Clinical Performance and Safety of AM-301 Nasal Spray in Seasonal Allergic Rhinitis (NASAR)

Auris Medical Pty. Ltd.0 个研究点目标入组 100 人开始时间: 2021年12月17日最近更新: 2023年1月30日

适应症

试验速览

暂无简介。

•1. Clinical history of seasonal AR, as reported by the subject, with symptoms for more than 2 seasons with exacerbations during the study season for the relevant seasonal allergen (eg, tree/grass pollen).
•2. Confirmed with positive skin prick test (ie, wheal greater than or equal to 3 mm larger than the diluent control with erythema) or in vitro tests for specific immunoglobulin E (IgE) at Baseline or within 12 months before enrolment.
•3. Age more than or equal to 18 years and less than or equal to 75 years on the day of Screening.
•4. Active symptoms of seasonal AR with a TNSS score greater than or equal to 5 (based on run-in) at randomization.

•1. Ongoing or in the 7 days prior to Screening, presence of active, medium or severe symptoms of rhinitis (non-allergic), acute inflammation of the nose or paranasal sinuses.
•2. Uncontrolled asthma, under treatment with any class of medications other than inhaled short-acting beta-2 agonists or with known FEV1 less than 70 percent (in previous 6 months).
•3. Ongoing or in the previous 4 weeks, diagnosis or symptoms of acute respiratory infections.
•4. Surgery of the nose or paranasal sinuses in the previous 8 weeks.
•5. Long-term continuous inhaled, intranasal glucocorticosteroids (intermittent use is allowed).
•6. Long-term continuous use of the oral or systemic H1 antihistamines, topical antiallergic treatment, nasal vasoconstrictors (intermittent use of provided relief medication is allowed during the trial).
•7. Immunotherapy starting at enrolment or with dose changed within 1 month before Screening.
•8. Treatment with leukotriene receptor antagonists (concomitant or up to one week before Screening) or nonsteroidal anti-inflammatory drugs (NSAIDs) (NSAID intermittent use is allowed as relief medication).

发起方

Auris Medical Pty. Ltd.