Last updated: 11/07/2018 05:55:37
24-week trial comparing GSK573719/GW642444 with GW642444 and with tiotropium in chronic obstructive pulmonary disease
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A multicenter trial comparing the efficacy and safety of GSK573719/GW642444 with GW642444 and with tiotropium over 24 weeks in subjects with COPD
Trial description: This is a Phase III multicenter, randomized, double-blind, double-dummy, parallel-group study to evaluate the efficacy and safety of two doses of GSK573719/GW642444 Inhalation Powder and GW642444 Inhalation Powder via a Novel Dry Powder Inhaler and tiotropium via HandiHaler when administered once-daily over a 24-week treatment period in subjects with chronic obstructive pulmonary disease (COPD). Subjects who meet eligibility criteria at Screening (Visit 1) will complete a 7 to10 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 26 weeks. The primary measure of efficacy is clinic visit trough (pre-bronchodilator and pre-dose) forced expiratory volume in one second (FEV1) on Treatment Day 169. Safety will be assessed by adverse events, 12-lead ECGs, vital signs, and clinical laboratory tests.
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:
Change from Baseline (BL) in weighted mean (WM) 0-6 hour FEV1 obtained post-dose at Day 168
Timeframe: Baseline and Day 168
Interventions:
Enrollment:
846
Primary completion date:
2012-24-04
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Maleki-Yazdi MR, Singh D, Anzueto A, Tombs L, Fahy WA, Naya I.Assessing Short-term Deterioration in Maintenance-naïve Patients with COPD Receiving Umeclidinium/Vilanterol and Tiotropium: A Pooled Analysis of Three Randomized Trials.Adv Ther.2017;33(12):2188-2199.
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
- outpatient
- signed and dated written informed consent
- women who are pregnant or lactating or are planning on becoming pregnant during the study
- current diagnosis of asthma
Inclusion and exclusion criteria
Inclusion criteria:
- outpatient
- signed and dated written informed consent
- 40 years of age or older
- male and female subjects
- COPD diagnosis
- at least 10 pack-year smoking history
- post-albuterol/salbutamol FEV1/FVC ratio of <0.70 and post-albuterol/salbutamol FEV1 of less than or equal to 70% predicted normal values
- score of greater than or equal to 2 on the Modified Medical Resarch Council Dyspnea Scale (mMRC)
Exclusion criteria:
- women who are pregnant or lactating or are planning on becoming pregnant during the study
- current diagnosis of asthma
- other respiratory disorders other than COPD
- other diseases/abnormalities that are uncontrolled including cancer not in remission for at least 5 years
- chest x-ray or CT scan with clinically significant abnormalities not believed to be due to COPD
- hypersensitivity to anticholinergics, beta-agonists, lactose/milk protein or magnesium stearate or medical conditions associated with inhaled anticholinergics
- hospitalization for COPD or pneumonia within 12 weeks prior to Visit 1
- lung volume reduction surgery within 12 months prior to Visit 1
- abnormal and clinically significant ECG at Visit 1
- significantly abnormal finding from laboratory tests at Visit 1
- unable to withhold albuterol/salbutamol at least 4 hours prior to spirometry at each visit
- use of depot corticosteroids within 12 weeks of Visit 1
- use of oral or parenteral corticosteroids, antibiotics for lower respiratory tract infection, or cytochrome P450 3A4 inhibitors, within 6 weeks of Visit 1
- use of long-acting beta-agonist (LABA)/inhaled corticosteroid (ICS) product if LABA/ICS therapy is discontinued withing 30 days of Visit 1
- use of ICS at a dose of >1000mcg/day of fluticasone propionate or equivalent within 30 days of Visit 1
- initiation or discontinuation of ICS within 30 days of Visit 1
- use of tiotropium or roflumilast within 14 days of Visit 1
- use of theophyllines, oral leukotriene inhibitors, long-acting oral beta-agonists, or inhaled long-acting beta-agonists within 48 hours of Visit 1
- short-acting oral beta-agonists within 12 hours of Visit 1
