RejuvenAir® System Trial for COPD With Chronic Bronchitis

Chronic Bronchitis Clinical Trial

— SPRAY-CB  

Official title:

A Sham Controlled Prospective Randomized Clinical Trial of the RejuvenAir® System for the Treatment of Moderate to Severe Chronic Obstructive Pulmonary Disease With Chronic Bronchitis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03893370
• Other study ID #: 016
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 9, 2020
• Est. completion date: September 2026

Study information

• Verified date: May 2024
• Source: CSA Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Chronic Obstructive Pulmonary Disease (COPD) is defined as an impaired ability to move air within the lungs and is a major public health problem that is projected to rank fifth worldwide in terms of disease burden and third in terms of mortality. Chronic bronchitis (CB) is a common clinical phenotype within the umbrella of a COPD diagnosis and is classically defined as chronic cough and sputum production for 3 months a year for 2 consecutive years2, but many studies have used different definitions to define it- chronic cough and sputum production for one year or cough and sputum production on most days of the week. CB is associated with multiple clinical consequences, including; the worsening of lung function decline, increasing risk of acute exacerbations of COPD, increased risk of developing pneumonia, reduced health related quality of life, and an increase in all-cause mortality.

Description:

The RejuvenAir® System is a cryosurgical device that applies medical-grade liquid nitrogen to the treatment area via a radial head catheter in a small, accurately directed spray. Cryotherapy with the RejuvenAir® System is designed to induce a regenerative endobronchial tissue effect by: 1) destroying via cryotherapy the abnormal surface epithelium that has become overgrown with mucin producing goblet cells, 2) thus allowing normal bronchial epithelium with a regrowth of ciliated epithelial cells that will facilitate the removal of mucins from the bronchial airways and 3) lead to a reduction in chronic inflammation and its accompanying mucosal swelling with resultant increase in the treated airway diameter. This reversal of inflamed epithelium may also lessen systemic inflammation.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 210
• Est. completion date: September 2026
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria

• Males and females =40 to =80 years of age

• Subject is able to read, understand, and sign a written Informed Consent in order to participate in the Study

• Subject has a diagnosis of chronic bronchitis (CB) and/or 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)

• Subject is classified as having a moderate or severe (GOLD 2/3) airflow obstruction defined by a post-bronchodilator of =30% FEV1 to <80% predicted with a baseline FEV1/FVC of <0.70

• Subject has a Baseline SGRQ of =50

• Subject demonstrates daily cough and significant mucus.

• Subject is being treated according to current medically accepted treatment guidelines for chronic bronchitis for minimum of 3 months prior to enrollment into the study. Subject agrees to continue maintenance pulmonary/COPD medications (GOLD standard medications recommended) for the duration of the study

• Non-smoking for a minimum of 2 months prior to consent and agrees to continue not smoking for the duration of the study

• Subject is able to adhere to and undergo 2 bronchoscopic procedures (cross over subjects may undergo two additional bronchoscopic procedures, if they agree to treatment), per hospital guidelines

• Subject demonstrates ability and willingness to use a daily eDiary

Exclusion Criteria

• Subject has had an acute pulmonary infection, exacerbation or pneumonia requiring medical treatment (with antibiotics and/or steroids) within 4 weeks prior of initially planned study bronchoscopy

• Current diagnosis of Asthma

• Subject has Alpha-1 antitrypsin deficiency as defined by blood level <59 mg/dL

• Subject has other origins of respiratory disease aside from chronic bronchitis and COPD

• Subject is using e-cigarettes, vaping or taking any inhaled substances not prescribed by a physician

• Subject has untreatable or life threatening arrhythmias, inability to adequately oxygenate during the bronchoscopy, or has acute respiratory failure

• Subject has bullous emphysema characterized as large bullae >30 millimeters on HRCT; or subject has stenosis in the tracheobronchial system, tracheobronchomegaly, trachea-bronchomalacia, amyloidosis or cystic fibrosis

