Back to resultsEfficacy and Safety of AM-301 on Allergic Symptoms of Perennial Allergic Rhinitis Sufferers
Primary Purpose
Perennial Allergic Rhinitis, Rhinitis, Allergic
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Treatment A
Treatment B
Treatment C
Sponsored by
About this trial
This is an interventional prevention trial for Perennial Allergic Rhinitis focused on measuring Allergic rhinitis symptoms, Runny nose, Itchy nose
Eligibility Criteria
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.
Sites / Locations
- Cliantha Research
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Sequence 1
Sequence 2
Sequence 3
Sequence 4
Sequence 5
Sequence 6
Arm Description
Treatment sequence for the 3 treatment exposure visits is ABC.
Treatment sequence for the 3 treatment exposure visits is BCA.
Treatment sequence for the 3 treatment exposure visits is CAB.
Treatment sequence for the 3 treatment exposure visits is ACB.
Treatment sequence for the 3 treatment exposure visits is BAC.
Treatment sequence for the 3 treatment exposure visits is CBA.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05122143
Brief Title
Efficacy and Safety of AM-301 on Allergic Symptoms of Perennial Allergic Rhinitis Sufferers
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
November 10, 2021 (Actual)
Primary Completion Date
March 28, 2022 (Actual)
Study Completion Date
April 4, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Altamira Medica Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perennial Allergic Rhinitis, Rhinitis, Allergic
Keywords
Allergic rhinitis symptoms, Runny nose, Itchy nose
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sequence 1
Arm Type
Experimental
Arm Description
Treatment sequence for the 3 treatment exposure visits is ABC.
Arm Title
Sequence 2
Arm Type
Experimental
Arm Description
Treatment sequence for the 3 treatment exposure visits is BCA.
Arm Title
Sequence 3
Arm Type
Experimental
Arm Description
Treatment sequence for the 3 treatment exposure visits is CAB.
Arm Title
Sequence 4
Arm Type
Experimental
Arm Description
Treatment sequence for the 3 treatment exposure visits is ACB.
Arm Title
Sequence 5
Arm Type
Experimental
Arm Description
Treatment sequence for the 3 treatment exposure visits is BAC.
Arm Title
Sequence 6
Arm Type
Experimental
Arm Description
Treatment sequence for the 3 treatment exposure visits is CBA.
Intervention Type
Device
Intervention Name(s)
Treatment A
Other Intervention Name(s)
Bentrio
Intervention Description
Nasal Spray with drug-free aqueous gel emulsion (AM-301) intended to help protect against airborne allergens.
One Spray of AM-301 per nostril
Intervention Type
Device
Intervention Name(s)
Treatment B
Other Intervention Name(s)
Bentrio
Intervention Description
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)
Intervention Type
Other
Intervention Name(s)
Treatment C
Intervention Description
No treatment
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Day 8 to Day 22
Secondary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
Day 8 to Day 22
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Couroux, MD, FRCPC, CPI
Organizational Affiliation
Cliantha Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cliantha Research
City
Mississauga
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Researchers may reach out to the Sponsor in order to ask for data sets.
Links:
URL
https://www.atcliantha.com/mississauga/study_ref_no_C2D01121.html
Description
Recruitment website for this study
Learn more about this trial
Efficacy and Safety of AM-301 on Allergic Symptoms of Perennial Allergic Rhinitis Sufferers
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