Evaluate Safety and Efficacy of the Nuvaira™ Lung Denervation System in Patients With COPD (Nuvaira Airflow-3)

This is a prospective, multicenter, double-blind, randomized, sham-controlled study to demonstrate the superiority of treatment with the Nuvaira Lung Denervation System compared to a sham procedure to decrease moderate or severe exacerbations in subjects with COPD on optimal medical care.

The procedure involves bronchoscopic ablation of pulmonary vagus nerve surrounding the main bronchi. This inhibits vagal reflexes responsible for smooth muscle constriction and mucus secretion.

End Points
  • moderate or severe COPD exacerbations for 12 months
  • compare long-term safety and other efficacy assessments
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Key inclusion criteria are:
  • Post-bronchodilator FEV1: 25% - 80% (for FEV1 < 30%, PaCO2 < 50)
  • ≥ 2 moderate or 1 severe exacerbation in past 12 months
  • LAMA/LABA maintenance inhaler therapy for at least 12 months 
  • COPD assessment based on CAT score ≥ 10
  • former ≥ 10 pack year smoking
ClinicalTrials.gov Identifier: NCT03639051

For more detailed information on this trial please click the link above to visit ClinicalTrials.gov

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