Safety And Efficacy Of GSK233705 Plus Salmeterol Compared With 2 Active Comparators And Placebo In Subjects With Chronic Obstructive Pulmonary Disease (COPD)
A Multicentre, 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 50µg Twice-daily Plus Two Different Doses of GSK233705B (20 and 50µg Twice-daily), Compared With Placebo, Salmeterol 50µg Twice-daily Alone, and Tiotropium 18µg Once-daily Alone, in Subjects With Chronic Obstructive Pulmonary Disease
1 other identifier
interventional
60
5 countries
11
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Oct 2006
Shorter than P25 for phase_2
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2006
CompletedFirst Submitted
Initial submission to the registry
January 15, 2007
CompletedFirst Posted
Study publicly available on registry
January 17, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2007
CompletedOctober 28, 2016
October 1, 2016
7 months
January 15, 2007
October 27, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Bronchodilator effect of GSK233705 plus salmeterol at day 7, compared with placebo in COPD subjects.
Secondary Outcomes (1)
Bronchodilator effect of salmeterol alone and tiotropium alone compared with placebo and GSK233705 at day 7. Safety and tolerability of GSK233705 plus salmeterol and the 2 active comparators at day 7.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- no instable COPD; max 1000 mcg inhaled steroids per day; no B-blockers
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (11)
GSK Investigational Site
Helsinki, 00029, Finland
GSK Investigational Site
Wiesbaden, Hesse, 65187, Germany
GSK Investigational Site
Großhansdorf, Schleswig-Holstein, 22927, Germany
GSK Investigational Site
Almelo, 7609 PP, Netherlands
GSK Investigational Site
Eindhoven, 5623 EJ, Netherlands
GSK Investigational Site
Heerlen, 6419 PC, Netherlands
GSK Investigational Site
Veldhoven, 5504 DB, Netherlands
GSK Investigational Site
Moscow, 105 229, Russia
GSK Investigational Site
Saint Petersburg, 197 089, Russia
GSK Investigational Site
Upton Road, Slough, Berkshire, SL1 2AD, United Kingdom
GSK Investigational Site
Manchester, M23 9QZ, United Kingdom
Related Publications (1)
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.
PMID: 22419863BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 15, 2007
First Posted
January 17, 2007
Study Start
October 1, 2006
Primary Completion
May 1, 2007
Study Completion
May 1, 2007
Last Updated
October 28, 2016
Record last verified: 2016-10
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.