Last updated: 11/07/2018 08:30:30
A 4-week Dose-Ranging, Dose-Interval, Efficacy, Safety and Tolerability Study of GSK961081 in Subjects with Chronic Obstructive Pulmonary Disease (COPD)
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A 4-week Dose-Ranging, Dose-Interval, Efficacy, Safety and Tolerability Study of GSK961081 in Subjects with Chronic Obstructive Pulmonary Disease (COPD)
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Change from baseline in morning (AM) trough forced expiratory volume in 1 second (FEV1) on Day 29
Timeframe: Day 29
Secondary outcomes:
Weighted mean for 0 to 24 hours serial FEV1 in the subset of participants with overnight spirometry on Day 28
Timeframe: Day 28
Serial AM FEV1 on Day 1 and Day 28 up to 12hours post AM dose
Timeframe: Day 1 and Day 28
Serial FEV1 on Day 28 in the subset of participants performing overnight spirometry up to 24H post AM dose
Timeframe: Day 28
Interventions:
Drug: GSK961081
Drug: Salmeterol
Drug: Placebo
Enrollment:
437
Observational study model:
Not applicable
Primary completion date:
2011-02-09
Time perspective:
Not applicable
Clinical publications:
Wielders PLML, 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;Feb 21:ePub ahead of print.
Claire L. Ambery , Pascal Wielders, Andrea Ludwig-Sengpiel, Robert Chan, John H. Riley. Population pharmacokinetics and pharmacodynamics of GSK961081 (batefenterol), a muscarinic antagonist and b2-agonist in moderate-to-severe COPD patients: substudy of a randomized trial. Drugs R D. 2015;15(3):281-291.
Norris V, Ambery C. Use of propranolol blockade to explore the pharmacology of GSK961081, a bi-functional bronchodilator, in healthy volunteers: results from two randomized trials. Drugs R D. 2014;[Epub ahead of print].
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
batefenterol, salmeterol
Collaborators
Not applicable
Study date(s)
December 2010 to September 2011
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
40+ years
Accepts healthy volunteers
No
- Outpatient Subjects
- Subjects who give their signed and dated informed consent to participate
- Women who are pregnant or lactating or are planning to become pregnant during the study.
- Current diagnosis of asthma
Inclusion and exclusion criteria
Inclusion criteria:
- Outpatient Subjects -Subjects who give their signed and dated informed consent to participate
- 40 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
Exclusion criteria:
- 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
- Use of long-acting beta-agonists within 48 hours of screening
- Use of tiotropium within 7 days of screening
- Use of theophyllines or anti-leukotrienes within 48 hours of screening
- Use of short-acting bronchodilators within 4 hours of screening
- Use of investigational medicines within 30 days of screening
- Use of high dose inhaled corticosteroids
- Use of long-term oxygen therapy, CPAP or NIPPV
- Participation in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to Visit 1
- Regular (q.i.d or greater) use of short acting bronchodilators, including nebulized therapy
- Affiliation with Investigator Site
- Questionable Validity of Consent
- Previous use of GSK961081
Trial location(s)
Location
GSK Investigational Site
Luebeck, Schleswig-Holstein, Germany, 23552
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2011-02-09
Actual study completion date
2011-02-09
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
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