Metered Cryospray for the Treatment of Patients With Chronic Obstructive Pulmonary Disease With Chronic Bronchitis
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|ClinicalTrials.gov Identifier: NCT03892694|
Recruitment Status : Active, not recruiting
First Posted : March 27, 2019
Last Update Posted : February 23, 2023
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|Condition or disease||Intervention/treatment||Phase|
|COPD Chronic Bronchitis||Device: RejuvenAir System Other: Sham||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||32 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||Prospective, multi-centre, randomised, blinded, sham controlled trial with 1:1 randomisation. Sham-control arm subjects are eligible to receive treatment after the 6-month visit.|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Masking Description:||Sham controlled.|
|Official Title:||Characterizing the Mechanism of Action of Metered Cryospray for the Treatment of Patients With Chronic Obstructive Pulmonary Disease With Chronic Bronchitis|
|Actual Study Start Date :||February 14, 2020|
|Actual Primary Completion Date :||April 15, 2022|
|Estimated Study Completion Date :||February 2023|
Active Comparator: Treatment
Device: RejuvenAir System
Bronchial metered cryospray using RejuvenAir® System.
Sham Comparator: Sham Control
Sham control procedure
- Goblet cell density [ Time Frame: 6-months post treatment ]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
- Histopathological examination of endobronchial cryobiopsies to determine Inflammatory cells and subtype density per mm of basement membrane [ Time Frame: 6-months post treatment ]Proportion of inflammatory cells per mm of basement membrane for Neutrophil and Lymphocyte sequencing (RNA-seq)
- Histopathological examination of endobronchial cryobiopsies to determine epithelial cell density and area (including respiratory epithelial, goblet and basal cells) per mm of basement membrane [ Time Frame: 6-months post treatment ]Proportion of epithelial cells per mm of basement membrane for Ciliary and Goblet cells
- Transcriptomics: Epithelial gene expression as measured by global gene expression sequencing (RNA-seq) [ Time Frame: 6-months post treatment ]Transcriptomics: Epithelial gene expression as measured by global gene expression sequencing (RNA-seq)
- Pulmonary function tests including spirometry, body plethysmography and transfer factors KCO and TLCO [ Time Frame: 6-months post treatment ]Pulmonary function tests including spirometry, body plethysmography and transfer factors KCO and TLCO
- Patient reported outcome measures including SGRQ, mMRC, CAT and Cough Questionnaires [ Time Frame: 6-months post treatment ]Patient reported outcome measures including SGRQ, mMRC, CAT and Cough Questionnaires
- 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 ]Health care utilisation assessments including number of respiratory exacerbations, emergency room visits, hospital and intensive care unit admissions related to respiratory adverse events
- The 6-minute walk tests [ Time Frame: 6-months post treatment ]The 6-minute walk tests
- Microvesicle quantification [ Time Frame: 6-months post treatment ]Microvesicle quantification
- Lobar volumes and gas trapping as determined by quantitative CT and parametric response mapping [ Time Frame: 6-months post treatment ]Lobar volumes and gas trapping as determined by quantitative CT and parametric response mapping
- Small airways function as assessed by Impulse Oscillometry (IOS) [ Time Frame: 6-months post treatment ]Small airways function as assessed by Impulse Oscillometry (IOS)
- Composition of epithelial ultrastructure as assessed by transmission electron microscopy [ Time Frame: 6-months post treatment ]Composition of epithelial ultrastructure as assessed by transmission electron microscopy
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||40 Years to 79 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
Each Subject must meet the following criteria to be enrolled in the study:
- Males and females ≥40 to <80 years of age.
- Subject is able to read, understand, and sign a written Informed Consent in order to participate in the study.
- Subject has a diagnosis of CB and COPD and has been symptomatic for a minimum of two years. (Chronic Bronchitis is defined clinically as chronic productive cough for 3 months in each of 2 successive years in a patient in whom other causes of productive cough have been excluded).
- Subject is classified as having moderate or severe (GOLD stage 2-3) airflow obstruction defined by a post-bronchodilator of =>30% FEV1 to <80% predicted with a baseline FEV1/FVC of <0.70.
- Subject has a COPD assessment tool (CAT) score of ≥10.
- Subject is being treated according to current medically accepted treatment guidelines without successful resolution of chronic bronchitis and agrees to continue maintenance pulmonary/COPD medications (as defined per GOLD Standard for medications) for the duration of the study (subject must be on a regime of pulmonary medications for a minimum of 2 weeks prior to enrolment into the study).
- Smoking history of at least 10 pack years.
- Non-smoking for a minimum of 2 months prior to consent and agrees to continue not smoking for the duration of the study.
- Subject is able to adhere to and undergo 4 bronchoscopic procedures (5 for control subjects accepting cross over option), in the opinion of the investigator or per hospital guidelines.
- For women of childbearing potential: non-pregnant, non-lactating, and agree to practice an adequate birth control method (abstinence, combination barrier and spermicide, or hormonal) for the duration of the study.
A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Subject has had an acute pulmonary infection, exacerbation or pneumonia requiring medical treatment (with antibiotics and/or steroids) within 6 weeks of initially planned study bronchoscopy.
- Diagnosis of asthma with an onset before 30 years of age.
- Subject has Alpha-1 antitrypsin deficiency.
- Subject has other origins of respiratory disease aside from chronic bronchitis and COPD.
- Subject is using e-cigarettes, vaping or taking any oral or inhaled substances not prescribed by a physician.
- Subject has untreatable or life-threatening arrhythmias, or history of inability to adequately oxygenate during a bronchoscopy, or has acute respiratory failure with hypercapnia.
- Subject has bullous emphysema characterized as large bullae >30 millimetres on HRCT; or subject has stenosis in the tracheobronchial system, tracheobronchomegaly, trachea-bronchomalacia, amyloidosis or cystic fibrosis.
- Subject has clinically significant bronchiectasis
- Subject has had a transplant procedure (any).
- Subject has a known mucosal tear, has undergone prior lung surgery such as pneumonectomy, lobectomy, bullectomy, or lung volume reduction surgery, bronchial thermoplasty, rheoplasty or cryotherapy.
- Subject has had a prior lung device procedure, including emphysema stent(s) implanted, lung coils, valves, lung denervation or other devices for emphysema.
- Subject is unable to temporarily discontinue use of anticoagulant therapy: warfarin, Coumadin, LMWH, heparin, clopidrogel (or equal).
- Subject has a serious medical condition, such as: uncontrolled coagulopathy or bleeding disorder, congestive heart failure, uncontrolled angina, myocardial infarction in the past year, renal failure, liver disease, cerebrovascular accident within the past 6 months, uncontrolled diabetes, uncontrolled hypertension, autoimmune disease or uncontrolled gastric reflux.
- Subject has or is receiving chemotherapy or active radiation therapy within the past 6 months or is expected to receive chemotherapy during participation in this study.
- Subject is or has been in another clinical investigational study within 6 weeks of enrolment.
- Subject has known sensitivity to medication required to perform bronchoscopy (such as lidocaine, atropine, and benzodiazepines).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03892694
|University Medical Center Groningen|
|The Royal Brompton Hospital|
|London, United Kingdom, SW3 6NP|
|Principal Investigator:||Pallav Shah, MD||The Royal Brompton Hospital|
|Responsible Party:||CSA Medical, Inc.|
|Other Study ID Numbers:||
|First Posted:||March 27, 2019 Key Record Dates|
|Last Update Posted:||February 23, 2023|
|Last Verified:||February 2023|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
|Product Manufactured in and Exported from the U.S.:||Yes|
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Respiratory Tract Infections