MedDataX Logo

Safety And Efficacy Of GSK233705 Plus Salmeterol Compared With 2 Active Comparators And Placebo In Subjects With Chronic Obstructive Pulmonary Disease (COPD)

NCT ID: NCT00422604

Last Updated: 2016-10-28

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2007-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The safety, tolerability, pharmacokinetics and pharmacodynamics/efficacy profiles of two different doses of GSK233705 will be compared with 2 active comparators and placebo, all medication delivered via dry powder inhaler.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

A multi-centre, randomised, partially blinded, placebo-controlled, three-way crossover, incomplete block design study to investigate the, safety, tolerability, pharmacodynamics/efficacy and pharmacokinetics of dual bronchodilator therapy with salmeterol 50 mcg twice daily plus two different doses of GSK233705 (20 and 50 mcg twice daily), compared with placebo, salmeterol 50 mcg twice daily alone, and tiotropium 18 mcg once daily alone, in subjects with chronic obstructive pulmonary disease

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pulmonary Disease, Chronic Obstructive

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

COPD plethysmography. muscarinic receptor antagonist anticholinergic

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

salmeterol

Intervention Type DRUG

tiotropium

Intervention Type DRUG

GSK233705

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

salmeterol tiotropium

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* females of non-childbearing potential or postmenopausal;
* history of COPD as defined by ATS/ERS criteria;
* moderate COPD responsive to ipratropium and salbutamol;
* current smoker or ex-smoker.

Exclusion Criteria

* no instable COPD; max 1000 mcg inhaled steroids per day; no B-blockers
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

GSK Investigational Site

Helsinki, , Finland

Site Status

GSK Investigational Site

Wiesbaden, Hesse, Germany

Site Status

GSK Investigational Site

Großhansdorf, Schleswig-Holstein, Germany

Site Status

GSK Investigational Site

Almelo, , Netherlands

Site Status

GSK Investigational Site

Eindhoven, , Netherlands

Site Status

GSK Investigational Site

Heerlen, , Netherlands

Site Status

GSK Investigational Site

Veldhoven, , Netherlands

Site Status

GSK Investigational Site

Moscow, , Russia

Site Status

GSK Investigational Site

Saint Petersburg, , Russia

Site Status

GSK Investigational Site

Upton Road, Slough, Berkshire, United Kingdom

Site Status

GSK Investigational Site

Manchester, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Finland Germany Netherlands Russia United Kingdom

References

Explore related publications, articles, or registry entries linked to this study.

Beier J, van Noord J, Deans A, Brooks J, Maden C, Baggen S, Mehta R, Cahn A. Safety and efficacy of dual therapy with GSK233705 and salmeterol versus monotherapy with salmeterol, tiotropium, or placebo in a crossover pilot study in partially reversible COPD patients. Int J Chron Obstruct Pulmon Dis. 2012;7:153-64. doi: 10.2147/COPD.S26100. Epub 2012 Mar 5.

Reference Type BACKGROUND
PMID: 22419863 (View on PubMed)

Study Documents

Access uploaded study-related documents such as protocols, statistical analysis plans, or lay summaries.

Document Type: Clinical Study Report

View Document

Document Type: Annotated Case Report Form

View Document

Document Type: Study Protocol

View Document

Document Type: Dataset Specification

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Individual Participant Data Set

View Document

Document Type: Informed Consent Form

View Document

Related Links

Access external resources that provide additional context or updates about the study.

https://www.clinicalstudydatarequest.com

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

AC2106956

Identifier Type: -

Identifier Source: org_study_id