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

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Perennial Allergic Rhinitis, Rhinitis, Allergic

Intervention / Treatment
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* Device: Treatment A
* Device: Treatment B
* Other: Treatment C


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequence 1<br>Treatment sequence for the 3 treatment exposure visits is ABC. | Device: Treatment A<br>* Nasal Spray with drug-free aqueous gel emulsion (AM-301) intended to help protect against airborne allergens. One Spray of AM-301 per nostril<br>* Other names: Bentrio;Device: Treatment B<br>* 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)<br>* Other names: Bentrio;Other: Treatment C<br>* No treatment<br>|
| Experimental: Sequence 2<br>Treatment sequence for the 3 treatment exposure visits is BCA. | Device: Treatment A<br>* Nasal Spray with drug-free aqueous gel emulsion (AM-301) intended to help protect against airborne allergens. One Spray of AM-301 per nostril<br>* Other names: Bentrio;Device: Treatment B<br>* 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)<br>* Other names: Bentrio;Other: Treatment C<br>* No treatment<br>|
| Experimental: Sequence 3<br>Treatment sequence for the 3 treatment exposure visits is CAB. | Device: Treatment A<br>* Nasal Spray with drug-free aqueous gel emulsion (AM-301) intended to help protect against airborne allergens. One Spray of AM-301 per nostril<br>* Other names: Bentrio;Device: Treatment B<br>* 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)<br>* Other names: Bentrio;Other: Treatment C<br>* No treatment<br>|
| Experimental: Sequence 4<br>Treatment sequence for the 3 treatment exposure visits is ACB. | Device: Treatment A<br>* Nasal Spray with drug-free aqueous gel emulsion (AM-301) intended to help protect against airborne allergens. One Spray of AM-301 per nostril<br>* Other names: Bentrio;Device: Treatment B<br>* 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)<br>* Other names: Bentrio;Other: Treatment C<br>* No treatment<br>|
| Experimental: Sequence 5<br>Treatment sequence for the 3 treatment exposure visits is BAC. | Device: Treatment A<br>* Nasal Spray with drug-free aqueous gel emulsion (AM-301) intended to help protect against airborne allergens. One Spray of AM-301 per nostril<br>* Other names: Bentrio;Device: Treatment B<br>* 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)<br>* Other names: Bentrio;Other: Treatment C<br>* No treatment<br>|
| Experimental: Sequence 6<br>Treatment sequence for the 3 treatment exposure visits is CBA. | Device: Treatment A<br>* Nasal Spray with drug-free aqueous gel emulsion (AM-301) intended to help protect against airborne allergens. One Spray of AM-301 per nostril<br>* Other names: Bentrio;Device: Treatment B<br>* 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)<br>* Other names: Bentrio;Other: Treatment C<br>* No treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Allergic rhinitis symptoms, Runny nose, Itchy nose