Pulmonary Disease, Chronic ObstructivePhase 2NCT01319019
A 4-week Dose-Ranging, Dose-Interval, Efficacy, Safety and Tolerability Study of GSK961081 in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
A Phase 2 study testing GSK961081 and Salmeterol in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 49 sites in 9 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- GSK961081 and Salmeterol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 437 participants
- Where
- 49 sitesin 9 countries
- Study dates
- Dec 2010to Sep 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 27Show fewer
- 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 locations and contacts
49 sites in 9 countries.
49 sites in 9 countries
Ukraine8 sites
GSK Investigational Site
Dnipropetrovsk, 49074
GSK Investigational Site
Ivano-Frankivsk, 76018
GSK Investigational Site
Kharkiv, 61124
GSK Investigational Site
Kiev, 03680
GSK Investigational Site
Kyiv, 03115
GSK Investigational Site
Kyiv, 03680
GSK Investigational Site
Simferopol, 95043
GSK Investigational Site
Vinnytsia, 21029
Germany7 sites
GSK Investigational Site
Berlin, State of Berlin, 10367
GSK Investigational Site
Berlin, State of Berlin, 10717
GSK Investigational Site
Berlin, State of Berlin, 10787
GSK Investigational Site
Dresden, Saxony, 01307
GSK Investigational Site
Frankfurt am Main, Hesse, 60596
GSK Investigational Site
Gelnhausen, Hesse, 63571
GSK Investigational Site
Lübeck, Schleswig-Holstein, 23552
Netherlands6 sites
GSK Investigational Site
Almelo, 7609 PP
GSK Investigational Site
Breda, 4819 EV
GSK Investigational Site
Eindhoven, 5623 EJ
GSK Investigational Site
Hoorn, 1624 NP
GSK Investigational Site
Veldhoven, 5504 DB
GSK Investigational Site
Zutphen, 7207 AE
South Africa6 sites
GSK Investigational Site
Bellville, 7530
GSK Investigational Site
Durban, 4001
GSK Investigational Site
Gatesville, 7764
GSK Investigational Site
Mowbray, 7700
GSK Investigational Site
Panorama, 7500
GSK Investigational Site
Tygerberg, 7505
Russia5 sites
GSK Investigational Site
Moscow, 105 077
GSK Investigational Site
Moscow, 115446
GSK Investigational Site
Saint Petersburg, 197022
GSK Investigational Site
Tomsk, 634001
GSK Investigational Site
Yekaterinburg, 620109
Slovakia5 sites
GSK Investigational Site
Bratislava, 826 06
GSK Investigational Site
Košice, 040 01
GSK Investigational Site
Nitra, 949 01
GSK Investigational Site
Nové Zámky, 940 01
GSK Investigational Site
Zvolen, 960 01
Estonia4 sites
GSK Investigational Site
Tallinn, 10138
GSK Investigational Site
Tallinn, 13419
GSK Investigational Site
Tallinn, 13619
GSK Investigational Site
Tartu, 51014
Romania4 sites
GSK Investigational Site
Bucharest, 020125
GSK Investigational Site
Bucharest, 050159
GSK Investigational Site
Iași, 700115
GSK Investigational Site
Timișoara, 300310
Sweden4 sites
GSK Investigational Site
Boden, SE-961 64
GSK Investigational Site
Gothenburg, SE-413 45
GSK Investigational Site
Lund, SE-221 85
GSK Investigational Site
Stockholm, SE-171 76
About this study
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.
