GSK BHR Study (Sont - Second Study) - Full Text View

Purpose

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
Asthma	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:

MedlinePlus related topics: Asthma

Drug Information available for: Fluticasone propionate Salmeterol Fluticasone Salmeterol xinafoate

U.S. FDA Resources

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

Eligibility

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

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01324362

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Locations

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

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov 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:

FP
Asthma
Sont
FSC
BHR

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 21, 2013