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

GSK BHR study (Sont - Second Study)

Request patient level data
GSK study ID
SAM40065
See study documents
Clinicaltrials.gov ID
NCT01324362
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
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
Observational study model:
Not applicable
Primary completion date:
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
Contact us
Contact us
Location
GSK Investigational Site
Upland, Pennsylvania, United States, 19013
Status
Study Complete
Contact us
Location
GSK Investigational Site
Winston-Salem, North Carolina, United States, 27103
Status
Study Complete
Contact us
Location
GSK Investigational Site
Wilmington, North Carolina, United States, 28401
Status
Study Complete
Contact us
Location
GSK Investigational Site
Englewood, Colorado, United States, 80112
Status
Study Complete
Contact us
Location
GSK Investigational Site
Mineola, New York, United States, 11501
Status
Study Complete
Contact us
Location
GSK Investigational Site
Tampa, Florida, United States, 33613
Status
Study Complete
Contact us
Location
GSK Investigational Site
Danville, Virginia, United States, 24541
Status
Terminated/Withdrawn
Contact us
Location
GSK Investigational Site
Aventura, Florida, United States, 33180
Status
Study Complete
Contact us
Location
GSK Investigational Site
Chesterfield, Missouri, United States, 63017
Status
Study Complete
Contact us
Location
GSK Investigational Site
Dallas, Texas, United States, 75231-4307
Status
Study Complete
Contact us
Location
GSK Investigational Site
Seattle, Washington, United States, 98105
Status
Study Complete
Contact us
Location
GSK Investigational Site
Madison, Wisconsin, United States, 53792
Status
Study Complete
Contact us
Location
GSK Investigational Site
Tampa, Florida, United States, 33609
Status
Study Complete
Contact us
Location
GSK Investigational Site
Toledo, Ohio, United States, 43614-5809
Status
Study Complete
Contact us
Location
GSK Investigational Site
Los Angeles, California, United States, 90025
Status
Study Complete
Contact us
Location
GSK Investigational Site
Baltimore, Maryland, United States, 21236
Status
Study Complete
Contact us
Location
GSK Investigational Site
Varna, Bulgaria, 9010
Status
Study Complete
Contact us
Location
GSK Investigational Site
Jacksonville, Florida, United States, 32207
Status
Study Complete
Contact us
Location
GSK Investigational Site
Cincinnati, Ohio, United States, 45231
Status
Study Complete
Contact us
Location
GSK Investigational Site
Rio de Janeiro, Rio De Janeiro, Brazil, 21941-590
Status
Study Complete
Contact us
Location
GSK Investigational Site
Lake Oswego, Oregon, United States, 97035
Status
Study Complete
Contact us
Location
GSK Investigational Site
Long Beach, California, United States, 90806
Status
Study Complete
Contact us
Location
GSK Investigational Site
Glendale, Arizona, United States, 85304
Status
Study Complete
Contact us
Location
GSK Investigational Site
San Juan, Puerto Rico, Puerto Rico, 00921
Status
Study Complete
Contact us
Location
GSK Investigational Site
Spartanburg, South Carolina, United States, 29303
Status
Study Complete
Contact us
Location
GSK Investigational Site
Tucson, Arizona, United States, 85724
Status
Terminated/Withdrawn
Contact us
Location
GSK Investigational Site
South Bend, Indiana, United States, 46617
Status
Study Complete
Contact us
Location
GSK Investigational Site
Des Moines, Iowa, United States, 50309-1426
Status
Study Complete
Contact us
Location
GSK Investigational Site
Milwaukee, Wisconsin, United States, 53209-0996
Status
Study Complete
Contact us
Location
GSK Investigational Site
Los Angeles, California, United States, 90048
Status
Study Complete
Contact us
Location
GSK Investigational Site
Fort Collins, Colorado, United States, 80526
Status
Study Complete
Contact us
Location
GSK Investigational Site
Birmingham, Alabama, United States, 35294-0012
Status
Study Complete
Contact us
Location
GSK Investigational Site
Cleveland, Ohio, United States, 44195
Status
Terminated/Withdrawn
Contact us
Location
GSK Investigational Site
Bellingham, Washington, United States, 98226
Status
Study Complete
Contact us
Location
GSK Investigational Site
Charlotte, North Carolina, United States, 28207
Status
Study Complete
Contact us
Location
GSK Investigational Site
Sofia, Bulgaria, 1431/1000
Status
Study Complete
Contact us
Location
GSK Investigational Site
Houston, Texas, United States, 77030
Status
Terminated/Withdrawn
Contact us
Location
GSK Investigational Site
Eugene, Oregon, United States, 97401
Status
Study Complete
Contact us
Location
GSK Investigational Site
Omaha, Nebraska, United States, 68131
Status
Study Complete
Contact us
Location
GSK Investigational Site
Los Angeles, California, United States, 90095-1752
Status
Study Complete
Contact us
Location
GSK Investigational Site
Wheat Ridge, Colorado, United States, 80033
Status
Terminated/Withdrawn
Contact us
Location
GSK Investigational Site
Knoxville, Tennessee, United States, 37922
Status
Study Complete
Contact us
Location
GSK Investigational Site
Pueblo, Colorado, United States, 81008
Status
Study Complete
Contact us
Location
GSK Investigational Site
Friendswood, Texas, United States, 77546
Status
Study Complete
Contact us
Location
GSK Investigational Site
Coeur D'Alene, Idaho, United States, 83814
Status
Study Complete
Contact us
Location
GSK Investigational Site
Jasper, Alabama, United States, 35501
Status
Study Complete
Contact us
Location
GSK Investigational Site
Huntington Beach, California, United States, 92647
Status
Study Complete
Contact us
Location
GSK Investigational Site
Denver, Colorado, United States, 80230
Status
Study Complete
Contact us
Location
GSK Investigational Site
Florianopolis, Santa Catarina, Brazil, 88040970
Status
Study Complete
Contact us
Location
GSK Investigational Site
Oak Brook, Illinois, United States, 60523
Status
Study Complete
Contact us
Location
GSK Investigational Site
Longwood, Florida, United States, 32750
Status
Terminated/Withdrawn
Contact us
Location
GSK Investigational Site
Omaha, Nebraska, United States, 68198-2456
Status
Study Complete
Contact us
Location
GSK Investigational Site
São Paulo, São Paulo, Brazil
Status
Study Complete
Contact us
Location
GSK Investigational Site
Livonia, Michigan, United States, 48152
Status
Terminated/Withdrawn
Contact us
Location
GSK Investigational Site
Richmond, Virginia, United States, 23229
Status
Study Complete
Contact us
Location
GSK Investigational Site
North Dartmouth, Massachusetts, United States, 02747
Status
Study Complete
Contact us

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
Completed
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

Participate in clinical trial
Additional information
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Click here
Access to clinical trial data by researchers
Visit website