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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01316913




Registration number
NCT01316913
Ethics application status
Date submitted
15/03/2011
Date registered
16/03/2011
Date last updated
4/04/2017

Titles & IDs
Public title
24-week Trial Comparing GSK573719/GW642444 With GSK573719 and With Tiotropium in Chronic Obstructive Pulmonary Disease
Scientific title
A Multi-center Trial Comparing the Efficacy and Safety of GSK573719/GW642444 With GSK573719 and With Tiotropium Over 24 Weeks in Subjects With COPD
Secondary ID [1] 0 0
113374
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary Disease, Chronic Obstructive 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - GSK573719/GW642444 125/25
Treatment: Drugs - GSK573719/GW642444 62.5/25
Treatment: Drugs - GSK573719
Treatment: Drugs - tiotropium bromide

Experimental: GSK573719/GW642444 125/25 - 125/25 mcg once-daily

Experimental: GSK573719/GW642444 62.5/25 - 62.5/25 mcg once-daily

Experimental: GSK573719 - 125 mcg once-daily

Active Comparator: tiotropium bromide - 18 mcg once-daily


Treatment: Drugs: GSK573719/GW642444 125/25
125/25 mcg once-daily

Treatment: Drugs: GSK573719/GW642444 62.5/25
62.5/25 mcg once-daily

Treatment: Drugs: GSK573719
125 mcg once-daily

Treatment: Drugs: tiotropium bromide
18 mcg once-daily

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in Clinic Visit Trough Forced Expiratory Volume in One Second (FEV1) at Day 169 - FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 measurements were taken electronically by spirometry on Days 2, 28, 56, 84, 112, 168, and 169. Baseline is defined as the mean of the assessments made 30 minutes pre-dose and 5 minutes pre-dose on Treatment Day 1. Trough FEV1 is defined as the mean of the FEV1 values obtained at 23 and 24 hours after the previous morning's dosing (i.e., trough FEV1 on Day 169 is the mean of the FEV1 values obtained 23 and 24 hours after the morning dosing on Day 168). Change from Baseline at a particular visit was calculated as the trough FEV1 at that visit minus Baseline. Analysis was performed using a repeated measures model with covariates of treatment, Baseline, smoking status, center group, day, and day by Baseline and day by treatment interactions. ITT=Intent-to-Treat.
Timepoint [1] 0 0
Baseline and Day 169
Secondary outcome [1] 0 0
Change From Baseline (BL) in Weighted Mean (WM) 0-6 Hour FEV1 Obtained Post-dose at Day 168 - FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The WM FEV1 was derived by calculating the area under the FEV1/time curve (AUC) using the trapezoidal rule, and then dividing the value by the time interval over which the AUC was calculated. The WM was calculated at Days 1, 84, and Day 168 using the 0-6-hour post-dose FEV1 measurements collected on that day, which included pre-dose (Day 1: 30 minutes [min] and 5 min prior to dosing; other serial visits: 23 and 24 hours after the previous morning dose) and post-dose at 15 minutes, 30 minutes, 1 hour, 3 hours, and 6 hours. Change from BL at a particular visit was calculated as WM at that visit minus BL. Analysis was performed using a repeated measures model with covariates of treatment, BL (mean of the two assessments made 30 minutes and 5 minutes pre-dose on Day 1), smoking status, center group, day, and day by BL and day by treatment interactions.
Timepoint [1] 0 0
Baseline and Day 168

Eligibility
Key inclusion criteria
- outpatient

- signed and dated written informed consent

- 40 years of age or older

- male and female subjects

- COPD diagnosis

- at least 10 pack-year smoking history

- post-albuterol/salbutamol FEV1/FVC ratio of <0.70 and post-albuterol/salbutamol FEV1
of less than or equal to 70% predicted normal values

- score of greater than or equal to 2 on the Modified Medical Resarch Council Dyspnea
Scale (mMRC)
Minimum age
40 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- women who are pregnant or lactating or are planning on becoming pregnant during the
study

- current diagnosis of asthma

- other respiratory disorders other than COPD

- other diseases/abnormalities that are uncontrolled including cancer not in remission
for at least 5 years

- chest x-ray or CT scan with clinically significant abnormalities not believed to be
due to COPD

- hypersensitivity to anticholinergics, beta-agonists, lactose/milk protein or magnesium
stearate or medical conditions associated with inhaled anticholinergics

- hospitalization for COPD or pneumonia within 12 weeks prior to Visit 1

- lung volume reduction surgery within 12 months prior to Visit 1

- abnormal and clinically significant ECG at Visit 1

- significantly abnormal finding from laboratory tests at Visit 1

- unable to withhold albuterol/salbutamol at least 4 hours prior to spirometry at each
visit

- use of depot corticosteroids within 12 weeks of Visit 1

- use of oral or parenteral corticosteroids, antibiotics for lower respiratory tract
infection, or cytochrome P450 3A4 inhibitors, within 6 weeks of Visit 1

- use of long-acting beta-agonist (LABA)/inhaled corticosteroid (ICS) product if
LABA/ICS therapy is discontinued withing 30 days of Visit 1

- use of ICS at a dose of >1000mcg/day of fluticasone propionate or equivalent within 30
days of Visit 1

- initiation or discontinuation of ICS within 30 days of Visit 1

- use of tiotropium or roflumilast within 14 days of Visit 1

- use of theophyllines, oral leukotriene inhibitors, long-acting oral beta-agonists, or
inhaled long-acting beta-agonists within 48 hours of Visit 1

