Exhalation Delivery System With Fluticasone Improves Sleep in Nasal Polyposis

In patients with moderate to severe chronic rhinosinusitis with nasal polyposis (CRSwNP), treatment with an Exhalation Delivery System With Fluticasone (EDS-FLU) is associated with improved sleep scores, according to findings presented at the American Academy of Allergy, Asthma & Immunology (AAAAI) Virtual Annual Meeting, held February 26 to March 1, 2021.

Patients with CRSwNP often experience poor quality of sleep, significantly lower quality of life scores, and chronic depression, and treatment with EDS-FLU has been shown to significantly improve the symptoms of CRSwNP. Researchers conducted a post hoc analysis to determine the effects of EDS-FLU on sleep from pivotal trials.

NAVIGATE I/II (ClinicalTrials.gov Identifier: NCT01624662) were similarly designed, prospective, randomized, 24-week (16 double-blind and 8 open-label) placebo-controlled studies in which 482 patients with moderate to severe CRSwNP received either EDS-FLU 186 µg (n=160), EDS-FLU 372 µg (n=161), or EDS-placebo (n=161) twice daily. Outcomes were assessed using the Medical Outcomes Study Sleep-Revised (MOS Sleep-R) Problems Index, the Sinonasal Outcome Test (SNOT-22) Sleep Function subscale, and the Patient Global Impression of Change (PGIC).

By week 16, greater improvements in the MOS Sleep-R Problems Index were observed with EDS-FLU 186 µg and 372 µg compared with EDS-placebo (least squares (LS) mean changes: -14.90 and -12.4 vs -9.1; P <.001 and P <.05, respectively). Improvements in the SNOT-22 Sleep Function subscale were consistent with the MOS-Sleep Problems Index, and LS mean changes from baseline were -3.86 and -4.13 with EDS-FLU 186 µg and 372 µg, respectively, vs -2.23 with EDS-placebo (P <.001, both comparisons). At week 24, patients reported continued improvement (-4.05, -4.29, and -3.66, respectively). Approximately 66% receiving EDS-FLU reported being “much/very much” improved as assessed by PGIC vs 33% with EDS-placebo at week 16, and 72% to 81% reported “much/very much” improvement at week 24.

The researchers concluded, “In patients with moderate-severe CRSwNP, EDS-FLU treatment is associated with improved sleep scores and satisfaction.”

Disclosure: Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.

Reference

Kapil A, Sacks H, Messina J, Mahdavinia M. EDS-FLU (Exhalation Delivery System With Fluticasone) is associated with improved sleep in patients with nasal polyposis. Presented at: the American Academy of Allergy, Asthma & Immunology (AAAAI) Virtual Annual Meeting; February 26-March 1, 2021. Abstract 546.