1,3])
    C0304229 (UMLS CUI [1,4])
    Item Group
    Medical Problems/Medication taken
    C1254481 (UMLS CUI-1)
    C3890583 (UMLS CUI-2)
    C0013227 (UMLS CUI-3)
    Medical Problem
    Item
    Medical Problem
    text
    C3540840 (UMLS CUI [1])
    C0012634 (UMLS CUI [2])
    Date Medical Problem Started
    Item
    Date Medical Problem Started
    date
    C3540840 (UMLS CUI [1,1])
    C0808070 (UMLS CUI [1,2])
    C0012634 (UMLS CUI [2,1])
    C0808070 (UMLS CUI [2,2])
    Date Medical Problem Stopped
    Item
    Date Medical Problem Stopped
    date
    C3540840 (UMLS CUI [1,1])
    C0806020 (UMLS CUI [1,2])
    C0012634 (UMLS CUI [2,1])
    C0806020 (UMLS CUI [2,2])
    Medication(s) Taken for Medical Problem
    Item
    Medication(s) Taken for Medical Problem
    text
    C3540840 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    C0012634 (UMLS CUI [2,1])
    C0013227 (UMLS CUI [2,2])
    Date Medication Started
    Item
    Date Medication Started
    date
    C3173309 (UMLS CUI [1])
    Date Medication Stopped
    Item
    Date Medication Stopped
    date
    C1531784 (UMLS CUI [1])
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