Last updated: 11/04/2018 06:09:56
Safety and Tolerability of repeat dosing of GSK233705/GW642444 in COPD
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A multicenter, randomized, double-blind, placebo-controlled, parallel-group, 4-week study to evaluate the safety, tolerability, pharmacodynamics and pharmacokinetics of repeat inhaled doses of the combination of GSK233705 and GW642444 administered once-daily in subjects with COPD
Trial description: The purpose of this study is the evaluate the safety and tolerability of repeat dosing of the combination of inhaled GSK233705 and GW642444 administered once-daily in subjects with COPD.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Change from Baseline in weighted mean pulse rate over (0-4 hours) at Day 28.
Timeframe: Baseline (Pre-dose, Day 1) and Day 28
Secondary outcomes:
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Timeframe: On-treatment; from treatment start until one day after treatment stop (Up to Day 29)
Interventions:
Drug: Placebo
Drug: GSK233705/GW642444
Enrollment:
61
Observational study model:
Not applicable
Primary completion date:
2009-12-02
Time perspective:
Not applicable
Clinical publications:
GSK has submitted manuscripts of these study results to peer-reviewed scientific journals which were not accepted for publication. GSK is providing the attached study results summary with a conclusion.
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
darotropium bromide, vilanterol
Collaborators
GSK
Study date(s)
November 2008 to February 2009
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
40 - 80 years
Accepts healthy volunteers
No
- male and females 40 to 80 years of age (inclusive)
- COPD diagnosis
- Pregnant or lactating females
- current diagnosis of asthma
Inclusion and exclusion criteria
Inclusion criteria:
- male and females 40 to 80 years of age (inclusive)
- COPD diagnosis
- Current or previous smokers with a cigarette smoking history of at least 10 pack-
- Post-albuterol FEV1/FVC of 0.70 or less
- Post-albuterol FEV1 of 35% to 80% (inclusive)
Exclusion criteria:
- Pregnant or lactating females
- current diagnosis of asthma
- respiratory disorders other than COPD
- clinically significant cardiovascular, neurological, psychiatric, renal, immunological, endocrine, or hematological abnormalities that are uncontrolled
- clinically significant sleep apnea
- previous lung resection surgery
- clinically significant abnormalities confirmed by chest x-ray that are not related to COPD
- hospitalization for COPD within 3 months of screening
- use of antibiotics for lower respiratory tract infection within 6 months of screening
- abnormal and clinically significant 12-lead ECG findings
- current malignancy in remission for less that 5 years
- medical conditions that would contraindicate the use of anticholinergics
- positive hepatitis B or C test
- history of alcohol or drug abuse
- unable to withhold albuterol for 6 or more hours
- use of long term oxygen therapy
- conditions that would limit the validity of informed consent
- use of GW642444 or GSK233705 in previous studies
- use of an investigation drug with 30 days of screening
- use of inhaled corticosteroids (ICS) at a dose greater than 1000mcg of fluticasone propionate or equivalent
- hypersensitivity to beta-agonists
- concurrent use of long-acting beta-agonists (LABA) or long-acting muscaring antagonists, LABA/ICS combination products, cytochrome p450 inhibitors, oral or depot corticosteroids, theophyllines, oral beta agonists, oral leukotrine modulators, inhaled short acting anticholinergics.
Trial location(s)
Location
GSK Investigational Site
Biddeford, Maine, United States, 04005
Status
Study Complete
Location
GSK Investigational Site
Erie, Pennsylvania, United States, 16508
Status
Study Complete
Location
GSK Investigational Site
Spartanburg, South Carolina, United States, 29303
Status
Study Complete
Location
GSK Investigational Site
San Antonio, Texas, United States, 78229
Status
Study Complete
Location
GSK Investigational Site
Wheat Ridge, Colorado, United States, 80033
Status
Study Complete
Location
GSK Investigational Site
Spokane, Washington, United States, 99204
Status
Study Complete
Location
GSK Investigational Site
Greenville, South Carolina, United States, 29615
Status
Study Complete
Location
GSK Investigational Site
St. Louis, Missouri, United States, 63141
Status
Study Complete
Location
GSK Investigational Site
Johnson City, Tennessee, United States, 37601
Status
Study Complete
Location
GSK Investigational Site
Summit, New Jersey, United States, 07091
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
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2009-12-02
Actual study completion date
2009-12-02
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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