Efficacy Of Three Thixotropic Nasal Spray Preparations On Seasonal Allergic Rhinitis Assessed By Allergen Challenge In An Environmental Exposure Unit

Two studies were undertaken to assess the efficacy and safety of three thixotropic nasal sprays (IQM11, IQM12, IQM13) on seasonal allergic rhinitis (SAR). The three nasal sprays differ only with respect to the emulsifying agent used in the formulation. In the prospective, randomized, cross-over pilot study, 16 patients with a history of SAR received 2 x 0.14 ml IQM11 per nostril or no treatment and were exposed to grass pollen twice for 4 hours in an environmental exposure unit. The SAR symptoms rhinorrhea, nasal congestion, nasal pruritus, sneezing, eye itching, and eye tearing were rated every 15 min. The randomized, semi-blind, comparative cross-over clinical trial followed the same study design: 18 patients with a history of SAR received the same amount of nasal spray (IQM12, IQM13) or no treatment and experienced the allergen challenge three times for 3 hours each. The main nasal SAR symptoms as well as the Total Nasal Symptom Score (TNSS) were recorded every 15 min. The pilot study showed that the total scores of main nasal symptoms rhinorrhea and nasal congestion were significantly lower in the treatment group compared to the control group (P < .05). Sneezing improved highly significantly under therapy with the nasal spray (P < .001). In the comparative study, all symptoms showed statistically significant improvement (P < .05) with both nasal sprays with the exception of nasal congestion under therapy with IQM12. In conclusion, these two allergen challenge studies demonstrated that thixotropic nasal sprays are effective in reducing the main nasal symptoms in SAR patients.