Royal Papworth Hospital NHS FT has launched phase II of the clinical trial for patients with cystic fibrosis with serious lung infections, such as Mycobacterium abscessus. The trial aims to reduce the amount of mycobacteria, by using a solution which releases nitric oxide into the upper airways and deep alveolar spaces of the lungs. The method is to help kill viruses and bacteria and boost a person’s immune response.
Clinical trials are expected to start soon – with the nebulised nitric oxide generating solution (RESP301) - administered via a handheld nebuliser. Laboratory testing has shown strong activity against many bacterial species including M. abscessus, as well as viruses such as various influenza and coronavirus strains.
The study – known as NOMAB – will treat patients with RESP301 over a 28-day period, aiming to measure the changes in the amount of mycobacteria in the lungs before and after treatment. It will also analyse whether there are any improvements in lung function.
Professor Andres Floto, the Research Director of the Cambridge Centre for Lung Infection (CCLI), Professor of Respiratory Biology at the University of Cambridge, and co-chief investigator for the study, said: “Infection with M. abscessus is a major problem for people with cystic fibrosis, is very difficult to treat, leads to accelerated lung damage, and can prevent safe lung transplantation.”
Dr Charles Haworth, co-chief investigator for the study and a respiratory consultant at the CCLI at the trust, added: “Lung infections in people with cystic fibrosis are becoming harder to treat due to the increasing prevalence of multi-drug resistant organisms such as M. abscessus. We urgently need new and effective approaches to combat these infections.”
There will initially be 12 subjects recruited, and if successful, expanded to a larger trial, broadening the scope of RESP301 in cystic fibrosis and other lung conditions.
The study will be conducted at the trust, one of the UK’s leading centres for cystic fibrosis.