To evaluate the relationship between airway structure and function in patients with chronic bronchitis treated with metered cryospray (MCS).
To identify the molecular and cellular targets of MCS treatment and determine the mechanistic relationship to airways remodelling in patients with chronic bronchitis. Phenotype, characterise and correlate clinical, physiological, histological and molecular parameters in patients with chronic bronchitis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
32
Bronchial metered cryospray using RejuvenAir® System.
Sham control procedure
University Medical Center Groningen
Groningen, Netherlands
The Royal Brompton Hospital
London, United Kingdom
Goblet cell density
Difference in change relative to baseline in goblet cell density per mm of basement membrane in endobronchial cryobiopsies at 6-months between treatment and sham-control groups
Time frame: 6-months post treatment
Histopathological examination of endobronchial cryobiopsies to determine Inflammatory cells and subtype density per mm of basement membrane
Proportion of inflammatory cells per mm of basement membrane for Neutrophil and Lymphocyte sequencing (RNA-seq)
Time frame: 6-months post treatment
Histopathological examination of endobronchial cryobiopsies to determine epithelial cell density and area (including respiratory epithelial, goblet and basal cells) per mm of basement membrane
Proportion of epithelial cells per mm of basement membrane for Ciliary and Goblet cells
Time frame: 6-months post treatment
Transcriptomics: Epithelial gene expression as measured by global gene expression sequencing (RNA-seq)
Transcriptomics: Epithelial gene expression as measured by global gene expression sequencing (RNA-seq)
Time frame: 6-months post treatment
Pulmonary function tests including spirometry, body plethysmography and transfer factors KCO and TLCO
Pulmonary function tests including spirometry, body plethysmography and transfer factors KCO and TLCO
Time frame: 6-months post treatment
Patient reported outcome measures including SGRQ, mMRC, CAT and Cough Questionnaires
Patient reported outcome measures including SGRQ, mMRC, CAT and Cough Questionnaires
Time frame: 6-months post treatment
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Health care utilisation assessments including number of respiratory exacerbations, emergency room visits, hospital and intensive care unit admissions related to respiratory adverse events
Health care utilisation assessments including number of respiratory exacerbations, emergency room visits, hospital and intensive care unit admissions related to respiratory adverse events
Time frame: 6-months post treatment
The 6-minute walk tests
The 6-minute walk tests
Time frame: 6-months post treatment