RT Journal Article
SR Electronic
T1 A Prospective Safety and Feasibility Study of Metered CryoSpray (MCS) 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
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/early/2020/06/25/13993003.00556-2020.abstract
AB Background No currently approved intervention counteracts airway metaplasia and mucus hypersecretion of Chronic Bronchitis (CB) in COPD. Metered Cryospray (MCS) delivering liquid nitrogen (LN2) 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 CB.Methods Patients with a FEV1, 30–80% of expected, taking optimal medication were recruited. Primary outcomes: feasibility – completion of treatments; efficacy – 3-month change in St George's Respiratory Questionnaire (SGRQ); safety – incidence of adverse events (AEs). Secondary outcomes: lung function, exercise capacity, additional patient-reported outcomes (PROs).Results 35 patients, 19 male/16 female, aged 47–76 years, GOLD grade I (3), II (10) and III (22), underwent staggered LN2 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. Approximately 1800 doses of MCS were delivered.Clinically meaningful improvements in PROs were observed at 3-months; ΔSGRQ −6·4 [95% CI −11.4, −1.3; p=0·01], COPD Assessment Test (CAT) −3·8 [95% CI −6.4, −1.3; p<0·01] and Leicester Cough Questionnaire (LCQ) 21·6 [95% CI 7.3, 35.9; p<0·01]. CAT changes were durable to 6-months (−3·4 [95% CI −5.9, −0.9; p=0·01]), SGRQ and LCQ to 9-months (−6·9 [95% CI −13.0, −0.9; p=0·03] and 13·4 [95% 2.1, 24.6; p=0·02], respectively).At 12-months, 14 serious AEs were recorded in 11 (31·4%) subjects, 6 moderate (43%) and 8 severe (57%). 9 were respiratory-related: 6 exacerbations of COPD, 2 pneumonias, and 1, increased coughing, recovered without sequelae. None were serious device or procedure-related AEs.Conclusion MCS is safe, feasible and associated with clinically meaningful improvements in multidimensional PROs.FootnotesThis manuscript has recently been accepted for publication in the European Respiratory Journal. It is published here in its accepted form prior to copyediting and typesetting by our production team. After these production processes are complete and the authors have approved the resulting proofs, the article will move to the latest issue of the ERJ online. Please open or download the PDF to view this article.Conflict of interest: Dr. Garner has nothing to disclose.Conflict of interest: Dr. Shaipanich has nothing to disclose.Conflict of interest: Dr. Hartman has nothing to disclose.Conflict of interest: Dr. Orton has nothing to disclose.Conflict of interest: Ms Caneja has nothing to disclose.Conflict of interest: Dr. Klooster has nothing to disclose.Conflict of interest: Dr. Klooster has nothing to disclose.Conflict of interest: Dr. Klooster has nothing to disclose.Conflict of interest: Dr. Slebos reports grants, non-financial support and other from CSA Medical, USA, during the conduct of the study; grants, non-financial support and other from PulmonX, USA, grants, non-financial support and other from Nuvaira, USA, grants, non-financial support and other from PneumRx/BTG, USA, other from FreeFlowMedical, USA, outside the submitted work; .Conflict of interest: Professor Shah was reimbursed for travel expenses incurred during the training with the medical device and trial protocol development. The hospital was reimbursed for all clinical trial related costs.