GSK BHR Study (Sont - Second Study)

August 31, 2016 updated by: GlaxoSmithKline

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)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

446

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Rio de Janeiro, Brazil, 21941-590
        • GSK Investigational Site
      • São Paulo, Brazil
        • GSK Investigational Site
    • Santa Catarina
      • Florianopolis, Santa Catarina, Brazil, 88040970
        • GSK Investigational Site
  • Bulgaria
      • Sofia, Bulgaria, 1431/1000
        • GSK Investigational Site
      • Varna, Bulgaria, 9010
        • GSK Investigational Site
  • Puerto Rico
      • San Juan, Puerto Rico, 00921
        • GSK Investigational Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294-0012
        • GSK Investigational Site
      • Jasper, Alabama, United States, 35501
        • GSK Investigational Site
    • Arizona
      • Glendale, Arizona, United States, 85304
        • GSK Investigational Site
      • Tucson, Arizona, United States, 85724
        • GSK Investigational Site
    • California
      • Huntington Beach, California, United States, 92647
        • GSK Investigational Site
      • Long Beach, California, United States, 90806
        • GSK Investigational Site
      • Los Angeles, California, United States, 90025
        • GSK Investigational Site
      • Los Angeles, California, United States, 90048
        • GSK Investigational Site
      • Los Angeles, California, United States, 90095-1752
        • GSK Investigational Site
    • Colorado
      • Denver, Colorado, United States, 80230
        • GSK Investigational Site
      • Englewood, Colorado, United States, 80112
        • GSK Investigational Site
      • Fort Collins, Colorado, United States, 80526
        • GSK Investigational Site
      • Pueblo, Colorado, United States, 81008
        • GSK Investigational Site
      • Wheat Ridge, Colorado, United States, 80033
        • GSK Investigational Site
    • Florida
      • Aventura, Florida, United States, 33180
        • GSK Investigational Site
      • Jacksonville, Florida, United States, 32207
        • GSK Investigational Site
      • Longwood, Florida, United States, 32750
        • GSK Investigational Site
      • Tampa, Florida, United States, 33613
        • GSK Investigational Site
      • Tampa, Florida, United States, 33609
        • GSK Investigational Site
    • Idaho
      • Coeur D'Alene, Idaho, United States, 83814
        • GSK Investigational Site
    • Illinois
      • Oak Brook, Illinois, United States, 60523
        • GSK Investigational Site
    • Indiana
      • South Bend, Indiana, United States, 46617
        • GSK Investigational Site
    • Iowa
      • Des Moines, Iowa, United States, 50309-1426
        • GSK Investigational Site
    • Maryland
      • Baltimore, Maryland, United States, 21236
        • GSK Investigational Site
    • Massachusetts
      • North Dartmouth, Massachusetts, United States, 02747
        • GSK Investigational Site
    • Michigan
      • Livonia, Michigan, United States, 48152
        • GSK Investigational Site
    • Missouri
      • Chesterfield, Missouri, United States, 63017
        • GSK Investigational Site
    • Nebraska
      • Omaha, Nebraska, United States, 68131
        • GSK Investigational Site
      • Omaha, Nebraska, United States, 68198-2456
        • GSK Investigational Site
    • New York
      • Mineola, New York, United States, 11501
        • GSK Investigational Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • GSK Investigational Site
      • Wilmington, North Carolina, United States, 28401
        • GSK Investigational Site
      • Winston-Salem, North Carolina, United States, 27103
        • GSK Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States, 45231
        • GSK Investigational Site
      • Cleveland, Ohio, United States, 44195
        • GSK Investigational Site
      • Toledo, Ohio, United States, 43614-5809
        • GSK Investigational Site
    • Oregon
      • Eugene, Oregon, United States, 97401
        • GSK Investigational Site
      • Lake Oswego, Oregon, United States, 97035
        • GSK Investigational Site
    • Pennsylvania
      • Upland, Pennsylvania, United States, 19013
        • GSK Investigational Site
    • South Carolina
      • Spartanburg, South Carolina, United States, 29303
        • GSK Investigational Site
    • Tennessee
      • Knoxville, Tennessee, United States, 37922
        • GSK Investigational Site
    • Texas
      • Dallas, Texas, United States, 75231
        • GSK Investigational Site
      • Dallas, Texas, United States, 75231-4307
        • GSK Investigational Site
      • Friendswood, Texas, United States, 77546
        • GSK Investigational Site
      • Houston, Texas, United States, 77030
        • GSK Investigational Site
    • Virginia
      • Danville, Virginia, United States, 24541
        • GSK Investigational Site
      • Richmond, Virginia, United States, 23229
        • GSK Investigational Site
    • Washington
      • Bellingham, Washington, United States, 98226
        • GSK Investigational Site
      • Seattle, Washington, United States, 98105
        • GSK Investigational Site
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • GSK Investigational Site
      • Milwaukee, Wisconsin, United States, 53209-0996
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Fluticasone propionate
Drug: Placebo
Twice daily dosing
Other Names:
  • FP 100mcg
  • FP 250mcg
  • FP 500mcg
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
Other Names:
  • FP 100mcg
  • FP 250mcg
  • FP 500mcg
Drug: FSC 100/50mcg
Twice daily dosing
Drug: FSC 250/50mcg
Twice daily dosing
Drug: FSC500/50mcg
Twice daily dosing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Average ICS treatment dose over the treatment period
Time Frame: Every 8 weeks through 40 weeks of treatment
Every 8 weeks through 40 weeks of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Pulmonary function measures
Time Frame: Every 8 weeks through 40 weeks of treatment
Every 8 weeks through 40 weeks of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • 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

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2003

Primary Completion (Actual)

October 1, 2004

Study Completion (Actual)

October 1, 2004

Study Registration Dates

First Submitted

February 3, 2011

First Submitted That Met QC Criteria

March 25, 2011

First Posted (Estimate)

March 29, 2011

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

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SAM40065

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. Informed Consent Form
    Information identifier: SAM40065
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  2. Clinical Study Report
    Information identifier: SAM40065
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  3. Statistical Analysis Plan
    Information identifier: SAM40065
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  4. Annotated Case Report Form
    Information identifier: SAM40065
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  5. Dataset Specification
    Information identifier: SAM40065
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  6. Individual Participant Data Set
    Information identifier: SAM40065
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  7. Study Protocol
    Information identifier: SAM40065
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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