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GSK BHR Study (Sont - Second Study)

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)

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01324362
Enrollment
446
Registered
2011-03-29
Start date
2003-01-31
Completion date
2004-10-31
Last updated
2016-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

FP, Asthma, Sont, FSC, BHR

Brief 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

Interventions

DRUGPlacebo

Twice daily dosing

DRUGFP 100mcg

Twice daily dosing

DRUGFP 250mcg

Twice daily dosing

DRUGFP 500mcg

Twice daily dosing

DRUGFSC 100/50mcg

Twice daily dosing

DRUGFSC 250/50mcg

Twice daily dosing

DRUGFSC500/50mcg

Twice daily dosing

Sponsors

GlaxoSmithKline
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Average ICS treatment dose over the treatment periodEvery 8 weeks through 40 weeks of treatment

Secondary

MeasureTime frame
Pulmonary function measuresEvery 8 weeks through 40 weeks of treatment

Countries

Brazil, Bulgaria, Puerto Rico, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026