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

Study Description

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Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Bronchitis, Chronic; Cryotherapy Effect	Device: RejuvenAir	Not Applicable

Detailed Description:

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	30 participants
Intervention Model:	Single Group Assignment
Intervention Model Description:	RejuvenAir
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	A Prospective Safety and Feasibility Study of the RejuvenAir™ System Metered Cryospray Therapy for Chronic Bronchitis Patients
Study Start Date :	February 2016
Estimated Primary Completion Date :	September 2019
Estimated Study Completion Date :	September 2019

Arms and Interventions

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Arm	Intervention/treatment
Experimental: RejuvenAir; 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; Device: RejuvenAir

Outcome Measures

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Primary Outcome Measures :

1. Adverse and Serious Adverse Events [ Time Frame: 60 days ]

Secondary Outcome Measures :

1. Histologic appearance of bronchial biopsies in Phase A subjects [ Time Frame: 60 days ]
2. Airway wall thickness using high resolution computed tomography (HRCT) [ Time Frame: 3 years ]

Eligibility Criteria

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Ages Eligible for Study:	40 Years to 75 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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, clopidrogel (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.

Contacts and Locations

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Locations

Canada, British Columbia
St. Paul's Hospital
Vancouver, British Columbia, Canada
Netherlands
University Medical Center Groningen
Groningen, Netherlands
United Kingdom
Chelsea and Westminster Hosptial/Royal Brompton Hosptial
London, United Kingdom, SW10 9NH

Sponsors and Collaborators

CSA Medical, Inc.

Investigators

Study Director:	Ellen Sheets, MD, MBA	CSA Medical

More Information

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Additional Information:

accessed 5.12.2015 

Publications:

Thompson AB, Daughton D, Robbins RA, Ghafouri MA, Oehlerking M, Rennard SI. Intraluminal airway inflammation in chronic bronchitis. Characterization and correlation with clinical parameters. Am Rev Respir Dis. 1989 Dec;140(6):1527-37.

Innes AL, Woodruff PG, Ferrando RE, Donnelly S, Dolganov GM, Lazarus SC, Fahy JV. Epithelial mucin stores are increased in the large airways of smokers with airflow obstruction. Chest. 2006 Oct;130(4):1102-8.

Ramos FL, Krahnke JS, Kim V. Clinical issues of mucus accumulation in COPD. Int J Chron Obstruct Pulmon Dis. 2014 Jan 24;9:139-50. doi: 10.2147/COPD.S38938. eCollection 2014. Review.

Godwin BL, Coad JE, "Healing responses following cryothermic and hyperthermic tissue ablation. " SPIE Proceedings 2009: Volume 7181, p1-9

Sciurba FC, Ernst A, Herth FJ, Strange C, Criner GJ, Marquette CH, Kovitz KL, Chiacchierini RP, Goldin J, McLennan G; VENT Study Research Group. A randomized study of endobronchial valves for advanced emphysema. N Engl J Med. 2010 Sep 23;363(13):1233-44. doi: 10.1056/NEJMoa0900928.

Shah PL, Zoumot Z, Singh S, Bicknell SR, Ross ET, Quiring J, Hopkinson NS, Kemp SV; RESET trial Study Group. Endobronchial coils for the treatment of severe emphysema with hyperinflation (RESET): a randomised controlled trial. Lancet Respir Med. 2013 May;1(3):233-40. doi: 10.1016/S2213-2600(13)70047-X. Epub 2013 Apr 23.

Gibson PG. Cough is an airway itch? Am J Respir Crit Care Med. 2004 Jan 1;169(1):1-2.

Jeffery P, Holgate S, Wenzel S; Endobronchial Biopsy Workshop. Methods for the assessment of endobronchial biopsies in clinical research: application to studies of pathogenesis and the effects of treatment. Am J Respir Crit Care Med. 2003 Sep 15;168(6 Pt 2):S1-17. Review.

Pulmonary Physiology, Levitzky M. 7th ed. 2007, The McGraw-Hill Companies

Smith BM, Hoffman EA, Rabinowitz D, Bleecker E, Christenson S, Couper D, Donohue KM, Han MK, Hansel NN, Kanner RE, Kleerup E, Rennard S, Barr RG. Comparison of spatially matched airways reveals thinner airway walls in COPD. The Multi-Ethnic Study of Atherosclerosis (MESA) COPD Study and the Subpopulations and Intermediate Outcomes in COPD Study (SPIROMICS). Thorax. 2014 Nov;69(11):987-96. doi: 10.1136/thoraxjnl-2014-205160. Epub 2014 Jun 13.

Responsible Party:	CSA Medical, Inc.
ClinicalTrials.gov Identifier:	NCT02483637 History of Changes
Other Study ID Numbers:	012
First Posted:	June 29, 2015
Last Update Posted:	October 12, 2017
Last Verified:	October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Keywords provided by CSA Medical, Inc.:

spray cryotherapy; cryotherapy; chronic bronchitis; airflow restrictions

Additional relevant MeSH terms:

Bronchitis; Acute Disease; Bronchitis, Chronic; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive	Lung Diseases; Respiratory Tract Infections; Disease Attributes; Pathologic Processes; Pulmonary Disease, Chronic Obstructive