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
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)
1 other identifier
interventional
342
1 country
35
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Dec 2008
Shorter than P25 for phase_4
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 31, 2008
CompletedFirst Posted
Study publicly available on registry
November 4, 2008
CompletedStudy Start
First participant enrolled
December 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedResults Posted
Study results publicly available
December 10, 2010
CompletedNovember 23, 2016
October 1, 2016
1 year
October 31, 2008
November 18, 2010
October 11, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean Change From Baseline in AM (Morning, Approximately 6-9 AM) Pre-dose Forced Expiratory Volume in One Second (FEV1) at Endpoint
Change from baseline was calculated as the Endpoint (defined as the last recorded measure of AM pre-dose FEV1 for each participant) value minus the baseline value. FEV1 is defined as the amount of air expelled from the lungs in one second after a full inspiration and is a measure of pulmonary function.
Baseline and Endpoint (defined as the last recorded measure [taken up to Week 24] of AM pre-dose FEV1 for each participant)
Secondary Outcomes (5)
Mean Change From Baseline in 2 Hour Post-dose FEV1 at Endpoint
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
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
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
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
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)
Study Arms (2)
ADVAIR DISKUS® inhlaer Plus SPIRIVA® HANDIHALER® inhaler
EXPERIMENTALFluticasone Propionate/Salmeterol Combination Product 250/50mcg BID Plus Tiotropium Bromide 18 mcg QD
SPIRIVA® HANDIHALER® inhaler
ACTIVE COMPARATORTiotropium Bromide 18mcg QD plus Placebo DISKUS BID
Interventions
Inhaled corticosteroid plus long-acting bronchodilator
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (35)
GSK Investigational Site
Riverside, California, 92506, United States
GSK Investigational Site
Fort Collins, Colorado, 80528, United States
GSK Investigational Site
Clearwater, Florida, 33756, United States
GSK Investigational Site
DeLand, Florida, 32720, United States
GSK Investigational Site
Naranja, Florida, 33032, United States
GSK Investigational Site
Coeur d'Alene, Idaho, 83814, United States
GSK Investigational Site
Gillespie, Illinois, 62033, United States
GSK Investigational Site
Elkhart, Indiana, 46514, United States
GSK Investigational Site
Olathe, Kansas, 66061, United States
GSK Investigational Site
Louisville, Kentucky, 40207, United States
GSK Investigational Site
Shreveport, Louisiana, 71103, United States
GSK Investigational Site
Sunset, Louisiana, 70584, United States
GSK Investigational Site
Saint Charles, Missouri, 63301, United States
GSK Investigational Site
Omaha, Nebraska, 68131, United States
GSK Investigational Site
Albany, New York, 12205, United States
GSK Investigational Site
Elizabeth City, North Carolina, 27909, United States
GSK Investigational Site
Mooresville, North Carolina, 28117, United States
GSK Investigational Site
Statesville, North Carolina, 28625, United States
GSK Investigational Site
Cincinnati, Ohio, 45231, United States
GSK Investigational Site
Cleveland, Ohio, 44122, United States
GSK Investigational Site
Erie, Pennsylvania, 16508, United States
GSK Investigational Site
Cumberland, Rhode Island, 02864, United States
GSK Investigational Site
Charleston, South Carolina, 29406-7108, United States
GSK Investigational Site
Gaffney, South Carolina, 29340, United States
GSK Investigational Site
Greenville, South Carolina, 29615, United States
GSK Investigational Site
Spartanburg, South Carolina, 29303, United States
GSK Investigational Site
Union, South Carolina, 29379, United States
GSK Investigational Site
Milan, Tennessee, 38358, United States
GSK Investigational Site
Boerne, Texas, 78006, United States
GSK Investigational Site
Houston, Texas, 77030, United States
GSK Investigational Site
Houston, Texas, 77054, United States
GSK Investigational Site
Plano, Texas, 75024, United States
GSK Investigational Site
West Jordan, Utah, 84088, United States
GSK Investigational Site
Newport News, Virginia, 23606, United States
GSK Investigational Site
Richmond, Virginia, 23229, United States
Related Publications (1)
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. doi: 10.1016/j.rmed.2011.09.002. Epub 2011 Oct 29.
PMID: 22040533BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 31, 2008
First Posted
November 4, 2008
Study Start
December 1, 2008
Primary Completion
December 1, 2009
Study Completion
December 1, 2009
Last Updated
November 23, 2016
Results First Posted
December 10, 2010
Record last verified: 2016-10
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.