NCT00920543CompletedPhase 4
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)
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- GlaxoSmithKline
- Enrollment
- 464
- Locations
- 1
- Primary Endpoint
- Average inhaled corticosteroid treatment dose over the treatment period
Study Overview
Brief Summary
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 12 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Fluticasone propionate
Active Comparator
Intervention: Placebo (Drug)
Fluticasone propionate
Active Comparator
Intervention: FP 100mcg (Drug)
Fluticasone propionate
Active Comparator
Intervention: FP 500mcg (Drug)
Fluticasone propionate
Active Comparator
Intervention: FP 250mcg (Drug)
Fluticasone propionate/salmeterol combination
Active Comparator
Intervention: Placebo (Drug)
Fluticasone propionate/salmeterol combination
Active Comparator
Intervention: FSC 100/50mcg (Drug)
Fluticasone propionate/salmeterol combination
Active Comparator
Intervention: FSC 250/50mcg (Drug)
Fluticasone propionate/salmeterol combination
Active Comparator
Intervention: FSC 500/50mcg (Drug)
Outcomes
Primary Outcomes
Average inhaled corticosteroid treatment dose over the treatment period
Time Frame: Every 8 weeks for the 40 week treatment period
Secondary Outcomes
- Pulmonary function measures(Every 8 weeks for the 40 week treatment period)
Investigators
Study Sites (1)
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