Conditions: Seasonal Allergic Rhinitis
Keywords: Drug therapy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 80
Healthy volunteers: no

Brief summary:
The purpose of this study is to explore the efficacy and safety of Ciclesonide Nasal Spray 200 microgram (mcg) once daily in the treatment of seasonal allergic rhinitis (SAR) in Russian participants.

Detailed description:
The drug being tested in this study is called ciclesonide. Ciclesonide is being tested to treat allergy symptoms in people who have SAR. This study will look at improvement of allergy symptoms in Russian participants who take ciclesonide nasal spray.

The study will enroll approximately 80 participants. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups-which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need):

* Ciclesonide nasal spray 200 mcg
* Placebo nasal spray (dummy inactive nasal spray) - this is a nasal spray that looks like the study drug but has no active ingredient.

All participants will be asked to take 2 actuations per nostril at the same time each day throughout the study, and will be asked to record the severity of their allergy symptoms twice a day in a diary.

This multi-centre trial will be conducted in Russia. The overall time to participate in this study is up to 5 weeks. Participants will make 3 visits to the clinic, and will be contacted by telephone 14 days after last dose of study drug for a follow-up assessment.

Arms:
arm 1: Ciclesonide 200 mcg nasal spray, 2 actuations (sprays) per nostril (50 mcg ciclesonide/actuation), daily, for 2 weeks. arm 2: Ciclesonide placebo-matching nasal spray, 2 actuations (sprays) per nostril, daily, for 2 weeks.

Interventions: intervention 1: Ciclesonide intervention 2: Ciclesonide Placebo
Intervention descriptions: intervention 1: Ciclesonide nasal spray 50 mcg/actuation intervention 2: Ciclesonide placebo-matching nasal spray

Protocol document: