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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:
ClinicalTrials.gov Identifier:
NCT00422604
First Posted: January 17, 2007
Last Update Posted: October 28, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  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 Drug: salmeterol Drug: tiotropium Drug: GSK233705 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: 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

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
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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Publications:
Study Data/Documents: Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: AC2106956
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: AC2106956
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: AC2106956
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: AC2106956
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: AC2106956
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: AC2106956
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: AC2106956
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00422604     History of Changes
Other Study ID Numbers: AC2106956
First Submitted: January 15, 2007
First Posted: January 17, 2007
Last Update Posted: October 28, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.

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

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