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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/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
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
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
Sex
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
1/03/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2012
Sample size
Target
Accrual to date
Final
872
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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California
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Florida
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Kansas
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Kentucky
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Louisiana
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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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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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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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Bayern
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Hessen
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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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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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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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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/ct2/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

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01316913