This article is part of Pulmonology Advisor‘s coverage of the American Academy of Allergy, Asthma & Immunology, taking place in Orlando, Florida. Our staff will report on medical research related to asthma and other respiratory conditions, conducted by experts in the field. Check back regularly for more news from AAAAI/WAO 2018.
ORLANDO — In a pooled analysis of two large trials examining exhalation delivery system with fluticasone (EDS-FLU) in chronic rhinosinusitis (CRS), EDS-FLU improved health domain and health utilities 2- to 3-fold after 16 weeks in patients with CRS compared with placebo, according to research presented at the 2018 American Academy of Allergy Asthma & Immunology/World Allergy Organization Joint Congress, held March 2-5 in Orlando, Florida.
To examine how EDS-FLU would affect both individual domains of the 36-Item Short-Form Health Survey version 2 (SF-36v2) as well as utilities assessed via the Short-Form Six-Dimension (SF-6D), researchers assessed pooled randomized clinical trial data (NAVIGATE I and II; N5641) to examine the change in SF-36v2 and SF-6D from baseline to the end of double blind (16 weeks) and to the end of the studies (24 weeks; 8 weeks open-label treatment).
The SF-36v2 was scored using 2009 US population norms (50 = general population t-score), and the SF-6D was calculated from UK population non-parametric preference weights. The average baseline SF-36v2 score was below population norms in all treatment arms.
At the end of double blind, the average improvement in all SF-36v2 domain/summary scores was significantly greater with EDS-FLU (range: 2.9/physical functioning to 5.11/bodily pain) compared with EDS-placebo (range: 0.81/mental health to 2.87/bodily pain) (each comparison P <.01).
SF-6D scores were also significantly improved compared with placebo (0.058 vs 0.023; P <.001). Of the average end-of-double-blind summary scores, 9 out of 10 were at or above population norms for EDS-FLU compared with 4 out of 10 for placebo.
At the end of the study, SF-36v2 and SF-6D scores improved in all treatment arms and all scored at or above SF-36v2 population norms.
In conclusion, this pooled analysis of 2 large, pivotal EDS-FLU trials showed improvements in health domain and health utilities that were 2- to 3-fold greater with EDS-FLU compared with placebo after 16 weeks. Improvements at the end of the studies were at or above population norms in all treatment arms.
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Velez FF, Mahlis EM, Messina JC, et al. EDS-FLU improves quality of life and health status: pooled analysis of phase 3 trials Navigate I and II. Presented at: AAAAI/WAO Joint Congress; March 2-5, 2018; Orlando, Florida. Abstract 519.