Metered-Dose Liquid Nitrogen Cryospray for Chronic Bronchitis: Results From the Prospective, Sham-Controlled Trial (SPRAY-CB).

Authors

Gerard J Criner, Robert F Browning, Muhanned Abu-Hijleh, Ken Y Yoneda, Charlie Strange, Momen M Wahidi, Joseph C Seaman, Ganesh Krishna, Gustavo Cumbo-Nacheli, Ashutosh Sachdeva, Richard Sue, Sandeep Bansal, Thomas R Gildea, Christian Ghattas, J Scott Ferguson, David Feller-Kopman, Jonathan S Kurman, Pallav L Shah

Published in

American journal of respiratory and critical care medicine. Sep 21, 2026. Epub Sep 21, 2026.

Abstract

COPD with chronic bronchitis is characterized by productive cough with sputum and mucociliary dysfunction, contributing to morbidity and impaired quality of life. The RejuvenAir® System, a cryosurgical device delivering metered doses of medical-grade liquid nitrogen (i.e., Metered Cryospray [MCS]) to bronchial airways, may stimulate healthy epithelial cell regeneration.
To assess the safety and effectiveness of MCS treatment in patients with COPD and CB.
Eligible patients were randomized 2:1 to receive two bronchoscopies with therapeutic mucus clearance, with or without MCS treatment (i.e., MCS or control group, respectively), 30-60 days apart. Safety and clinical effectiveness outcomes were assessed 12 months post-MCS treatment.
Overall, 203 patients (MCS: N = 136; sham: N = 67) were evaluated. MCS-treated patients had significantly greater improvement in Total St. George's Respiratory Questionnaire (SGRQ) scores versus controls (treatment difference [95% confidence interval; CI]: -5.9 [-11.6, -0.2]; p = 0.0422), and Total COPD Assessment Test (CAT) scores (treatment difference [95% CI]: -3.4 [-5.8, -1.0]; p = 0.005). Acute exacerbation of COPD (AECOPD; all severities) rates were 70.6% (MCS group) versus 67.2% (control group). Severe AECOPD rates were 21.3% (MCS group) versus 26.9% (control group). Periprocedural pneumothoraces rate per number of MCS treatments delivered was 3.6% (n/N=10/276). Eight deaths, 6 (4.3%; MCS) and 2 (2.9%; control), occurred during the study, none were device- or procedure-related. No unanticipated adverse device effects occurred.
MCS treatment demonstrated significant improvement in Total SGRQ and CAT scores, greater reductions in severe AECOPD rates compared to sham, and an acceptable risk-benefit safety profile in patients with COPD and CB.

PMID:
42768446
Bibliographic data and abstract were imported from PubMed on 22 Sep 2026.

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