GSK BHR Study (Sont - Second Study)

Asthma Clinical Trial

Official title:

A Multicenter, Randomized, Double-blind, Parallel Group, 40-week Comparison of Asthma Control Using Bronchial Hyperresponsiveness as an Additional Guide to Long-term Treatment in Adolescents and Adults Receiving Either Fluticasone Propionate/Sameterol DISKUS Twice Daily or Fluticasone Propionate DISKUS Twice Daily (or Placebo Twice Daily if Asymptomatic)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01324362
• Other study ID #: SAM40065
• Status: Completed
• Phase: Phase 4
• First received: February 3, 2011
• Last updated: August 31, 2016
• Start date: January 2003
• Est. completion date: October 2004

Study information

• Verified date: August 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study was to determine whether asthma control and reduced bronchial responsiveness could be achieved and maintained at a lower dose of inhaled corticosteroids with ADVAIR DISKUS BID or FP BID in adult and adolescent patients with persistent asthma

Recruitment information / eligibility

• Status: Completed
• Enrollment: 446
• Est. completion date: October 2004
• Est. primary completion date: October 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of asthma

• Controller asthma medication or medium dose ICS

• Current or historical reversibility

Exclusion Criteria:

• Life-threatening asthma

• Asthma instability

• Concurrent respiratory disease

• Drug allergies

• Respiratory tract infection

• Systemic corticosteroid use

• Immunosuppressive medication use

• Postive pregnancy test

• Tobacco use

• Investigation medication use

• Site affiliation

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Placebo
Twice daily dosing
• Placebo
Twice daily dosing
• FP 100mcg
Twice daily dosing
• FP 250mcg
Twice daily dosing
• FP 500mcg
Twice daily dosing
• FSC 100/50mcg
Twice daily dosing
• FSC 250/50mcg
Twice daily dosing
• FSC500/50mcg
Twice daily dosing

Locations

Country	Name	City	State
Brazil	GSK Investigational Site	Florianopolis	Santa Catarina
Brazil	GSK Investigational Site	Rio de Janeiro
Brazil	GSK Investigational Site	São Paulo
Bulgaria	GSK Investigational Site	Sofia
Bulgaria	GSK Investigational Site	Varna
Puerto Rico	GSK Investigational Site	San Juan
United States	GSK Investigational Site	Aventura	Florida
United States	GSK Investigational Site	Baltimore	Maryland
United States	GSK Investigational Site	Bellingham	Washington
United States	GSK Investigational Site	Birmingham	Alabama
United States	GSK Investigational Site	Charlotte	North Carolina
United States	GSK Investigational Site	Chesterfield	Missouri
United States	GSK Investigational Site	Cincinnati	Ohio
United States	GSK Investigational Site	Cleveland	Ohio
United States	GSK Investigational Site	Coeur D'Alene	Idaho
United States	GSK Investigational Site	Dallas	Texas
United States	GSK Investigational Site	Dallas	Texas
United States	GSK Investigational Site	Danville	Virginia
United States	GSK Investigational Site	Denver	Colorado
United States	GSK Investigational Site	Des Moines	Iowa
United States	GSK Investigational Site	Englewood	Colorado
United States	GSK Investigational Site	Eugene	Oregon
United States	GSK Investigational Site	Fort Collins	Colorado
United States	GSK Investigational Site	Friendswood	Texas
United States	GSK Investigational Site	Glendale	Arizona
United States	GSK Investigational Site	Houston	Texas
United States	GSK Investigational Site	Huntington Beach	California
United States	GSK Investigational Site	Jacksonville	Florida
United States	GSK Investigational Site	Jasper	Alabama
United States	GSK Investigational Site	Knoxville	Tennessee
United States	GSK Investigational Site	Lake Oswego	Oregon
United States	GSK Investigational Site	Livonia	Michigan
United States	GSK Investigational Site	Long Beach	California
United States	GSK Investigational Site	Longwood	Florida
United States	GSK Investigational Site	Los Angeles	California
United States	GSK Investigational Site	Los Angeles	California
United States	GSK Investigational Site	Los Angeles	California
United States	GSK Investigational Site	Madison	Wisconsin
United States	GSK Investigational Site	Milwaukee	Wisconsin
United States	GSK Investigational Site	Mineola	New York
United States	GSK Investigational Site	North Dartmouth	Massachusetts
United States	GSK Investigational Site	Oak Brook	Illinois
United States	GSK Investigational Site	Omaha	Nebraska
United States	GSK Investigational Site	Omaha	Nebraska
United States	GSK Investigational Site	Pueblo	Colorado
United States	GSK Investigational Site	Richmond	Virginia
United States	GSK Investigational Site	Seattle	Washington
United States	GSK Investigational Site	South Bend	Indiana
United States	GSK Investigational Site	Spartanburg	South Carolina
United States	GSK Investigational Site	Tampa	Florida
United States	GSK Investigational Site	Tampa	Florida
United States	GSK Investigational Site	Toledo	Ohio
United States	GSK Investigational Site	Tucson	Arizona
United States	GSK Investigational Site	Upland	Pennsylvania
United States	GSK Investigational Site	Wheat Ridge	Colorado
United States	GSK Investigational Site	Wilmington	North Carolina
United States	GSK Investigational Site	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Brazil,  Bulgaria,  Puerto Rico, 

References & Publications (1)

Stauffer JL, Yancey SW, Baitinger LA, Prillaman BA, Dorinsky PM. Measuring airway hyperresponsiveness: Does it add to routine measures of clinical efficacy in guiding asthma therapy? Proc Am Thorac Soc 2006;3:A213

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average ICS treatment dose over the treatment period		Every 8 weeks through 40 weeks of treatment	No
Secondary	Pulmonary function measures		Every 8 weeks through 40 weeks of treatment	No

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.