AIRFLOW-2 two-year data confirm sustained reduction of severe COPD exacerbation risk vs. a control group
MINNEAPOLIS, Nov. 23, 2020 /PRNewswire/ -- Nuvaira, a developer of novel therapeutic strategies to treat obstructive lung diseases, announced today publication of two-year follow-up data from its randomized, sham-controlled, double-blinded trial (AIRFLOW-2) that confirms long-term safety and durable effect of Targeted Lung Denervation (TLD) therapy in COPD patients.
TLD, a novel bronchoscopic procedure that disrupts pulmonary nerve input to the lung, has been developed to reduce the clinical consequences of neural hyperactivity, including airway hyper-responsiveness, a pathophysiologic underpinning of both COPD and asthma. Nuvaira's proprietary TLD technology has demonstrated safety and feasibility in three completed clinical studies, and physician and patient interest in the therapy has enabled continued enrollment in Nuvaira's FDA pivotal trial (AIRFLOW-3).
AIRFLOW-2 was a double-blinded, sham controlled, multicenter randomized clinical trial (RCT) to assess respiratory adverse events in 82 moderate-to-severe COPD patients with high symptom burden despite optimal drug therapy. COPD exacerbations represent the highest proportion of COPD costs to the healthcare system and are associated with decreased lung function and poor quality of life. Valipour and colleagues (Int J COPD 2020:15 2807-2816) confirmed that the risk of severe COPD exacerbation requiring hospitalization was significantly lower in the TLD treatment group compared to the control group through two years of follow-up (p=0.04). Lung function and Quality of Life measures showed clinical stability in TLD-treated patients over two years of follow-up.
Five peer reviewed publications contribute to the growing body of evidence supporting the therapeutic potential of Targeted Lung Denervation to meet a significant unmet medical need in patients at risk of COPD exacerbation.
Nuvaira's proprietary Lung Denervation System addresses airway hyper-responsiveness, a pathophysiologic underpinning of both COPD and asthma, in a procedure called Targeted Lung Denervation (TLD). The Nuvaira® Lung Denervation System is CE Mark approved. The Nuvaira® Lung Denervation System is under clinical investigation and is not commercially available in the USA. Nuvaira and dNerva are registered trademarks of Nuvaira, Inc.
Please visit our clinical trial website www.airflowtrial.com and publication bibliographies at www.Nuvaira.com.