Fluticasone Nasal Spray Patient Preference Study

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Rhinitis, Allergic, Perennial

Treatments: Drug: fluticasone propionate (FP); Drug: fluticasone furoate (FF)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00398476

FFU108556

Details and patient eligibility

About

The objectives of this study are to evaluate and compare patient preference for FF (Fluticasone Furoate) and FP (Fluticasone Propionate Aqueous)nasal sprays in the treatment of allergic rhinitis following single-dose administration.

Enrollment: 127 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• allergic rhinitis
• literate

Exclusion criteria

• clinical significant uncontrolled disease
• Use of intranasal corticosteroids (<4 weeks of FP [branded or generic],<4 week exposure to FF, <4 weeks use of other INS)
• Use of intranasal medications <1 week
• Use of meds that significantly inhibit CYP4503A4
• Use of perfume or oral rinse on study day
• Allergy/intolerance to INS, antihistamines, or excipients
• Positive pregnancy test or female who is breastfeeding
• Affiliation with investigational site

Trial design

127 participants in 2 patient groups

fluticasone propionate (FP)

Active Comparator group

Description:

200 micrograms (mcg); an aqueous suspension of microfine FP

Treatment:

Drug: fluticasone propionate (FP)

fluticasone furoate (FF)

Active Comparator group

Description:

110 mcg; an aqueous suspension containing 0.05% w/w of micronized FF

Treatment:

Drug: fluticasone furoate (FF)