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GSK BHR Study (Sont - Second Study)

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Asthma

Intervention: Placebo (Drug); Placebo (Drug); FP 100mcg (Drug); FP 250mcg (Drug); FP 500mcg (Drug); FSC 100/50mcg (Drug); FSC 250/50mcg (Drug); FSC500/50mcg (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

Summary

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

Clinical Details

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 ...

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Average ICS treatment dose over the treatment period

Secondary outcome: Pulmonary function measures

Eligibility

Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

GSK Investigational Site, Rio de Janeiro 21941-590, Brazil

GSK Investigational Site, São Paulo, Brazil

GSK Investigational Site, Sofia 1431/1000, Bulgaria

GSK Investigational Site, Varna 9010, Bulgaria

GSK Investigational Site, San Juan 00921, Puerto Rico

GSK Investigational Site, Birmingham, Alabama 35294-0012, United States

GSK Investigational Site, Jasper, Alabama 35501, United States

GSK Investigational Site, Glendale, Arizona 85304, United States

GSK Investigational Site, Tucson, Arizona 85724, United States

GSK Investigational Site, Huntington Beach, California 92647, United States

GSK Investigational Site, Long Beach, California 90806, United States

GSK Investigational Site, Los Angeles, California 90025, United States

GSK Investigational Site, Los Angeles, California 90048, United States

GSK Investigational Site, Los Angeles, California 90095-1752, United States

GSK Investigational Site, Pueblo, Colorado 81008, United States

GSK Investigational Site, Wheat Ridge, Colorado 80033, United States

GSK Investigational Site, Aventura, Florida 33180, United States

GSK Investigational Site, Jacksonville, Florida 32207, United States

GSK Investigational Site, Longwood, Florida 32750, United States

GSK Investigational Site, Tampa, Florida 33609, United States

GSK Investigational Site, Tampa, Florida 33613, United States

GSK Investigational Site, Coeur D'Alene, Idaho 83814, United States

GSK Investigational Site, Oak Brook, Illinois 60523, United States

GSK Investigational Site, South Bend, Indiana 46617, United States

GSK Investigational Site, Des Moines, Iowa 50309-1426, United States

GSK Investigational Site, North Dartmouth, Massachusetts 02747, United States

GSK Investigational Site, Livonia, Michigan 48152, United States

GSK Investigational Site, Chesterfield, Missouri 63017, United States

GSK Investigational Site, Omaha, Nebraska 68198-2456, United States

GSK Investigational Site, Mineola, New York 11501, United States

GSK Investigational Site, Charlotte, North Carolina 28207, United States

GSK Investigational Site, Wilmington, North Carolina 28401, United States

GSK Investigational Site, Winston-Salem, North Carolina 27103, United States

GSK Investigational Site, Cincinnati, Ohio 45231, United States

GSK Investigational Site, Cleveland, Ohio 44195, United States

GSK Investigational Site, Toledo, Ohio 43614-5809, United States

GSK Investigational Site, Eugene, Oregon 97401, United States

GSK Investigational Site, Lake Oswego, Oregon 97035, United States

GSK Investigational Site, Upland, Pennsylvania 19013, United States

GSK Investigational Site, Florianopolis, Santa Catarina 88040970, Brazil

GSK Investigational Site, Spartanburg, South Carolina 29303, United States

GSK Investigational Site, Dallas, Texas 75231-4307, United States

GSK Investigational Site, Dallas, Texas 75231, United States

GSK Investigational Site, Friendswood, Texas 77546, United States

GSK Investigational Site, Houston, Texas 77030, United States

GSK Investigational Site, Danville, Virginia 24541, United States

GSK Investigational Site, Richmond, Virginia 23229, United States

GSK Investigational Site, Bellingham, Washington 98226, United States

GSK Investigational Site, Seattle, Washington 98105, United States

GSK Investigational Site, Madison, Wisconsin 53792, United States

GSK Investigational Site, Milwaukee, Wisconsin 53209-0996, United States

Additional Information

Related 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

Starting date: January 2003
Last updated: October 13, 2011

Page last updated: August 23, 2015

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