Efficacy and Safety of AM-301 on Allergic Symptoms of Perennial Allergic Rhinitis Sufferers
NCT ID: NCT05122143
Last Updated: 2024-09-19
Study Results
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View full resultsBasic Information
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COMPLETED
NA
37 participants
INTERVENTIONAL
2021-11-10
2022-04-04
Brief Summary
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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).
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Detailed Description
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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
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
NONE
Study Groups
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Sequence 1
Treatment sequence for the 3 treatment exposure visits is ABC.
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
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)
Treatment C
No treatment
Sequence 2
Treatment sequence for the 3 treatment exposure visits is BCA.
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
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)
Treatment C
No treatment
Sequence 3
Treatment sequence for the 3 treatment exposure visits is CAB.
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
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)
Treatment C
No treatment
Sequence 4
Treatment sequence for the 3 treatment exposure visits is ACB.
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
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)
Treatment C
No treatment
Sequence 5
Treatment sequence for the 3 treatment exposure visits is BAC.
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
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)
Treatment C
No treatment
Sequence 6
Treatment sequence for the 3 treatment exposure visits is CBA.
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
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)
Treatment C
No treatment
Interventions
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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
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)
Treatment C
No treatment
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Altamira Medica Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Patricia Couroux, MD, FRCPC, CPI
Role: PRINCIPAL_INVESTIGATOR
Cliantha Research
Locations
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Cliantha Research
Mississauga, , Canada
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Related Links
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Peer-reviewed publication of study results. PMID: 37488728
Other Identifiers
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AM-301-CL-21-02
Identifier Type: -
Identifier Source: org_study_id
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