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

April 6, 2022 updated by: Altamira Medica Ltd.

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Mississauga, Canada
        • Cliantha Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sequence 1
Treatment sequence for the 3 treatment exposure visits is ABC.
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

Other Names:
  • Bentrio
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 Names:
  • Bentrio
Other: Treatment C
No treatment
Experimental: Sequence 2
Treatment sequence for the 3 treatment exposure visits is BCA.
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

Other Names:
  • Bentrio
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 Names:
  • Bentrio
Other: Treatment C
No treatment
Experimental: Sequence 3
Treatment sequence for the 3 treatment exposure visits is CAB.
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

Other Names:
  • Bentrio
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 Names:
  • Bentrio
Other: Treatment C
No treatment
Experimental: Sequence 4
Treatment sequence for the 3 treatment exposure visits is ACB.
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

Other Names:
  • Bentrio
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 Names:
  • Bentrio
Other: Treatment C
No treatment
Experimental: Sequence 5
Treatment sequence for the 3 treatment exposure visits is BAC.
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

Other Names:
  • Bentrio
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 Names:
  • Bentrio
Other: Treatment C
No treatment
Experimental: Sequence 6
Treatment sequence for the 3 treatment exposure visits is CBA.
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

Other Names:
  • Bentrio
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 Names:
  • Bentrio
Other: Treatment C
No treatment

What is the study measuring?

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
Time Frame: Day 8 to Day 22
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.
Time Frame: Day 8 to Day 22
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Altamira Medica Ltd.

Investigators

  • Principal Investigator: Peter Couroux, MD, FRCPC, CPI, Cliantha Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 10, 2021

Primary Completion (Actual)

March 28, 2022

Study Completion (Actual)

April 4, 2022

Study Registration Dates

First Submitted

October 26, 2021

First Submitted That Met QC Criteria

November 4, 2021

First Posted (Actual)

November 16, 2021

Study Record Updates

Last Update Posted (Actual)

April 7, 2022

Last Update Submitted That Met QC Criteria

April 6, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AM-301-CL-21-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Researchers may reach out to the Sponsor in order to ask for data sets.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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