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

Pulmonary Disease, Chronic Obstructive Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00422604
• Other study ID #: AC2106956
• Status: Completed
• Phase: Phase 2
• First received: January 15, 2007
• Last updated: October 27, 2016
• Start date: October 2006
• Est. completion date: May 2007

Study information

• Verified date: October 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• salmeterol

• tiotropium

• GSK233705

Locations

Country	Name	City	State
Finland	GSK Investigational Site	Helsinki
Germany	GSK Investigational Site	Grosshansdorf	Schleswig-Holstein
Germany	GSK Investigational Site	Wiesbaden	Hessen
Netherlands	GSK Investigational Site	Almelo
Netherlands	GSK Investigational Site	Eindhoven
Netherlands	GSK Investigational Site	Heerlen
Netherlands	GSK Investigational Site	Veldhoven
Russian Federation	GSK Investigational Site	Moscow
Russian Federation	GSK Investigational Site	St. Petersburg
United Kingdom	GSK Investigational Site	Manchester
United Kingdom	GSK Investigational Site	Upton Road, Slough	Berkshire

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Finland,  Germany,  Netherlands,  Russian Federation,  United Kingdom, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bronchodilator effect of GSK233705 plus salmeterol at day 7, compared with placebo in COPD subjects.
Secondary	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.

External Links

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