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

NCT05122143 | Completed Results

• 1 other identifier: AM-301-CL-21-02
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Allergic rhinitis symptoms; Runny nose; Itchy nose

Outcome Measures

Primary Outcomes (1)

• Overall Change From Baseline in TNSS at Visits 3, 4 and 5

  Total Nasal Symptom Score (TNSS) average from 20 - 180 minutes will be compared between treated and non-treated subjects. Data from all three visits are combined. Scale for a single symptom is from 0 - 3, 0 meaning no symptoms and 3 severe symptoms. Assessed symptoms are: nasal congestion, runny nose, nasal itching and sneezing. TNSS is the sum of the rating of all 4 symptoms and ranges from 0-12.

  Day 8 to Day 22

Secondary Outcomes (1)

• 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.

  Day 8 to Day 22

Study Arms (6)

Sequence 1

EXPERIMENTAL

Treatment sequence for the 3 treatment exposure visits is ABC.

Device: Treatment A; Device: Treatment B; Other: Treatment C

Sequence 2

EXPERIMENTAL

Treatment sequence for the 3 treatment exposure visits is BCA.

Device: Treatment A; Device: Treatment B; Other: Treatment C

Sequence 3

EXPERIMENTAL

Treatment sequence for the 3 treatment exposure visits is CAB.

Device: Treatment A; Device: Treatment B; Other: Treatment C

Sequence 4

EXPERIMENTAL

Treatment sequence for the 3 treatment exposure visits is ACB.

Device: Treatment A; Device: Treatment B; Other: Treatment C

Sequence 5

EXPERIMENTAL

Treatment sequence for the 3 treatment exposure visits is BAC.

Device: Treatment A; Device: Treatment B; Other: Treatment C

Sequence 6

EXPERIMENTAL

Treatment sequence for the 3 treatment exposure visits is CBA.

Device: Treatment A; Device: Treatment B; Other: Treatment C

Interventions

Treatment A DEVICE

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

Also known as: Bentrio

Sequence 1; Sequence 2; Sequence 3; Sequence 4; Sequence 5; Sequence 6

Treatment B DEVICE

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)

Also known as: Bentrio

Sequence 1; Sequence 2; Sequence 3; Sequence 4; Sequence 5; Sequence 6

Treatment C OTHER

No treatment

Sequence 1; Sequence 2; Sequence 3; Sequence 4; Sequence 5; Sequence 6

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Altamira Medica Ltd.: lead

Study Sites (1)

Cliantha Research

Mississauga, Canada

Location

Related Links

• Peer-reviewed publication of study results. PMID: 37488728

MeSH Terms

Conditions

Rhinitis, Allergic, Perennial; Rhinitis, Allergic; Rhinorrhea

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Thomas Meyer
• Organization: Altamira Medica Ltd.

ra@altamiramedica.com

0041 61 201 13

Study Officials

• Patricia Couroux, MD, FRCPC, CPI

  Cliantha Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2021
• First Posted: November 16, 2021
• Study Start: November 10, 2021
• Primary Completion: March 28, 2022
• Study Completion: April 4, 2022
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)