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   (Child, Adult, Senior)
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:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Salmeterol Xinafoate
Fluticasone Propionate, Salmeterol Xinafoate Drug Combination
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones, Hormone Substitutes, and Hormone Antagonists processed this record on August 30, 2016