Seasonal Allergic Rhinitis Clinical Trial
Official title:
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
The purpose of this study is to explore the efficacy and safety of Ciclesonide Nasal Spray 200 mcg once daily in the treatment of seasonal allergic rhinitis (SAR) in Russian participants.
The drug being tested in this study is called ciclesonide. Ciclesonide is being tested to
treat allergy symptoms in people who have seasonal allergic rhinitis (SAR). This study will
look at improvement of allergy symptoms in Russian patients who take ciclesonide nasal
spray.
The study will enroll approximately 80 patients. Participants will be randomly assigned (by
chance, like flipping a coin) to one of the two treatment groups—which will remain
undisclosed to the patient 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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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