ReOpen Trial Results: XHANCE Efficacy in Chronic Sinusitis Published in Allergy and Clinical Immunology Practice Journal

Two pivotal Phase 3 trials, ReOpen1 and ReOpen2, have demonstrated the effectiveness of the Exhalation Delivery System with fluticasone (EDS-FLU), a novel treatment for chronic rhinosinusitis (CRS). The trials, involving 120 sites across 13 countries, revealed that EDS-FLU significantly improved symptoms and reduced sinus inflammation in adult patients with CRS, irrespective of nasal polyps.

The ReOpen trials were designed to assess the efficacy of EDS-FLU in 332 and 223 patients, respectively, over a 24-week period. The primary outcomes measured were the composite symptom score (CSS) and the reduction in sinus opacification observed through computed tomography (CT) scans at week 24. The results showed marked improvements in CSS for both trials with EDS-FLU treatment compared to the placebo group. The least-squares mean change in CSS for EDS-FLU was -1.58 and -1.60 for ReOpen1, and -1.54 and -1.74 for ReOpen2, compared to -0.62 and -0.81 for the placebo, respectively.

Moreover, the trials indicated that EDS-FLU significantly reduced sinus opacification, a key indicator of sinus inflammation. In ReOpen1, the least-squares mean change in sinus opacification was -5.58 and -6.20 for EDS-FLU, compared to -1.60 for placebo. Similarly, in ReOpen2, the changes were -7.00 and -5.14 for EDS-FLU, compared to an increase of +1.19 for placebo.

Acute exacerbations of CRS were also significantly reduced by 56% to 66% with EDS-FLU treatment. The safety profile of EDS-FLU was found to be consistent with standard-delivery intranasal steroids, with adverse events being similar.

The findings of the ReOpen trials are groundbreaking as they provide the first placebo-controlled evidence of a medication's efficacy in CRS without nasal polyps. EDS-FLU has emerged as a potential first-line treatment for CRS, particularly for patients whose symptoms persist despite the use of over-the-counter medications.

The publication of the trial results in the Journal of Allergy and Clinical Immunology: In Practice highlights the significance of EDS-FLU as a nonsurgical treatment option for CRS. The innovative delivery system of EDS-FLU ensures that the medication reaches the sinus drainage pathways, areas often not accessible by standard nasal sprays.

The ReOpen trials have set a new benchmark in the management of CRS, offering hope to millions of patients suffering from this chronic inflammatory disease. The results emphasize the potential of EDS-FLU as an effective treatment to improve symptoms, reduce inflammation, and decrease acute exacerbations in CRS patients, regardless of polyp status.