• Subject has clinically significant bronchiectasis

• Subject has had a solid transplant procedure

• Subject has a known mucosal tear, has undergone prior lung surgery such as pneumonectomy, lobectomy, bullectomy, or lung volume reduction surgery

• Subject has had a prior lung device procedure, including emphysema stent(s) implanted, lung coils, valves, lung denervation, bronchial thermoplasty, cryotherapy or other therapies

• Subject is unable to temporarily discontinue use of anticoagulant therapy: warfarin, Coumadin, LMWH, heparin, clopidrogel (or equal)

• Subject has a serious medical condition, such as: uncontrolled coagulopathy or bleeding disorder, congestive heart failure, uncontrolled angina, myocardial infarction in the past year, renal failure, liver disease, cerebrovascular accident within the past 6 months, uncontrolled diabetes, uncontrolled hypertension or uncontrolled gastric reflux

• Subject is pregnant, nursing, or planning to get pregnant during study duration

• Subject has or is receiving chemotherapy or active radiation therapy within the past 6 months or is expected to receive chemotherapy during participation in this study

• Subject is or has been in another treatment study within 6 weeks of enrollment and agrees to not participate in any other treatment studies for the duration of study participation

• Subject has known sensitivity to medication required to perform bronchoscopy (such as lidocaine, atropine, and benzodiazepines)

Related Conditions & MeSH terms

• Acute Disease
• Bronchitis
• Bronchitis, Chronic
• Chronic Bronchitis

Intervention

Device:
• RejuvenAir System
RejuvenAir Metered CryoSpray
• Sham Control Procedure
Sham Control Procedure

Locations

Country	Name	City	State
United Kingdom	The Royal Brompton Hospital	London
United States	Clinical Research Associates of Central PA	Altoona	Pennsylvania
United States	Johns Hopkins Universtiy	Baltimore	Maryland
United States	University of Maryland	Baltimore	Maryland
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Cooper Health System	Camden	New Jersey
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Northwestern University	Chicago	Illinois
United States	University Of Cincinnati	Cincinnati	Ohio
United States	The Cleveland Clinic Foundation	Cleveland	Ohio
United States	Prisma Health - Midlands	Columbia	South Carolina
United States	The Ohio State Universisty	Columbus	Ohio
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	Henry Ford Health System	Detroit	Michigan
United States	Duke University	Durham	North Carolina
United States	St. David's Georgetown Hospital	Georgetown	Texas
United States	Spectrum Health	Grand Rapids	Michigan
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	Advanced Pulmonary Research Institute	Loxahatchee Groves	Florida
United States	University of Wisconsin Hospital and Clinics	Madison	Wisconsin
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	El Camino Hospital	Mountain View	California
United States	Temple University - Of the Commonwealth System of Higher Education	Philadelphia	Pennsylvania
United States	University of California, Davis Medical Center	Sacramento	California
United States	Sarasota Memorial Hospital	Sarasota	Florida
United States	Honor Health	Scottsdale	Arizona
United States	Louisiana State University Medical Center	Shreveport	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
CSA Medical, Inc.

Countries where clinical trial is conducted

United States,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	St. George's Respiratory Questionnaire	Change in St. George Respiratory Questionnaire (SGRQ) score from Baseline to 12 months	12 months
Secondary	Subjects experiencing serious adverse events (SAEs) rated as probably or definitely related to the study device or procedure	Number of subjects experiencing one or more serious adverse events (SAEs) rated as probably or definitely related to the study device or procedure by the investigator within 30 days after either the first or second study procedure.	Within 30 days after either the first or second study procedure
Secondary	Reduction of cough	Reduction of cough from Baseline through 12 months	Baseline through 12 months
Secondary	Reduction of sputum	Reduction of sputum from Baseline through 12 months	Baseline through 12 months
Secondary	Acute Exacerbation Rate (AECOPD)	Acute Exacerbation rate (AECOPD, all severities) over 12 months	12 months
Secondary	COPD assessment test (CAT) score	COPD assessment test (CAT) from Baseline through 12 months	12 months