A phase III study to evaluate safety and efficacy of fluticasone/formoterol combination (flutiform® aerosol) in long-term administration (24 weeks) in Japanese pediatric patients with bronchial asthma

Background: The combination drug of inhaled corticosteroid (ICS)/long-acting (32 agonist is being used as a long-term control medication for pediatric asthma patients for those who are poorly controlled by ICS alone. Long-term efficacy and safety of Fluticasone propionate/formoterol fumarate hydrate (FP/FM) was evaluated in pediatric patients with bronchial asthma. Methods: Two inhales of FP/FM (50/5|ag) at one time, twice daily were administered for 24 weeks to Japanese asthma patients aged 5 to < 16 years who had asthma symptoms during the observation period while using the same dosage of ICS during a certain period of time. Adverse drug reactions, morning peak flow (mPEF) and asthma symptoms were evaluated 24 weeks after administration. Results: FP/FM was administered to 53 subjects. 52 subjects completed the 24 week administration. The incidence of adverse drug reactions was 9.4% (5 of 53), and all of the adverse drug reactions were mild. The mPEF increased from the starting value and was maintained through the treatment period. The average change from baseline in the mPEF after 24 weeks of treatment was 21.39 ± 2.93L/min (Least squares mean ± standard error). Changes in asthma symptoms were similar to that of morning peak flow. Conclusion: It was considered that FP/FM could be useful for long-term control of pediatric asthma. © 2020 Japanese Society of Allergology.