A 4-week Dose-Ranging, Dose-Interval, Efficacy, Safety and Tolerability Study of GSK961081 in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

November 30, 2016 updated by: GlaxoSmithKline
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
437

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Estonia
      • Tallinn, Estonia, 13419
        • GSK Investigational Site
      • Tallinn, Estonia, 13619
        • GSK Investigational Site
      • Tallinn, Estonia, 10138
        • GSK Investigational Site
      • Tartu, Estonia, 51014
        • GSK Investigational Site
  • Germany
      • Berlin, Germany, 10367
        • GSK Investigational Site
      • Berlin, Germany, 10717
        • GSK Investigational Site
      • Berlin, Germany, 10787
        • GSK Investigational Site
    • Hessen
      • Frankfurt, Hessen, Germany, 60596
        • GSK Investigational Site
      • Gelnhausen, Hessen, Germany, 63571
        • GSK Investigational Site
    • Sachsen
      • Dresden, Sachsen, Germany, 01307
        • GSK Investigational Site
    • Schleswig-Holstein
      • Luebeck, Schleswig-Holstein, Germany, 23552
        • GSK Investigational Site
  • Netherlands
      • Almelo, Netherlands, 7609 PP
        • GSK Investigational Site
      • Breda, Netherlands, 4819 EV
        • GSK Investigational Site
      • Eindhoven, Netherlands, 5623 EJ
        • GSK Investigational Site
      • Hoorn, Netherlands, 1624 NP
        • GSK Investigational Site
      • Veldhoven, Netherlands, 5504 DB
        • GSK Investigational Site
      • Zutphen, Netherlands, 7207 AE
        • GSK Investigational Site
  • Romania
      • Bucharest, Romania, 050159
        • GSK Investigational Site
      • Bucharest, Romania, 020125
        • GSK Investigational Site
      • Iasi, Romania, 700115
        • GSK Investigational Site
      • Timisoara, Romania, 300310
        • GSK Investigational Site
  • Russian Federation
      • Ekaterinburg, Russian Federation, 620109
        • GSK Investigational Site
      • Moscow, Russian Federation, 115446
        • GSK Investigational Site
      • Moscow, Russian Federation, 105 077
        • GSK Investigational Site
      • St. Petersburg, Russian Federation, 197022
        • GSK Investigational Site
      • Tomsk, Russian Federation, 634001
        • GSK Investigational Site
  • Slovakia
      • Bratislava, Slovakia, 826 06
        • GSK Investigational Site
      • Kosice, Slovakia, 040 01
        • GSK Investigational Site
      • Nitra, Slovakia, 949 01
        • GSK Investigational Site
      • Nove Zamky, Slovakia, 940 01
        • GSK Investigational Site
      • Zvolen, Slovakia, 960 01
        • GSK Investigational Site
  • South Africa
      • Bellville, South Africa, 7530
        • GSK Investigational Site
      • Durban, South Africa, 4001
        • GSK Investigational Site
      • Gatesville, South Africa, 7764
        • GSK Investigational Site
      • Mowbray, South Africa, 7700
        • GSK Investigational Site
      • Panorama, South Africa, 7500
        • GSK Investigational Site
      • Tygerberg, South Africa, 7505
        • GSK Investigational Site
  • Sweden
      • Boden, Sweden, SE-961 64
        • GSK Investigational Site
      • Göteborg, Sweden, SE-413 45
        • GSK Investigational Site
      • Lund, Sweden, SE-221 85
        • GSK Investigational Site
      • Stockholm, Sweden, SE-171 76
        • GSK Investigational Site
  • Ukraine
      • Dnipropetrovsk, Ukraine, 49074
        • GSK Investigational Site
      • Ivano-Frankivsk, Ukraine, 76018
        • GSK Investigational Site
      • Kharkiv, Ukraine, 61124
        • GSK Investigational Site
      • Kiev, Ukraine, 03680
        • GSK Investigational Site
      • Kyiv, Ukraine, 03680
        • GSK Investigational Site
      • Kyiv, Ukraine, 03115
        • GSK Investigational Site
      • Simferopol, Ukraine, 95043
        • GSK Investigational Site
      • Vinnytsia, Ukraine, 21029
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
PLACEBO_COMPARATOR: Placebo
Drug: Placebo
Placebo arm
EXPERIMENTAL: GSK961081 100 mcg QD
Drug: GSK961081
Comparison of different doses and dosing regimens of the drug
EXPERIMENTAL: GSK961081 100mcg BD
Drug: GSK961081
Comparison of different doses and dosing regimens of the drug
EXPERIMENTAL: GSK961081 200mcg QD
Drug: GSK961081
Comparison of different doses and dosing regimens of the drug
EXPERIMENTAL: GSK961081 400mcg QD
Drug: GSK961081
Comparison of different doses and dosing regimens of the drug
EXPERIMENTAL: GSK961081 400mcg BD
Drug: GSK961081
Comparison of different doses and dosing regimens of the drug
EXPERIMENTAL: GSK961081 800mcg QD
Drug: GSK961081
Comparison of different doses and dosing regimens of the drug
ACTIVE_COMPARATOR: Salmeterol 50mcg BD
Drug: Salmeterol
Positive control

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
28 Day

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Weighted Mean and Serial FEV1 at multiple timepoints
Time Frame: 28 Days
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)
28 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2010

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2011

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 3, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 17, 2011

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 21, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 1, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 30, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 115032

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

  1. Individual Participant Data Set
    Information identifier: 115032
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  2. Annotated Case Report Form
    Information identifier: 115032
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  3. Dataset Specification
    Information identifier: 115032
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  4. Clinical Study Report
    Information identifier: 115032
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  5. Informed Consent Form
    Information identifier: 115032
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  6. Study Protocol
    Information identifier: 115032
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  7. Statistical Analysis Plan
    Information identifier: 115032
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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