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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)

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pulmonary Disease, Chronic Obstructive; Chronic Obstructive Pulmonary Disease (COPD)

Intervention: salmeterol (Drug); tiotropium (Drug); GSK233705 (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

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.

Clinical Details

Official title: See Detailed Description

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

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

Secondary outcome: 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.

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

Minimum age: 40 Years. Maximum age: 75 Years. Gender(s): Both.

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

Locations and Contacts

GSK Investigational Site, Helsinki 00029, Finland

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, Russian Federation

GSK Investigational Site, St. Petersburg 197 089, Russian Federation

GSK Investigational Site, Manchester M23 9QZ, United Kingdom

GSK Investigational Site, Upton Road, Slough, Berkshire SL1 2AD, United Kingdom

GSK Investigational Site, Wiesbaden, Hessen 65187, Germany

GSK Investigational Site, Grosshansdorf, Schleswig-Holstein 22927, Germany

Additional Information

Related publications:

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.

Starting date: October 2006
Last updated: May 31, 2012

Page last updated: August 23, 2015

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