International Journal of General Medicine (Feb 2024)
Carrageenan-Containing Nasal Spray Alleviates Allergic Symptoms in Participants with Grass Pollen Allergy: A Randomized, Controlled, Crossover Clinical Trial
Abstract
Nicole Unger-Manhart,1,* Martina Morokutti-Kurz,1,* Petra U Zieglmayer,2,3 Patrick Lemell,2 Markus Savli,4 René Zieglmayer,2 Eva Prieschl-Grassauer1 1Marinomed Biotech AG, Korneuburg, Austria; 2Vienna Challenge Chamber, Vienna, Austria; 3Competence Center for Allergology and Immunology, Karl Landsteiner University, Krems, Austria; 4Biostatistik & Consulting GmbH, Zurich, Switzerland*These authors contributed equally to this workCorrespondence: Eva Prieschl-Grassauer, Marinomed Biotech AG, Hovengasse 25, Korneuburg, 2100, Austria, Tel +43 226292300, Email [email protected]: Nonpharmacological, barrier-forming nasal sprays are used to manage symptoms of allergic rhinitis. We aim to evaluate the safety and effectiveness of Callergin (investigational product, IP), a nasal spray containing barrier-forming iota-carrageenan, in the treatment of allergic rhinitis (AR).Methods: In this randomized, controlled, crossover trial, adults with grass pollen allergy underwent a treatment sequence with IP, VisAlpin (comparator product, CP), and no treatment in random order. Treatment blocks consisted in prophylactic administration of the assigned treatment or no treatment, followed by a 3-hr allergen exposure, and were separated by a washout period of 7 days. Primary endpoint was a mean change from baseline in “Total Nasal Symptom Score” (TNSS, sum of rhinorrhea, itching, sneezing, and congestion scores) over 3 hr, recorded every 15 min during the challenge period.Results: A total of 42 participants underwent randomization. Exposure to grass pollen for 3 hr induced a notable TNSS increase from baseline in all participants at all times. Mean TNSS change from baseline over 3 hr was lower when participants received IP compared to no treatment, although the difference did not reach statistical significance (untreated 6.96 ± 2.30; IP 6.59 ± 1.93; difference 0.37 points [95% CI (confidence interval) − 0.17 to 0.91]; p=0.170). In a post-hoc analysis, mean TNSS at 3 hr was significantly reduced after IP treatment compared to no treatment (untreated 8.29 ± 2.64; IP 7.70 ± 2.56; difference 0.60 points [95% CI − 0.10 to 1.29] p=0.028). While all individual nasal symptoms contributed to this effect, rhinorrhea (p=0.013) and congestion (p=0.076) contributed most. Consistently, nasal secretion weight was slightly reduced with IP treatment (p=0.119). IP was safe and well-tolerated, with similar incidence of adverse events across treatment groups.Conclusion: Prophylactic treatment with the iota-carrageenan nasal spray IP is safe, well-tolerated, and alleviates nasal allergy symptoms in adults with grass pollen-induced AR.Trial Registration: NCT04531358.Keywords: allergic rhinitis, nonpharmacological, drug-free, barrier, iota-carrageenan
