This article is part of Pulmonology Advisor‘s coverage of the ACAAI 2019 meeting, taking place in Houston, TX. Our staff will report on medical research related to allergies, asthma, and more conducted by experts in the field. Check back regularly for more news from ACAAI 2019.
HOUSTON — Exhalation delivery system with fluticasone (EDS-FLU) provided significant reduction in nasal congestion and polyp grade in patients with nasal polyps with moderate or severe congestion receiving conventional intranasal steroids (INS), according to research presented at the 2019 Annual Scientific Meeting of the American College of Allergy, Asthma and Immunology, held November 7 to 11 in Houston, Texas.
Researchers conducted a pooled post hoc analysis of the NAVIGATE I and II trials (ClinicalTrials.gov Identifiers: NCT01622569 and NCT01624662) to evaluate the change in disease activity after treatment with either EDS-FLU or placebo (EDS-PBO) in a subgroup of patients who reported using INS within 30 days of the screening visit. The trials included patients with bilateral polyposis with moderate to severe congestion despite use of conventional nasal steroids. The coprimary end points were reduction in nasal congestion and polyp grade. A secondary end point was the change in Sino-Nasal Outcome Test-22 (SNOT-22).
Results demonstrated that treatment with EDS-FLU was associated with significant improvements in nasal congestion, polyp grade, and SNOT-22 in patients on INS at study entry. Change in nasal congestion was -0.24 for EDS-PBO, -0.59 for EDS-FLU 186 μg, and -0.73 for EDS-FLU 372 μg (P <.001, both doses). Change in polyp grade was -0.46, -1.13, and -1.47 for EDS-PBO, EDS-FLU 186 μg, and EDS-FLU 372 μg, respectively (P <.001, both doses). In addition, SNOT-22 was significantly improved in patients treated with EDS-FLU (EDS-PBO: -8.27; EDS-FLU 186 μg: -21.13; EDS-FLU 372 μg: -21.01 [P <.001, both doses]). Similar results were observed in patients who did not receive INS at study entry.
The researchers concluded that treatment with EDS-FLU “provides significant reduction in disease severity in nasal polyp patients with moderate/severe congestion using conventional INS.” EDS-FLU has the ability to deliver steroid “more posteriorly and superiorly within the nasal cavity than conventional nasal sprays.”
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Velez F, Mahmoud A, Cunningham G, Radewonuk J, Messina J. Exhalation delivery system with fluticasone treatment in patients not controlled with conventional intranasal steroids. Presented at: American College of Allergy, Asthma, &Immunology Annual Scientific Meeting 2019; November 7-11, 2019; Houston, TX. Abstract P455.