A 4-week Dose-Ranging, Dose-Interval, Efficacy, Safety and Tolerability Study of GSK961081 in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
1 other identifier
interventional
437
9 countries
49
Brief Summary
This study is primarily designed to assess the dose response, dose interval, efficacy and safety of three once daily (QD) doses (100mcg, 400mcg and 800mcg) and three twice daily (BID) doses (100mcg, 200mcg and 400mcg,) of GSK961081 administered via DISKUS™ for 28 days in subjects with moderate/severe COPD versus placebo. Salmeterol 50mcg BID is included in the study as an active comparator.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2010
Shorter than P25 for phase_2
49 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2010
CompletedFirst Submitted
Initial submission to the registry
March 3, 2011
CompletedFirst Posted
Study publicly available on registry
March 21, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedDecember 1, 2016
November 1, 2016
9 months
March 3, 2011
November 30, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in FEV1 from baseline in pre-dose AM trough.
Pre-dose change in AM FEV1 on day 29 vs baseline . (defined as the mean values recorded 11 and 12 hours after the PM dose on day 28)
28 Day
Secondary Outcomes (1)
Weighted Mean and Serial FEV1 at multiple timepoints
28 Days
Study Arms (8)
GSK961081 100 mcg QD
EXPERIMENTALGSK961081 100mcg BD
EXPERIMENTALGSK961081 200mcg QD
EXPERIMENTALGSK961081 400mcg QD
EXPERIMENTALGSK961081 400mcg BD
EXPERIMENTALGSK961081 800mcg QD
EXPERIMENTALSalmeterol 50mcg BD
ACTIVE COMPARATORPlacebo
PLACEBO COMPARATORInterventions
Comparison of different doses and dosing regimens of the drug
Eligibility Criteria
You may qualify if:
- Outpatient Subjects
- Subjects who give their signed and dated informed consent to participate
- or more years of age, inclusive, at Visit 1
- Male or females
- Subjects with an established clinical history of COPD
- Current or previous cigarette smokers with a history of ≥ 10 pack-years of cigarette smoking
- Subjects with the following liver function test values:
- Subjects with a measured post-salbutamol FEV1/FVC ratio of \< 0.70 at Visit 1 (Screening).
- Subjects with a measured post-salbutamol FEV1 30-70% of predicted normal values
You may not qualify if:
- Women who are pregnant or lactating or are planning to become pregnant during the study.
- Current diagnosis of asthma
- Other significant respiratory disorders besides COPD, including alpha-1 deficiency
- Previous lung resection surgery
- Significant abnormalities in chest x-ray presentation
- Hospitalization for a COPD exacerbation within 12 weeks prior screening
- Use of oral corticosteroids or antibiotics for COPD or antibiotics for a lower respiratory tract infection within 6 weeks
- Any significant disease that would put subject at risk through study participation
- BMI greater than 35
- Pacemaker
- Significantly abnormal ECG, clinical lab finding (including Hepatitis B or C)
- Cancer
- Allergy or hypersensitivity to beta adrenergic receptor-agonist, sympathomimetic, anticholinergic/anti-muscarinic receptor antagonist, or inhaler excipients
- Diseases that would contra-indicate the use of anticholinergics
- Use of sysemic corticosteroids within 6 weeks of screening
- +12 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (49)
GSK Investigational Site
Tallinn, 10138, Estonia
GSK Investigational Site
Tallinn, 13419, Estonia
GSK Investigational Site
Tallinn, 13619, Estonia
GSK Investigational Site
Tartu, 51014, Estonia
GSK Investigational Site
Frankfurt am Main, Hesse, 60596, Germany
GSK Investigational Site
Gelnhausen, Hesse, 63571, Germany
GSK Investigational Site
Dresden, Saxony, 01307, Germany
GSK Investigational Site
Lübeck, Schleswig-Holstein, 23552, Germany
GSK Investigational Site
Berlin, State of Berlin, 10367, Germany
GSK Investigational Site
Berlin, State of Berlin, 10717, Germany
GSK Investigational Site
Berlin, State of Berlin, 10787, Germany
GSK Investigational Site
Almelo, 7609 PP, Netherlands
GSK Investigational Site
Breda, 4819 EV, Netherlands
GSK Investigational Site
Eindhoven, 5623 EJ, Netherlands
GSK Investigational Site
Hoorn, 1624 NP, Netherlands
GSK Investigational Site
Veldhoven, 5504 DB, Netherlands
GSK Investigational Site
Zutphen, 7207 AE, Netherlands
GSK Investigational Site
Bucharest, 020125, Romania
GSK Investigational Site
Bucharest, 050159, Romania
GSK Investigational Site
Iași, 700115, Romania
GSK Investigational Site
Timișoara, 300310, Romania
GSK Investigational Site
Moscow, 105 077, Russia
GSK Investigational Site
Moscow, 115446, Russia
GSK Investigational Site
Saint Petersburg, 197022, Russia
GSK Investigational Site
Tomsk, 634001, Russia
GSK Investigational Site
Yekaterinburg, 620109, Russia
GSK Investigational Site
Bratislava, 826 06, Slovakia
GSK Investigational Site
Košice, 040 01, Slovakia
GSK Investigational Site
Nitra, 949 01, Slovakia
GSK Investigational Site
Nové Zámky, 940 01, Slovakia
GSK Investigational Site
Zvolen, 960 01, Slovakia
GSK Investigational Site
Bellville, 7530, South Africa
GSK Investigational Site
Durban, 4001, South Africa
GSK Investigational Site
Gatesville, 7764, South Africa
GSK Investigational Site
Mowbray, 7700, South Africa
GSK Investigational Site
Panorama, 7500, South Africa
GSK Investigational Site
Tygerberg, 7505, South Africa
GSK Investigational Site
Boden, SE-961 64, Sweden
GSK Investigational Site
Gothenburg, SE-413 45, Sweden
GSK Investigational Site
Lund, SE-221 85, Sweden
GSK Investigational Site
Stockholm, SE-171 76, Sweden
GSK Investigational Site
Dnipropetrovsk, 49074, Ukraine
GSK Investigational Site
Ivano-Frankivsk, 76018, Ukraine
GSK Investigational Site
Kharkiv, 61124, Ukraine
GSK Investigational Site
Kiev, 03680, Ukraine
GSK Investigational Site
Kyiv, 03115, Ukraine
GSK Investigational Site
Kyiv, 03680, Ukraine
GSK Investigational Site
Simferopol, 95043, Ukraine
GSK Investigational Site
Vinnytsia, 21029, Ukraine
Related Publications (1)
Wielders PL, Ludwig-Sengpiel A, Locantore N, Baggen S, Chan R, Riley JH. A new class of bronchodilator improves lung function in COPD: a trial with GSK961081. Eur Respir J. 2013 Oct;42(4):972-81. doi: 10.1183/09031936.00165712. Epub 2013 Feb 21.
PMID: 23429913BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 3, 2011
First Posted
March 21, 2011
Study Start
December 1, 2010
Primary Completion
September 1, 2011
Study Completion
September 1, 2011
Last Updated
December 1, 2016
Record last verified: 2016-11
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.