EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy and safety of GSK573719 delivered once-daily over 28 days in subjects with COPD
Trial description: The study will evaluate the efficacy, safety, and pharmacokinetics of GSK573719 compared with placebo 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 trough forced expiratory volume in one second (FEV1) at Day 29
Timeframe: Baseline and Day 29
Secondary outcomes:
Change from Baseline in weighted mean 0-6 hour FEV1 obtained post-dose at Day 1 and Day 28
Timeframe: Baseline, Day 1, and Day 28
Change from Baseline in serial FEV1 over 24 hours after dosing at Day 1 and Day 28
Timeframe: Baseline, Day 1, and Day 28
Interventions:
Drug: GSK573719 125mcg
Drug: GSK573719 250mcg
Drug: GSK573719 500mcg
Drug: Placebo
Enrollment:
285
Observational study model:
Not applicable
Primary completion date:
2010-04-07
Time perspective:
Not applicable
Clinical publications:
Decramer M, Maltais F, Feldman G, Brooks J, Harris S, Mehta R, Crater G. Bronchodilation of umeclidinium, a new long-acting muscarinic antagonist, in COPD patients. Respir Physiol Neurobiol. 2013;185(2):393-399.
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
umeclidinium bromide
Collaborators
GlaxoSmithKline
Study date(s)
December 2009 to July 2010
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
40 - 80 years
Accepts healthy volunteers
No
- A signed and dated written informed consent prior to study participation
- Males or females of non-childbearing potential
- Asthma
- Other significant respiratory disorders besides COPD, including alpha-1 deficiency
Inclusion and exclusion criteria
Inclusion criteria:
- A signed and dated written informed consent prior to study participation
- Males or females of non-childbearing potential
- 40 to 80 years of age
- COPD diagnosis
- 10 pack-years history or greater of cigarette smoking
- Post-bronchodilator FEV1/FVC ratio of 0.70 or less
- Post-bronchodilator FEV1 of 25 to 70% of predicted normal
Exclusion criteria:
- Asthma
- Other significant respiratory disorders besides COPD, including alpha-1 deficiency
- Previous lung resection surgery
- Chest X-ray or CP scan showing clinically significant abnormalities not due to COPD
- Use of oral steroids or antibiotics for a COPD exacerbation within 6 weeks of screening
- Hospitalization for COPD or pneumonia within 3 months of screening
- Any significant disease that would put subject at risk through study participation
- BMI greater than 35
- Pacemaker
- Significantly abnormal ECG or clinical lab finding (including Hepatitis B or C)
- Cancer
- Allergy or hypersensitivity to anticholinergics or inhaler excipients
- Diseases that would contraindicate the use of anticholinergics
- Use of oral corticosteroids within 6 weeks of screening
- Use of long-acting beta-agonists within 48 hours of screening
- Use of tiotropium within 14 days of screening
- Use of theophyllines or anti-leukotrienes within 48 hours of screening
- Use of short-acting bronchodilators within 4 to 6 hours of screening
- Use of investigational medicines within 30 days of screening
- Use of high dose inhaled corticosteroids
- Use of long-term oxygen therapy, CPAP or NIPPV
- Participation in acute phase of pulmonary rehabilitation program
- History of alcohol or drug abuse within 2 years prior to screening
- History of psychiatric disease limiting validity of consent
- Affiliation with the investigative site
- Previous use of GSK573719
Trial location(s)
Location
GSK Investigational Site
Spartanburg, South Carolina, United States, 29303
Status
Study Complete
Location
GSK Investigational Site
Schwerin, Mecklenburg-Vorpommern, Germany, 19055
Status
Study Complete
Location
GSK Investigational Site
Union, South Carolina, United States, 29379
Status
Study Complete
Location
GSK Investigational Site
Madisonville, Kentucky, United States, 42431
Status
Study Complete
Location
GSK Investigational Site
Grosshansdorf, Schleswig-Holstein, Germany, 22927
Status
Study Complete
Location
GSK Investigational Site
Charlotte, North Carolina, United States, 28207
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
2010-04-07
Actual study completion date
2010-04-07
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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