Volume 29, Issue 163, September 2025

Efficacy and Safety of Ensifentrine in Moderate to Severe COPD: A Systematic Review of Randomized Clinical Trials

Paula Szarek^1♦, Julia Urbańska², Danuta Borowska2, Kamil Nieczaj², Julia Sztubińska², Marta Urszula Marciniak², Marta Tortyna², Natalia Sioch², Julia Krotofil², Olga Samsel², Maciej Trzciński²

¹Faculty of Medicine and Health Sciences, Collegium Medicum of the University of Zielona Góra, ul. Zyty 28, 65-046 Zielona Góra, Poland
²Faculty of Medicine, Medical University of Gdańsk, ul. M. Skłodowskiej-Curie 3a, 80-210 Gdańsk, Poland

^♦Corresponding author
Paula Szarek, Faculty of Medicine and Health Sciences, Collegium Medicum of the University of Zielona Góra, ul. Zyty 28, 65-046 Zielona Góra, Poland

ABSTRACT

Chronic obstructive pulmonary disease is a lung condition that restricts airflow, causes ongoing inflammation, and results in frequent flare-ups. It has a significant impact on health and death rates around the world. Even with improved medications such as long-acting bronchodilators and inhaled corticosteroids, many patients still experience symptoms and are at risk for flare-ups. Ensifentrine is a new inhaled dual phosphodiesterase 3 and 4 (PDE3/PDE4) inhibitor. It provides a unique treatment by delivering both bronchodilation and anti-inflammatory effects through a single mechanism. This review evaluates randomized clinical trials published between 2020 and 2024 that studied the effectiveness and safety of ensifentrine. The results showed many benefits. Patients receiving ensifentrine had higher FEV₁ values, reported fewer symptoms, and experienced fewer exacerbations compared with those given a placebo. The results were even better when combined with standard bronchodilators. These findings show that ensifentrine could be a valuable addition to current COPD treatments. It offers benefits both when used alone and when combined with existing therapies. Its dual mechanism tackles key problems by targeting bronchoconstriction and airway inflammation at the same time. More long-term trials are required to confirm its lasting effectiveness and safety.

Keywords: Ensifentrine, Chronic Obstructive Pulmonary Disease, COPD, Severe Early-Onset, Lung Diseases

Medical Science, 2025, 29, e157ms3649

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DOI: https://doi.org/10.54905/disssi.v29i163.e157ms3649

Published: 07 September 2025