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GSK BHR Study (Sont)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00920543
First received: June 12, 2009
Last updated: April 11, 2013
Last verified: March 2011
History of Changes
  Purpose

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


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

MedlinePlus related topics: Asthma
U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Average inhaled corticosteroid treatment dose over the treatment period [ Time Frame: Every 8 weeks for the 40 week treatment period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pulmonary function measures [ Time Frame: Every 8 weeks for the 40 week treatment period ] [ Designated as safety issue: No ]

Enrollment: 464
Study Start Date: February 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
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

  Eligibility

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00920543

Locations
United States, Alabama
GSK Investigational Site
Birmingham, Alabama, United States, 35209
United States, Florida
GSK Investigational Site
Bay Pines, Florida, United States, 33744
United States, North Carolina
GSK Investigational Site
Statesville, North Carolina, United States, 28625
United States, Oregon
GSK Investigational Site
Tigard, Oregon, United States, 97223
United States, Washington
GSK Investigational Site
Bellingham, Washington, United States, 98226
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

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.

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00920543     History of Changes
Other Study ID Numbers: SAM40086
Study First Received: June 12, 2009
Last Updated: April 11, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Asthma
Bronchial Hyperreactivity
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Salmeterol
Fluticasone
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
 Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Dermatologic Agents
Anti-Allergic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on May 22, 2013