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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05122143
Other study ID # AM-301-CL-21-02
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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