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

Cryotherapy Effect Clinical Trial

— Feasibility  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02483637
• Other study ID #: 012
• Status: Completed
• Phase: N/A
• Start date: February 2016
• Est. completion date: May 20, 2022

Study information

• Verified date: February 2023
• Source: CSA Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 20, 2022
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Disease
• Bronchitis
• Bronchitis, Chronic
• Cryotherapy Effect

Intervention

Device:
• RejuvenAir
Device: RejuvenAir

Locations

Country	Name	City	State
Canada	St. Paul's Hospital	Vancouver	British Columbia
Netherlands	University Medical Center Groningen	Groningen
United Kingdom	Chelsea and Westminster Hosptial/Royal Brompton Hosptial	London

Sponsors (1)

Lead Sponsor	Collaborator
CSA Medical, Inc.

Countries where clinical trial is conducted

Canada,  Netherlands,  United Kingdom, 

References & Publications (10)

Gibson PG. Cough is an airway itch? Am J Respir Crit Care Med. 2004 Jan 1;169(1):1-2. doi: 10.1164/rccm.2310009. No abstract available. — View Citation

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

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. doi: 10.1378/chest.130.4.1102. — View Citation

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. doi: 10.1164/rccm.200202-150WS. No abstract available. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. doi: 10.1164/ajrccm/140.6.1527. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exacerbation Rate	Annualized exacerbation rates	Change from Baseline to 3-Months, 1 year, 2 year and 3 year Following Completion of Treatments
Other	Airway Wall Thickness Using HRCT	Lumen radius in mm.	Change from Baseline to 3-Months, 1 year, 2 year and 3 year Following Completion of Treatments
Other	Plasma Fibrinogen	150-400mg/dL	Change from Baseline to 3-Months, 1 year, 2 year and 3 year Following Completion of Treatments
Primary	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
Primary	Ability to Complete all 3 MCS Treatments	Number of subjects completing all 3 treatments.	Change from Baseline to 3-Months Following Completion of Treatments
Primary	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	Spirometry Testing	FEV1, FEV1/FVC, VC, FIV1	Change from Baseline to 3-Months, 1 year, 2 year and 3 year Following Completion of Treatments
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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