An exhalation system with fluticasone was shown to significantly reduce nasal polyp score at 4 and 16 weeks compared with placebo, with improvements also observed in several patient-reported outcomes.
Objective and patient-reported outcomes of nasal polyp (NP) severity were significantly improved by an exhalation system with fluticasone (EDS-FLU), according to study findings published in Ear, Nose & Throat Journal.
Although topical, nasally delivered corticosteroids, administered via sprays or nebulizer/atomization, are currently considered first-line medical therapy for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP), researchers note that many patients report frustration with these drugs due to inadequate symptom relief.
“This may be because the anatomical configuration of the nasal cavity prevents conventional delivery approaches from consistently depositing corticosteroids in the appropriate sinus regions (the middle meatus and ostiomeatal complex),” they explained.
The recent development of EDS-FLU, which deposits fluticasone high and deep in key regions affected by chronic inflammation due to CRS, has shown potential to enhance the delivery of medication vs standard corticosteroid nasal sprays.
Prior findings of the NAVIGATE I (NCT01622569) and II (NCT01624662) randomized, controlled, double-blind, 24-week trials in patients with CRSwNP indicate that EDS-FLU reduced NP grade, an objective measure of efficacy, and yielded clinically meaningful improvements on subjective measures of symptoms.
“In patients with CRS, disease burden and individual sinonasal symptoms are typically described using symptom scales, endoscopic grading systems, and/or sinus-specific quality of life instruments,” said the researchers.
They conducted a post hoc analysis of the NAVIGATE I and II clinical trials to better characterize responses to EDU-FLU by patients with CRSwNP. Pooling data from the two 24-week (16-week, double-blind and 8-week, open-label), placebo-controlled studies, patients with CRSwNP were given EDS-FLU (186 mcg [n = 161] or 372 mcg [n = 160]) or EDS-placebo (n = 161) twice daily during the double-blind phase.
Responder criteria included NP grade reduction (≥ 1 point), 22-item Sino-Nasal Outcome Test (SNOT-22) reduction (> 12 points), Patient Global Impression of Change (PGIC) (much/very much improved), and congestion score improvement (> 0.5 points). The overall study population was analyzed, as well as subgroups of patients with or without prior endoscopic sinus surgery (ESS) or prior use of a standard intranasal corticosteroid spray (INS).
Among the study cohort, 31.1% to 32.9% of patients had prior ESS, most (89.4%-92.5%) had used corticosteroids for nasal disease within the prior 10 years, and 43.1% to 47.8% had used a standard INS in the 30 days prior to study entry.
Findings indicated that a greater proportion of patients in the EDS-FLU group responded to each of the 4 responder criteria compared with EDS-placebo. Using a measure of greater than or equal to 1 criterion, significantly more patients in the EDS-FLU group met responder criteria vs the EDS-placebo group at week 4 (82.7% vs 60.4%) and week 16 (95.7% vs 80.3%).
Patients were shown to respond similarly irrespective of prior sinus surgery or prior INS use, with patient-reported outcome measures garnering earlier responses than NP scores.
“The current data suggest that symptomatic improvement occurs as early as 4 weeks, but continued improvement across a broad array of symptoms can be expected up to 4 months after initiation of therapy,” noted the study authors. “This may inform decisions regarding the duration of EDS-FLU use prior to assessing treatment response and considering escalation of therapy.”
Ow RA, McGinnis JP, Sacks HJ, Mehle ME. The effect of EDS-FLU on objective and patient-reported subjective outcomes for patients with chronic rhinosinusitis with nasal polyps. Ear Nose Throat J. Published online April 18, 2022. doi:10.1177/01455613221088698