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

February 22, 2023 updated by: CSA Medical, Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse and Serious Adverse Events
Time Frame: Change from Baseline to 3-Months Following Completion of Treatments
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
Time Frame: Change from Baseline to 3-Months Following Completion of 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)
Time Frame: Change from Baseline to 3-Months Following Completion of Treatments
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
Time Frame: Change from Baseline to 3-Months, 1 year, 2 year and 3 year Following Completion of Treatments
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
Time Frame: Change from Baseline to 3-Months, 1 year, 2 year and 3 year Following Completion of Treatments
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)
Time Frame: Change from Baseline to 3-Months, 1 year, 2 year and 3 year Following Completion of Treatments
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)
Time Frame: Change from Baseline to 3-Months, 1 year, 2 year and 3 year Following Completion of Treatments
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)
Time Frame: Change from Baseline to 3-Months, 1 year, 2 year and 3 year Following Completion of Treatments
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)
Time Frame: Change from Baseline to 3-Months, 1 year, 2 year and 3 year Following Completion of Treatments
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exacerbation Rate
Time Frame: Change from Baseline to 3-Months, 1 year, 2 year and 3 year Following Completion of Treatments
Annualized exacerbation rates
Change from Baseline to 3-Months, 1 year, 2 year and 3 year Following Completion of Treatments
Airway Wall Thickness Using HRCT
Time Frame: Change from Baseline to 3-Months, 1 year, 2 year and 3 year Following Completion of Treatments
Lumen radius in mm.
Change from Baseline to 3-Months, 1 year, 2 year and 3 year Following Completion of Treatments
Plasma Fibrinogen
Time Frame: Change from Baseline to 3-Months, 1 year, 2 year and 3 year Following Completion of Treatments
150-400mg/dL
Change from Baseline to 3-Months, 1 year, 2 year and 3 year Following Completion of Treatments

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CSA Medical, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Actual)

May 1, 2019

Study Completion (Actual)

May 20, 2022

Study Registration Dates

First Submitted

June 25, 2015

First Submitted That Met QC Criteria

June 26, 2015

First Posted (Estimate)

June 29, 2015

Study Record Updates

Last Update Posted (Estimate)

February 23, 2023

Last Update Submitted That Met QC Criteria

February 22, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 012

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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