Trial of STAHIST in Seasonal Allergic Rhinitis

• Total Symptom Scores (TSS) [ Time Frame: Every 12 hours, two weeks trial duration ] [ Designated as safety issue: No ]
  To report and compare total symptom scores (TSS) by SAR subjects rating the efficacy of STAHIST vs. placebo in relieving nasal congestion, rhinorrhea, nasal itching, sneezing, and post-nasal drip over the two-week study period.
  
  

• Adverse Events (AEs) Assessment [ Time Frame: Every 12 hours, two weeks study duration ] [ Designated as safety issue: Yes ]
  B) Report any side effects or adverse drug reactions and rate the severity of any incident.
  
  

Phase 3 clinical trial will be conducted in conformance with Good Clinical Practices and is a multi-center, double-blind, randomized, placebo-controlled, parallel-group study evaluating the safety and efficacy of STAHIST (IMP) in 300 adult and adolescent subjects 12-60 years of age, of either sex or any race with a minimum 2-year history of seasonal allergic rhinitis (SAR) and a baseline minimum total symptom score (TSS) of not less than 8 on the S5 Subject Diary. Subjects will be treated twice daily with IMP or placebo for a period of two weeks. Subjects will visit the study site for at least 4 visits: screening, randomization/study inception, end-of-week one, final visit, and unscheduled visits as appropriate.

Run In (washout period): Subjects will be required to stop using oral nasal decongestants or first generation antihistamines for 48 hours, second generation antihistamines and Singulair for seven days, systemic corticosteroids for 30 days, and nasal or ocular corticosteroid medications for two weeks. Use of these drugs will also not be allowed during the study.

The first dose will be administered at the study site and subjects will be monitored on-site for one hour following dosing. There will be 24-hour on-call telephone access between physician/office staff and study subjects.

A Study Flow Chart will be used to facilitate trial management, record completed tasks as well as document their time of completion (See Study Flow Chart and Source Documents—Appendix D).

Safety evaluations will include monitoring of subject-reported AEs, measurement of vital signs, and assessment of safety laboratory data. Qualified independent, non-study administration individuals will be selected prior to the start of treatment for the purpose of safety monitoring.

300 subjects will be randomized. Assuming a screen failure test rate of approximately 33%, approximately 450 subjects will be screened.

At the conclusion of the study, the CSR will be prepared by the Sponsor, reviewed and approved by the Principal/Coordinator Investigator before submission.