SESSION TITLE: Allergy and Airway Posters
SESSION TYPE: Original Investigation Poster
PRESENTED ON: Wednesday, October 28, 2015 at 01:30 PM - 02:30 PM
PURPOSE: Flunisolide HFA is a small-particle inhaled corticosteroid with a built-in spacer tested in clinical trials. A 12-week, randomized, multicenter, double-blind, placebo-controlled trial was conducted to evaluate the efficacy and safety of flunisolide HFA in adult and adolescent patients 12 years and older with mild-to-moderate asthma. In addition to the primary analysis (improvement in percent predicted FEV1 over the 12-week treatment period), secondary analysis determined the efficacy of flunisolide HFA at the earliest evaluation points during treatment.
METHODS: Patients with mild-to-moderate asthma using inhaled steroids and meeting all study entry criteria were randomized to treatment with flunisolide HFA 80 mcg (1 puff, n=75), flunisolide HFA 160 mcg (2 puffs, n=100), flunisolide HFA 320 mcg (4 puffs, n=113), or placebo (n=104) each BID for a 12-week double-blind study period. The primary efficacy assessment was change from baseline in percent predicted FEV1 after 12 weeks of treatment. Secondary analyses were performed at week 3 (based on change in percent predicted FEV1) and at weeks 1 and 2 (based on patient diary data) to determine the onset of efficacy.
RESULTS: In the primary analysis, patients treated with flunisolide dosages of 160 mcg and 320 mcg BID had statistically superior (P<.05) improvement in percent predicted FEV1 compared to patients treated with placebo over the 12-week treatment period. In the secondary analyses, flunisolide dosages of 160 and 320 mcg BID were statistically superior (P<.05) to placebo for all efficacy endpoints recorded daily in diaries (prn Albuterol use, PEFR, asthma symptoms, and nocturnal awakenings) at week 2 and in some endpoints at week 1. At week 3, the first post-baseline visit measuring FEV1 changes from baseline in percent predicted FEV1 in both these groups were statistically superior (P<.001) to placebo confirming the early onset of effect. This improvement remained statistically significant through week 12.
CONCLUSIONS: The results of this study demonstrated that flunisolide HFA dosages of 160 and 320 mcg BID, delivered with a built-in spacer, were effective and safe for treatment of patients with mild-to-moderate asthma and demonstrated significant improvement in asthma efficacy endpoints with flunisolide HFA 160 and 320 mcg BID within 2 weeks of start of treatment.
CLINICAL IMPLICATIONS: The flunisolide HFA fine-particle formulation provides effective therapy for patients with asthma, with an early onset of therapeutic effect and a favorable safety profile.
DISCLOSURE: Michael Marcus: Consultant fee, speaker bureau, advisory committee, etc.: Received payment for consulting services from Meda Pharmaceuticals John Karafilidis: Employee: employee meda pharmaceuticals
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