Imperial College Healthcare NHS Trust

Government Agency (Health and Adult Social Care)

Clinical Sponsor is not required

Unknown

Yes

NIBDAPC_2024_0036

People who smoke and have chronic bronchitis and emphysema (now recognised as Chronic Obstructive Pulmonary Disease, or COPD) often experience a worsening of their symptoms (an ‘exacerbation’) after they catch a cold. However, this does not occur in every individual with COPD, and not every cold leads to an exacerbation or illness. The aim of this research is to test a new therapeutic drug (vapendavir) in a double blinded placebo-controlled Phase 2a clinical trial that may act to reduce or even prevent the increases in symptoms in individuals with COPD when they catch a cold. A double blinded, placebo controlled clinical trial means that neither the patient nor study team are aware which patients are receiving the investigational drug or placebo, to remove any possible bias. A phase 2a clinical trial is a type of study that is looking to investigate the safety and effectiveness of a treatment, providing a “proof of concept” for an investigational medicine The study will involve participants experiencing an infection with a common cold virus (not everybody who gets given the virus gets infected). Depending on whether, and how quickly participants’ symptoms develop, they may be assigned at random to take an experimental drug (vapendavir) or placebo for 7 days. By doing this, we will be able to determine if the possible increase in symptoms individuals with COPD may experience when they get a cold is improved by treatment with vapendavir. If successful, the drug vapendavir could have a large impact on how we may treat individuals with COPD in the future. In addition, we will have the opportunity to measure a number of different proteins (called biomarkers) to better understand how the treatment works, and how virus infections cause a worsening of symptoms in people with COPD. As the trial is nearly completed to recruitment, we have not done any study specific patient involvement and engagement prior to submission, however we are going to commit to disseminating results using lay language to the public and key COPD stakeholders through various channels. We will also commit to involving and engaging the public for any future research proposals.

This research is important because viral infections, particularly those caused by rhinovirus (which is the primary cause of the common cold), significantly impact people with stage II COPD. In people with COPD, viral infections like rhinovirus can cause sudden worsening of symptoms, known as exacerbations. These exacerbations are one of the main reasons patients with COPD end up in the hospital, experience a reduced quality of life, and see their disease progress more rapidly. Studies show that between 40% and 50% of COPD exacerbations are caused by rhinovirus infections. These viral exacerbations can lead to further loss of lung function. Even though there are treatments available for COPD, such as bronchodilators (which help open the airways), inhaled corticosteroids (which reduce inflammation), and antibiotics (which fight bacterial infections), these treatments are not fully effective for managing exacerbations caused by viruses and often come with significant side effects. This study suggests that developing a treatment specifically aimed at stopping rhinovirus could significantly improve outcomes for COPD patients. The idea is that if an anti-rhinovirus treatment is given early during an infection, it could prevent or limit the virus from replicating and spreading. This would, in turn, reduce the severity and duration of the exacerbation.The potential benefits of such a treatment include fewer exacerbations, less need for hospital visits, and better long-term health for COPD patients. By reducing the frequency and severity of exacerbations, this approach could not only improve the day-to-day lives of COPD patients but also help lower healthcare costs by reducing hospitalizations and the need for intensive treatments.

Public Health Research

25/10/2024

Not applicable

Not applicable

One-off

TRE