Clinical trial NCT00784550: 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).
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Spirometry
COPD
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2008-11-04
Enrollment: 342
Sex: ALL
Minimum age (years): 40
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: 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:
measure: 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)
measure: 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)
measure: 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)
measure: 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)
measure: 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)
Other outcomes:
Locations:
city: Riverside
country: United States
facility: GSK Investigational Site
state: California
city: Fort Collins
country: United States
facility: GSK Investigational Site
state: Colorado
city: Clearwater
country: United States
facility: GSK Investigational Site
state: Florida
city: Deland
country: United States
facility: GSK Investigational Site
state: Florida
city: Naranja
country: United States
facility: GSK Investigational Site
state: Florida
city: Coeur D'Alene
country: United States
facility: GSK Investigational Site
state: Idaho
city: Gillespie
country: United States
facility: GSK Investigational Site
state: Illinois
city: Elkhart
country: United States
facility: GSK Investigational Site
state: Indiana
city: Olathe
country: United States
facility: GSK Investigational Site
state: Kansas
city: Louisville
country: United States
facility: GSK Investigational Site
state: Kentucky
city: Shreveport
country: United States
facility: GSK Investigational Site
state: Louisiana
city: Sunset
country: United States
facility: GSK Investigational Site
state: Louisiana
city: St. Charles
country: United States
facility: GSK Investigational Site
state: Missouri
city: Omaha
country: United States
facility: GSK Investigational Site
state: Nebraska
city: Albany
country: United States
facility: GSK Investigational Site
state: New York
city: Elizabeth City
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Mooresville
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Statesville
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Cincinnati
country: United States
facility: GSK Investigational Site
state: Ohio
city: Cleveland
country: United States
facility: GSK Investigational Site
state: Ohio
city: Erie
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Cumberland
country: United States
facility: GSK Investigational Site
state: Rhode Island
city: Charleston
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Gaffney
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Greenville
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Spartanburg
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Union
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Milan
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Boerne
country: United States
facility: GSK Investigational Site
state: Texas
city: Houston
country: United States
facility: GSK Investigational Site
state: Texas
city: Houston
country: United States
facility: GSK Investigational Site
state: Texas
city: Plano
country: United States
facility: GSK Investigational Site
state: Texas
city: West Jordan
country: United States
facility: GSK Investigational Site
state: Utah
city: Newport News
country: United States
facility: GSK Investigational Site
state: Virginia
city: Richmond
country: United States
facility: GSK Investigational Site
state: Virginia
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.