August 2025

PULMONARY

INSIGHTS ON THE BREATHE TRIAL AND WHAT IT MEANS FOR BRONCHOSCOPIC LUNG VOLUME REDUCTION

Featuring: Christopher M. Kapp, MD, and Ravi Kalhan, MD, MS
​The BREATHE trial published promising results regarding airway scaffolding as a form of bronchoscopic lung volume reduction to treat emphysema-related hyperinflation. Christopher M. Kapp, MD, and Ravi Kalhan, MD, MS, wrote an analysis of the recently published six-month results from the BREATHE trial where they explored the use of self-expanding nitinol airway scaffolds to connect hyperinflated emphysematous lung regions to central airways.

Data Details From the BREATHE Trial
  • The trial involved 89 patients with 60 receiving the airway scaffold treatment.
  • Inclusion and exclusion criteria closely mirrored those of established methods using one-way endobronchial valves (EBVs), while allowing broader patient access by focusing on unique emphysema characteristics.
  • 328 airway scaffolds were placed with a success rate of 92.4% and minimal need for removals.
  • The primary outcome measured was the incidence of serious adverse events over six months, which occurred in 21.7% of participants and mainly consisted of pneumonia and respiratory infections.
  • The scaffolding technique did not result in any pneumothorax, a common complication seen with traditional EBV methods, thereby reducing the need for extended hospital stays.

Takeaways From Dr. Kapp and Dr. Kalhan
The BREATHE trial was not powered for efficacy outcomes so the promising results, while exciting, should be treated with mild skepticism until they’re reproduced in a randomized controlled trial.
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However, the trial offers a fresh perspective on how to address persistent hyperinflation in patients with COPD. The success rates and the reduced incidence of procedural complications highlight the potential of these scaffolds as a viable alternative to existing treatments. More randomized trials are needed to better assess safety and efficacy.
Christopher M. Kapp, MD, Assistant Professor of Pulmonary and Critical Care
Ravi Kalhan, MD, MS, Associate Dean for Faculty Affairs, Louis A. Simpson Professor of Pulmonary Medicine, Professor of Pulmonary and Critical Care, Professor of Epidemiology

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