OptiNose today announced important new results from a Phase II trial of its novel nasal drug delivery device with fluticasone for the treatment of chronic rhinosinusitis. Patients in the active treatment group experienced significant improvements in nasal symptoms, nasal discomfort and sense of smell. There was also a highly significant and progressive reduction in nasal swelling.
The results from the study, which was conducted at the AMC in Amsterdam, Holland with Professor Wytske Fokkens as the principal investigator, were presented at the Rhinology World conference in Philadelphia. Patients self-administered fluticasone propionate 400 µg or placebo twice-daily at home over a 12-week period using the OptiNose delivery device.
Endoscopic assessment of the nasal mucosa showed a highly significant and progressive improvement to a normal state in the actively treated group. At the post-study examination, 30% had a normal ENT-examination. Peak nasal inspiratory flow and rhinosinusitis outcome measures were also significantly improved. MR imaging before and after treatment showed significant improvement compared to baseline.
Chronic rhinosinusitis (CRS) is a common disease, severely reducing the quality of life of millions of patients, with few effective treatments currently available. OptiNose's breath-actuated, bi-directional nasal delivery technology significantly improves delivery to the target sites deep into the nose where the openings to the sinuses are located, which is considered essential to achieving clinical effects in CRS with topical treatments.
"We are extremely pleased with the effectiveness of our treatment for chronic rhinosinusitis", 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 there is currently no product available in the US that has been approved by the FDA. Many recent clinical trials in CRS patients have been unsuccessful, leaving millions of suffering patients with an unmet need. These results suggest that we now have a highly promising new therapy"
This is the third Phase II trial OptiNose has conducted demonstrating the effectiveness of its novel device in delivering drugs to target sites throughout the nasal cavity. A previous study showed that OptiNose's novel device with fluticasone was highly effective in the treatment of chronic rhinosinusitis with nasal polyps.