A Prospective Safety and Feasibility Study of Metered CryoSpray (MCS) for Patients with Chronic Bronchitis in COPD

Abstract

<jats:sec><jats:title>Background</jats:title><jats:p>No currently approved intervention counteracts airway metaplasia and mucus hypersecretion of Chronic Bronchitis (CB) in COPD. Metered Cryospray (MCS) delivering liquid nitrogen (LN<jats:sub>2</jats:sub>) 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.</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>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).</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>35 patients, 19 male/16 female, aged 47–76 years, GOLD grade I (3), II (10) and III (22), underwent staggered LN<jats:sub>2</jats:sub> treatments to the tracheobronchial tree.</jats:p><jats:p>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.</jats:p><jats:p>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&lt;0·01] and Leicester Cough Questionnaire (LCQ) 21·6 [95% CI 7.3, 35.9; p&lt;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).</jats:p><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p>MCS is safe, feasible and associated with clinically meaningful improvements in multidimensional PROs.</jats:p></jats:sec>

A prospective study of spray cryotherapy in patients with COPD

“…No adverse events were observed during treatment and follow-up. 13 In a clinical trial 14 conducted in 2020, which included 35 subjects (19 men and 16 women) aged 47-76 years, 34 patients were observed to have significant clinical improvement at 3 months after all three metered cryospray treatments. Specifically, there was a mean reduction of 6.4 points on the SGRQ scale (95% CI −11.4 to −1.3; p = .01), a mean reduction of 3.8 points in the CAT score (95% CI −6.4 to −1.3; p < .01) and a mean increase in LCQ score of 21.6 (95% CI 7.3−35.9; p < .01).…”

Endoscopic Options for Moderate COPD, Chronic Bronchitis, and Uncontrolled Asthma

“…This reversal of inflamed epithelium may also lessen systemic inflammation. 24 Initial studies have demonstrated safety and efficacy of this technology. A multicentric, randomized, sham controlled trial is currently recruiting.…”

New bronchoscopic treatment modalities for patients with chronic bronchitis

“…In the first clinical trial, the cryospray procedure was performed in three separate treatments (right lower lobe, left lower lobe and both upper lobes and trachea separately) with ∼45 days in between. The treatment was performed under general anasethesia with an average procedure time of ∼30 min [29]. In future trials the treatment will be completed in two procedures.…”

“…The RejuvenAir study (NCT02483637) was a prospective, single-arm, open-label trial investigating the safety and feasibility of the treatment for the first time in chronic bronchitis patients [29]. The treatment was completed in three separate procedures and the patients were fit for discharge the same day (except for two pre-planned overnight stays).…”