The effects of Metered cryospray on quantitative computed tomography metrics in patients with COPD with chronic bronchitis

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Introduction: Metered cryospray (MCS) uses titrated applications of liquid nitrogen to remodel the bronchial epithelium, in patients with COPD with chronic bronchitis (CB). Aims: To investigate the effects of MCS on quantitative CT metrics in patients with COPD with CB. Methods: A multicentre, randomised, blinded, sham-controlled trial, in patients with COPD with CB, to receive MCS or sham-procedure, plus standard care. Clinical characterisations, and CT thoraces were performed and assessed using LungQ-AA, Thirona, the Netherlands. NCT: 03892694 Results: 32 patients were assigned to MCS (n=15) or sham-procedure (n=17). A -9.6 points between groups improvement in SGRQ total score (SD ± 11.1; n=31; p=0.02) was observed at 6-months post-MCS, relative to baseline. MCS led to a -8·6 % (SD 4·6; n=27; p=<0·0001) fall in expiratory Low Attenuation Area at -856 HU compared to sham control, at six-months, relative to baseline. Following MCS, VERA (Ventilation Estimation deep learning Analysis) ‘air trapping general’ lung tissue was reduced by -6·3 % (SD 5·6 %; n=27; p=0·007), and VERA ‘normal’ lung tissue increased by 8·3 % (SD 5·0; n=27; p=0·0002) at six-months, relative to baseline. After MCS, a 3·3 % (SD 3·4 %; n=31; p=0·01) increase in pre-segmental airway wall thickness was demonstrated, at six-months, relative to baseline. No difference in mucous plug count, or luminal calibre was identified. Conclusions: The clinical efficacy of MCS corresponds with sustained reduction in radiological air trapping metrics, and large airways treatment effect, progressing mechanistic understanding, and confirming the disease modifying potential of induced epithelial remodelling.

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