NCT02155881

Efficacy and Safety of Ciclesonide Nasal Spray in Participants With Seasonal Allergic Rhinitis (SAR) in Russia

A Multi-Center, Double-Blind, Placebo-Controlled, Two-Arm, Parallel-Group, Phase III (Registration) Study to Assess the Efficacy and Safety of Ciclesonide Nasal Spray (Omnaris®) 200 mcg Once Daily in the Treatment of the Patients With Seasonal Allergic Rhinitis (SAR) in Russia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Seasonal Allergic Rhinitis

Interventions

Type	Name	Description
DRUG	Ciclesonide	Ciclesonide nasal spray 50 mcg/actuation
DRUG	Ciclesonide Placebo	Ciclesonide placebo-matching nasal spray

Timeline

• Start date: 2014-08-01
• Primary completion: 2014-10-01
• Completion: 2014-11-01
• First posted: 2014-06-04
• Last updated: 2017-02-02
• Results posted: 2016-10-06

Locations

5 sites across 1 country: Russia