RT Journal Article
SR Electronic
T1 A prospective safety and feasibility study of metered cryospray for patients with chronic bronchitis in COPD
JF European Respiratory Journal
JO Eur Respir J
FD European Respiratory Society
SP 2000556
DO 10.1183/13993003.00556-2020
VO 56
IS 6
A1 Justin L. Garner
A1 Tawimas Shaipanich
A1 Jorine E. Hartman
A1 Christopher M. Orton
A1 Cielito Caneja
A1 Karin Klooster
A1 John Thornton
A1 Don D. Sin
A1 Dirk-Jan Slebos
A1 Pallav L. Shah
YR 2020
UL http://erj.ersjournals.com/content/56/6/2000556.abstract
AB Background No currently approved intervention counteracts airway metaplasia and mucus hypersecretion of chronic bronchitis in COPD. However, metered cryospray (MCS) delivering liquid nitrogen to the tracheobronchial airways ablates abnormal epithelium and facilitates healthy mucosal regeneration. The objective of this study was to evaluate the feasibility, efficacy and safety of MCS in chronic bronchitis.Methods Patients with a forced expiratory volume in 1 s of 30–80% predicted who were taking optimal medication were recruited. Primary outcomes were feasibility (completion of treatments), efficacy (3-month change in St George's Respiratory Questionnaire (SGRQ)) and safety (incidence of adverse events). Secondary outcomes were lung function, exercise capacity and additional patient-reported outcomes.Results 35 patients, 19 male/16 female, aged 47–76 years, Global Initiative for Chronic Obstructive Lung Disease grade I (n=3), II (n=10) and III (n=22), underwent staggered liquid nitrogen treatments to the tracheobronchial tree. 34 patients completed three treatments, each lasting 34.3±12.1 min, separated by 4–6 weeks; one withdrew after the first treatment. ∼1800 doses of MCS were delivered. Clinically meaningful improvements in patient-reported outcomes were observed at 3 months: change in SGRQ −6.4 (95% CI −11.4 to −1.3; p=0.01), COPD Assessment Test (CAT) −3.8 (95% CI −6.4 to −1.3; p<0.01) and Leicester Cough Questionnaire (LCQ) 21.6 (95% CI 7.3 to 35.9; p<0.01). Changes in CAT were durable to 6 months (−3.4, 95% CI −5.9 to −0.9; p=0.01); changes in SGRQ and LCQ were durable to 9 months (−6.9, 95% CI −13.0 to −0.9; p=0.03 and 13.4, 95% CI 2.1 to 24.6; p=0.02, respectively. At 12 months, 14 serious adverse events were recorded in 11 (31.4%) subjects; six (43%) moderate and eight (57%) severe. Nine were respiratory-related: six exacerbations of COPD, two pneumonias and one case of increased coughing; all recovered without sequelae. None were serious device- or procedure-related adverse events.Conclusion MCS is safe, feasible and associated with clinically meaningful improvements in multidimensional patient-reported outcomes.RejuvenAir system treatment for individuals with chronic bronchitis in COPD is safe, feasible, well tolerated, and resulted in clinically meaningful improvements in multidimensional measures of cough, sputum production, breathlessness and quality of life https://bit.ly/30KBfPs