None listed
Conditions
Brief summary
A study to determine the safety and efficacy of treatment with AM-301 in subjects who suffer from seasonal AR. In this study, a saline nasal spray, ie, a drug free standard-of-care product commercially available in Australia will be used as a comparator After Screening, subjects will undergo a 7 day Run-in Period to establish Baseline, followed by a 2-week Treatment Period. The AM-301 medical nasal spray device is being developed as a nasal spray intended to treat Allergic Rhinitis by limiting exposure to airborne allergens and promoting alleviation of allergic symptoms triggered by the inhalation of airborne allergens. It is hoped that the AM-301 nasal spray device will be better than the standard of care saline spray nasal spray device (comparator) to help in improvement of Allergic Rhinitis symptoms.
Interventions
The aim of the study is to compare AM-301 nasal spray with a drug free standard of care product in the clinical performance and safety over a treatment period of 14 days. AM-301 is a thixotropic, aqueous gel emulsion. It works by forming a protective layer on the nasal mucosa that acts as a mechanical barrier against allergens.
Subjects will be randomized to 1 of 2 treatment groups at a ratio of 1:1
AM-301 will be self-administered 1 puff /nostril 3 times per day or as needed (not more than 8
The aim of the study is to compare AM-301 nasal spray with a drug free standard of care product in the clinical performance and safety over a treatment period of 14 days. AM-301 is a thixotropic, aqueous gel emulsion. It works by forming a protective layer on the nasal mucosa that acts as a mechanical barrier against allergens. Subjects will be randomized to 1 of 2 treatment groups at a ratio of 1:1 AM-301 will be self-administered 1 puff /nostril 3 times per day or as needed (not more than 8 sprays/nostril per day) for 2 weeks with each actuation delivering 0.14 mL. Adherence to dosing is being monitored via a self reported diary and patient facing instructions on IP administration with specified dosing will be provided.
Sponsors
Auris Medical Pty. Ltd.
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
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.
Exclusion criteria
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).
Outcome results
None listed