RejuvenAir® System Trial for COPD With Chronic Bronchitis
Purpose
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.
Condition
- Chronic Bronchitis
Eligibility
- Eligible Ages
- Between 40 Years and 80 Years
- Eligible Genders
- All
- Accepts 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)
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover Assignment
- Intervention Model Description
- randomized, sham-controlled
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator Treatment |
RJA MCS |
|
|
Sham Comparator Sham Control |
Sham |
|
More Details
- Status
- Active, not recruiting
- Sponsor
- CSA Medical, Inc.
Study Contact
Detailed 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.