Safety and Feasibility Study of Rejuvenair™ for Treating Chronic Bronchitis Patients

Study Overview
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Brief Summary
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This study evaluates the safety of RejuvenAir Cryospray therapy to treat symptomatic chronic bronchitis patients with airflow restrictions.

Detailed Description
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Prospective, open label, single arm study with sequential accrual of subjects with known chronic bronchitis. There are two phases to this study. Phase A will enroll up to 12 subjects and will treat a single lobe to assess safety, feasibility and histology/immunology. After review of the data by the Data Safety Monitoring Board, Phase B of the study would begin. In Phase B of the study, Phase A subjects would have their remaining two lobes treated. In addition up to 24 subjects will be enrolled and will have all upper and lower lobes treated to assess safety, feasibility and immunology.

Official Title
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A Prospective Safety and Feasibility Study of the RejuvenAir™ System Metered Cryospray Therapy for Chronic Bronchitis Patients

Conditions
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Bronchitis, Chronic, Cryotherapy Effect

Intervention / Treatment
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* Device: RejuvenAir


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females ≥40 to ≤75 years of age. Subject is able to read, understand, and sign a written Informed Consent in order to participate in the study. Subject agrees to continue maintenance pulmonary/COPD medications for the duration of the study. Diagnosis of chronic bronchitis (CB) and chronic obstructive pulmonary disease (COPD) 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.) Pre-procedure post bronchodilator FEV1 of greater than or equal to 30% and less than or equal to 80% of predicted within 3 months of enrollment. Smoking history of at least 10 pack years. Non-smoking for a minimum of 6 months prior to consent and agrees to continue not smoking for the duration of the study. Subject is able to adhere to and undergo 3 (4 if in Phase A) bronchoscope procedures that includes lung biopsies and multiple MCS treatments in the opinion of the investigator Exclusion Criteria: Subject has had an acute pulmonary infection or pneumonia within prior 6 weeks of study bronchoscopy. Subject has had a CB and/or COPD exacerbation (requiring steroids and/or antibiotics) within 6 weeks prior to study bronchoscopy, as defined by their treating physician Subject has clinically significant bronchiectasis or other respiratory disease other than chronic bronchitis and COPD. Diagnosis of asthma with an onset before 30 years of age Subject has bullous emphysema characterized as large bullae >30 millimeters on CT. Subject has had a transplant. Subject has the inability to walk >140 meters Subject has PaC02 >8kPa, or a PaO2<7kPa at room air. Subject has a RVSP >45mmHg or a LVEF<45% on 2D-cardiac echo. Subject has undergone lung surgery: pneumonectomy, lobectomy, bullectomy, lung volume reduction surgery 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, clopidogrel (or equal) Subject is on >10 mg of prednisolone/day. Subject has a serious medical condition, such as: uncontrolled congestive heart failure, uncontrolled angina, myocardial infarction in the past year, renal failure, liver disease, cerebrovascular accident within the past 6 months, uncontrolled diabetes, hypertension, autoimmune disease or uncontrolled gastric reflux Subject is pregnant, nursing, or planning to get pregnant during study duration. Subject has received chemotherapy 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 baseline. Subject has known sensitivity to medication required to perform bronchoscopy (such as lidocaine, atropine, and benzodiazepines). Subject has been in another clinical investigational study within 6 weeks of baseline.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: RejuvenAir
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RejuvenAir<br>RejuvenAir treatment of the right lower lobe and right main stem bronchus. Each MCS will be tailored to the bronchial area undergoing treatment and the amount of liquid nitrogen delivered will vary depending on the airway diameter. | Device: RejuvenAir<br>* Device: RejuvenAir<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse and Serious Adverse Events | Number of subjects with treatment emergent adverse events. Observed rates and two-sided 95% exact confidence interval will be calculated for AE rates and SAE rates overall and for organ class. | Change from Baseline to 3-Months Following Completion of Treatments | 
| Ability to Complete all 3 MCS Treatments | Number of subjects completing all 3 treatments. | Change from Baseline to 3-Months Following Completion of Treatments | 
| Patient Reported Outcome Instrument: St. George's Respiratory Questionnaire (SGRQ) | Scale is 0-100; a higher score is worse | Change from Baseline to 3-Months Following Completion of Treatments | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spirometry Testing | FEV1, FEV1/FVC, VC, FIV1 | Change from Baseline to 3-Months, 1 year, 2 year and 3 year Following Completion of Treatments | 
| 6 Minute Walk Test | Number of meters walked in six minutes | Change from Baseline to 3-Months, 1 year, 2 year and 3 year Following Completion of Treatments | 
| Leicester Cough Questionnaire (LCQ) | The total score range is 19-133; a higher score is better. | Change from Baseline to 3-Months, 1 year, 2 year and 3 year Following Completion of Treatments | 
| COPD Assessment Test (CAT) | The total score range is 0-40; a higher score is worse | Change from Baseline to 3-Months, 1 year, 2 year and 3 year Following Completion of Treatments | 
| Visual Analog Scale (VAS) | The total score range is 0-100; a higher score is worse | Change from Baseline to 3-Months, 1 year, 2 year and 3 year Following Completion of Treatments | 
| Modified Medical Research Council (mMRC) | The total score range is 0-4; a higher score is worse | Change from Baseline to 3-Months, 1 year, 2 year and 3 year Following Completion of Treatments | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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spray cryotherapy, cryotherapy, chronic bronchitis, airflow restrictions