NCT02273817

A Study Comparing The Bioequivalence Of Ciclesonide Nasal Spray (Apotex, Inc.) To That Of Omnaris™ Nasal Spray (Sepracor, Inc.) In The Treatment Of Seasonal Allergic Rhinitis

A Randomized, Double-blind, Placebo-controlled, Parallel-group Study Comparing the Bioquivalence of Ciclesonide Nasal Spray(Apotex Inc.) to That of Omnaris ™Nasal Spray (Sepracor, Inc.) in the Treatment of Seasonal Allergic Rhinitis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 580 (actual)
• Sponsor: Apotex Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study is to evaluate the equivalence of generic ciclesonide nasal spray with that of the marketed drug, Omnaris™ nasal spray, in the treatment of seasonal allergic rhinitis, and to evaluate the safety and tolerability of generic ciclesonide nasal spray compared with Omnaris™ nasal spray.

Conditions

• Seasonal Allergic Rhinitis

Interventions

Type	Name	Description
DRUG	Ciclesonide nasal spray, 50 μg per actuation.	During placebo lead-in period: patients received placebo nasal spray, two actuations in each nostril once daily for 7 days. During treatment period: subjects were then assigned to one of the following three treatments according to the randomization scheme: 1. Ciclesonide nasal spray: 50 μg per actuation, two actuations in each nostril once daily (200 μg per day) for 14 days. 2. Omnaris™ nasal spray: 50 μg per actuation, two actuations in each nostril once daily (200 μg per day) for 14 days. 3. Placebo nasal spray: 0 μg per actuation, two actuations in each nostril once daily for 14 days.

Timeline

• Start date: 2011-03-01
• Primary completion: 2011-08-01
• Completion: 2011-08-01
• First posted: 2014-10-24
• Last updated: 2014-10-24