Last updated: 11/04/2018 04:26:33
Safety And Efficacy Of GSK233705 Plus Salmeterol Compared With 2 Active Comparators And Placebo In Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Single (Participant)
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Drug: salmeterol
Drug: tiotropium
Drug: GSK233705
Enrollment:
60
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Beier J, Van Noord J, Deans A, Brooks J, Maden C, Baggen S, 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;7:153-164.
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
darotropium bromide, salmeterol
Collaborators
Not applicable
Study date(s)
October 2006 to May 2007
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
40 - 75 years
Accepts healthy volunteers
No
- females of non-childbearing potential or postmenopausal;
- history of COPD as defined by ATS/ERS criteria;
- no instable COPD;
- max 1000 mcg inhaled steroids per day;
Inclusion and exclusion 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
Trial location(s)
Location
GSK Investigational Site
Grosshansdorf, Schleswig-Holstein, Germany, 22927
Status
Study Complete
Location
GSK Investigational Site
Upton Road, Slough, Berkshire, United Kingdom, SL1 2AD
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2007-31-05
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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