Efficacy of EDS-FLU for Chronic Rhinosinusitis: Two Randomized Controlled Trials (ReOpen1 and ReOpen2)

Area of Science:

• Otolaryngology
• Pulmonology
• Allergy & Immunology

Background:

• Chronic rhinosinusitis (CRS) is a common inflammatory condition affecting the sinuses.
• Currently, no FDA-approved medications exist for CRS without nasal polyps.
• The exhalation delivery system with fluticasone (EDS-FLU) utilizes novel biomechanics to target sinonasal areas, including sinus drainage pathways.

Purpose of the Study:

• To evaluate the efficacy of EDS-FLU in treating chronic rhinosinusitis, irrespective of nasal polyp presence.
• To assess the impact of EDS-FLU on CRS symptoms, sinus opacification, and disease exacerbations.

Main Methods:

• Two replicate randomized, placebo-controlled trials (ReOpen1 and ReOpen2) were conducted in adults with CRS.
• Patients received either EDS-FLU (1-2 sprays/nostril) or EDS-placebo twice daily for 24 weeks.
• Primary endpoints included composite symptom scores and ethmoid/maxillary sinus opacification via CT scan.

Main Results:

• EDS-FLU significantly reduced composite symptom scores compared to placebo in both trials (P < .001 in ReOpen1; P = .011 to .001 in ReOpen2).
• Significant reductions in sinus opacification were observed with EDS-FLU versus placebo (P = .045 to .018 in ReOpen1; P < .001 to .009 in ReOpen2).
• Acute CRS exacerbations decreased by 56-66% with EDS-FLU (P = .001), and adverse events were comparable to standard intranasal steroids.

Conclusions:

• EDS-FLU is the first non-surgical treatment demonstrating efficacy in reducing symptoms, sinus opacification, and exacerbations in CRS.
• These findings were consistent across replicate trials and in patients with or without nasal polyps.
• The study supports EDS-FLU as a novel therapeutic option for managing chronic rhinosinusitis.