Last updated: 11/07/2018 03:12:03
A 24-Week Study to Evaluate the Safety and Efficacy of ADVAIR DISKUS® inhaler 250/50mcg Plus SPIRIVA HANDIHALER® inhaler Versus SPIRIVA HANDIHALER® inhaler Plus Placebo DISKUS® inhaler in Subjects with Chronic Obstructive Pulmonary Disease (COPD).ADC111114
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A Randomized, Double-Blind, Parallel-Group, 24-Week Study to Evaluate the Efficacy and Safety of ADVAIR DISKUS (Fluticasone Propionate/Salmeterol Combination Product 250/50mcg Inhalation Powder) BID Plus Spiriva HandiHaler (Tiotropium Bromide Inhalation Powder 18mcg) QD Versus Spiriva QD Plus Placebo DISKUS BID in Subjects with Chronic Obstructive Pulmonary Disease (COPD)
Trial description: The purpose of the study is to determine the efficacy and safety of the combination of ADVAIR DISKUS® 250/50mcg (FLUTICASONE PROPIONATE/SALMETEROL COMBINATION PRODUCT) plus SPIRIVA® HANDIHALER® inhaler 18mcg (TIOTROPIUM) compared to SPIRIVA® HANDIHALER® inhaler 18mcg (TIOTROPIUM) in patients with COPD. SPIRIVA® and HANDIHALER® are trade marks of Boehringer Ingelheim Pharma GmbH & Co. KG.ADVAIR DISKUS® are registered trademarks of the GSK group of companies.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Mean change from baseline in AM (morning, approximately 6-9 AM) pre-dose forced expiratory volume in one second (FEV1) at Endpoint
Timeframe: Baseline and Endpoint (defined as the last recorded measure [taken up to Week 24] of AM pre-dose FEV1 for each participant)
Secondary outcomes:
Mean change from baseline in 2 hour post-dose FEV1 at Endpoint
Timeframe: Baseline and Endpoint (defined as the last recorded measure [taken up to Week 24] of 2 hour post-dose FEV1 for each participant)
Mean change from baseline in AM (morning, approximately 6-9 AM) pre-dose forced vital capacity (FVC) at Endpoint
Timeframe: Baseline and Endpoint (defined as the last recorded measure [up to Week 24] of AM pre-dose FVC for each participant)
Mean change from baseline in 2 hour post-dose FVC at Endpoint
Timeframe: Baseline and Endpoint (defined as the last recorded measure of 2 hour post-dose FVC [up to Week 24] for each participant)
Mean change from baseline in AM (morning, approximately 6-9 AM) Pre-Dose inspiratory capacity (IC) at Endpoint
Timeframe: Baseline and Endpoint (defined as the last recorded measure of AM pre-dose IC [up to Week 24] for each participant)
Mean Change from Baseline in Scores on the Chronic Respiratory Disease Questionnaire-Self-Administered Standardized (CRQ-SAS) at Endpoint
Timeframe: Baseline and Endpoint (defined as the last recorded score [up to Week 24 or the early withdrawal visit] on each of the questions on this questionnaire)
Interventions:
Drug: Tiotropium Bromide
Drug: Fluticasone Propionate/Salmeterol
Enrollment:
342
Observational study model:
Not applicable
Primary completion date:
2009-08-12
Time perspective:
Not applicable
Clinical publications:
Hanania NA, Crater GD, Morris AN, Emmett AH, O'Dell DM, Niewoehner DE. Benefits of adding fluticasone propionate/salmeterol to tiotropium in moderate to severe COPD. Respir Med. 2012 Jan;106(1):91-101.
Hanania N, O’Dell, D, Morris A, Emmett A, Niewoehner D, Crater G. Benefit of adding fluticasone propionate/salmeterol to tiotropium in COPD patients. Respir Med. 2011;106(1):91-101.
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
fluticasone propionate, fluticasone propionate/salmeterol, salmeterol
Collaborators
GSK
Study date(s)
December 2008 to December 2009
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
40 - 99 years
Accepts healthy volunteers
No
- COPD diagnosis
- At least 10 pack year smoking history
- Current diagnosis of asthma
- Other respiratory disorder other than COPD
Inclusion and exclusion criteria
Inclusion criteria:
- COPD diagnosis -At least 10 pack year smoking history -Post-albuterol FEV1 greater than or equal to 40% to less than or equal to 80% of predicted normal -An FEV1/FVC ratio of less than or equal to 0.70
Exclusion criteria:
- Current diagnosis of asthma -Other respiratory disorder other than COPD -Abnormal and clinical significant ECG -Chest x-ray clinically significant abnormality not believed to be due to COPD -Body Mass Index of greater than or equal to 40/kg/m2 -Use of Long Term Oxygen Therapy -Lung resection surgery -Women pregnant or lactating at Visit 1 -Previously diagnosed cancer unless in complete remission for 2 years at Visit 1
Trial location(s)
Location
GSK Investigational Site
Sunset, Louisiana, United States, 70584
Status
Study Complete
Location
GSK Investigational Site
Cumberland, Rhode Island, United States, 02864
Status
Study Complete
Location
GSK Investigational Site
Naranja, Florida, United States, 33032
Status
Study Complete
Location
GSK Investigational Site
Union, South Carolina, United States, 29379
Status
Study Complete
Location
GSK Investigational Site
Albany, New York, United States, 12205
Status
Study Complete
Location
GSK Investigational Site
Elizabeth City, North Carolina, United States, 27909
Status
Study Complete
Location
GSK Investigational Site
West Jordan, Utah, United States, 84088
Status
Study Complete
Location
GSK Investigational Site
Richmond, Virginia, United States, 23229
Status
Study Complete
Location
GSK Investigational Site
Gaffney, South Carolina, United States, 29340
Status
Study Complete
Location
GSK Investigational Site
Shreveport, Louisiana, United States, 71103
Status
Study Complete
Location
GSK Investigational Site
Greenville, South Carolina, United States, 29615
Status
Study Complete
Location
GSK Investigational Site
Statesville, North Carolina, United States, 28625
Status
Study Complete
Location
GSK Investigational Site
Mooresville, North Carolina, United States, 28117
Status
Study Complete
Location
GSK Investigational Site
Erie, Pennsylvania, United States, 16508
Status
Study Complete
Location
GSK Investigational Site
Charleston, South Carolina, United States, 29406-7108
Status
Study Complete
Location
GSK Investigational Site
Riverside, California, United States, 92506
Status
Study Complete
Location
GSK Investigational Site
Gillespie, Illinois, United States, 62033
Status
Study Complete
Location
GSK Investigational Site
Coeur D'Alene, Idaho, United States, 83814
Status
Study Complete
Location
GSK Investigational Site
Clearwater, Florida, United States, 33756
Status
Study Complete
Location
GSK Investigational Site
St. Charles, Missouri, United States, 63301
Status
Study Complete
Location
GSK Investigational Site
Cincinnati, Ohio, United States, 45231
Status
Study Complete
Location
GSK Investigational Site
Newport News, Virginia, United States, 23606
Status
Study Complete
Location
GSK Investigational Site
Elkhart, Indiana, United States, 46514
Status
Study Complete
Location
GSK Investigational Site
Milan, Tennessee, United States, 38358
Status
Study Complete
Location
GSK Investigational Site
Louisville, Kentucky, United States, 40207
Status
Study Complete
Location
GSK Investigational Site
Spartanburg, South Carolina, United States, 29303
Status
Study Complete
Location
GSK Investigational Site
Fort Collins, Colorado, United States, 80528
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
2009-08-12
Actual study completion date
2009-08-12
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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