In:
International Archives of Allergy and Immunology, S. Karger AG, Vol. 184, No. 2 ( 2023), p. 111-121
Abstract:
〈 b 〉 〈 i 〉 Introduction: 〈 /i 〉 〈 /b 〉 Symptoms of allergic rhinitis can be reduced by nonpharmacological nasal sprays that create a barrier between allergens and the nasal mucosa. A new nasal spray (AM-301) containing the clay mineral bentonite was tested for its ability to reduce symptoms of grass pollen. 〈 b 〉 〈 i 〉 Methods: 〈 /i 〉 〈 /b 〉 This open-label, crossover, noninferiority trial compared the efficacy and safety of AM-301 to that of hydroxypropyl methylcellulose (HPMC; Nasaleze® Allergy Blocker), an established barrier method. Adults with seasonal allergic rhinitis were exposed to 〈 i 〉 Dactylis glomerata 〈 /i 〉 pollen, in a controlled setting, the Fraunhofer allergen challenge chamber, first without protection and then protected by HPMC or AM-301 (7 days apart). Efficacy was assessed from total nasal symptom score (TNSS), nasal secretion weight, and subjective rating. The primary endpoint was the difference, between AM-301 and HPMC, in least square mean change in TNSS over a 4-h exposure to allergen. 〈 b 〉 〈 i 〉 Results: 〈 /i 〉 〈 /b 〉 The study enrolled 36 persons, and 35 completed all study visits. The mean TNSS was 5.91 (SD = 1.45) during unprotected exposure, 5.20 (SD = 1.70) during protection with HPMC, and 4.82 (SD = 1.74) during protection with AM-301. The difference in least square means between the two treatments was −0.39 (95% CI: −0.89 to 0.10), establishing the noninferiority of AM-301. No difference in mean weight of nasal secretions was observed between the treatments. Efficacy was rated as good or very good for AM-301 by 31% and for HPMC by 14% of subjects. Sixteen subjects reported adverse events with a relationship to AM-301 or HPMC; most adverse events were mild, and none was serious. 〈 b 〉 〈 i 〉 Discussion/Conclusion: 〈 /i 〉 〈 /b 〉 AM-301 demonstrated noninferiority toward HPMC in the primary endpoint and was perceived better in subjective secondary endpoints. Both barrier-forming products had a persisting protective effect over 4 h and were safe.
Type of Medium:
Online Resource
ISSN:
1018-2438
,
1423-0097
Language:
English
Publisher:
S. Karger AG
Publication Date:
2023
detail.hit.zdb_id:
1482722-0
Permalink
