Flecainide Acetate Inhalation Solution for Cardioversion of Recent-Onset, Symptomatic Atrial Fibrillation

Summary

This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled clinical study designed to evaluate the efficacy and safety of FlecIH-103 (flecainide acetate inhalation solution) compared with placebo in patients with recent-onset, symptomatic newly diagnosed or paroxysmal AF. Approximately 400 patients are expected to be enrolled in this study. Patients will be randomized 3:1 to receive FlecIH-103 at a total dose of up to 120 mg estimated total lung dose (eTLD) (n=300) or placebo inhalation solution (n=100). Randomization will be stratified by geographic region (US and ex-US) and duration of symptoms of the current AF episode (≥1 hour to ≤24 hours and \>24 hours to ≤48 hours).

Timeline

Start

2022-04-26

Primary completion

2023-05-22

Completion

2023-05-22

Publications

• Rienstra M, Woite-Silva AC, Kuijper A, Eijsbouts S, Kraaier K, Janota T, Van Ofwegen C, Tuininga Y, Badings E, Merino JL, Ruskin JN, Camm AJ, Kowey PR, Dufton C, Maupas J, Parsell D, Belardinelli L. Flecainide acetate inhalation solution for cardioversion of recent-onset, symptomatic atrial fibrillation: results of the phase 3 RESTORE-1 trial. Europace. 2025 Mar 28;27(4):euaf064. doi: 10.1093/europace/euaf064.

Drugs

Indications