Clinical trial NCT00115492: Advair® DISKUS® Versus Serevent® DISKUS® For Chronic Obstructive Pulmonary Disease Exacerbations
Official title: A Randomized, Double-Blind, Parallel Group, 52-Week Study to Compare the Effect of Fluticasone Propionate/Salmeterol Diskus Combination Product 250/50mcg BID With Salmeterol Diskus 50mcg BID on the Annual Rate of Moderate/Severe Exacerbations in Subjects With Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Breathing
Exacerbation
Chronic Obstructive Pulmonary Disease
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2005-06-23
Enrollment: 797
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the effect of two medicines on COPD (Chronic Obstructive Pulmonary Disease) exacerbations. This study will last up to 56 weeks, and subjects will visit the clinic 10 times. Subjects will be given breathing tests and will record their breathing symptoms daily on diary cards. All study related medicines and medical examinations will be provided at no cost. The two drugs used in this study have been approved by FDA for use in patients with COPD.

Detailed description: A Randomized, Double-Blind, Parallel Group, 52-week Study to Compare the Effect of the Fluticasone Propionate/Salmeterol DISKUS Combination Product 250/50mcg BID with Salmeterol DISKUS 50mcg BID on the Annual Rate of Moderate/Severe Exacerbations in Subjects with Chronic Obstructive Pulmonary Disease (COPD)

Eligibility criteria: Inclusion criteria:

* Diagnosis of COPD.
* Current or previous cigarette smokers with a smoking history of at least 10 pack-years.
* History of at least 1 COPD exacerbation in the 12 months prior to screening.
* Forced expiratory volume in one second (FEV1) of less than or equal to 50% of predicted normal.

Exclusion criteria:

* Diagnosis of asthma.
* Additional respiratory disorders other than COPD (eg, sarcoidosis, alpha-1 antitrypsin deficiency, cystic fibrosis, or active tuberculosis).
* Concurrent use of long-acting beta-agonists, long-acting anticholinergics, inhaled and oral corticosteroids, theophylline, investigational medications, ritonavir, and anti-leukotrienes.
* Lung resection surgery within 1 year of screening.
* Abnormal and clinically significant ECG findings at screening.
* Other inclusion and exclusion criteria will be evaluated at the first study visit.

