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

NCT05122143 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2024-09-19

Study results available
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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).

Conditions

  • Perennial Allergic Rhinitis
  • Rhinitis, Allergic

Interventions

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

Sponsors & Collaborators

  • Altamira Medica Ltd.

    lead INDUSTRY

Principal Investigators

  • Patricia Couroux, MD, FRCPC, CPI · Cliantha Research

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-10
Primary Completion
2022-03-28
Completion
2022-04-04

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05122143 on ClinicalTrials.gov