Advair® DISKUS® Versus Serevent® DISKUS® For Chronic Obstructive Pulmonary Disease Exacerbations

Pulmonary Disease, Chronic Obstructive Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00115492
• Other study ID #: SCO100250
• Status: Completed
• Phase: Phase 4
• First received: June 22, 2005
• Last updated: January 19, 2017
• Start date: December 2004
• Est. completion date: June 2007

Study information

• Verified date: January 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 797
• Est. completion date: June 2007
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Fluticasone Propionate/Salmeterol Combination Product

• Salmeterol

Locations

Country	Name	City	State
Canada	GSK Investigational Site	Bay Roberts	Newfoundland and Labrador
Canada	GSK Investigational Site	Bonaventure	Quebec
Canada	GSK Investigational Site	Chandler	Quebec
Canada	GSK Investigational Site	Charlesbourg	Quebec
Canada	GSK Investigational Site	Gatineau	Quebec
Canada	GSK Investigational Site	Grimsby	Ontario
Canada	GSK Investigational Site	Holyrood	Newfoundland and Labrador
Canada	GSK Investigational Site	London	Ontario
Canada	GSK Investigational Site	Saint John	New Brunswick
Canada	GSK Investigational Site	Saint Leonard	Quebec
Canada	GSK Investigational Site	Sherbrooke	Quebec
Canada	GSK Investigational Site	Thunder Bay	Ontario
Canada	GSK Investigational Site	Trois Rivieres	Quebec
Canada	GSK Investigational Site	Vancouver	British Columbia
Canada	GSK Investigational Site	Winnipeg	Manitoba
United States	GSK Investigational Site	Abingdon	Virginia
United States	GSK Investigational Site	Absecon	New Jersey
United States	GSK Investigational Site	Albany	New York
United States	GSK Investigational Site	Atlanta	Georgia
United States	GSK Investigational Site	Atlantis	Florida
United States	GSK Investigational Site	Auburn	Maine
United States	GSK Investigational Site	Baltimore	Maryland
United States	GSK Investigational Site	Bayshore	New York
United States	GSK Investigational Site	Bellingham	Washington
United States	GSK Investigational Site	Berkeley	California
United States	GSK Investigational Site	Billings	Montana
United States	GSK Investigational Site	Boston	Massachusetts
United States	GSK Investigational Site	Bristol	Tennessee
United States	GSK Investigational Site	Butte	Montana
United States	GSK Investigational Site	Canton	Ohio
United States	GSK Investigational Site	Chapel Hill	North Carolina
United States	GSK Investigational Site	Chardon	Ohio
United States	GSK Investigational Site	Charlotte	North Carolina
United States	GSK Investigational Site	Chattanooga	Tennessee
United States	GSK Investigational Site	Chesterfield	Missouri
United States	GSK Investigational Site	Clear Water	Florida
United States	GSK Investigational Site	Dallas	Texas
United States	GSK Investigational Site	Deland	Florida
United States	GSK Investigational Site	East Providence	Rhode Island
United States	GSK Investigational Site	Elizabeth City	North Carolina
United States	GSK Investigational Site	Elkhart	Indiana
United States	GSK Investigational Site	Erie	Pennsylvania
United States	GSK Investigational Site	Evansville	Indiana
United States	GSK Investigational Site	Evansville	Indiana
United States	GSK Investigational Site	Fort Collins	Colorado
United States	GSK Investigational Site	Fort Lauderdale	Florida
United States	GSK Investigational Site	Fullerton	California
United States	GSK Investigational Site	Gaffney	South Carolina
United States	GSK Investigational Site	Gig Harbor	Washington
United States	GSK Investigational Site	Glendale	Arizona
United States	GSK Investigational Site	Greer	South Carolina
United States	GSK Investigational Site	Hershey	Pennsylvania
United States	GSK Investigational Site	High Point	North Carolina
United States	GSK Investigational Site	Houston	Texas
United States	GSK Investigational Site	Indianapolis	Indiana
United States	GSK Investigational Site	Iowa City	Iowa
United States	GSK Investigational Site	Ithaca	New York
United States	GSK Investigational Site	Jasper	Alabama
United States	GSK Investigational Site	Jefferson City	Missouri
United States	GSK Investigational Site	Johnson City	Tennessee
United States	GSK Investigational Site	Kingsport	Tennessee
United States	GSK Investigational Site	Kirkland	Washington
United States	GSK Investigational Site	La Crosse	Wisconsin
United States	GSK Investigational Site	Lafayette	Louisiana
United States	GSK Investigational Site	Lake Oswego	Oregon
United States	GSK Investigational Site	Larchmont	New York
United States	GSK Investigational Site	Lynchburg	Virginia
United States	GSK Investigational Site	Madisonville	Kentucky
United States	GSK Investigational Site	McKeesport	Pennsylvania
United States	GSK Investigational Site	Milwaukee	Wisconsin
United States	GSK Investigational Site	Minneapolis	Minnesota
United States	GSK Investigational Site	Mobile	Alabama
United States	GSK Investigational Site	Mogadore	Ohio
United States	GSK Investigational Site	Morgantown	West Virginia
United States	GSK Investigational Site	New Braunfels	Texas
United States	GSK Investigational Site	New Orleans	Louisiana
United States	GSK Investigational Site	New York	New York
United States	GSK Investigational Site	Newport News	Virginia
United States	GSK Investigational Site	Olathe	Kansas
United States	GSK Investigational Site	Omaha	Nebraska
United States	GSK Investigational Site	Omaha	Nebraska
United States	GSK Investigational Site	Pensacola	Florida
United States	GSK Investigational Site	Phoenix	Arizona
United States	GSK Investigational Site	Pittsburgh	Pennsylvania
United States	GSK Investigational Site	Pittsburgh	Pennsylvania
United States	GSK Investigational Site	Providence	Rhode Island
United States	GSK Investigational Site	Raleigh	North Carolina
United States	GSK Investigational Site	Richmond	Virginia
United States	GSK Investigational Site	Riverside	California
United States	GSK Investigational Site	Sacramento	California
United States	GSK Investigational Site	San Antonio	Texas
United States	GSK Investigational Site	San Antonio	Texas
United States	GSK Investigational Site	San Diego	California
United States	GSK Investigational Site	San Marcos	Texas
United States	GSK Investigational Site	Sarasota	Florida
United States	GSK Investigational Site	Shreveport	Louisiana
United States	GSK Investigational Site	Simpsonville	South Carolina
United States	GSK Investigational Site	South Bend	Indiana
United States	GSK Investigational Site	Spartanburg	South Carolina
United States	GSK Investigational Site	Spokane	Washington
United States	GSK Investigational Site	Springfield	Illinois
United States	GSK Investigational Site	St. Charles	Missouri
United States	GSK Investigational Site	St. Joseph	Michigan
United States	GSK Investigational Site	St. Louis	Missouri
United States	GSK Investigational Site	Stamford	Connecticut
United States	GSK Investigational Site	Sunset	Louisiana
United States	GSK Investigational Site	Tamarac	Florida
United States	GSK Investigational Site	Vista	California
United States	GSK Investigational Site	Winston-Salem	North Carolina
United States	GSK Investigational Site	Woodstock	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of moderate/severe exacerbations over a 52 week treatment period
Secondary	The time until the first moderate/severe exacerbation; the annual rate of exacerbations requiring oral corticosteroid treatment, and breathing tests conducted over one year

External Links

•   Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.