N/A
N=37
Efficacy and Safety of AM-301 on Allergic Symptoms of Perennial Allergic Rhinitis Sufferers
Perennial Allergic Rhinitis · Rhinitis, Allergic
Bottom Line
View on ClinicalTrials.gov: NCT05122143 ↗Enrolled (actual)
37
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcome: Primary: Overall Change From Baseline in TNSS at Visits 3, 4 and 5 — 3.9; 4.1; 5.2 TNSS score (0-12) — p=0.0085
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Treatment A (Device); Treatment B (Device); Treatment C (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Altamira Medica Ltd.
- Primary completion
- Mar 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Change From Baseline in TNSS at Visits 3, 4 and 5 |
3.9; 4.1; 5.2 | 0.0085 sig |
| SECONDARY 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. |
0.1; 0.1; 0.2; 2.3; 2.4; 2.3 | — |
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. 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).
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.
Data sourced from ClinicalTrials.gov (NCT05122143). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.