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

Sponsor

GlaxoSmithKline (Industry)

Overall Status

Completed

CT.gov ID

NCT00422604

Collaborator

(none)

Enrollment

Locations

Duration (Months)

5.5

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Disease, Chronic Obstructive	Drug: salmeterol Drug: tiotropium Drug: GSK233705	Phase 2

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

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

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

Study Start Date :

Oct 1, 2006

Actual Primary Completion Date :

May 1, 2007

Actual Study Completion Date :

May 1, 2007

Outcome Measures

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. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Helsinki		Finland	00029
2	GSK Investigational Site	Wiesbaden	Hessen	Germany	65187
3	GSK Investigational Site	Grosshansdorf	Schleswig-Holstein	Germany	22927
4	GSK Investigational Site	Almelo		Netherlands	7609 PP
5	GSK Investigational Site	Eindhoven		Netherlands	5623 EJ
6	GSK Investigational Site	Heerlen		Netherlands	6419 PC
7	GSK Investigational Site	Veldhoven		Netherlands	5504 DB
8	GSK Investigational Site	Moscow		Russian Federation	105 229
9	GSK Investigational Site	St. Petersburg		Russian Federation	197 089
10	GSK Investigational Site	Upton Road, Slough	Berkshire	United Kingdom	SL1 2AD
11	GSK Investigational Site	Manchester		United Kingdom	M23 9QZ