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
Subject identification number
Description

Subject identification number

Data type

text

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

Date of next visit

Data type

date

Alias
UMLS CUI [1]
C2735342
Diary type
Description

Diary type

Data type

text

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

Study Contact Name

Data type

text

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

Study site telephone number

Data type

integer

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

Subject Daily Diary

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

Date of assessment

Data type

date

Alias
UMLS CUI [1]
C2985720
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
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
Description

Number of rescue albuterol nebules used during the last 24 hours

Data type

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)
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
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)
Description

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

Data type

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
Description

Medical Problems/Medication taken

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

Medical Problem

Data type

text

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

Date Medical Problem Started

Data type

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
Description

Date Medical Problem Stopped

Data type

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
Description

Medication(s) Taken for Medical Problem

Data type

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
Description

Date Medication Started

Data type

date

Alias
UMLS CUI [1]
C3173309
Date Medication Stopped
Description

Date Medication Stopped

Data type

date

Alias
UMLS CUI [1]
C1531784
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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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