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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00422604
First received: January 15, 2007
Last updated: May 31, 2012
Last verified: March 2011
  Purpose

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.


Condition Intervention Phase
Pulmonary Disease, Chronic Obstructive
Chronic Obstructive Pulmonary Disease (COPD)
Drug: salmeterol
Drug: tiotropium
Drug: GSK233705
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: See Detailed Description

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Bronchodilator effect of GSK233705 plus salmeterol at day 7, compared with placebo in COPD subjects.

Secondary Outcome Measures:
  • 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.

Enrollment: 60
Study Start Date: October 2006
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: salmeterol Drug: tiotropium Drug: GSK233705
    Other Names:
    • salmeterol
    • tiotropium
    • GSK233705
Detailed Description:

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

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00422604

Locations
Finland
GSK Investigational Site
Helsinki, Finland, 00029
Germany
GSK Investigational Site
Wiesbaden, Hessen, Germany, 65187
GSK Investigational Site
Grosshansdorf, Schleswig-Holstein, Germany, 22927
Netherlands
GSK Investigational Site
Almelo, Netherlands, 7609 PP
GSK Investigational Site
Eindhoven, Netherlands, 5623 EJ
GSK Investigational Site
Heerlen, Netherlands, 6419 PC
GSK Investigational Site
Veldhoven, Netherlands, 5504 DB
Russian Federation
GSK Investigational Site
Moscow, Russian Federation, 105 229
GSK Investigational Site
St. Petersburg, Russian Federation, 197 089
United Kingdom
GSK Investigational Site
Upton Road, Slough, Berkshire, United Kingdom, SL1 2AD
GSK Investigational Site
Manchester, United Kingdom, M23 9QZ
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00422604     History of Changes
Other Study ID Numbers: AC2106956
Study First Received: January 15, 2007
Last Updated: May 31, 2012
Health Authority: Finland: Finnish Medicines Agency

Keywords provided by GlaxoSmithKline:
COPD
plethysmography.
muscarinic receptor antagonist
anticholinergic

Additional relevant MeSH terms:
Chronic Disease
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases
Salmeterol
Tiotropium
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Parasympatholytics
Cholinergic Antagonists
Cholinergic Agents

ClinicalTrials.gov processed this record on July 23, 2014