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

NCT02483637 | Completed DMC

• 1 other identifier: 012
• Study Type: interventional
• Target: 30
• Locations: 3 countries
• Sites: 3

Brief Summary

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

Conditions

Bronchitis, Chronic; Cryotherapy Effect

Keywords

spray cryotherapy; cryotherapy; chronic bronchitis; airflow restrictions

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Spirometry Testing

  Change from Baseline to 3-Months, 1 year, 2 year and 3 year Following Completion of Treatments

• 6 Minute Walk Test

  Change from Baseline to 3-Months, 1 year, 2 year and 3 year Following Completion of Treatments

• Leicester Cough Questionnaire (LCQ)

  Change from Baseline to 3-Months, 1 year, 2 year and 3 year Following Completion of Treatments

• COPD Assessment Test (CAT)

  Change from Baseline to 3-Months, 1 year, 2 year and 3 year Following Completion of Treatments

• Visual Analog Scale (VAS)

  Change from Baseline to 3-Months, 1 year, 2 year and 3 year Following Completion of Treatments

Other Outcomes (3)

• Exacerbation Rate

  Change from Baseline to 3-Months, 1 year, 2 year and 3 year Following Completion of Treatments

• Airway Wall Thickness Using HRCT

  Change from Baseline to 3-Months, 1 year, 2 year and 3 year Following Completion of Treatments

• Plasma Fibrinogen

  Change from Baseline to 3-Months, 1 year, 2 year and 3 year Following Completion of Treatments

Study Arms (1)

RejuvenAir

EXPERIMENTAL

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

Interventions

RejuvenAir DEVICE

Device: RejuvenAir

RejuvenAir

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• CSA Medical, Inc.: lead

Study Sites (3)

St. Paul's Hospital

Vancouver, British Columbia, Canada

Location

University Medical Center Groningen

Groningen, Netherlands

Location

Chelsea and Westminster Hosptial/Royal Brompton Hosptial

London, SW10 9NH, United Kingdom

Location

Related Publications (11)

• 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.

  PMID: 2604284 BACKGROUND

• 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.

  PMID: 17035444 BACKGROUND

• 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.

  PMID: 24493923 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 20860505 BACKGROUND

• 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.

  PMID: 24429129 BACKGROUND

• 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.

  PMID: 14695099 BACKGROUND

• 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.

  PMID: 14555461 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 24928812 BACKGROUND

• Agrawal A. Interventional Pulmonology: Diagnostic and Therapeutic Advances in Bronchoscopy. Am J Ther. 2021 Feb 9;28(2):e204-e216. doi: 10.1097/MJT.0000000000001344.

  PMID: 33590989 DERIVED

MeSH Terms

Conditions

Bronchitis, Chronic

Condition Hierarchy (Ancestors)

Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Pulmonary Disease, Chronic Obstructive; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Heather Nigro

  CSA Medical

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: RejuvenAir

Study Record Dates

• First Submitted: June 25, 2015
• First Posted: June 29, 2015
• Study Start: February 1, 2016
• Primary Completion: May 1, 2019
• Study Completion: May 20, 2022
• Last Updated: February 23, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1); GB (1); NL (1)