- use of LABA/ICS combination products only if discontinuing LABA therapy and switching to ICS monotherapy within 48 hours of Visit 1 for the LABA component
- use of sodium cromoglycate or nedocromil sodium within 24 hours of Visit 1
- use of inhaled short-acting beta-agonists, inhaled short-acting anticholinergics, or inhaled short-acting anticholinergic/short-acting beta-agonist combination products within 4 hours of Visit 1
- use of any other investigational medication within 30 days or 5 drug half-lives (whichever is longer)
- long-term oxygen therapy prescribed for >12 hours per day
- regular use of nebulized short-acting bronchodilators
- participation in acute phase of pulmonary rehabilitation program
- known or suspected history of alcohol or drug abse within 2 years prior to Visit 1
- anyone affiliated with the investigator site (e.g., investigator, sub-investigator, study coordinator, employee of a participating investigator or study site, or immediate family member)
- previous exposure to GSK573719, GSK573719/GW642444 combination, GW642444 (vilanterol), or fluticasone furoate/GW642444 combination
Trial location(s)
Location
GSK Investigational Site
Orlando, Florida, United States, 32822
Status
Study Complete
Location
GSK Investigational Site
Birmingham, Alabama, United States, 35216
Status
Study Complete
Location
GSK Investigational Site
Clermont Ferrand cedex 1, France, 63003
Status
Study Complete
Location
GSK Investigational Site
Dortmund, Nordrhein-Westfalen, Germany, 44147
Status
Study Complete
Location
GSK Investigational Site
Seneca, South Carolina, United States, 29678
Status
Study Complete
Location
GSK Investigational Site
Phoenixville, Pennsylvania, United States, 19460
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Santiago de Surco, Lima, Peru, Lima 33
Status
Study Complete
Location
GSK Investigational Site
Charleston, South Carolina, United States, 29406-7108
Status
Study Complete
Location
GSK Investigational Site
Richmond, Virginia, United States, 23229
Status
Study Complete
Location
GSK Investigational Site
San Antonio, Texas, United States, 78229
Status
Study Complete
Location
GSK Investigational Site
Greenville, South Carolina, United States, 29615
Status
Study Complete
Location
GSK Investigational Site
Saint Pierre Cedex, France, 97448
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73103
Status
Study Complete
Location
GSK Investigational Site
Rock Hill, South Carolina, United States, 29732
Status
Study Complete
Location
GSK Investigational Site
Hannover, Niedersachsen, Germany, 30159
Status
Study Complete
Location
GSK Investigational Site
Stuttgart, Baden-Wuerttemberg, Germany, 70378
Status
Study Complete
Location
GSK Investigational Site
Sinsheim, Baden-Wuerttemberg, Germany, 74889
Status
Study Complete
Location
GSK Investigational Site
Pordenone, Friuli-Venezia-Giulia, Italy, 33170
Status
Study Complete
Location
GSK Investigational Site
St. Charles, Missouri, United States, 63301
Status
Study Complete
Location
GSK Investigational Site
Albuquerque, New Mexico, United States, 87108
Status
Study Complete
Location
GSK Investigational Site
San Diego, California, United States, 92117
Status
Study Complete
Location
GSK Investigational Site
Newport News, Virginia, United States, 23606
Status
Study Complete
Location
GSK Investigational Site
Dortmund, Nordrhein-Westfalen, Germany, 44263
Status
Study Complete
Location
GSK Investigational Site
Rapid City, South Dakota, United States, 57702
Status
Study Complete
Location
GSK Investigational Site
Decatur, Georgia, United States, 30033
Status
Study Complete
Location
GSK Investigational Site
Pietra Ligure (SV), Liguria, Italy, 17027
Status
Study Complete
Location
GSK Investigational Site
Hannover, Niedersachsen, Germany, 30173
Status
Study Complete
Location
GSK Investigational Site
Gaffney, South Carolina, United States, 29340
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
2012-24-04
Actual study completion date
2012-24-04
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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