Conditions: Rhinitis, Allergic, Seasonal
Keywords: Rhinitis Seasonal Allergic Rhinitis Mometasone Furoate Equivalence Hay fever
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 795
Healthy volunteers: no

Brief summary:
This study compared the efficacy and safety of a generic mometasone 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 mometasone furoate monohydrate, 50 mcg/actuation nasal spray (Lek Pharmaceuticals d.d.) with the reference formulation Nasonex® nasal spray (Schering) 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 200 mcg was 4 actuations, each containing 50 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: Mometasone furoate 50 mcg/actuation nasal spray (Lek Pharmaceuticals) administered once daily at a dose of 200 mcg (4 actuations) for 14 days. arm 2: Mometasone furoate (Nasonex®) 50 mcg/actuation nasal spray administered once daily at a dose of 200 mcg (4 actuations) for 14 days. arm 3: Placebo nasal spray administered once daily for 14 days.

Interventions: intervention 1: Mometasone furoate 50 mcg/actuation nasal spray (Lek Pharmaceuticals) intervention 2: Mometasone furoate (Nasonex®) 50 mcg/actuation nasal spray intervention 3: Placebo
Intervention descriptions: intervention 1: Mometasone nasal spray administered once daily at a dose of 200 mcg (4 actuations) for 14 days. intervention 2: Mometasone nasal spray administered once daily at a dose of 200 mcg (4 actuations) for 14 days. intervention 3: Placebo nasal spray administered once daily (4 actuations) for 14 days.

Protocol document: