Flecainide Acetate Inhalation Solution for Cardioversion of Recent-Onset, Symptomatic Atrial Fibrillation
Status:
Not yet recruiting
Trial end date:
2023-03-30
Target enrollment:
Participant gender:
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).