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Clinical Trials in the UK / NCT03893370
Active, not recruiting Not applicable

RejuvenAir® System Trial for COPD With Chronic Bronchitis

NCT03893370 · tracked via the Priya Life Science UK tracker
Sponsor
CSA Medical, Inc.
Phase
Not applicable
Started
2020-07-09
Last updated
2024-06-03

Condition(s) studied

Chronic Bronchitis

Investigational drug(s) / intervention(s)

RejuvenAir SystemSham Control Procedure

RejuvenAir System: RejuvenAir Metered CryoSpray

Sham Control Procedure: Sham Control Procedure

Study 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.

Eligibility

Sex
ALL
Min age
40 Years
Max age
80 Years
Healthy volunteers
No
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)

Primary outcome measure(s)

Trial sites (27)

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

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03893370 on ClinicalTrials.gov ↗ ← All trials in the UK