27 January 2023

This week in PVD

Enrollment complete for phase 3 trial testing INOpulse for PH

Enrollment is now complete in REBUILD, a Phase 3 clinical trial evaluating INOpulse, an investigational treatment for people with pulmonary fibrosis (PF) who are at risk of developing pulmonary hypertension (PH).

According to the therapy’s developer, Bellerophon Therapeutics, the trial’s enrollment was completed earlier than expected. As a result, top-line data are now expected by the middle of this year, with positive results supporting the company’s bid to seek INOpulse’s regulatory approval.

“We are pleased to have completed enrollment in this important study sooner than previously anticipated, which represents a significant milestone for Bellerophon [and] our INOpulse clinical development program,” Naseem Amin, MD, chairman of Bellerophon’s board of directors, said in a press release.


Triple therapy more beneficial than dual therapy for COPD, regardless of EOS

Patients with chronic obstructive pulmonary disease (COPD) and an exacerbation history whose blood eosinophil counts are at least 100 cells/mm3 stand to benefit from the use of triple therapy with budesonide/glycopyrronium/formoterol fumarate dihydrate (BGF) 320/14.4/10 more than dual therapy, according to study results published in the International Journal of Chronic Obstructive Pulmonary Disease.

Researchers conducted a subgroup post hoc analysis of data from the ETHOS trial (ClinicalTrials.gov identifier: NCT02465567) to evaluate how baseline blood eosinophil (EOS) counts affected the treatment benefits of BGF triple therapy over dual therapy (ie, either glycopyrronium/formoterol fumarate dihydrate [GFF] or budesonide/formoterol fumarate dihydrate [BFF]) in patients who had experienced moderate to severe COPD exacerbations.

Q&A: Chronic bronchial infections require close monitoring, care for patients with COPD

Some patients with COPD experience lung function decline over time, and a study recently showed that chronic bronchial infection by any pathogenic microorganism can hasten this decline.

In a post-hoc analysis of a prospective study cohort published in Annals of the American Thoracic Society, researchers analyzed 201 patients (mean age, 70.3 years; 90.5% men) with COPD every 3 to 6 months for a total of 84 months to see if chronic bronchial infection (CBI), particularly by Pseudomonas aeruginosa, are related to FEV1 decline.

As Healio previously reported, researchers found that FEV1 decline was 33.7 mL per year overall, which significantly increased to 57.1 mL per year among patients with CBI by any pathogenic microorganism and to 48.5 mL per year among patients in whom P. aeruginosa was isolated at least once.

Research proposals being accepted for PHenomenal impact fund

The PHenomenal Impact Fund for Global PH Research is accepting research proposals, according to a press release.

On its fifth year, Team PHenomenal Hope’s research fund will award up to $50,000 for 12 months for proposals that focus on new concepts in pulmonary hypertension (PH) that have the potential to change the field. The concept’s goals must be achievable within a year and within the time the award is allocated, according to the nonprofit’s webpage.

Applications are expected to demonstrate eventual clinical impact on the care of PH and are open to researchers in the U.S. and other countries with Team PHenomenal Hope presence — Belgium, Brazil, Germany, Mexico, and South Africa. Applicants should be within the first seven years after their fellowship, although exceptions may apply. Healthcare providers who are not medical doctors, such as registered nurses and doctors of pharmacy, are welcome to apply.

Pregnancy with idiopathic PAH may be riskier than other types

Pregnant women with idiopathic pulmonary arterial hypertension (iPAH) had higher rates of mortality and pregnancy complications than those with other types of PAH or pulmonary hypertension due to left heart disease (LHD-PH), according to a study in China.

The prevalence of babies born with low birth weight was also higher in mothers with iPAH (PAH without a known cause), as well as with LHD-PH, than with other PAH types.

“iPAH patients should be advised to prevent pregnancy,” the researchers wrote, adding that “standardized and multidiscipline-assisted maternal management is the key to improving maternal-fetal outcomes” for people with pulmonary hypertension (PH) who are or wish to become pregnant.

Asthma and COPD have long-term effect on total and cause-specific mortality

Patients with asthma and chronic obstructive pulmonary disease (COPD) are at risk for higher mortality, according to results of a longitudinal study published in Respiratory Medicine.

To determine the long-term effect of these disease on total and cause-specific mortality, as well as the comorbidities associated with these diseases, researchers conducted an 18-year follow-up study of patients with asthma, COPD, and asthma-COPD overlap (ACO) who had taken part in Health 2000, a Finnish national health examination survey of adults administered from 2000 to 2001.

At the time that Health 2000 was administered, investigators invited individuals who had asthma, COPD, or ACO and were aged 30 years and older (8028 participants) who completed the survey to take part in a comprehensive clinical examination. The 5922 (73.8%) participants who ultimately completed spirometry, a physician’s evaluation, questionnaires, and serologic determinations were included in the current 18-year follow-up analysis.

Computer finds common biomarkers for PAH, metabolic syndrome

Genes associated with both pulmonary arterial hypertension (PAH) and metabolic syndrome have been identified using computer software tools, a study reports.

Metabolic syndrome, thought to promote PAH, is a cluster of conditions marked by high blood pressure, elevated blood sugar, excess body fat around the waist, and abnormal cholesterol or blood fat levels.

According to researchers, this is the first study to identify common biomarkers and related metabolic pathways of PAH and metabolic syndrome.

The computer study, “Identification of diagnostic biomarkers for idiopathic pulmonary hypertension with metabolic syndrome by bioinformatics and machine learning,” was published in the journal Nature Scientific Reports.

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