Last updated: 11/07/2018 05:56:23
A 24-week evaluation of GSK573719/vilanterol (125/25mcg) and components in COPDDB2113361
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A 24-Week, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GSK573719/GW642444 Inhalation Powder and the Individual Components Delivered Once-Daily via a Novel Dry Powder Inhaler in Subjects with Chronic Obstructive Pulmonary Disease
Trial description: This is a phase III multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of GSK573719/GW642444 Inhalation Powder, GSK573719 Inhalation Powder, GW642444 Inhalation Powder and Placebo when administered once-daily via a Novel Dry Powder Inhaler over a 24-week treatment period in subjects with COPD. Subjects who meet eligibility criteria at Screening (Visit 1) will complete a 7 to14 day run-in period followed by a randomization visit (Visit 2) then a 24-week treatment period. There will be a total of 9 clinic study visits. A follow-up phone contact for adverse event assessment will be conducted approximately one week after the last study visit (Visit 9 or Early Withdrawal). The total duration of subject participation in the study will be approximately 27 weeks. A subset of subjects at selected sites will also perform 24-hour serial spirometry and Holter monitoring during the study and provide serial blood samples for pharmacokinetic analysis. Sparse pharmacokinetic sampling for population pharmacokinetic analyses will be obtained from non-subset subjects. The primary measure of efficacy is clinic visit trough (pre-bronchodilator and pre-dose) FEV1 on Treatment Day 169. Safety will be assessed by adverse events, 12-lead ECGs, vital signs, clinical laboratory tests, and 24 hour Holter monitoring (subset only).
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Change from Baseline (BL) in trough forced expiratory volume in one second (FEV1) on Day 169 (Week 24)
Timeframe: Baseline and Day 169
Secondary outcomes:
Mean Transition Dyspnea Index (TDI) focal score at Day 168 (Week 24)
Timeframe: Day 168 (Week 24)
Change from Baseline in weighted mean (WM) 0-6 hour FEV1 obtained post-dose at Day 168
Timeframe: Baseline and Day 168
Interventions:
Enrollment:
1493
Primary completion date:
2012-19-04
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Celli B, Crater G, Kilbride S, Mehta R, Tabberer M, Kalberg C, Church A .Once-daily umeclidinium/vilanterol 125/25 mcg in COPD: a randomized, controlled study.Chest.2014;145(5):981-991
Goyal N, Beerahee M, Kalberg C, Church A, Kilbride S, Mehta R. Population pharmacokinetics of inhaled umeclidinium and vilanterol in patients with COPD. Clin Pharmacokinet. 2014;53(7):637-48.
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
umeclidinium bromide, vilanterol
Collaborators
Not applicable
Study date(s)
March 2011 to April 2012
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
40+ years
Accepts healthy volunteers
No
- Diagnosis of COPD
- 10 pack-year or greater history of cigarette smoking
- Women who are pregnant, lactating, or planning to become pregnant
- Respiratory disorders other than COPD, including a current diagnosis of asthma
Inclusion and exclusion criteria
Inclusion criteria:
- Diagnosis of COPD
- 10 pack-year or greater history of cigarette smoking
- Post-bronchodilator FEV1/FVC of <0.7
- Predicted FEV1 of 70% of normal or less
- Modified Medical Research Council (mMRC) dyspnea score of 2 or greater
Exclusion criteria:
- Women who are pregnant, lactating, or planning to become pregnant
- Respiratory disorders other than COPD, including a current diagnosis of asthma
- Clinically significant non-respiratory diseases or abnormalities that are not adequately controlled
- Significant allergy or hypersensitivity to anticholinergics, beta2-agonists, or the excipients of magnesium stereate or lactose used in the inhaler delivery device
- Hospitalization for COPD or pneumonia within 12 weeks prior to screening
- Lung volume reduction surgery within 12 weeks prior to screening
- Abnormal and clinically significant ECG findings at screening
- Clinically significant laboratory findings at screening
- Use of systemic corticosteroids, antibiotics for respiratory tract infections, strong cytochrome P450 3A4 inhibitors, high dose inhaled steroids (>1000mcg fluticasone propionate or equivalent), PDE4 inhibitors, tiotropium, oral beta2-agoinists, short- and long-acting inhaled beta2-agonists, ipratropium, inhaled sodium cromoglycate or nedocromil sodium, or investigational medicines for defined time periods prior to the screening visit
- Use of long-term oxygen therapy (12 hours or greater per day)
- Regular use of nebulized treatment with short-acting bronchodilators
- Participation in the acute phase of a pulmonary rehabilitation program
- A know or suspected history of alcohol or drug abuse
- Affiliation with the investigational site
- Previous use of GSK573719 or GW642444 alone or in combination, including the combination of fluticasone furoate and GW642444
Trial location(s)
Location
GSK Investigational Site
Topeka, Kansas, United States, 66606
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Richmond, Virginia, United States, 23225
Status
Study Complete
Location
GSK Investigational Site
Plymouth, Minnesota, United States, 55441
Status
Study Complete
Location
GSK Investigational Site
Palo Alto, California, United States, 94304
Status
Study Complete
Location
GSK Investigational Site
Clearwater, Florida, United States, 33765
Status
Study Complete
Location
GSK Investigational Site
Long Beach, California, United States, 90822
Status
Study Complete
Location
GSK Investigational Site
Greenville, South Carolina, United States, 29615
Status
Study Complete
Location
GSK Investigational Site
Spartanburg, South Carolina, United States, 29303
Status
Study Complete
Location
GSK Investigational Site
Panama City, Florida, United States, 32405
Status
Study Complete
Location
GSK Investigational Site
Torrance, California, United States, 90502
Status
Study Complete
Location
GSK Investigational Site
Koeln, Nordrhein-Westfalen, Germany, 51069
Status
Study Complete
Location
GSK Investigational Site
San Diego, California, United States, 92103-8415
Status
Study Complete
Location
GSK Investigational Site
Charlotte, North Carolina, United States, 28207
Status
Study Complete
Location
GSK Investigational Site
Livonia, Michigan, United States, 48152
Status
Study Complete
Location
GSK Investigational Site
Union, South Carolina, United States, 29379
Status
Study Complete
Location
GSK Investigational Site
Cherry Hill, New Jersey, United States, 08003
Status
Study Complete
Location
GSK Investigational Site
Lincoln, Nebraska, United States, 68506
Status
Study Complete
Location
GSK Investigational Site
Los Angeles, California, United States, 90095
Status
Study Complete
Location
GSK Investigational Site
Phoenix, Arizona, United States, 85006
Status
Study Complete
Location
GSK Investigational Site
Orlando, Florida, United States, 32822
Status
Study Complete
Location
GSK Investigational Site
Magdeburg, Sachsen-Anhalt, Germany, 39112
Status
Study Complete
Location
GSK Investigational Site
Geesthacht, Schleswig-Holstein, Germany, 21502
Status
Study Complete
Location
GSK Investigational Site
Riverside, California, United States, 92506
Status
Study Complete
Location
GSK Investigational Site
San Diego, California, United States, 92117
Status
Study Complete
Location
GSK Investigational Site
Easley, South Carolina, United States, 29640
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
Study complete
Actual primary completion date
2012-19-04
Actual study completion date
2012-19-04
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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