From early trials to global treatment: developing the next generation of COPD medicines

Developing new treatments for chronic obstructive pulmonary disease, or COPD, is challenging because the condition affects people in different ways. Clinical trials led in Manchester are helping researchers test new medicines, understand who is most likely to benefit and move towards more personalised care.

COPD is a long-term lung condition that makes breathing difficult, usually because the airways have become damaged or narrowed. It is highly complex and often underdiagnosed, with people developing the condition through different combinations of smoking, air pollution, occupational exposure, infections, ageing and wider social factors.

Because COPD affects people in different ways, it can be difficult to predict how the condition will progress or determine which treatments will work best for each patient.

However, the way COPD is understood and treated is changing. Research led by Professor Dave Singh at The University of Manchester is helping to drive that progress through respiratory clinical trials. His work includes designing and delivering studies, recruiting patients, and interpreting results to establish whether new medicines are safe, effective and most likely to benefit particular groups of patients.

Spanning early phase studies through to large international trials, this research is helping to move promising treatments towards clinical use and support a more personalised future for COPD care.

The challenge of developing new treatments

For many years, COPD was viewed as a condition with limited treatment options. Damage to the lungs was often seen as progressive and difficult to alter, particularly for people with a long history of smoking or long-term exposure to harmful environments, infections, ageing and wider social factors.

Today, the treatment outlook is more optimistic, with inhaled therapies, which help relax and open the airways to ease breathlessness and improve day-to-day symptoms, remaining the foundation of COPD treatment.

However, developing new medicine as a treatment option is complex. Before any treatments can be used widely, researchers need to understand whether it is safe, whether it works, and which patients are most likely to benefit.

This is especially important in COPD because the disease varies so much between people. Different patients can have different underlying biological processes driving their symptoms and disease progression. This means the future of COPD treatment is about not just developing more medicines, but also developing the right medicines for the right patients.

Testing medicines safely

Clinical trials are a crucial part of this process. New medicines usually move through several stages of testing, beginning with small early phase studies before progressing into larger trials involving hundreds or thousands of patients.

Manchester has a particular strength in early phase respiratory research through the Medicines Evaluation Unit, which is accredited to carry out Phase 1 studies. Professor Singh is a licensed Phase 1 investigator, and works across the design and delivery of these trials, helping to oversee participant safety and interpret whether new respiratory medicines should progress to the next stage of development.

These are the first studies in humans, and require careful monitoring because researchers are still learning how a medicine behaves in the body. Participants may stay in a specialist research centre for several days while safety, side effects and early signals of how the treatment works are assessed. Many potential medicines do not progress beyond this point, making early phase research a vital part of deciding which treatments should move forward.

This specialist capability allows Manchester to contribute to the full drug development pathway, from early safety testing through to larger studies that assess whether a treatment improves lung function, symptoms and quality of life.

From trial to treatment

One example of this pathway is Ensifentrine, a new inhaled medicine for COPD. Manchester researchers, led by Professor Singh through the Medicines Evaluation Unit, played an important role in its clinical development, carrying out early studies and helping to test its safety and effectiveness in people with COPD.

Many existing inhaled treatments work by opening up the airways, helping people breathe more easily. However, there had not been a new class of inhaled bronchodilator for COPD since the 1980s. Early studies tested the safety of Ensifentrine and explored whether it could also reduce inflammation in the lungs. Inflammation occurs when immune cells become activated and contribute to disease, even when there is no infection present. In COPD, this can play an important role in symptoms and lung damage.

The medicine was then tested in people with COPD, with studies showing improved lung function and patients reporting that they felt better. Larger Phase 3 trials later confirmed benefits in wider patient groups, and the treatment is now licensed in the United States, with further work planned to support wider availability.

This shows how respiratory research can move from early testing into a medicine with the potential to improve care for patients.

Personalising COPD care

Another important shift is the move towards more personalised treatment. Rather than treating COPD as one single disease, researchers are increasingly identifying different patterns of inflammation that may respond to different therapies.

In some patients, a type of inflammation can be detected through a blood test measuring eosinophils, a type of white blood cell. This has helped identify groups of patients who may benefit from targeted biological treatments.

Research in this area has contributed to large clinical trials of biologic therapies in COPD, including treatments designed for patients with specific inflammatory profiles. This approach is helping to change how COPD is understood, moving towards care that is more closely matched to the biology of the individual patient.

Looking ahead

The future of COPD care is likely to combine better inhaled therapies with more targeted biological treatments for patients whose disease is driven by specific inflammatory processes.

The aim is to continue building evidence through clinical trials, identifying which treatments work, who they work for, and how they can be used to improve care.

By combining respiratory science with expertise in early phase and large-scale clinical trials, Professor Singh's work is helping to identify promising new treatments, establish which patients may benefit from them, and generate the evidence needed for their wider clinical use. Through his contribution to international COPD guidance, this evidence can also help shape how new treatments are understood and used around the world.