Perennial Allergic RhinitisNCT05122143
Efficacy and Safety of AM-301 on Allergic Symptoms of Perennial Allergic Rhinitis Sufferers
A study testing Treatment A, Treatment B and Treatment C in people with Perennial Allergic Rhinitis and Rhinitis, Allergic, run by Altamira Medica Ltd. at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Perennial Allergic Rhinitis, Rhinitis, Allergic
- What is being tested?
- Treatment A, Treatment B and Treatment C
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteCanada
- Study dates
- 10 Nov 2021to 4 Apr 2022
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
Read the detailed description
This was a randomized, open-label, 3-period crossover study. The total study duration was approximately 65 days and consisted of 2 screening visits and 3 treatment visits (total 5 visits) followed by a telephone call. Patients with HDM allergy as assessed by their medical history and a positive skin prick test for Dermatophagoides pteronyssinus (der p) allergen were enrolled into the screening phase.
At least 7 days after the second screening visit, the treatment visits started. Eligible subjects were randomized to one of the six treatment sequences (ABC, BCA, CAB, ACB, BAC, CBA) at an equal ratio. The treatments were applied 10 minutes before the challenge at Visit 3, 4 and 5:
- Treatment A: One spray AM-301 (0.14 mL) per nostril,
- Treatment B: Two sprays AM-301 (0.28 mL) per nostril (at two defined spray angles in order to obtain a broader coverage of the nasal mucosa),
- Treatment C: no treatment.
The cross-over design allowed treatment C to be used as internal control. Between the three treatment visits in the chamber there was a 7±2 days wash-out period.
- Conditions
- Perennial Allergic Rhinitis, Rhinitis, Allergic
- Being tested
- Treatment A, Treatment B, Treatment C
- Keywords
- Allergic rhinitis symptoms, Runny nose, Itchy nose
- Medical subject headings
- Rhinitis, Allergic, Perennial, Rhinitis, Allergic, Rhinorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment ADevice
Also called Bentrio
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 BDevice
Also called Bentrio
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)
Treatment COther
No treatment
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Experimental | Treatment sequence for the 3 treatment exposure visits is ABC. Receives: Device: Treatment A; Device: Treatment B; Other: Treatment C |
| Sequence 2 | Experimental | Treatment sequence for the 3 treatment exposure visits is BCA. Receives: Device: Treatment A; Device: Treatment B; Other: Treatment C |
| Sequence 3 | Experimental | Treatment sequence for the 3 treatment exposure visits is CAB. Receives: Device: Treatment A; Device: Treatment B; Other: Treatment C |
| Sequence 4 | Experimental | Treatment sequence for the 3 treatment exposure visits is ACB. Receives: Device: Treatment A; Device: Treatment B; Other: Treatment C |
| Sequence 5 | Experimental | Treatment sequence for the 3 treatment exposure visits is BAC. Receives: Device: Treatment A; Device: Treatment B; Other: Treatment C |
| Sequence 6 | Experimental | Treatment sequence for the 3 treatment exposure visits is CBA. Receives: Device: Treatment A; Device: Treatment B; Other: Treatment C |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Total Nasal Symptom Score (TNSS) average from 20 - 180 min was compared between treated and non-treated subjects.
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.
This descriptive endpoint was not corrected for baseline.
Measured: Day 8 to Day 22
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2021
- Study start10 Nov 2021
- Primary completion28 Mar 2022
- Study completion4 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Perennial Allergic RhinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Altamira Medica Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Patricia Couroux, MD, FRCPC, CPI, Principal investigator, Cliantha Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05122143
- Sponsor's protocol ID
- AM-301-CL-21-02
- Status last verified
- Apr 2024
- First submitted
- 26 Oct 2021
- Last updated
- 19 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Researchers may reach out to the Sponsor in order to ask for data sets.