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

Perennial Allergic Rhinitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05122143
• Other study ID #: AM-301-CL-21-02
• Status: Completed
• Phase: N/A
• Start date: November 10, 2021
• Est. completion date: April 4, 2022

Study information

• Verified date: April 2022
• Source: Auris Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: April 4, 2022
• Est. primary completion date: March 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Main Inclusion Criteria:

• Body mass index between 18.0 and 32.0 kg/m2 inclusive.
• History of perennial allergic rhinitis to house dust mite for more than 1 year.
• Positive Skin Prick Test (SPT) for Dermatophagoides pteronyssinus (der p) allergen at screening or within 12 months prior to the screening visit.

Main Exclusion Criteria:

• Any clinically relevant abnormal findings in physical examination, clinical chemistry, hematology, urinalysis, vital signs, lung function at screening visit, which, in the opinion of the investigator, may either put the subject at risk because of participation in the study or may influence the results of the study, or the subject's ability to participate in the study.
• Use of any medication considered to have an influence on the outcome of the study during the EEC session, at the discretion of the Investigator and/or designee.
• Recent nasal ulcers, mucosal erosion, nasal surgery, or nasal trauma, that might interfere with study results as determined by the Investigator and/or designee.

Related Conditions & MeSH terms

• Perennial Allergic Rhinitis
• Rhinitis
• Rhinitis, Allergic
• Rhinitis, Allergic, Perennial

Intervention

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
• 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

Locations

Country	Name	City	State
Canada	Cliantha Research	Mississauga

Sponsors (1)

Lead Sponsor	Collaborator
Altamira Medica Ltd.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes from baseline in Total Nasal Symptom Score (TNSS) at each post-dose assessment time points (0 to 3 hours) at Visit 3, Visit 4 and Visit 5	Total Nasal Symptom Score (TNSS) average from 20 - 180 min will be compared between treated and non-treated subjects. Scale is from 0 - 3, 0 meaning no symptoms and 3 severe symptoms. Assessed symptoms are: nasal congestion, runny nose, nasal itching and sneezing.	Day 8 to Day 22
Secondary	Difference of Total Nasal Symptom Score (TNSS) at individual timepoints during house dust mite challenge in the EEC (0-180 min) between single and double application of AM-301 and no treatment.	Total Nasal Symptom Score (TNSS) average from 20 - 180 min will be compared between treated and non-treated subjects. Scale is from 0 - 3, 0 meaning no symptoms and 3 severe symptoms. Assessed symptoms are: nasal congestion, runny nose, nasal itching and sneezing.	Day 8 to Day 22

External Links

•   Recruitment website for this study