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

PHASE3CompletedINTERVENTIONAL
Enrollment

580

Participants

Timeline

Start Date

March 31, 2011

Primary Completion Date

August 31, 2011

Study Completion Date

August 31, 2011

Conditions
Seasonal Allergic Rhinitis
Interventions
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."

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Apotex Inc.

INDUSTRY