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)

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

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: Placebo; Drug: FP 100mcg; Drug: FP 500mcg; Drug: FP 250mcg; Drug: FSC 100/50mcg; Drug: FSC 250/50mcg; Drug: FSC 500/50mcg

• Study Type: Interventional
• Enrollment (Actual): 464
• Phase: Phase 4

Contacts and Locations

Study Locations

• Brazil
  • Bahía
    • Salvador, Bahía, Brazil, 41940-060
      • GSK Investigational Site
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil, 40110-160
      • GSK Investigational Site
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90035 003
      • GSK Investigational Site
• Latvia
  • Riga, Latvia, LV 1002
    • GSK Investigational Site
  • Riga, Latvia, LV 1003
    • GSK Investigational Site
• Puerto Rico
  • Ponce, Puerto Rico, 00716
    • GSK Investigational Site
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35209
      • GSK Investigational Site
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • GSK Investigational Site
    • Tucson, Arizona, United States, 85712
      • GSK Investigational Site
  • California
    • Carmichael, California, United States, 95608
      • GSK Investigational Site
    • Palmdale, California, United States, 93551
      • GSK Investigational Site
    • San Diego, California, United States, 92103
      • GSK Investigational Site
    • San Diego, California, United States, 92123
      • GSK Investigational Site
    • San Diego, California, United States, 92120
      • GSK Investigational Site
    • San Jose, California, United States, 95117
      • GSK Investigational Site
    • San Jose, California, United States, 95128
      • GSK Investigational Site
    • Walnut Creek, California, United States, 94598
      • GSK Investigational Site
  • Colorado
    • Colorado Springs, Colorado, United States, 80907
      • GSK Investigational Site
    • Denver, Colorado, United States, 80206
      • GSK Investigational Site
    • Wheat Ridge, Colorado, United States, 80033
      • GSK Investigational Site
  • Connecticut
    • Hartford, Connecticut, United States, 06106
      • GSK Investigational Site
    • Trumbull, Connecticut, United States, 06611
      • GSK Investigational Site
  • Florida
    • Bay Pines, Florida, United States, 33744
      • GSK Investigational Site
    • Gainesville, Florida, United States, 32610
      • GSK Investigational Site
    • Sarasota, Florida, United States, 34233
      • GSK Investigational Site
  • Illinois
    • Chicago, Illinois, United States, 60637
      • GSK Investigational Site
    • Normal, Illinois, United States, 61761
      • GSK Investigational Site
  • Indiana
    • Indianapolis, Indiana, United States, 46208
      • GSK Investigational Site
    • Lafayette, Indiana, United States, 47904
      • GSK Investigational Site
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • GSK Investigational Site
  • Kentucky
    • Louisville, Kentucky, United States, 40215
      • GSK Investigational Site
  • Louisiana
    • New Orleans, Louisiana, United States, 70119
      • GSK Investigational Site
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • GSK Investigational Site
  • Michigan
    • Petoskey, Michigan, United States, 49770
      • GSK Investigational Site
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407
      • GSK Investigational Site
  • Montana
    • Butte, Montana, United States, 59701
      • GSK Investigational Site
  • Nebraska
    • Papillion, Nebraska, United States, 68046
      • GSK Investigational Site
  • New Jersey
    • Absecon, New Jersey, United States, 8201
      • GSK Investigational Site
    • Cherry Hill, New Jersey, United States, 08003
      • GSK Investigational Site
  • New York
    • Rockville Center, New York, United States, 11570
      • GSK Investigational Site
  • North Carolina
    • Asheville, North Carolina, United States, 28801
      • GSK Investigational Site
    • Statesville, North Carolina, United States, 28625
      • GSK Investigational Site
  • Ohio
    • Canton, Ohio, United States, 44718
      • GSK Investigational Site
    • Sylvania, Ohio, United States, 43560
      • GSK Investigational Site
    • Toledo, Ohio, United States, 43617
      • GSK Investigational Site
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73120
      • GSK Investigational Site
  • Oregon
    • Medford, Oregon, United States, 97504
      • GSK Investigational Site
    • Portland, Oregon, United States, 97213
      • GSK Investigational Site
    • Tigard, Oregon, United States, 97223
      • GSK Investigational Site
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15241
      • GSK Investigational Site
    • Pittsburgh, Pennsylvania, United States, 15213
      • GSK Investigational Site
  • Rhode Island
    • Lincoln, Rhode Island, United States, 2865
      • GSK Investigational Site
  • South Carolina
    • Charleston, South Carolina, United States, 29407
      • GSK Investigational Site
  • Tennessee
    • Nashville, Tennessee, United States, 37203-1424
      • GSK Investigational Site
  • Texas
    • Houston, Texas, United States, 77090
      • GSK Investigational Site
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • GSK Investigational Site
  • Washington
    • Bellingham, Washington, United States, 98226
      • GSK Investigational Site
  • West Virginia
    • Morgantown, West Virginia, United States, 26505
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Asthma diagnosis
• Controller medications or moderate inhaled corticosteroid dose
• Evidence of reversibility

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Fluticasone propionate	Drug: Placebo; Twice daily dosing; Drug: FP 100mcg; Twice daily dosing; Drug: FP 500mcg; Twice daily dosing; Drug: FP 250mcg; Twice daily dosing
Active Comparator: Fluticasone propionate/salmeterol combination	Drug: Placebo; Twice daily dosing; Drug: FSC 100/50mcg; Twice daily dosing; Drug: FSC 250/50mcg; Twice daily dosing; Drug: FSC 500/50mcg; Twice daily dosing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Average inhaled corticosteroid treatment dose over the treatment period	Every 8 weeks for the 40 week treatment period

Secondary Outcome Measures

Outcome Measure	Time Frame
Pulmonary function measures	Every 8 weeks for the 40 week treatment period

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

General Publications

• 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.
• Kerwin 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.
• Koenig 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.

Helpful 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2003
• Primary Completion (Actual): October 1, 2004
• Study Completion (Actual): October 1, 2004

Study Registration Dates

• First Submitted: June 12, 2009
• First Submitted That Met QC Criteria: June 12, 2009
• First Posted (Estimate): June 15, 2009

Study Record Updates

• Last Update Posted (Estimate): September 1, 2016
• Last Update Submitted That Met QC Criteria: August 31, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: SAM40086

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

1. Individual Participant Data Set
   Information identifier: SAM40086
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
2. Informed Consent Form
   Information identifier: SAM40086
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
3. Statistical Analysis Plan
   Information identifier: SAM40086
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
4. Annotated Case Report Form
   Information identifier: SAM40086
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
5. Dataset Specification
   Information identifier: SAM40086
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
6. Study Protocol
   Information identifier: SAM40086
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
7. Clinical Study Report
   Information identifier: SAM40086
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register