Results from AIRFLOW-2 Trial Reveal Reduction in Exacerbations and other Respiratory Adverse Events
PARIS, Sept. 18, 2018 (GLOBE NEWSWIRE) — Nuvaira, a developer of medical devices to treat obstructive lung diseases, announced the acceptance of a clinical abstract by the European Respiratory Society (ERS) for oral presentation at the 28th International Congress 2018 in Paris. Co-principal Investigator, Dirk-Jan Slebos, M.D., Ph.D., from the University Medical Center Groningen in the Netherlands, today will make the first public presentation of results from the AIRFLOW-2 clinical trial (NCT#02058459), the first multi-center, double-blind, randomized, sham-controlled study of Targeted Lung Denervation (TLD) using the Nuvaira™ Lung Denervation System to treat patients with moderate to severe COPD.
“Results from this phase II trial demonstrate a significant reduction in respiratory adverse events such as COPD exacerbations and hospitalizations of greater than 50 percent,” said Dr. Slebos. “I believe these results may have important implications for COPD sufferers and their overall quality of life, as well as for healthcare costs, as there is significant expense associated with exacerbations and hospitalizations.
“TLD is a one-time medical procedure, and it’s the first to target the whole lung by bronchoscopically disrupting parasympathetic nerves to promote airway dilation to make it easier for patients to breathe,” continued Dr. Slebos. “This novel lung denervation system may offer patients who suffer from COPD a long-term treatment that has added effect on top of medical management.”
The oral presentation entitled, “A double-blind, randomized, sham-controlled study of Targeted Lung Denervation in patients with moderate to severe COPD,” by Dr. Slebos et al., takes place today at 15:00 CEST in room 7.3Z2 as part of the session on “Interventional pulmonology highlights in 2018: ELVR, TLD and BT” (Session 496, Abstract no. OA4929) at the Paris Expo Porte de Versailles.
“We are gratified to have had a clinical abstract on results of the AIRFLOW-2 trial accepted for oral presentation at the ERS International Congress, the largest worldwide meeting of leaders in respiratory medicine,” said Martin Mayse, M.D., co-founder and chief technology officer of Nuvaira. “After proving safety and feasibility of TLD in earlier trials, this sham-controlled trial was the logical next step to further study the potential effectiveness of TLD for patients.”
Nuvaira also hosted an industry mini-symposium at the ERS Congress on Monday evening, which focused on TLD as a one-time treatment for COPD and asthma. The program was co-chaired by Alvar Agustí, M.D., Ph.D., director of the Thorax Clinic Institute at Hospital Clinic in Barcelona, and Professor Felix Herth, M.D., Ph.D., chairman of the Division of Pulmonology and Respiratory Care Medicine at the Thoraxklinik in Heidelberg.
Five medical experts presented clinical findings at the mini-symposium on topics that included: neural control of airway smooth muscle, mechanism of action and the Nuvaira Lung Denervation System, TLD in COPD and data from the AIRFLOW-1 and AIRFLOW-2 trials, TLD in severe asthma, and information regarding the upcoming AIRFLOW-3 pivotal trial, which is planned for sites in Europe, Canada and the U.S.
COPD is the umbrella term used to describe a group of diseases such as small airway disease (chronic bronchitis) and emphysema, characterized by chronic and incompletely reversible airway obstruction that interferes with normal breathing. It
is estimated that COPD affects more than 300 million people globally1,.
Pharmacological treatment is the approach for most patients today. Inhaled drugs are used once or twice daily to relax and temporarily open airways. Other forms of treatment include pulmonary rehabilitation, oxygen administration and surgical intervention. The annual financial burden of lung disease in Europe is €141 billion and COPD accounts for almost half3. In the United States, COPD costs are estimated to be more than $50 billion annually4.
The AIRFLOW-2 (NCT#02058459) sham-controlled trial was designed to assess the safety of TLD in patients suffering from moderate to severe COPD. The trial included 82 patients at 15 institutions throughout Western Europe. Enrollment has been completed and long-term follow-up is ongoing. The principal investigators are Dirk-Jan Slebos, M.D., Ph.D., University Medical Center, Groningen, The Netherlands and Arschang Valipour, M.D., Ph.D., Otto Wagner Spital, Vienna, Austria.
Nuvaira is a privately held company headquartered in Minneapolis, Minn. The company has developed the Nuvaira™ Lung Denervation System to address chronic obstructive pulmonary disease (COPD) and asthma by treating the overactive airway nerves during Targeted Lung Denervation* (TLD). Nuvaira received CE Mark approval for its Nuvaira Lung Denervation System for use during TLD in January 2016. More information may be found at www.Nuvaira.com.
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*Targeted Lung Denervation (TLD) is currently under clinical investigation for chronic obstructive pulmonary disease and is not yet commercially available.
Nuvaira is a trademark of Nuvaira, Inc.
1 Global Chronic Obstructive Pulmonary Disease Epidemiology and Patient Flow – 2017. Fore Pharma.
4 Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2017 Report
A photo accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/7a4d08f3-b50c-4544-bc2c-cf5b7041311a