Pulmonology Month in Review: June 2024

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In this summary of major news in pulmonology covered in June 2024, approvals by the FDA, new episodes of Lungcast, news on COPD, and more are highlighted.

Pulmonology Month in Review: June 2024

In June 2024, the HCPLive editorial team covered some of the most significant developments and research within the field of pulmonology. Topics such as the development of community-acquired pneumonia, new diagnostic tools and their post-COVID-19 evolution, approvals by the US Food and Drug Administration (FDA), and more were explored in June.

A summary of several such analyses was compiled by the editorial team. The following list of articles highlights the fast-changing nature of pulmonology research:

Study Suggests COPD Preventative Measures Needed During Seasonal Virus Circulations

A notable study published in June demonstrated that preventive measures designed for infection transmission overlapped with reductions in exacerbations of chronic obstructive pulmonary disease (COPD). The study’s investigators also found that the re-emergence of seasonal viruses was associated with recurrence of such exacerbations.

The research team was led by Dr. Arnaud Bourdin from the Department of Respiratory Diseases at the University of Montpellier’s Centre Hospitalier Universitaire (CHU) Montpellier in France. They had evaluated COPD admission data that had been recorded before, during, and after the COVID-19 pandemic, concluding that those with COPD, along with their family and caregivers, should continue to implement protective measures in the winter.

FDA Clears Wireless Electrocardiogram Device for Collecting Spirometry, ECG Data

One major story covered in June was the company Clario’s announcement that FDA officials had granted 510(k) clearance for the 'SpiroSphere' system, a tool integrated with the wireless COR-12 Electrocardiogram (ECG) device. The company’s integration was designed to allow for the simultaneous collection of spirometry and ECG data in a single site visit, ensuring that all ECG information is gathered into a single database.

"The launch of our FDA-cleared SpiroSphere wireless ECG device represents a significant step in improving clinical trial technology," Tom Stuckey, Clario’s senior vice president of Respiratory & Precision Motion, said in a statement. "This clearance and product launch emphasizes our commitment to optimizing data collection, efficiency, and consistency, further enhancing how we deliver respiratory trials with cardiac safety."

FDA Approves Ensifentrine (Ohtuvayre) for COPD

Another decision by the FDA which was explored was the agency’s approval announcement regarding ensifentrine (Ohtuvayre), developed by Verona Pharma and indicated for the treatment of patients with COPD. The decision by the FDA was the first approval of a treatment for COPD with a new mechanism of action in the past decade.

Ensifentrine itself was formulated as an inhaled nonsteroidal nebulizer therapy, designed to inhibit both the phosphodiesterase 3 and 4 (PDE3; PDE4) pathways in the body.

“The approval of Ohtuvayre is a significant advance in COPD care, and we believe Ohtuvayre’s novel profile can change the treatment paradigm for COPD,” David Zaccardelli, PharmD, president and chief executive officer of Verona Pharma, said in the statement. “We plan to launch Ohtuvayre in the third quarter 2024, ensuring Ohtuvayre is available to help the millions of patients who still experience daily COPD symptoms.”

Cost, Healthcare Resource Utilization Greater in Patients with AATD with Liver, Lung Disease

A recent study indicates that patients with alpha-1 antitrypsin deficiency (AATD) who also suffer from liver and/or lung disease incur higher overall costs and use more healthcare resources compared to those with only AATD. This retrospective, observational analysis utilized linked administrative claims data and electronic medical records, offering new insights into the additional costs associated with AATD when complicated by liver disease, lung disease, or both. The findings highlight a significant increase in healthcare resource utilization and per-person-year (PPY) healthcare costs in patients with concurrent liver and/or lung disease.

Stopping Lung Cancer Before It Starts with Steven Dubinett, MD, and Avrum Spira, MD

In a June episode of Lungcast, the show saw the return of Avrum Spira, the head of the computational biomedicine division for Boston University’s School of Medicine, and Steven M. Dubinett, dean of the David Geffen UCLA’s School of Medicine. Both speakers would be featured on Lungcast for the first time since November 2020, touching on recent updates to their ongoing lung cancer interception research collaborative project.

Dubinett and Spira spoke to host Albert Rizzo, chief medical officer of the American Lung Association (ALA), about advancements in their 7-year research initiative, highlighting enhancements to the foundational "genome atlas.” The genome atlas aids in evaluating pre-lung cancer risk, and the 2 speakers touched on new insights into the role of the lung-associated microbiome. Additionally, they spoke about the significance of cell-free DNA fragmentation patterns within some of their research.

The Changing Community-Acquired Pneumonia Landscape with Thomas File, MD, MSc, MACP

Another June episode of Lungcast, featured Thomas M. File, Jr., who provided an in-depth discussion of the current research and approaches into community-acquired pneumonia (CAP). File is a distinguished physician in infectious diseases at Summa Health as well as a professor emeritus for Northeast Ohio Medical University.

During this episode, File spoke to host Albert Rizzo about a few key talking points, some of which included the ATS-IDSA guidelines for standard CAP treatment and advancements in diagnostic tools which have taken place since the COVID-19 pandemic. They also spoke about the introduction of mRNA technology and the possible future role played by biomarkers such as procalcitonin.

New pneumonia treatments which are in development were also highlighted in the Lungcast episode, as well as the increased emphasis on antibiotic stewardship in CAP post-pandemic. Gaps in CAP research were touched upon by File as well, in addition to a discussion of the link between CAP and cardiovascular events.

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