Characterizing the Mechanism of Action of Metered Cryospray for the Treatment of Patients with Chronic Obstructive Pulmonary Disease with Chronic Bronchitis
CSA Medical, Inc.
Duration of Study in the UK
2 years, 11 months, 30 days
32 subjects will be enrolled in this prospective, multi-centre, blinded, sham-controlled trial with 1:1 randomisation, evaluating the relationship between airway structure and function in patients with chronic bronchitis treated with metered cryospray (MCS).
Patients randomised to the treatment arm will undergo two MCS treatments performed through a bronchoscopy at general anaesthetic, with sequential treatments of the left and right lungs. To explore the effects of MCS treatment, samples will be collected before each treatment to enable laboratory based scientific evaluation.
Treatment arm subjects will be followed up at 3, 6 and 12 months with further bronchoscopies performed at the 6 and 12 month time points to enable comparative sampling.
Patients randomised to the control arm will undergo two sham procedures to maintain the blind and to enable the collection of control samples.
Control arm subjects will be followed up at 3 and 6 months with a further bronchoscopy performed at the 6 month time point to enable comparative sampling.
Subjects is both arms will additionally undergo pre- and post- treatment pulmonary function testing, small airways testing, HRCT, 6MWT (six minute walk test) and be asked to complete patient reported outcome measures (PROM) questionnaires at the specific intervals.
Control arm subjects are eligible to receive treatment after the 6-month (primary endpoint) visit with a single further visit at 6 months post-MCS treatment.
Following completion of the study follow-up period, all subjects will be offered ongoing NHS clinical follow-up.
London - London Bridge Research Ethics Committee
Date of REC Opinion
28 May 2019
Further Information Favourable Opinion