GSK BHR Study (Sont)
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/Salmeterol DISKUS Twice Daily or Fluticasone Propionate DISKUS Twice Daily (or Placebo BID if Asymptomatic)
1 other identifier
interventional
464
4 countries
58
Brief Summary
The purpose of this study was to determine whether asthma control and reduced bronchial hyperresponsiveness could be achieved and maintained at a lower dose of inhaled corticosteroids with ADVAIR DISKUS twice-daily or FP twice-daily in adult and adolescent subjects 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 Feb 2003
58 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
February 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
June 12, 2009
CompletedFirst Posted
Study publicly available on registry
June 15, 2009
CompletedSeptember 1, 2016
August 1, 2016
1.7 years
June 12, 2009
August 31, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Average inhaled corticosteroid treatment dose over the treatment period
Every 8 weeks for the 40 week treatment period
Secondary Outcomes (1)
Pulmonary function measures
Every 8 weeks for the 40 week treatment period
Study Arms (2)
Fluticasone propionate
ACTIVE COMPARATORFluticasone propionate/salmeterol combination
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Asthma diagnosis
- Controller medications or moderate inhaled corticosteroid dose
- Evidence of reversibility
You may not qualify if:
- Life-threatening asthma
- Asthma instability
- Concurrent respiratory disease
- Drug allergy
- Respiratory tract infection
- Systemic corticosteroid use
- Immunosuppressive medication use
- Positive pregnancy test
- Tobacco use
- Site affiliation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (58)
GSK Investigational Site
Birmingham, Alabama, 35209, United States
GSK Investigational Site
Phoenix, Arizona, 85006, United States
GSK Investigational Site
Tucson, Arizona, 85712, United States
GSK Investigational Site
Carmichael, California, 95608, United States
GSK Investigational Site
Palmdale, California, 93551, United States
GSK Investigational Site
San Diego, California, 92103, United States
GSK Investigational Site
San Diego, California, 92120, United States
GSK Investigational Site
San Diego, California, 92123, United States
GSK Investigational Site
San Jose, California, 95117, United States
GSK Investigational Site
San Jose, California, 95128, United States
GSK Investigational Site
Walnut Creek, California, 94598, United States
GSK Investigational Site
Colorado Springs, Colorado, 80907, United States
GSK Investigational Site
Denver, Colorado, 80206, United States
GSK Investigational Site
Wheat Ridge, Colorado, 80033, United States
GSK Investigational Site
Hartford, Connecticut, 06106, United States
GSK Investigational Site
Trumbull, Connecticut, 06611, United States
GSK Investigational Site
Bay Pines, Florida, 33744, United States
GSK Investigational Site
Gainesville, Florida, 32610, United States
GSK Investigational Site
Sarasota, Florida, 34233, United States
GSK Investigational Site
Chicago, Illinois, 60637, United States
GSK Investigational Site
Normal, Illinois, 61761, United States
GSK Investigational Site
Indianapolis, Indiana, 46208, United States
GSK Investigational Site
Lafayette, Indiana, 47904, United States
GSK Investigational Site
Iowa City, Iowa, 52242, United States
GSK Investigational Site
Louisville, Kentucky, 40215, United States
GSK Investigational Site
New Orleans, Louisiana, 70119, United States
GSK Investigational Site
Baltimore, Maryland, 21224, United States
GSK Investigational Site
Petoskey, Michigan, 49770, United States
GSK Investigational Site
Minneapolis, Minnesota, 55407, United States
GSK Investigational Site
Butte, Montana, 59701, United States
GSK Investigational Site
Papillion, Nebraska, 68046, United States
GSK Investigational Site
Absecon, New Jersey, 8201, United States
GSK Investigational Site
Cherry Hill, New Jersey, 08003, United States
GSK Investigational Site
Rockville Centre, New York, 11570, United States
GSK Investigational Site
Asheville, North Carolina, 28801, United States
GSK Investigational Site
Statesville, North Carolina, 28625, United States
GSK Investigational Site
Canton, Ohio, 44718, United States
GSK Investigational Site
Sylvania, Ohio, 43560, United States
GSK Investigational Site
Toledo, Ohio, 43617, United States
GSK Investigational Site
Oklahoma City, Oklahoma, 73120, United States
GSK Investigational Site
Medford, Oregon, 97504, United States
GSK Investigational Site
Portland, Oregon, 97213, United States
GSK Investigational Site
Tigard, Oregon, 97223, United States
GSK Investigational Site
Pittsburgh, Pennsylvania, 15213, United States
GSK Investigational Site
Pittsburgh, Pennsylvania, 15241, United States
GSK Investigational Site
Lincoln, Rhode Island, 2865, United States
GSK Investigational Site
Charleston, South Carolina, 29407, United States
GSK Investigational Site
Nashville, Tennessee, 37203-1424, United States
GSK Investigational Site
Houston, Texas, 77090, United States
GSK Investigational Site
Charlottesville, Virginia, 22908, United States
GSK Investigational Site
Bellingham, Washington, 98226, United States
GSK Investigational Site
Morgantown, West Virginia, 26505, United States
GSK Investigational Site
Salvador, Estado de Bahia, 41940-060, Brazil
GSK Investigational Site
Porto Alegre, Rio Grande do Sul, 40110-160, Brazil
GSK Investigational Site
Porto Alegre, Rio Grande do Sul, 90035 003, Brazil
GSK Investigational Site
Riga, LV 1002, Latvia
GSK Investigational Site
Riga, LV 1003, Latvia
GSK Investigational Site
Ponce, Puerto Rico, 00716, Puerto Rico
Related Publications (3)
Dorinsky P, Yancey S, Baitinger L, Stauffer J. Measuring Airway Hyperresponsiveness: Does it add to routine measures of clinical efficacy in guiding asthma therapy? Eur Respir J 2006;28(50):319s.
BACKGROUNDKerwin EM, Nathan RA, Meltzer EO, Ortega HG, Yancey SW, Schoaf L, Dorinsky PM. Efficacy and safety of fluticasone propionate/salmeterol 250/50 mcg Diskus administered once daily. Respir Med. 2008 Apr;102(4):495-504. doi: 10.1016/j.rmed.2007.12.002. Epub 2008 Feb 21.
PMID: 18206361BACKGROUNDKoenig SM, Murray JJ, Wolfe J, Andersen L, Yancey S, Prillaman B, Stauffer J, Dorinsky P. Does measuring BHR add to guideline derived clinical measures in determining treatment for patients with persistent asthma? Respir Med. 2008 May;102(5):665-73. doi: 10.1016/j.rmed.2007.12.023. Epub 2008 Mar 6.
PMID: 18328683BACKGROUND
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
June 12, 2009
First Posted
June 15, 2009
Study Start
February 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.