Nuvaira’s targeted lung denervation (TLD) therapy lowers the risk of hospitalization due to exacerbations in people with chronic obstructive pulmonary disease (COPD), Phase 2 trial data show, according to a company press release.
A new clinical study, called AIRFLOW-3 (NCT03639051), is currently recruiting COPD patients at multiple clinical sites in the U.S. and Europe to further confirm the safety and effectiveness of Nuvaira’s TLD technology. More information on enrollment is available here.
The study, “Two-Year Outcomes for the Double-Blind, Randomized, Sham-Controlled Study of Targeted Lung Denervation in Patients with Moderate to Severe COPD: AIRFLOW-2,” was published in the International Journal of Chronic Obstructive Pulmonary Disease.
Patients with COPD often experience disease exacerbations, which are associated with worse clinical outcomes and increased healthcare costs. Previous research has suggested that the risk of mortality increases by up to 14-fold in the year following a severe exacerbation.
Despite this, few treatment options are available for people with the chronic inflammatory disease.
Acute exacerbations often follow viral or bacterial respiratory infections, which are known to cause an overstimulation of the vagus nerve branches that enervate the lungs. This leads to the release of the neurotransmitter acetylcholine, which in COPD patients causes changes in inflammation in the lungs, increases mucus secretion, and makes airways hyper-responsive.
Therapies that block this nerve activation, such as long-acting muscarinic antagonists (LAMA), have been used for the clinical management of COPD patients.
Targeted lung denervation (TLD) is a new type of therapy that targets the branches of the vagus nerve present in the bronchi — the main passageway into the lungs — reducing nerve stimulation. This is a durable treatment and previous clinical trials have shown that, in combination with optimal medical therapy, it improves patient outcomes.
Nuvaira’s proprietary TLD technology was tested in the AIRFLOW-2 Phase 2 trial (NCT02058459) in patients with moderate or severe COPD.
In total, 82 patients, ages 40-75, were randomly assigned to receive Nuvaira’s TLD (41 patients) or to a control group (41 patients). Participants in the control group received a sham bronchoscopy protocol. All of the individuals continued to receive their maintenance inhaler therapy during the study.
At the 12.5-month follow-up, 20 participants in the control group (49%) were offered the chance to receive TLD therapy for up to two years.
The results showed that the risk of severe COPD exacerbation requiring hospitalization was significantly reduced in patients in the TLD group compared with controls through two years of follow-up. Yet, “there was no statistical difference in risk of first moderate or severe COPD exacerbation from baseline to 2 years,” the researchers wrote, suggesting a similar reduction for moderate and severe COPD exacerbations.
In the second year of follow-up, 11.1% of patients in the TLD group underwent hospitalization due to a respiratory complication compared with 28.6% in those in the control group. Of note, before the start of the trial, the hospitalization rate in the previous year was similar for both groups, at 24%.
While no significant differences were found between groups for the rate of severe adverse events, a trend to lower respiratory severe adverse events was observed in the TLD group following the two years of follow-up.
Pulmonary function tests revealed that lung function remained stable for the two years in patients who received TLD. In the control group, despite an improvement trend, lung function was more variable during the follow-up period.
Health-related quality of life, as measured by the COPD-specific St. George’s Respiratory Questionnaire (SGRQ-C), remained stable in both groups throughout the two years, with no significant changes between groups.
Overall, the results suggested that the “clinical impact of TLD is durable, as it is found to reduce the risk of serious COPD adverse events over 2 years with stabilized lung function,” the researchers wrote.
“The reduction of severe COPD exacerbations has the potential to improve long-term clinical outcomes and reduce healthcare costs,” the team added.
The team also noted that further studies with larger groups of patients is needed “to confirm the healthcare impact of TLD.”
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