A double-blind, randomized, sham-controlled study of Targeted Lung Denervation in patients with moderate to severe COPD
2018
Background: Targeted Lung Denervation (TLD) is a novel bronchoscopic therapy that disrupts parasympathetic pulmonary nerve input to the lung. Aim: Evaluate safety and efficacy of TLD + tiotropium compared to sham bronchoscopy + tiotropium at 6 months. Methods: TLD was performed in stable COPD patients (FEV1/FVC<0.7, FEV1 30-60% predicted, CAT≥10 or mMRC≥2) in a double-blind, 1:1 randomized, sham-controlled, multicenter (n=15) study (NCT02058459) using a novel lung denervation system (Nuvaira, Inc., USA). Primary endpoint was % of patients with respiratory adverse events (respiratory failure; pneumonia; COPD exacerbation; influenza; respiratory infection; worsening bronchitis; worsening dyspnea; tachypnea; wheezing; or airway defects requiring therapeutic intervention) between 3 and 6 months. Secondary endpoints included SGRQ, TDI, EQ-5D, spirometry, and plethysmography. Results: 82 patients (FEV1 41.6±7.4 %pred., 50.0% male, age 63.7±6.8 yrs) were randomized with 81 patients completing 6-month follow-up. There were no deaths or treatment related AEs requiring therapeutic interventions. The primary endpoint was met with pre-defined respiratory AEs in 71% of sham and 32% of treatment patients between 3 and 6 months (p=0.0008). Change at 6 months compared to baseline in sham vs treatment arms: SGRQ -3.8±13.8 vs -8.3 ± 12.6, TDI -1.5±3.7 vs +0.25±3.2, EQ-5D VAS 3.1±21.5 vs 9.1±22.5, FEV1 86±180 vs 127±201 ml, FVC 147±361 vs 240±390 ml, RV -93±926 vs -322±760 ml. Conclusion: TLD + tiotropium demonstrated a significant reduction in respiratory adverse events and trends toward improved quality of life, dyspnea, and pulmonary function testing when compared to sham + tiotropium.
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