NCT05122143

Efficacy and Safety of AM-301 on Allergic Symptoms of Perennial Allergic Rhinitis Sufferers

Pivotal, Randomized, Open-Label, 3-Period Crossover Study to Assess the Efficacy and Safety of AM-301 on Allergic Symptoms During House Dust Mite Challenge in an Exposure Chamber in Study Participants With Perennial Allergic Rhinitis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Altamira Medica Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Alleviation of allergic symptoms induced by house dust mites when using the medical device AM-301. This clinical investigation explored the efficacy and safety of AM-301 when used to reduce symptoms of house dust mite sufferers. The primary objective was to compare the efficacy of AM-301 Device between treated and non-treated subjects in the treatment of perennial allergic rhinitis (PAR).

Detailed description

This was a randomized, open-label, 3-period crossover study. The total study duration was approximately 65 days and consisted of 2 screening visits and 3 treatment visits (total 5 visits) followed by a telephone call. Patients with HDM allergy as assessed by their medical history and a positive skin prick test for Dermatophagoides pteronyssinus (der p) allergen were enrolled into the screening phase. At least 7 days after the second screening visit, the treatment visits started. Eligible subjects were randomized to one of the six treatment sequences (ABC, BCA, CAB, ACB, BAC, CBA) at an equal ratio. The treatments were applied 10 minutes before the challenge at Visit 3, 4 and 5: * Treatment A: One spray AM-301 (0.14 mL) per nostril, * Treatment B: Two sprays AM-301 (0.28 mL) per nostril (at two defined spray angles in order to obtain a broader coverage of the nasal mucosa), * Treatment C: no treatment. The cross-over design allowed treatment C to be used as internal control. Between the three treatment visits in the chamber there was a 7±2 days wash-out period.

Conditions

• Perennial Allergic Rhinitis
• Rhinitis, Allergic

Interventions

Type	Name	Description
DEVICE	Treatment A	Nasal Spray with drug-free aqueous gel emulsion (AM-301) intended to help protect against airborne allergens. One Spray of AM-301 per nostril
DEVICE	Treatment B	Nasal Spray with drug-free aqueous gel emulsion (AM-301) intended to help protect against airborne allergens. Two Sprays of AM-301 per nostril (with different spray angles)
OTHER	Treatment C	No treatment

Timeline

• Start date: 2021-11-10
• Primary completion: 2022-03-28
• Completion: 2022-04-04
• First posted: 2021-11-16
• Last updated: 2024-09-19
• Results posted: 2024-09-19

Locations

1 site across 1 country: Canada