CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 37 enrolled
Drug / intervention
Treatment A +2 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05122143
NCT05122143N/ACompleted

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

Altamira Medica Ltd.·interventional·Posted Nov 16, 2021·Updated Sep 19, 2024

In Brief

A clinical study evaluating Treatment A, Treatment B, and 1 other intervention for Perennial Allergic Rhinitis and Rhinitis, Allergic. Completed, enrolled 37 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada
Collaborators--

Timeline

N/ACompletedFinished
20222023202420252026
First PostedNov 16, 2021
Enrollment StartNov 10, 2021
Primary CompletionMar 28, 2022
Study CompletionApr 4, 2022
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 4.6 years ago

Interventions

Treatment Adevice

Nasal Spray with drug-free aqueous gel emulsion (AM-301) intended to help protect against airborne allergens. One Spray of AM-301 per nostril

Treatment Bdevice

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)

Treatment Cother

No treatment