Last updated: 11/04/2018 11:13:22

GSK BHR study (Sont - Second Study)

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GSK study ID
SAM40065
See study documents
Clinicaltrials.gov ID
NCT01324362
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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/sameterol DISKUS twice daily or fluticasone propionate DISKUS twice daily (or placebo twice daily if asymptomatic)
Trial description: 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
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

Average ICS treatment dose over the treatment period

Timeframe: Every 8 weeks through 40 weeks of treatment

Secondary outcomes:

Pulmonary function measures

Timeframe: Every 8 weeks through 40 weeks of treatment

Interventions:
  • Drug: Placebo
  • Drug: FP 100mcg
  • Drug: FP 250mcg
  • Drug: FP 500mcg
  • Drug: FSC 100/50mcg
  • Drug: FSC 250/50mcg
  • Drug: FSC500/50mcg
    • Enrollment:
    446
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical 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
    Medical condition
    Asthma
    Product
    fluticasone propionate, fluticasone propionate/salmeterol, salmeterol
    Collaborators
    Not applicable
    Study date(s)
    January 2003 to October 2004
    Type
    Interventional
    Phase
    4

    Participation criteria

    Sex
    Female & Male
    Age
    12+ years
    Accepts healthy volunteers
    No
    • Diagnosis of asthma
    • Controller asthma medication or medium dose ICS
    • Life-threatening asthma
    • Asthma instability
    Inclusion and exclusion 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

    Trial location(s)

    Location
    Status
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    Location
    GSK Investigational Site
    Upland, Pennsylvania, United States, 19013
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Winston-Salem, North Carolina, United States, 27103
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Wilmington, North Carolina, United States, 28401
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Englewood, Colorado, United States, 80112
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Mineola, New York, United States, 11501
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Tampa, Florida, United States, 33613
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Danville, Virginia, United States, 24541
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Aventura, Florida, United States, 33180
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Chesterfield, Missouri, United States, 63017
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Dallas, Texas, United States, 75231-4307
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Seattle, Washington, United States, 98105
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Madison, Wisconsin, United States, 53792
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Tampa, Florida, United States, 33609
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Toledo, Ohio, United States, 43614-5809
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Los Angeles, California, United States, 90025
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Baltimore, Maryland, United States, 21236
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Varna, Bulgaria, 9010
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Jacksonville, Florida, United States, 32207
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Cincinnati, Ohio, United States, 45231
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Rio de Janeiro, Rio De Janeiro, Brazil, 21941-590
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Lake Oswego, Oregon, United States, 97035
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Long Beach, California, United States, 90806
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Glendale, Arizona, United States, 85304
    Status
    Study Complete
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    Location
    GSK Investigational Site
    San Juan, Puerto Rico, Puerto Rico, 00921
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Spartanburg, South Carolina, United States, 29303
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Tucson, Arizona, United States, 85724
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    South Bend, Indiana, United States, 46617
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Des Moines, Iowa, United States, 50309-1426
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Milwaukee, Wisconsin, United States, 53209-0996
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Los Angeles, California, United States, 90048
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Fort Collins, Colorado, United States, 80526
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Birmingham, Alabama, United States, 35294-0012
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Cleveland, Ohio, United States, 44195
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Bellingham, Washington, United States, 98226
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Charlotte, North Carolina, United States, 28207
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Sofia, Bulgaria, 1431/1000
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Houston, Texas, United States, 77030
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Eugene, Oregon, United States, 97401
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Omaha, Nebraska, United States, 68131
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Los Angeles, California, United States, 90095-1752
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Wheat Ridge, Colorado, United States, 80033
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Knoxville, Tennessee, United States, 37922
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Pueblo, Colorado, United States, 81008
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Friendswood, Texas, United States, 77546
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Coeur D'Alene, Idaho, United States, 83814
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Jasper, Alabama, United States, 35501
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Huntington Beach, California, United States, 92647
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Denver, Colorado, United States, 80230
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Florianopolis, Santa Catarina, Brazil, 88040970
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Oak Brook, Illinois, United States, 60523
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Longwood, Florida, United States, 32750
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Omaha, Nebraska, United States, 68198-2456
    Status
    Study Complete
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    Location
    GSK Investigational Site
    São Paulo, São Paulo, Brazil
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Livonia, Michigan, United States, 48152
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Richmond, Virginia, United States, 23229
    Status
    Study Complete
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    Location
    GSK Investigational Site
    North Dartmouth, Massachusetts, United States, 02747
    Status
    Study Complete
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    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2004-19-10

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

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