0 Bedömningar
ID

41658

Beskrivning

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.

Länk

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

Nyckelord

Versioner (3)
  1. 2020-12-01 2020-12-01 -
  2. 2020-12-05 2020-12-05 -
  3. 2020-12-05 2020-12-05 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

5 december 2020

DOI

För en begäran logga in.

Licens

Creative Commons BY-NC 4.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

  • Senaste
  • Äldsta
  • Önskad
  • Senaste
    • Senaste
    • Äldsta
    • Önskad

    Inga kommentarer

    Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

    Efficacy and Safety of ADVAIR DISKUS Plus Spiriva HandiHaler Versus Spiriva HandiHaler in COPD NCT00784550

    Engelsk

    Subject Diary

    1 Formulär  
    1. StudyEvent: ODM
      1. Subject Diary
    Administrative Data
    Beskrivning

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Subject identification number
    Beskrivning

    Subject identification number

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C2348585
    Date of next visit
    Beskrivning

    Date of next visit

    Datatyp

    date

    Alias
    UMLS CUI [1]
    C2735342
    Diary type
    Beskrivning

    Diary type

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C3890583
    UMLS CUI [1,2]
    C0332307
    Study Contact Name
    Beskrivning

    Study Contact Name

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0337611
    UMLS CUI [1,2]
    C0008976
    Study site telephone number
    Beskrivning

    Study site telephone number

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C1515258
    UMLS CUI [1,2]
    C2825164
    Subject Daily Diary
    Beskrivning

    Subject Daily Diary

    Alias
    UMLS CUI-1
    C3890583
    UMLS CUI-2
    C0332173
    Date of assessment
    Beskrivning

    Date of assessment

    Datatyp

    date

    Alias
    UMLS CUI [1]
    C2985720
    Number of puffs of rescue albuterol taken during the last 24 hours
    Beskrivning

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

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C0884980
    UMLS CUI [1,2]
    C0001927
    UMLS CUI [1,3]
    C1533107
    UMLS CUI [1,4]
    C1442770
    Number of rescue albuterol nebules used during the last 24 hours
    Beskrivning

    Number of rescue albuterol nebules used during the last 24 hours

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C0884980
    UMLS CUI [1,2]
    C0001927
    UMLS CUI [1,3]
    C2347333
    UMLS CUI [1,4]
    C1442770
    Number of inhalations of open-label SPIRIVA HANDIHALER study medication taken during the last 24 hours (AM dosing only)
    Beskrivning

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

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C0001559
    UMLS CUI [1,2]
    C1705566
    UMLS CUI [1,3]
    C1442770
    UMLS CUI [1,4]
    C1306772
    Number of inhalations of double-blind DISKUS study medication taken during the last 24 hours (AM and PM dosing)
    Beskrivning

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

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C0001559
    UMLS CUI [1,2]
    C1705566
    UMLS CUI [1,3]
    C1442770
    UMLS CUI [1,4]
    C0304229
    Medical Problems/Medication taken
    Beskrivning

    Medical Problems/Medication taken

    Alias
    UMLS CUI-1
    C1254481
    UMLS CUI-2
    C3890583
    UMLS CUI-3
    C0013227
    Medical Problem
    Beskrivning

    Medical Problem

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C3540840
    UMLS CUI [2]
    C0012634
    Date Medical Problem Started
    Beskrivning

    Date Medical Problem Started

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C3540840
    UMLS CUI [1,2]
    C0808070
    UMLS CUI [2,1]
    C0012634
    UMLS CUI [2,2]
    C0808070
    Date Medical Problem Stopped
    Beskrivning

    Date Medical Problem Stopped

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C3540840
    UMLS CUI [1,2]
    C0806020
    UMLS CUI [2,1]
    C0012634
    UMLS CUI [2,2]
    C0806020
    Medication(s) Taken for Medical Problem
    Beskrivning

    Medication(s) Taken for Medical Problem

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C3540840
    UMLS CUI [1,2]
    C0013227
    UMLS CUI [2,1]
    C0012634
    UMLS CUI [2,2]
    C0013227
    Date Medication Started
    Beskrivning

    Date Medication Started

    Datatyp

    date

    Alias
    UMLS CUI [1]
    C3173309
    Date Medication Stopped
    Beskrivning

    Date Medication Stopped

    Datatyp

    date

    Alias
    UMLS CUI [1]
    C1531784
    Tillbaka till toppen

    Similar models

    Subject Diary

    1 Formulär
    1. StudyEvent: ODM
      1. Subject Diary
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    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])
    Tillbaka till toppen 

    Hjälp

    Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

    Watch Tutorial