Quality of Life (QOL) in Ragweed Allergic Patients Treated with Captisol-Enabled® Budesonide Nasal Solution (32μg/spray) when Exposed to Ragweed Pollen in an Environmental Exposure Chamber (EEC) Using an EEC-Specific Rhinoconjunctivitis Quality of Life Questionnaire (EEC-RQOLQ)

Abstract

Captisol-Enabled Budesonide Nasal Solution is a nasal spray incorporating an innovative technology whereby the synthetic corticosteroid Budesonide is complexed with the functional excipient Captisol®. Recognizing the need to assess QOL, we developed an EEC-RQOLQ, consisting of domains, Non-nose/Eye Symptoms, Practical Problems, and Emotional, to measure the QOL experienced by patients in the EEC. The higher the score, the worse patients feel. A randomized, double-blind, placebo-controlled, single-center, cross-over study including 63 patients allergic to ragweed pollen was conducted. Comparisons between treatments were completed using ANCOVA. The EEC-RQOLQ was administered at -0.75 hours pre-dose, and 2, 6 and 10 hours post-dose. Quality of life was improved in patients treated with Captisol-Enabled Budesonide Nasal Solution compared to placebo in all domains. The mean change from baseline in EEC-RQOLQ scores for Captisol-Enabled Budesonide Nasal Solution versus placebo were for each domain, respectively: Emotional: 2h: -0.3; -0.1; 6h: 0.1; 0.3; 10h: 0.4; 0.4. Non-nose/Eye symptoms 2h:-0.1; 0.1; 6h: 0.1; 0.3; 10h: 0.3; 0.5. Practical Problems: 2h: -0.9; -0.2 (p = 0.008); 6h: -0.5; 0.1 (p = 0.016), 10h: -0.3; 0.3 (p = 0.019). This study demonstrates that this EEC-RQOLQ is a good indicator of QOL in the EEC. Practical Problems is an important domain in the EEC-RQOLQ as it assesses the need to rub nose/eyes and to blow nose repeatedly, thus having an impact on daily activity. QOL scores in this domain were significantly improved in patients treated with Captisol-Enabled Budesonide Nasal Solution compared to placebo.