Iodixanol Nasal Solution Reduces Allergic Rhinoconjunctivitis Signs and Symptoms in Allergen BioCube®: Randomized Clinical Trial | | Author : Gomes PJ*, Abelson MB, Stein L, Viirre E, Villafranca JE and Lasser EC | | Abstract | Full Text | Abstract :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®, an environmental exposure unit. Iodixanol is a commonly used contrast media agent that shows efficacy on the signs and symptoms of AR. |
| Nasapaque Nasal Solution reduces Allergic Rhinoconjunctivitis signs and symptoms in Allergen BioCube® in a randomized clinical trial | | Author : Gomes PJ*, Abelson MB, Stein L, Viirre E, Villafranca JE and Lasser EC | | Abstract | Full Text | Abstract :Importance: Allergic rhinitis affects about 20% of the population worldwide. Available pharmacological treatments are helpful but not ideal in providing relief; safer and more effective treatments are needed.
Objective: To evaluate the efficacy and safety of Nasapaque nasal solution vs placebo for relief or prophylactic treatment of seasonal allergic rhinitis.
Design: Single-center, double-masked, RCT (March to July 2015) conducted outside of ragweed season.
Setting: Study conducted in the Allergen BioCube®.
Participants: Adult subjects (aged = 18 years) with history of allergic rhinitis, positive skin test for ragweed, and positive BioCube challenge response.
Interventions: Day 1: Subjects received treatment (250 µl/nostril) followed by 7.5-hr BioCube ragweed exposure. Day 8: Subjects received treatment prior to 3.5-hr BioCube ragweed exposure.
Main Outcomes and Measures: Primary endpoint: Total Nasal Symptom Score (TNSS, 0-12 scale), comprised of four individual nasal symptom scores. Secondary endpoints: Peak Nasal Inspiratory Flow (PNIF) and nasal inflammation score. Exploratory endpoints: Total Ocular Symptom Score, comprised of three ocular symptom scores. Safety was evaluated at all visits. P<0.10 was statistically significant in this proof-of-concept study; p<0.05 is also reported. |
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