857
Contrast Agent Reduces Allergic Rhinitis Symptoms
Monday, March 7, 2016
South Exhibit Hall H (Convention Center)
Erik Viirre, MD PhD, J. Ernest Villafranca, PhD, S. David Miller, MD, Paul Gomes, Elliott Lasser, MD
Rationale:

We hypothesized that the contrast agent iodixanol, as Nasapaque nasal solution, was effective in reducing nasal allergy symptoms. 

Methods:

This clinical trial enrolled 73 adult subjects with seasonal allergic rhinitis and positive ragweed skin tests. After priming at earlier visits, treatment efficacy (Nasapaque or placebo) was assessed at Visit 4 (90 minutes ragweed exposure in Ora’s Allergen BioCube® [ABC]) followed by treatment and additional 7.5 hours ABC exposure) and at Visit 5 (treatment 30 minutes before 3 hours ABC exposure). The primary efficacy endpoint was total nasal symptom score (TNSS, 0-12 scale) assessed at multiple time points pre- and during exposure. Mean TNSS differences between active and placebo treatment groups and change from baseline/pre-treatment differences were calculated (1-sided t-test, alpha = 0.10). 

Results:

Subjects treated with Nasapaque (N = 36) had lower TNSS scores and greater change from baseline than placebo (N = 37) subjects. Onset of action for Nasapaque was as early as 15 minutes (mean Δ from baseline -3.2; treatment difference -0.9, 80% CI -1.6 to -0.2, p = 0.0602). Statistically significant differences were seen as late as 4.25 hours post-treatment (mean Δ from baseline -4.1; treatment difference -0.9, 80% CI -1.7, -0.1, p = 0.0754). Visit 4 3-hour post-treatment mean TNSS scores were 3.9 (Nasapaque) and 5.0 (placebo); -1.1 difference, 80% CI -2.0, -0.02, p = 0.0625. Visit 5 results also indicated greater efficacy with Nasapaque treatment, which was safe and well tolerated. 

Conclusions:

Nasapaque nasal solution is effective in reducing nasal allergy symptoms. Further evaluations of efficacy are warranted.