SESSION TITLE: Asthma - Bronchiectasis Posters
SESSION TYPE: Original Investigation Poster
PRESENTED ON: Wednesday, October 28, 2015 at 01:30 PM - 02:30 PM
PURPOSE: Taste can affect tolerability and adherence to oral and inhaled medications. Taste distortion incidence upwards of 10% was previously seen with the large-particle CFC-MDI flunisolide. Flunisolide HFA is a new small-particle inhaled steroid with a built-in spacer device. In total, 833 patients were treated with flunisolide HFA within four Phase 3 trials performed. Two of these were 12-week efficacy trials (studies of asthma patients age 4 - 11 years and 12 years and older, respectively), while the other two were 52-week safety trials. The objective of this evaluation is to assess the reports of taste distortion (captured as taste perversion) within these four Phase 3 trials.
METHODS: In the two 12-week trials, qualified patients with mild-to-moderate asthma currently using inhaled steroids were first treated with 2 weeks of flunisolide CFC and then randomized to: flunisolide HFA 80 mcg (1 puff; ped and adult trials), HFA 160 mcg (2 puffs; ped and adult trials), HFA 320 mcg (4 puffs, adult trials only), or placebo BID for a 12-week double-blind study period. In the two 52-week trials, patients with mild-to-moderate asthma received daily doses of flunisolide HFA ranging from 160 mcg (80 mcg BID) to 640 mcg (320 mcg BID). The four trials utilized detailed assessments of adverse events, including discontinuation rates due to specific adverse events.
RESULTS: Within the 12-week trials, 0 (0%) of 519 asthma patients discontinued treatment with flunisolide HFA due to taste distortion. Overall, 8 (1.5%) of those 519 patients in the 12-week trials treated with flunisolide HFA experienced taste distortion, with no apparent dose-related increases seen in the incidence of taste distortion (80 mcg BID = 1.6%; 160 mcg BID = 1.8%; 320 mcg BID = 0.9%; placebo BID = 0.5%). No differences in the incidence of taste distortion were seen based on age, gender or race. Within the 52-week trials, 4 (1.3%) of 314 asthma patients discontinued treatment with flunisolide HFA due to taste distortion.
CONCLUSIONS: In these studies with flunisolide HFA small-particle formulation with the built-in spacer, dosages of up to 320 mcg BID were well tolerated regarding taste, with an incidence of taste distortion similar to that seen with placebo.
CLINICAL IMPLICATIONS: Few patients experienced and/or discontinued treatment due to taste distortion, with no apparent dose-related increases noted.
DISCLOSURE: Randall Brown: Consultant fee, speaker bureau, advisory committee, etc.: Received payment for consulting services from Meda Pharmaceuticals John Karafilidis: Employee: employee meda pharmaceuticals The following authors have nothing to disclose: Michael Marcus
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