Primary outcomes:
measure: Rate of moderate/severe exacerbations over a 52 week treatment period
Secondary outcomes:
measure: The time until the first moderate/severe exacerbation; the annual rate of exacerbations requiring oral corticosteroid treatment, and breathing tests conducted over one year
Other outcomes:
Locations:
city: Jasper
country: United States
facility: GSK Investigational Site
state: Alabama
city: Mobile
country: United States
facility: GSK Investigational Site
state: Alabama
city: Glendale
country: United States
facility: GSK Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: GSK Investigational Site
state: Arizona
city: Berkeley
country: United States
facility: GSK Investigational Site
state: California
city: Fullerton
country: United States
facility: GSK Investigational Site
state: California
city: Riverside
country: United States
facility: GSK Investigational Site
state: California
city: Sacramento
country: United States
facility: GSK Investigational Site
state: California
city: San Diego
country: United States
facility: GSK Investigational Site
state: California
city: Vista
country: United States
facility: GSK Investigational Site
state: California
city: Fort Collins
country: United States
facility: GSK Investigational Site
state: Colorado
city: Stamford
country: United States
facility: GSK Investigational Site
state: Connecticut
city: Atlantis
country: United States
facility: GSK Investigational Site
state: Florida
city: Clear Water
country: United States
facility: GSK Investigational Site
state: Florida
city: Deland
country: United States
facility: GSK Investigational Site
state: Florida
city: Fort Lauderdale
country: United States
facility: GSK Investigational Site
state: Florida
city: Pensacola
country: United States
facility: GSK Investigational Site
state: Florida
city: Sarasota
country: United States
facility: GSK Investigational Site
state: Florida
city: Tamarac
country: United States
facility: GSK Investigational Site
state: Florida
city: Atlanta
country: United States
facility: GSK Investigational Site
state: Georgia
city: Woodstock
country: United States
facility: GSK Investigational Site
state: Georgia
city: Springfield
country: United States
facility: GSK Investigational Site
state: Illinois
city: Elkhart
country: United States
facility: GSK Investigational Site
state: Indiana
city: Evansville
country: United States
facility: GSK Investigational Site
state: Indiana
city: Evansville
country: United States
facility: GSK Investigational Site
state: Indiana
city: Indianapolis
country: United States
facility: GSK Investigational Site
state: Indiana
city: South Bend
country: United States
facility: GSK Investigational Site
state: Indiana
city: Iowa City
country: United States
facility: GSK Investigational Site
state: Iowa
city: Olathe
country: United States
facility: GSK Investigational Site
state: Kansas
city: Madisonville
country: United States
facility: GSK Investigational Site
state: Kentucky
city: Lafayette
country: United States
facility: GSK Investigational Site
state: Louisiana
city: New Orleans
country: United States
facility: GSK Investigational Site
state: Louisiana
city: Shreveport
country: United States
facility: GSK Investigational Site
state: Louisiana
city: Sunset
country: United States
facility: GSK Investigational Site
state: Louisiana
city: Auburn
country: United States
facility: GSK Investigational Site
state: Maine
city: Baltimore
country: United States
facility: GSK Investigational Site
state: Maryland
city: Boston
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: St. Joseph
country: United States
facility: GSK Investigational Site
state: Michigan
city: Minneapolis
country: United States
facility: GSK Investigational Site
state: Minnesota
city: Chesterfield
country: United States
facility: GSK Investigational Site
state: Missouri
city: Jefferson City
country: United States
facility: GSK Investigational Site
state: Missouri
city: St. Charles
country: United States
facility: GSK Investigational Site
state: Missouri
city: St. Louis
country: United States
facility: GSK Investigational Site
state: Missouri
city: Billings
country: United States
facility: GSK Investigational Site
state: Montana
city: Butte
country: United States
facility: GSK Investigational Site
state: Montana
city: Omaha
country: United States
facility: GSK Investigational Site
state: Nebraska
city: Omaha
country: United States
facility: GSK Investigational Site
state: Nebraska
city: Absecon
country: United States
facility: GSK Investigational Site
state: New Jersey
city: Albany
country: United States
facility: GSK Investigational Site
state: New York
city: Bayshore
country: United States
facility: GSK Investigational Site
state: New York
city: Ithaca
country: United States
facility: GSK Investigational Site
state: New York
city: Larchmont
country: United States
facility: GSK Investigational Site
state: New York
city: New York
country: United States
facility: GSK Investigational Site
state: New York
city: Chapel Hill
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Charlotte
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Elizabeth City
country: United States
facility: GSK Investigational Site
state: North Carolina
city: High Point
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Raleigh
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Canton
country: United States
facility: GSK Investigational Site
state: Ohio
city: Chardon
country: United States
facility: GSK Investigational Site
state: Ohio
city: Mogadore
country: United States
facility: GSK Investigational Site
state: Ohio
city: Lake Oswego
country: United States
facility: GSK Investigational Site
state: Oregon
city: Erie
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Hershey
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: McKeesport
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: East Providence
country: United States
facility: GSK Investigational Site
state: Rhode Island
city: Providence
country: United States
facility: GSK Investigational Site
state: Rhode Island
city: Gaffney
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Greer
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Simpsonville
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Spartanburg
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Bristol
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Chattanooga
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Johnson City
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Kingsport
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Dallas
country: United States
facility: GSK Investigational Site
state: Texas
city: Houston
country: United States
facility: GSK Investigational Site
state: Texas
city: New Braunfels
country: United States
facility: GSK Investigational Site
state: Texas
city: San Antonio
country: United States
facility: GSK Investigational Site
state: Texas
city: San Antonio
country: United States
facility: GSK Investigational Site
state: Texas
city: San Marcos
country: United States
facility: GSK Investigational Site
state: Texas
city: Abingdon
country: United States
facility: GSK Investigational Site
state: Virginia
city: Lynchburg
country: United States
facility: GSK Investigational Site
state: Virginia
city: Newport News
country: United States
facility: GSK Investigational Site
state: Virginia
city: Richmond
country: United States
facility: GSK Investigational Site
state: Virginia
city: Bellingham
country: United States
facility: GSK Investigational Site
state: Washington
city: Gig Harbor
country: United States
facility: GSK Investigational Site
state: Washington
city: Kirkland
country: United States
facility: GSK Investigational Site
state: Washington
city: Spokane
country: United States
facility: GSK Investigational Site
state: Washington
city: Morgantown
country: United States
facility: GSK Investigational Site
state: West Virginia
city: La Crosse
country: United States
facility: GSK Investigational Site
state: Wisconsin
city: Milwaukee
country: United States
facility: GSK Investigational Site
state: Wisconsin
city: Vancouver
country: Canada
facility: GSK Investigational Site
state: British Columbia
city: Winnipeg
country: Canada
facility: GSK Investigational Site
state: Manitoba
city: Saint John
country: Canada
facility: GSK Investigational Site
state: New Brunswick
city: Bay Roberts
country: Canada
facility: GSK Investigational Site
state: Newfoundland and Labrador
city: Holyrood
country: Canada
facility: GSK Investigational Site
state: Newfoundland and Labrador
city: Grimsby
country: Canada
facility: GSK Investigational Site
state: Ontario
city: London
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Thunder Bay
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Bonaventure
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Chandler
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Charlesbourg
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Gatineau
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Saint Leonard
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Sherbrooke
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Trois Rivieres
country: Canada
facility: GSK Investigational Site
state: Quebec
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Disantostefano RL, Li H, Rubin DB, Stempel DA. Which patients with chronic obstructive pulmonary disease benefit from the addition of an inhaled corticosteroid to their bronchodilator? A cluster analysis. BMJ Open. 2013 Apr 22;3(4):e001838. doi: 10.1136/bmjopen-2012-001838. Print 2013.