Iodixanol nasal solution reduces allergic rhinoconjunctivitis signs and symptoms in Allergen BioCube®: a randomized clinical trial
Authors Gomes PJ, Abelson MB, Stein L, Viirre E, Villafranca JE, Lasser EC
Received 29 August 2017
Accepted for publication 22 October 2018
Published 1 March 2019 Volume 2019:12 Pages 71—81
Checked for plagiarism Yes
Review by Single-blind
Peer reviewer comments 4
Editor who approved publication: Dr Amrita Dosanjh
Paul J Gomes,1 Mark B Abelson,1,2 Linda Stein,1 Erik Viirre,3 J Ernest Villafranca,3 Elliott C Lasser3
1Allergy Department, Ora, Inc., Andover, MA, USA; 2Department of Ophthalmology, Harvard Medical School, Cambridge, MA, USA; 33E Therapeutics Corporation, La Jolla, CA, USA
Purpose: Allergic rhinitis (AR) affects ~20% of the population worldwide. The objectives of this study were to evaluate the safety and efficacy of iodixanol nasal solution (Nasapaque) for AR treatment, using the Allergen BioCube® (ABC®), an environmental exposure unit. Iodixanol is a commonly used contrast media agent that shows efficacy on the signs and symptoms of AR.
Patients and methods: Seventy-three adult subjects with AR were randomized to iodixanol or placebo treatment in a double-masked efficacy and safety study conducted outside of ragweed pollen season. In-office treatment was administered after BioCube® ragweed pollen exposure, and again 8 days later prior to ragweed exposure. Nasal and ocular efficacy and safety assessments were conducted before and after treatment.
Results: Iodixanol treatment resulted in statistically significantly lower total nasal symptom scores as compared to placebo at several time points post-treatment and ABC exposure. Individual nasal and ocular symptoms, notably nasal itching and ocular itching, showed evidence of lower scores in the iodixanol group. Peak nasal inspiratory flow (PNIF) improved (9%–16%) with iodixanol from baseline as compared to PNIF in the placebo group which ranged from 3% worsening to improvement of 2%. Few (9) adverse events occurred.
Conclusion: Iodixanol nasal solution demonstrated efficacy for relief of several nasal and ocular allergic rhinoconjunctivitis signs and symptoms, and was safe and well tolerated in this early Phase II exploratory trial. Further studies with iodixanol are warranted. Allergy challenge models such as the ABC provide valuable assessments of allergen exposures and drug efficacies.
Study Identification Number: NCT02377895
Keywords: allergic rhinitis, contrast media agent, allergy, environmental exposure unit
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