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
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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.
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05122143
- Acronym / sponsor ID
- AM-301-CL-21-02
- Conditions
- Perennial Allergic Rhinitis, Rhinitis, Allergic
- Keywords
- Allergic rhinitis symptoms, Runny nose, Itchy nose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Altamira Medica Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Nov 2021 (actual)
- Primary completion
- 28 Mar 2022 (actual)
- Study completion
- 4 Apr 2022 (actual)
- First posted
- 16 Nov 2021 (actual)
- Results
- Posted 19 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Experimental | Device: Treatment A, Device: Treatment B, Other: Treatment CTreatment sequence for the 3 treatment exposure visits is ABC. |
| Sequence 2 | Experimental | Device: Treatment A, Device: Treatment B, Other: Treatment CTreatment sequence for the 3 treatment exposure visits is BCA. |
| Sequence 3 | Experimental | Device: Treatment A, Device: Treatment B, Other: Treatment CTreatment sequence for the 3 treatment exposure visits is CAB. |
| Sequence 4 | Experimental | Device: Treatment A, Device: Treatment B, Other: Treatment CTreatment sequence for the 3 treatment exposure visits is ACB. |
| Sequence 5 | Experimental | Device: Treatment A, Device: Treatment B, Other: Treatment CTreatment sequence for the 3 treatment exposure visits is BAC. |
| Sequence 6 | Experimental | Device: Treatment A, Device: Treatment B, Other: Treatment CTreatment sequence for the 3 treatment exposure visits is CBA. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment AAlso: BentrioNasal Spray with drug-free aqueous gel emulsion (AM-301) intended to help protect against airborne allergens. One Spray of AM-301 per nostril | Device | Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6 |
| Treatment BAlso: BentrioNasal 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) | Device | Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6 |
| Treatment CNo treatment | Other | Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6 |
Primary outcome
Overall Change From Baseline in TNSS at Visits 3, 4 and 5
Time frame: Day 8 to Day 22
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.
1 secondary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Peer-reviewed publication of study results. PMID: 37488728Link provided by the sponsor.
- Individual participant dataSharing planned: No. Researchers may reach out to the Sponsor in order to ask for data sets.
Related trials for Perennial Allergic Rhinitis
Active, not recruitingPhase 3
A Study of Lebrikizumab in Adult Participants With Perennial Allergic Rhinitis (PREPARED-1)
Perennial Allergic Rhinitis (PAR)
Not yet recruitingPhase 2
Study of CM512 Injection in Patients With Perennial Allergic Rhinitis on Background Therapy
Perennial Allergic Rhinitis (PAR)
RecruitingObservational study
Identification of B Regulatory Cells by Flow Cytometry
Pollen Allergy, Venom Allergy
Not yet recruitingPhase 4
A Study to Visualize Multi-Symptom Allergy in Adults With Seasonal Allergic Rhinitis
Rhinitis Allergic, Rhinitis Seasonal
Active, not recruitingPhase 2
Dupilumab Effects Against Aeroallergen Challenge
Asthma, Allergic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patricia Couroux, MD, FRCPC, CPI principal investigator
Cliantha Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Change From Baseline in TNSS at Visits 3, 4 and 5 (time frame: Day 8 to Day 22). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.