Adults 18 to 65, any sex, with Perennial Allergic Rhinitis or Rhinitis, Allergic. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Overall Change From Baseline in TNSS at Visits 3, 4 and 5Primary· 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.
Group
Value
95% CI
Treatment A
3.9
± 2.59
Treatment B
4.1
± 2.93
Treatment C
5.2
± 2.58
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.Secondary· Day 8 to Day 22
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.
Pre-chamber
Group
Value
95% CI
Treatment A
0.1
± 0.35
Treatment B
0.1
± 0.49
Treatment C
0.2
± 0.39
20 min in chamber
Group
Value
95% CI
Treatment A
2.3
± 2.42
Treatment B
2.4
± 2.64
Treatment C
2.3
± 2.25
40 min in chamber
Group
Value
95% CI
Treatment A
3.6
± 2.71
Treatment B
3.6
± 2.85
Treatment C
4.2
± 3.09
60 min in chamber
Group
Value
95% CI
Treatment A
4.6
± 2.79
Treatment B
3.6
± 3.04
Treatment C
4.8
± 3.42
80 min in chamber
Group
Value
95% CI
Treatment A
4.3
± 3.05
Treatment B
4.3
± 3.18
Treatment C
5.6
± 2.77
100 min in chamber
Group
Value
95% CI
Treatment A
4.2
± 2.99
Treatment B
4.7
± 3.40
Treatment C
6.5
± 3.08
120 min in chamber
Group
Value
95% CI
Treatment A
4.5
± 3.06
Treatment B
4.8
± 3.67
Treatment C
6.2
± 3.32
140 min in chamber
Group
Value
95% CI
Treatment A
4.4
± 3.00
Treatment B
5.1
± 3.69
Treatment C
6.3
± 2.96
Adverse events — posted to ClinicalTrials.gov
Time frame: For each participant, adverse event data were collected from day 0 to day 65 (last follow-up call)..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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).
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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· completed
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Altamira Medica Ltd.
Last refreshed: 19 September 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05122143.