Last updated: 11/07/2018 05:34:47
GSK573719 Dose Ranging Study in Chronic Obstructive Pulmonary Disease
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A Randomized, Double-Blind, Placebo-Controlled, 3-Way Cross-Over Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of GSK573719 Administered Once- and Twice-Daily in Subjects with COPD
Trial description: The study will evaluate the dose response, safety, and pharmacokinetics of GSK573719 compared with placebo in subjects with COPD.
Primary purpose:
Treatment
Trial design:
Crossover 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 15 of each treatment period
Timeframe: Baseline and Day 15 of each treatment period (up to Study Day 71)
Secondary outcomes:
Change from Baseline (BL) in weighted mean FEV1 over 0 to 24 hours obtained post-dose on Day 14 of each treatment period
Timeframe: Baseline and Day 14 of each treatment period (TP; up to Study Day 70)
Change from Baseline (BL) in serial FEV1 over 0-28 hours after the morning dose at Day 14 of each treatment period
Timeframe: Baseline and Day (D) 14 of each treatment period (TP; up to Study Day 70)
Interventions:
Drug: Tiotropium
Drug: Placebo
Drug: GSK573179
Enrollment:
176
Observational study model:
Not applicable
Primary completion date:
2010-15-03
Time perspective:
Not applicable
Clinical publications:
Donohue JF, Anzueto A, Brooks J, Crater G, Mehta R, Kalberg C. A randomized, double-blind, dose-ranging study of the novel LAMA GSK573719 in patients with COPD. [Respir Med]. 2012;106(7):970-979.
Donohue JF, Anzueto A, Brooks J, Crater G, Mehta R, Kalberg C. A randomized, double-blind, dose-ranging study of the novel LAMA GSK573719 in patients with COPD. Respir Med.2012;106(7):970-979.
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
umeclidinium bromide
Collaborators
GSK
Study date(s)
September 2009 to March 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 35 to 70% of predicted normal
Exclusion criteria:
- Asthma
- Other significant respiratory disorders besides COPD, including alpha-1 deficiency
- Previous lung resection surgery
- 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, Holter, or clinical lab finding (including Hepatitis B or C)
- Cancer
- Allergy or hypersensitivity to anticholinergics or inhaler excipients
- Diseases that would contra-indicate 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
- Previous use of GSK573719
Trial location(s)
Location
GSK Investigational Site
Gaffney, South Carolina, United States, 29340
Status
Study Complete
Location
GSK Investigational Site
Hannover, Niedersachsen, Germany, 30159
Status
Study Complete
Location
GSK Investigational Site
Greenville, South Carolina, United States, 29615
Status
Study Complete
Location
GSK Investigational Site
Seneca, South Carolina, United States, 29678
Status
Study Complete
Location
GSK Investigational Site
Phoenix, Arizona, United States, 85013
Status
Study Complete
Location
GSK Investigational Site
Magdeburg, Sachsen-Anhalt, Germany, 39112
Status
Study Complete
Location
GSK Investigational Site
Upland, California, United States, 91786
Status
Study Complete
Location
GSK Investigational Site
Easley, South Carolina, United States, 29640
Status
Study Complete
Location
GSK Investigational Site
Spartanburg, South Carolina, United States, 29303
Status
Study Complete
Location
GSK Investigational Site
Cincinnati, Ohio, United States, 45231
Status
Study Complete
Location
GSK Investigational Site
Union, South Carolina, United States, 29379
Status
Study Complete
Location
GSK Investigational Site
Grosshansdorf, Schleswig-Holstein, Germany, 22927
Status
Study Complete
Location
GSK Investigational Site
Mainz, Rheinland-Pfalz, Germany, 55131
Status
Study Complete
Location
GSK Investigational Site
San Diego, California, United States, 92117
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
2010-15-03
Actual study completion date
2010-15-03
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.
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