Clinical Trials and Regulatory Issues of Nanocarriers Employed in the Treatment of Chronic Obstructive Pulmonary Disease

In the 21st century, chronic obstructive pulmonary disease (COPD) is one of the major global health concerns characterized by high prevalence and substantial morbidity and mortality due to long-term exposure to irritants like smoke, pollution, genetic factors and respiratory infections. Chronic respiratory failure is a leading outcome, and it is linked with a significant economic burden resulting from healthcare costs and lost productivity. COPD is a significant healthcare challenge due to limited treatment options. Nanocarriers, like nanoparticles and liposomes, offer promise for targeted drug delivery to the lungs, potentially enhancing treatment effectiveness and safety. In regular clinical practice, nanocarriers require careful consideration and adherence to regulations. This includes evaluating safety, potential toxicity, and impact on patient outcomes. However, the achievement of real-world application in regular clinical practice necessitated the development of harmonized regulatory environments. Advancing COPD care globally requires thorough clinical trials, navigating complex regulations, and proving effectiveness in diverse patient populations. Researchers, investors, and regulatory agencies are actively collaborating to tackle challenges in developing safe and effective nanocarriers for COPD treatment. This chapter addresses the present state of clinical trials and the regulatory landscape, along with future prospects for nanocarriers employed in COPD treatment. This chapter also highlights emerging market and regulatory trends as well as proposes solutions to enhance the efficiency of the regulatory process in the context of COPD.