Read the detailed description
This is a phase IIb multicentre, randomised, double-blind, double-dummy, placebo- and active-controlled, parallel-group, dose-ranging and dose-interval study. Eligible subjects will enter a seven-day run-in period followed by 28 days of double-blind, double-dummy treatment via the DISKUS inhaler. The study will consist of 8 visits, mainly conducted on an outpatient basis, 6 of which will be clinic visits and 2 of which will be phone contacts, including a post-treatment visit to follow up any adverse events. There will be approximately 425 subjects randomised to the study.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- GSK961081, Salmeterol, Placebo
- Keywords
- lung function, bronchodilator, COPD, dose response, dosing interval, efficacy, safety, PD, PK
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK961081Drug
Comparison of different doses and dosing regimens of the drug
SalmeterolDrug
Positive control
PlaceboDrug
Placebo arm
| Study group | Role | What they receive |
|---|---|---|
| GSK961081 100 mcg QD | Experimental | Not described Receives: Drug: GSK961081 |
| GSK961081 100mcg BD | Experimental | Not described Receives: Drug: GSK961081 |
| GSK961081 200mcg QD | Experimental | Not described Receives: Drug: GSK961081 |
| GSK961081 400mcg QD | Experimental | Not described Receives: Drug: GSK961081 |
| GSK961081 400mcg BD | Experimental | Not described Receives: Drug: GSK961081 |
| GSK961081 800mcg QD | Experimental | Not described Receives: Drug: GSK961081 |
| Salmeterol 50mcg BD | Active comparator | Not described Receives: Drug: Salmeterol |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 28 Day
Secondary outcomes (1)
Weighted Mean and Serial FEV1 at multiple timepoints
In the subset of patients with overnight spirometry on day 28 (pre-dose and post dose after 15,30, and 60 min and 2, 4,6, 11 and 12 hours)
Measured: 28 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2011 (estimated)
- Study startDec 2010
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 437 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01319019
- Sponsor's protocol ID
- 115032
- Status last verified
- Nov 2016
- First submitted
- 3 Mar 2011
- Last updated
- 1 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Publications
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.
PubMed 23429913
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 4-week Dose-Ranging, Dose-Interval, Efficacy, Safety and Tolerability Study of GSK961081 in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT01319019
- Acronym / sponsor ID
- 115032
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- lung function, bronchodilator, COPD, dose response, dosing interval, efficacy, safety, PD, PK
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 437 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 21 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a phase IIb multicentre, randomised, double-blind, double-dummy, placebo- and active-controlled, parallel-group, dose-ranging and dose-interval study. Eligible subjects will enter a seven-day run-in period followed by 28 days of double-blind, double-dummy treatment via the DISKUS inhaler. The study will consist of 8 visits, mainly conducted on an outpatient basis, 6 of which will be clinic visits and 2 of which will be phone contacts, including a post-treatment visit to follow up any adverse events. There will be approximately 425 subjects randomised to the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| GSK961081 100 mcg QD | Experimental | Drug: GSK961081 |
| GSK961081 100mcg BD | Experimental | Drug: GSK961081 |
| GSK961081 200mcg QD | Experimental | Drug: GSK961081 |
| GSK961081 400mcg QD | Experimental | Drug: GSK961081 |
| GSK961081 400mcg BD | Experimental | Drug: GSK961081 |
| GSK961081 800mcg QD | Experimental | Drug: GSK961081 |
| Salmeterol 50mcg BD | Active comparator | Drug: Salmeterol |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (27 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GSK961081Comparison of different doses and dosing regimens of the drug | Drug | GSK961081 100 mcg QD, GSK961081 100mcg BD, GSK961081 200mcg QD, GSK961081 400mcg BD, GSK961081 400mcg QD, GSK961081 800mcg QD |
| SalmeterolPositive control | Drug | Salmeterol 50mcg BD |
| PlaceboPlacebo arm | Drug | Placebo |
Primary outcome
Change in FEV1 from baseline in pre-dose AM trough.
Time frame: 28 Day
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)
1 secondary outcome
Weighted Mean and Serial FEV1 at multiple timepoints
Time frame: 28 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2016.
- Background: PubMed 23429913Wielders 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.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
49 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GSK961081 and Salmeterol in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 49 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 49 sites in Ukraine, Germany, Netherlands, South Africa, Russia and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in FEV1 from baseline in pre-dose AM trough. (time frame: 28 Day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01319019, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2016.