The ATS is making history with its first-ever in-person Clinical Trials Symposium. Breaking News: Clinical Trial Results in Pulmonary Medicine will debut live 9:30-11 a.m. PT on Monday, May 16, with the latest clinical results related to COVID-19, bronchiectasis, idiopathic pulmonary fibrosis, and asthma before they make headlines.
“This session is all about breaking news, trials that we all know about and are waiting for, with results that are being presented for the first time,” said International Conference Committee Chair Andrew Halayko, PhD, ATSF, professor and Canada Research Chair in Lung Pathobiology and Treatment Physiology and Pathophysiology, University of Manitoba, and Biology of Breathing Group, Children’s Hospital Research Institute of Manitoba, Canada. “This session is going to open the door to new treatments that could be available almost immediately or are very close.”
The symposium opens with the Study to Assess Efficacy and Safety of Inhaled Interferon-β Therapy for COVID-19 (SPRINTER), a randomized, double-blind, placebo-controlled phase 3 trial involving patients hospitalized with COVID-19. Results will be presented by Tom Wilkinson Cantab, MBBS, PhD, professor of respiratory medicine and honorary National Health Service consultant, University of Southampton, United Kingdom.
Preliminary results of the trial found a non-significant 36 percent reduction in progression to severe disease and death in the per-protocol population. Dr. Cantab will discuss new subgroup analyses of older patients, patients with specific comorbidities, and other high-risk groups.
Charles Haworth, MD, director of the Cambridge Centre for Lung Infection, Royal Papworth Hospital, United Kingdom, will discuss Efficacy and Safety of Colistimethate Sodium Delivered Via the I-Neb in Patients with Bronchiectasis and Pseudomonas Aeruginosa.
“We don’t see a lot of trials in the bronchiectasis space, and there hasn’t been a huge amount of movement or innovation in this area,” Dr. Halayko said. “This is quite exciting because there have been promising early results with patients that progress quite badly when they have the Pseudomonas load with their bronchiectasis.”
A phase 2 trial of a phosphodiesterase 4B inhibitor for idiopathic pulmonary fibrosis will be presented by Luca Richeldi, PhD, professor and director of pulmonology at the Fondazione Policlinico Universitario Agostino Gemelli, Italy.
The trial is designed to assess the safety and efficacy of an investigational molecule, BI 1015550. The oral PDE4B inhibitor was granted breakthrough therapy designation for IPF by the U.S. Food and Drug Administration earlier this year. The molecule appears to address both pulmonary fibrosis and the inflammation associated with progressive fibrosing interstitial lung disease.
A Study to Assess the Efficacy and Safety of Budesonide/Albuterol Metered-dose Inhaler (BDA MDI/PT027) in Adults and Children 4 Years of Age or Older With Asthma (MANDALA) could settle a long-running controversy over single-agent albuterol versus albuterol-budesonide combination as rescue therapy in patients with moderate-to-severe asthma. Alberto Papi, MD, professor of respiratory medicine and director of respiratory diseases at the University of Ferrara, Italy, will present the results.
“MANDALA has patients as young as four years old, which is really exciting, being able to look at rescue therapy in children, adolescents, and adults with moderate-to-severe asthma in the same trial,” Dr. Halayko said. “This study has the potential to answer important questions that clinicians and patients have, and will likely have an almost immediate impact on approaches to care.”