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

NCT ID: NCT01319019

Last Updated: 2016-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

437 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2011-09-30

Brief Summary

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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

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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

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Pulmonary Disease, Chronic Obstructive

Keywords

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lung function bronchodilator COPD, dose response, dosing interval, efficacy, safety, PD, PK

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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GSK961081 100 mcg QD

Group Type EXPERIMENTAL

GSK961081

Intervention Type DRUG

Comparison of different doses and dosing regimens of the drug

GSK961081 100mcg BD

Group Type EXPERIMENTAL

GSK961081

Intervention Type DRUG

Comparison of different doses and dosing regimens of the drug

GSK961081 200mcg QD

Group Type EXPERIMENTAL

GSK961081

Intervention Type DRUG

Comparison of different doses and dosing regimens of the drug

GSK961081 400mcg QD

Group Type EXPERIMENTAL

GSK961081

Intervention Type DRUG

Comparison of different doses and dosing regimens of the drug

GSK961081 400mcg BD

Group Type EXPERIMENTAL

GSK961081

Intervention Type DRUG

Comparison of different doses and dosing regimens of the drug

GSK961081 800mcg QD

Group Type EXPERIMENTAL

GSK961081

Intervention Type DRUG

Comparison of different doses and dosing regimens of the drug

Salmeterol 50mcg BD

Group Type ACTIVE_COMPARATOR

Salmeterol

Intervention Type DRUG

Positive control

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo arm

Interventions

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GSK961081

Comparison of different doses and dosing regimens of the drug

Intervention Type DRUG

Salmeterol

Positive control

Intervention Type DRUG

Placebo

Placebo arm

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Tallinn, , Estonia

Site Status

GSK Investigational Site

Tallinn, , Estonia

Site Status

GSK Investigational Site

Tallinn, , Estonia

Site Status

GSK Investigational Site

Tartu, , Estonia

Site Status

GSK Investigational Site

Frankfurt am Main, Hesse, Germany

Site Status

GSK Investigational Site

Gelnhausen, Hesse, Germany

Site Status

GSK Investigational Site

Dresden, Saxony, Germany

Site Status

GSK Investigational Site

Lübeck, Schleswig-Holstein, Germany

Site Status

GSK Investigational Site

Berlin, State of Berlin, Germany

Site Status

GSK Investigational Site

Berlin, State of Berlin, Germany

Site Status

GSK Investigational Site

Berlin, State of Berlin, Germany

Site Status

GSK Investigational Site

Almelo, , Netherlands

Site Status

GSK Investigational Site

Breda, , Netherlands

Site Status

GSK Investigational Site

Eindhoven, , Netherlands

Site Status

GSK Investigational Site

Hoorn, , Netherlands

Site Status

GSK Investigational Site

Veldhoven, , Netherlands

Site Status

GSK Investigational Site

Zutphen, , Netherlands

Site Status

GSK Investigational Site

Bucharest, , Romania

Site Status

GSK Investigational Site

Bucharest, , Romania

Site Status

GSK Investigational Site

Iași, , Romania

Site Status

GSK Investigational Site

Timișoara, , Romania

Site Status

GSK Investigational Site

Moscow, , Russia

Site Status

GSK Investigational Site

Moscow, , Russia

Site Status

GSK Investigational Site

Saint Petersburg, , Russia

Site Status

GSK Investigational Site

Tomsk, , Russia

Site Status

GSK Investigational Site

Yekaterinburg, , Russia

Site Status

GSK Investigational Site

Bratislava, , Slovakia

Site Status

GSK Investigational Site

Košice, , Slovakia

Site Status

GSK Investigational Site

Nitra, , Slovakia

Site Status

GSK Investigational Site

Nové Zámky, , Slovakia

Site Status

GSK Investigational Site

Zvolen, , Slovakia

Site Status

GSK Investigational Site

Bellville, , South Africa

Site Status

GSK Investigational Site

Durban, , South Africa

Site Status

GSK Investigational Site

Gatesville, , South Africa

Site Status

GSK Investigational Site

Mowbray, , South Africa

Site Status

GSK Investigational Site

Panorama, , South Africa

Site Status

GSK Investigational Site

Tygerberg, , South Africa

Site Status

GSK Investigational Site

Boden, , Sweden

Site Status

GSK Investigational Site

Gothenburg, , Sweden

Site Status

GSK Investigational Site

Lund, , Sweden

Site Status

GSK Investigational Site

Stockholm, , Sweden

Site Status

GSK Investigational Site

Dnipropetrovsk, , Ukraine

Site Status

GSK Investigational Site

Ivano-Frankivsk, , Ukraine

Site Status

GSK Investigational Site

Kharkiv, , Ukraine

Site Status

GSK Investigational Site

Kiev, , Ukraine

Site Status

GSK Investigational Site

Kyiv, , Ukraine

Site Status

GSK Investigational Site

Kyiv, , Ukraine

Site Status

GSK Investigational Site

Simferopol, , Ukraine

Site Status

GSK Investigational Site

Vinnytsia, , Ukraine

Site Status

Countries

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Estonia Germany Netherlands Romania Russia Slovakia South Africa Sweden Ukraine

References

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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.

Reference Type BACKGROUND
PMID: 23429913 (View on PubMed)

Study Documents

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Document Type: Individual Participant Data Set

View Document

Document Type: Annotated Case Report Form

View Document

Document Type: Dataset Specification

View Document

Document Type: Clinical Study Report

View Document

Document Type: Informed Consent Form

View Document

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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https://www.clinicalstudydatarequest.com

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Other Identifiers

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115032

Identifier Type: -

Identifier Source: org_study_id