December 1, 2009: OptiNose is pleased to announce the publication of results from its Phase II clinical study investigating the efficacy and tolerability of its novel, intranasal drug/device product for the topical treatment of chronic rhinosinusitis with nasal polyps in Rhinology, the official journal of the International and European Rhinologic Societies.
Chronic rhinosinusitis with nasal polyps is a chronic disease that can significantly reduce a patient’s quality of life, causing facial pressure and pain, nasal obstruction and reduced sense of smell. The novel OptiNose device delivers drugs to target sites deep in the nose, including the sinus openings where nasal polyps emerge. These targets are often difficult to reach with traditional nasal sprays.
In the Phase II study conducted by OptiNose, patients in the active treatment group experienced highly significant reductions in polyp size compared to placebo with corresponding significant and progressive improvements of all symptom scores including rhinitis symptoms, nasal discomfort and sense of smell. At the conclusion of the study, the polyps had disappeared in 10 out of 54 patients in the active group, whereas polyps were still present in all patients in the control group.
The multicenter, placebo-controlled study, conducted in 109 patients with mild-to-moderate bilateral nasal polyposis, assessed the efficacy, safety and tolerability of 400 micrograms of fluticasone propionate delivered twice daily with OptiNose’s liquid nasal drug delivery device over a 12 week period. Reduction in polyp size was measured using Lildholdt’s Scale, a 4-point scale used to rate the size of nasal polyps. A significantly greater percentage of subjects using the OptiNose product showed a reduction in polyp size greater than or equal to 1 on the Lildholdt’s Scale when compared to placebo at 4, 8 and 12 weeks (22% vs 7%, p = 0.011; 43% vs 7%, p < 0.001; 57% vs 9%, p < 0.001). The summed polyp score was reduced by 35% in the OptiNose treatment group after 12 weeks, compared to an increase in polyp score in the placebo group (-0.98 vs +0.23, p < 0.001). The peak nasal inspiratory airflow (PNIF) of subjects in the active group increased progressively during treatment (p < 0.001) and 76% of subjects treated were improved or very much improved after 12 weeks of treatment (p < 0.001).
“We are extremely pleased with these results”, said ENT-specialist Per Djupesland, M.D., Ph.D., the study’s co-author and Chief Scientific Officer at OptiNose AS. “This disease is difficult to treat and often recurs, even after repeated surgeries. Existing medical treatments offer only limited efficacy, especially on small and moderate sized polyps which are difficult to reach. The progressive reduction of small and moderate polyps in our study, including the complete removal in almost 20% of patients is particularly encouraging.”
Chronic rhinosinusitis with nasal polyps is a common disease, severely reducing a patient’s quality of life, with few effective treatments currently available. It is estimated that as much 10% of the population is affected by chronic rhinosinusitis, making it one of the most common chronic diseases. A substantial proportion (25-30%) of these patients suffer from nasal polyps and many undergo repeated costly surgeries. Improved medical treatment can reduce or eliminate the need for surgery. Furthermore, up to 50% of patients with nasal polyps suffer from asthma. Optimal treatment of chronic rhinosinusitis and nasal polyps can improve asthma symptoms and reduce the need for asthma medication.