- short-acting oral beta-agonists within 12 hours of Visit 1

- use of LABA/ICS combination products only if discontinuing LABA therapy and switching
to ICS monotherapy within 48 hours of Visit 1 for the LABA component

- use of sodium cromoglycate or nedocromil sodium within 24 hours of Visit 1

- use of inhaled short-acting beta-agonists, inhaled short-acting anticholinergics, or
inhaled short-acting anticholinergic/short-acting beta-agonist combination products
within 4 hours of Visit 1

- use of any other investigational medication within 30 days or 5 drug half-lives
(whichever is longer)

- long-term oxygen therapy prescribed for >12 hours per day

- regular use of nebulized short-acting bronchodilators

- participation in acute phase of pulmonary rehabilitation program

- known or suspected history of alcohol or drug abse within 2 years prior to Visit 1

- anyone affiliated with the investigator site (e.g., investigator, sub-investigator,
study coordinator, employee of a participating investigator or study site, or
immediate family member)

- previous exposure to GSK573719, GSK573719/GW642444 combination, GW642444 (vilanterol),
or fluticasone furoate/GW642444 combination

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
GSK Investigational Site - Concord
Recruitment hospital [2] 0 0
GSK Investigational Site - Cairns
Recruitment hospital [3] 0 0
GSK Investigational Site - Carina Heights
Recruitment hospital [4] 0 0
GSK Investigational Site - Kippa Ring
Recruitment hospital [5] 0 0
GSK Investigational Site - Adelaide
Recruitment hospital [6] 0 0
GSK Investigational Site - Daw Park
Recruitment hospital [7] 0 0
GSK Investigational Site - Frankston
Recruitment hospital [8] 0 0
GSK Investigational Site - Parkville
Recruitment hospital [9] 0 0
GSK Investigational Site - Nedlands
Recruitment postcode(s) [1] 0 0
2139 - Concord
Recruitment postcode(s) [2] 0 0
4870 - Cairns
Recruitment postcode(s) [3] 0 0
4152 - Carina Heights
Recruitment postcode(s) [4] 0 0
4021 - Kippa Ring
Recruitment postcode(s) [5] 0 0
5000 - Adelaide
Recruitment postcode(s) [6] 0 0
5041 - Daw Park
Recruitment postcode(s) [7] 0 0
3199 - Frankston
Recruitment postcode(s) [8] 0 0
3050 - Parkville
Recruitment postcode(s) [9] 0 0
6009 - Nedlands
Recruitment outside Australia
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United States of America
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Alabama
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United States of America
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California
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Florida
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United States of America
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Georgia
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Kansas
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Kentucky
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Louisiana
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United States of America
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Missouri
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North Carolina
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Ohio
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Oregon
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Pennsylvania
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South Carolina
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United States of America
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West Virginia
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Argentina
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Buenos Aires
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Argentina
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Ciudad Autónoma de Buenos Aires
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Argentina
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Mendoza
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Canada
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Manitoba
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Canada
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Newfoundland and Labrador
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Canada
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Nova Scotia
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Canada
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Ontario
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Canada
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Quebec
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Chile
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Región De Los Lagos
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Chile
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Región Metro De Santiago
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Chile
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Santiago
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Germany
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Baden-Wuerttemberg
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Germany
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Bayern
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Germany
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Brandenburg
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Germany
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Hessen
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Germany
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Niedersachsen
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Germany
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Nordrhein-Westfalen
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Germany
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Rheinland-Pfalz
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Germany
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Sachsen
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Germany
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Berlin
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Germany
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Hamburg
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Korea, Republic of
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Bucheon-si,
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Korea, Republic of
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Cheongju, Chungcheongbuk-do
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Korea, Republic of
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Daegu
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Korea, Republic of
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Incheon
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Korea, Republic of
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Kangwon-do
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Korea, Republic of
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Seongnam-si, Gyeonggi-do
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Korea, Republic of
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Seoul
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Korea, Republic of
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Suwon, Kyonggi-do
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Mexico
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Jalisco
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Mexico
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Nuevo León
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Mexico
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Durango
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Mexico
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Mexico
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Romania
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Constanta
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Romania
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Ploiesti
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Romania
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Targoviste
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South Africa
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Bloemfontein
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South Africa
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Boksburg North
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South Africa
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Die Wilgers
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South Africa
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Durban
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South Africa
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Gatesville
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South Africa
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Groenkloof
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South Africa
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Pretoria
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South Africa
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Thabazimbi

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a Phase III multicenter, randomized, double-blind, double-dummy, parallel-group study
to evaluate the efficacy and safety of two doses of GSK573719/GW642444 Inhalation Powder,
GSK573719 Inhalation Powder via a Novel Dry Powder Inhaler and tiotropium via HandiHaler when
administered once-daily over a 24-week treatment period in subjects with chronic obstructive
pulmonary disease (COPD). Subjects who meet eligibility criteria at Screening (Visit 1) will
complete a 7 to10 day run-in period followed by a randomization visit (Visit 2) then a
24-week treatment period. There will be a total of 9 clinic study visits. A follow-up phone
contact for adverse event assessment will be conducted approximately one week after the last
study visit (Visit 9 or Early Withdrawal). The total duration of subject participation in the
study will be approximately 26 weeks. The primary measure of efficacy is clinic visit trough
(pre-bronchodilator and pre-dose) forced expiratory volume in one second (FEV1) on Treatment
Day 169. Safety will be assessed by adverse events, 12-lead ECGs, vital signs, and clinical
laboratory tests.
Trial website
https://clinicaltrials.gov/show/NCT01316913
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications