TOPLINE

An exhalation delivery system with fluticasone (EDS-FLU), which uses a unique delivery mechanism to deposit steroid into the superior/posterior regions of the nasal labyrinth and the ostiomeatal complex — areas not reached with standard delivery — significantly reduced symptom burden and improved quality of life in adults with chronic rhinosinusitis (CRS), with benefits remaining consistent regardless of asthma status, environmental allergy status, or baseline blood eosinophil count.

METHODOLOGY

• Researchers conducted a post hoc analysis using pooled data from two phase 3 trials to evaluate whether comorbid asthma, environmental allergies, or baseline blood eosinophil counts influenced treatment response to EDS-FLU in adults with CRS.
• Overall, 547 participants (mean age ranging from 47.8 to 49.6 years; 53%-56% men) were randomly assigned to receive EDS-FLU 186 µg, EDS-FLU 372 µg, or a matched placebo, all administered as one or two sprays per nostril twice daily using the exhalation delivery device.
• Key outcomes included the change in composite symptom score (CSS; the sum of congestion, facial pain or pressure, and nasal discharge scores); the 22-item Sino-Nasal Outcome Test (SNOT-22), a patient-reported quality of life measure; and the Patient Global Impression of Change (PGIC), which measured overall change in clinical status.
• Subgroup analyses evaluated treatment response by asthma status, environmental allergy status, and baseline blood eosinophil counts over the 24-week treatment period.

TAKEAWAY

• When both doses were pooled, EDS-FLU produced significantly greater least-squares mean reductions in CSS than placebo as early as week 4, with improvements sustained through week 12 across all subgroups (all P < .05).
• When analyzed separately, the higher dose showed more consistent improvements in CSS than placebo in patients with lower eosinophil counts, achieving statistical significance at all timepoints; however, the lower dose did not reach significance at weeks 8 and 12 in this subgroup.
• At week 24, both doses produced greater least-squares mean reductions in SNOT-22 scores than placebo across all subgroups (all P < .05).
• A significantly higher proportion of patients receiving EDS-FLU reported overall improvement on the PGIC scale than those receiving placebo across all subgroups (all P < .05).

IN PRACTICE

"[The study] results suggest that despite the endotype heterogeneity that defines CRS, EDS-FLU is an effective treatment that can be considered regardless of patients' endotype," the authors wrote.

SOURCE

Anju T. Peters, MD, of Northwestern University Feinberg School of Medicine in Chicago, was the corresponding author of this study, which was published online on September 3, 2026, in Annals of Allergy, Asthma & Immunology.

LIMITATIONS

This analysis was exploratory and post hoc in nature, with relatively small subgroup sample sizes. The trials were not powered to evaluate treatment effects within subgroups defined by asthma status, environmental allergy status, and baseline blood eosinophil count. Some outcome measures showed a high placebo response, which may have reduced the observed difference in treatment effect between EDS-FLU and placebo.

DISCLOSURES

The study was funded by Paratek Pharmaceuticals, Inc. and its affiliated companies. Several authors reported receiving consulting fees, advisory board honoraria, grant support, or speaker fees from various pharmaceutical and medical device companies. One author reported being an employee of Paratek Pharmaceuticals. Additional disclosures included equity interests in healthcare companies and leadership roles in professional societies and peer-reviewed journals.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.