GSK BHR Study (Sont - Second Study)

This study has been completed.
Information provided by:
GlaxoSmithKline Identifier:
First received: February 3, 2011
Last updated: October 13, 2011
Last verified: October 2011
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

Condition Intervention Phase
Drug: Placebo
Drug: FP 100mcg
Drug: FP 250mcg
Drug: FP 500mcg
Drug: FSC 100/50mcg
Drug: FSC 250/50mcg
Drug: FSC500/50mcg
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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/Salmeterol DISKUSTM BID or Fluticasone Propionate DISK ...

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Average ICS treatment dose over the treatment period [ Time Frame: Every 8 weeks through 40 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pulmonary function measures [ Time Frame: Every 8 weeks through 40 weeks of treatment ] [ Designated as safety issue: No ]

Enrollment: 446
Study Start Date: January 2003
Study Completion Date: October 2004
Primary Completion Date: October 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 250mcg
Twice daily dosing
Drug: FP 500mcg
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: FSC500/50mcg
Twice daily dosing


Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01324362

  Show 51 Study Locations
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

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

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure Identifier: NCT01324362     History of Changes
Other Study ID Numbers: SAM40065 
Study First Received: February 3, 2011
Last Updated: October 13, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

Additional relevant MeSH terms:
Fluticasone Propionate, Salmeterol Xinafoate Drug Combination
Anti-Allergic Agents
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Autonomic Agents
Bronchodilator Agents
Dermatologic Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Peripheral Nervous System Agents
Physiological Effects of Drugs
Respiratory System Agents
Sympathomimetics processed this record on May 26, 2016