GSK BHR Study (Sont - Second Study)
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)
1 other identifier
interventional
446
4 countries
57
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 asthma
Started Jan 2003
57 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
Study Start
First participant enrolled
January 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2004
CompletedFirst Submitted
Initial submission to the registry
February 3, 2011
CompletedFirst Posted
Study publicly available on registry
March 29, 2011
CompletedSeptember 1, 2016
August 1, 2016
1.8 years
February 3, 2011
August 31, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Average ICS treatment dose over the treatment period
Every 8 weeks through 40 weeks of treatment
Secondary Outcomes (1)
Pulmonary function measures
Every 8 weeks through 40 weeks of treatment
Study Arms (2)
Fluticasone propionate
ACTIVE COMPARATORFluticasone propionate/salmeterol combination
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Diagnosis of asthma
- Controller asthma medication or medium dose ICS
- Current or historical reversibility
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (57)
GSK Investigational Site
Birmingham, Alabama, 35294-0012, United States
GSK Investigational Site
Jasper, Alabama, 35501, United States
GSK Investigational Site
Glendale, Arizona, 85304, United States
GSK Investigational Site
Tucson, Arizona, 85724, United States
GSK Investigational Site
Huntington Beach, California, 92647, United States
GSK Investigational Site
Long Beach, California, 90806, United States
GSK Investigational Site
Los Angeles, California, 90025, United States
GSK Investigational Site
Los Angeles, California, 90048, United States
GSK Investigational Site
Los Angeles, California, 90095-1752, United States
GSK Investigational Site
Denver, Colorado, 80230, United States
GSK Investigational Site
Englewood, Colorado, 80112, United States
GSK Investigational Site
Fort Collins, Colorado, 80526, United States
GSK Investigational Site
Pueblo, Colorado, 81008, United States
GSK Investigational Site
Wheat Ridge, Colorado, 80033, United States
GSK Investigational Site
Aventura, Florida, 33180, United States
GSK Investigational Site
Jacksonville, Florida, 32207, United States
GSK Investigational Site
Longwood, Florida, 32750, United States
GSK Investigational Site
Tampa, Florida, 33609, United States
GSK Investigational Site
Tampa, Florida, 33613, United States
GSK Investigational Site
Coeur d'Alene, Idaho, 83814, United States
GSK Investigational Site
Oak Brook, Illinois, 60523, United States
GSK Investigational Site
South Bend, Indiana, 46617, United States
GSK Investigational Site
Des Moines, Iowa, 50309-1426, United States
GSK Investigational Site
Baltimore, Maryland, 21236, United States
GSK Investigational Site
North Dartmouth, Massachusetts, 02747, United States
GSK Investigational Site
Livonia, Michigan, 48152, United States
GSK Investigational Site
Chesterfield, Missouri, 63017, United States
GSK Investigational Site
Omaha, Nebraska, 68131, United States
GSK Investigational Site
Omaha, Nebraska, 68198-2456, United States
GSK Investigational Site
Mineola, New York, 11501, United States
GSK Investigational Site
Charlotte, North Carolina, 28207, United States
GSK Investigational Site
Wilmington, North Carolina, 28401, United States
GSK Investigational Site
Winston-Salem, North Carolina, 27103, United States
GSK Investigational Site
Cincinnati, Ohio, 45231, United States
GSK Investigational Site
Cleveland, Ohio, 44195, United States
GSK Investigational Site
Toledo, Ohio, 43614-5809, United States
GSK Investigational Site
Eugene, Oregon, 97401, United States
GSK Investigational Site
Lake Oswego, Oregon, 97035, United States
GSK Investigational Site
Upland, Pennsylvania, 19013, United States
GSK Investigational Site
Spartanburg, South Carolina, 29303, United States
GSK Investigational Site
Knoxville, Tennessee, 37922, United States
GSK Investigational Site
Dallas, Texas, 75231-4307, United States
GSK Investigational Site
Dallas, Texas, 75231, United States
GSK Investigational Site
Friendswood, Texas, 77546, United States
GSK Investigational Site
Houston, Texas, 77030, United States
GSK Investigational Site
Danville, Virginia, 24541, United States
GSK Investigational Site
Richmond, Virginia, 23229, United States
GSK Investigational Site
Bellingham, Washington, 98226, United States
GSK Investigational Site
Seattle, Washington, 98105, United States
GSK Investigational Site
Madison, Wisconsin, 53792, United States
GSK Investigational Site
Milwaukee, Wisconsin, 53209-0996, United States
GSK Investigational Site
Rio de Janeiro, Rio de Janeiro, 21941-590, Brazil
GSK Investigational Site
Florianópolis, Santa Catarina, 88040970, Brazil
GSK Investigational Site
São Paulo, São Paulo, Brazil
GSK Investigational Site
Sofia, 1431/1000, Bulgaria
GSK Investigational Site
Varna, 9010, Bulgaria
GSK Investigational Site
San Juan, Puerto Rico, 00921, Puerto Rico
Related 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
BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
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
February 3, 2011
First Posted
March 29, 2011
Study Start
January 1, 2003
Primary Completion
October 1, 2004
Study Completion
October 1, 2004
Last Updated
September 1, 2016
Record last verified: 2016-08
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.