Last updated: 11/04/2018 11:14:02

GSK BHR study (Sont)

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GSK study ID
SAM40086
See study documents
Clinicaltrials.gov ID
NCT00920543
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/salmeterol DISKUS twice daily or fluticasone propionate DISKUS twice daily (or placebo BID if asymptomatic)
Trial description: 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
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

Average inhaled corticosteroid treatment dose over the treatment period

Timeframe: Every 8 weeks for the 40 week treatment period

Secondary outcomes:

Pulmonary function measures

Timeframe: Every 8 weeks for the 40 week treatment period

Interventions:
  • Drug: Placebo
  • Drug: FP 100mcg
  • Drug: FP 500mcg
  • Drug: FP 250mcg
  • Drug: FSC 100/50mcg
  • Drug: FSC 250/50mcg
  • Drug: FSC 500/50mcg
    • Enrollment:
    464
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical 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.
    Kerwin EM, Nathan RA, Meltzer EO, et al. Efficacy and safety of fluticasone propionate/salmeterol 250/50 mcg Diskus administered once daily. Respir Med 2008;102(4):495–504.
    Koenig SM, Murray JJ, Wolfe J, et al. Does measuring BHR add to guideline derived clinical measures in determining treatment for patients with persistent asthma? Respir Med 2008;102(5):665–73.
    Medical condition
    Asthma
    Product
    fluticasone propionate, fluticasone propionate/salmeterol, salmeterol
    Collaborators
    Not applicable
    Study date(s)
    February 2003 to October 2004
    Type
    Interventional
    Phase
    4

    Participation criteria

    Sex
    Female & Male
    Age
    12+ years
    Accepts healthy volunteers
    No
    • Asthma diagnosis
    • Controller medications or moderate inhaled corticosteroid dose
    • Life-threatening asthma
    • Asthma instability
    Inclusion and exclusion 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

    Trial location(s)

    Location
    Status
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    Location
    GSK Investigational Site
    Toledo, Ohio, United States, 43617
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Pittsburgh, Pennsylvania, United States, 15241
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Chicago, Illinois, United States, 60637
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Hartford, Connecticut, United States, 06106
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Charlottesville, Virginia, United States, 22908
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Trumbull, Connecticut, United States, 06611
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Salvador, Bahía, Brazil, 41940-060
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Denver, Colorado, United States, 80206
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Lincoln, Rhode Island, United States, 2865
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Indianapolis, Indiana, United States, 46208
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Riga, Latvia, LV 1003
    Status
    Study Complete
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    Location
    GSK Investigational Site
    San Diego, California, United States, 92123
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Houston, Texas, United States, 77090
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Tigard, Oregon, United States, 97223
    Status
    Study Complete
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    Location
    GSK Investigational Site
    San Jose, California, United States, 95117
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Sylvania, Ohio, United States, 43560
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Porto Alegre, Rio Grande Do Sul, Brazil, 90035 003
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Morgantown, West Virginia, United States, 26505
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Palmdale, California, United States, 93551
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Lafayette, Indiana, United States, 47904
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Canton, Ohio, United States, 44718
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Bay Pines, Florida, United States, 33744
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Wheat Ridge, Colorado, United States, 80033
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Colorado Springs, Colorado, United States, 80907
    Status
    Study Complete
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    Location
    GSK Investigational Site
    San Jose, California, United States, 95128
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Louisville, Kentucky, United States, 40215
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Iowa City, Iowa, United States, 52242
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Medford, Oregon, United States, 97504
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Statesville, North Carolina, United States, 28625
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Minneapolis, Minnesota, United States, 55407
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Papillion, Nebraska, United States, 68046
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Pittsburgh, Pennsylvania, United States, 15213
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Asheville, North Carolina, United States, 28801
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Walnut Creek, California, United States, 94598
    Status
    Study Complete
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    Location
    GSK Investigational Site
    San Diego, California, United States, 92120
    Status
    Study Complete
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    Location
    GSK Investigational Site
    New Orleans, Louisiana, United States, 70119
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Normal, Illinois, United States, 61761
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Oklahoma City, Oklahoma, United States, 73120
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Absecon, New Jersey, United States, 8201
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Carmichael, California, United States, 95608
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Rockville Center, New York, United States, 11570
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Bellingham, Washington, United States, 98226
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Birmingham, Alabama, United States, 35209
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Ponce, Puerto Rico, Puerto Rico, 00716
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Porto Alegre, Rio Grande Do Sul, Brazil, 40110-160
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Petoskey, Michigan, United States, 49770
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Cherry Hill, New Jersey, United States, 08003
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Phoenix, Arizona, United States, 85006
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Baltimore, Maryland, United States, 21224
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Gainesville, Florida, United States, 32610
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Nashville, Tennessee, United States, 37203-1424
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Tucson, Arizona, United States, 85712
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Portland, Oregon, United States, 97213
    Status
    Study Complete
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    Location
    GSK Investigational Site
    San Diego, California, United States, 92103
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Butte, Montana, United States, 59701
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Charleston, South Carolina, United States, 29407
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Sarasota, Florida, United States, 34233
    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
    2004-22-10

    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.

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