Conditions: Rhinitis, Allergic, Seasonal
Keywords: Rhinitis Seasonal Allergic Rhinitis Fluticasone furoate Equivalence Hay fever
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 727
Healthy volunteers: no

Brief summary:
This study compared the safety and efficacy of a generic fluticasone furoate (Lek Pharmaceuticals) nasal spray to the reference listed drug in the treatment of seasonal allergic rhinitis. Additionally both the test and the reference formulations were tested for superiority against a placebo nasal spray.

Detailed description:
The study was designed as a double-blind, randomized, placebo-controlled, parallel group, multi-site to compare the clinical equivalence of the test formulation of fluticasone furoate, 27.5 mcg/actuation nasal spray (Lek Pharmaceuticals d.d.) with the reference formulation Veramyst® nasal spray (GlaxoSmithKline) in the relief of the signs and symptoms of seasonal allergic rhinitis. Participants who met the inclusion/exclusion criteria entered a 7-day placebo lead-in period. Following this placebo lead-in period, on Day 1 participants who continued to meet eligibility criteria were randomly assigned in a 2:2:1 ratio to one of three treatment groups (Test Product:Reference Product:Placebo) for 14 days of treatment. In all treatment groups, participants were instructed to administer the study drug once daily at approximately the same time each day. A single dose of 110 mcg was 4 actuations, each containing 27.5 mcg per actuation. Patients were instructed to administer the 4 actuations alternating between right and left nostril, such that 2 actuations were not administered back to back to the same nostril.

Arms:
arm 1: Fluticasone furoate 27.5 mcg/actuation nasal spray (Lek Pharmaceuticals) administered once daily at a dose of 110 mcg (4 actuations) for 14 days. arm 2: Fluticasone furoate (Veramyst®) 27.5 mcg/actuation nasal spray administered once daily at a dose of 110 mcg (4 actuations) for 14 days. arm 3: Placebo nasal spray administered once daily for 14 days.

Interventions: intervention 1: Fluticasone furoate 27.5 mcg/actuation nasal spray (Lek Pharmaceuticals) intervention 2: Fluticasone furoate (Veramyst®) 27.5 mcg/actuation nasal spray intervention 3: Placebo
Intervention descriptions: intervention 1: Nasal spray administered once daily at a dose of 110 mcg (4 actuations) for 14 days. intervention 2: Nasal spray administered once daily at a dose of 110 mcg (4 actuations) for 14 days. intervention 3: Placebo nasal spray administered once daily (4 actuations) for 14 days.

Protocol document: