Status:
COMPLETED
Safety And Efficacy Of GSK233705 Plus Salmeterol Compared With 2 Active Comparators And Placebo In Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Lead Sponsor:
GlaxoSmithKline
Conditions:
Pulmonary Disease, Chronic Obstructive
Eligibility:
All Genders
40-75 years
Phase:
PHASE2
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 v...
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 pharmacoki...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2007
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00422604
Start Date
October 1 2006
End Date
May 1 2007
Last Update
October 28 2016
Active Locations (11)
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1
GSK Investigational Site
Helsinki, Finland, 00029
2
GSK Investigational Site
Wiesbaden, Hesse, Germany, 65187
3
GSK Investigational Site
Großhansdorf, Schleswig-Holstein, Germany, 22927
4
GSK Investigational Site
Almelo, Netherlands, 7609 PP