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Fluticasone Nasal Spray Patient Preference Study

GlaxoSmithKline (GSK) logo

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)

Trial contacts and locations

14

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Data sourced from clinicaltrials.gov

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