RejuvenAir® System Trial for COPD With Chronic Bronchitis
Кључне речи
Апстрактан
Опис
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.
Датуми
| Последња верификација: | 06/30/2020 |
| Фирст Субмиттед: | 03/25/2019 |
| Предвиђена пријава послата: | 03/25/2019 |
| Прво објављено: | 03/27/2019 |
| Послато последње ажурирање: | 07/19/2020 |
| Последње ажурирање објављено: | 07/21/2020 |
| Стварни датум почетка студије: | 07/08/2020 |
| Процењени датум примарног завршетка: | 09/30/2022 |
| Предвиђени датум завршетка студије: | 08/31/2024 |
Стање или болест
Интервенција / лечење
Device: Treatment
Device: Sham Control
Фаза
Групе руку
| Арм | Интервенција / лечење |
|---|---|
| Active Comparator: Treatment RJA MCS | Device: Treatment RejuvenAir Metered CryoSpray |
| Sham Comparator: Sham Control Sham | Device: Sham Control Sham Control Procedure |
Критеријуми
| Узраст подобан за студирање | 40 Years До 40 Years |
| Полови подобни за студирање | All |
| Прихвата здраве волонтере | да |
| Критеријуми | 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 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 has had either 2 moderate exacerbations or 1 severe exacerbation in the past year. (exacerbations must be documented) - 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 - Smoking history of at least 10 pack years - 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 - Diagnosis of Asthma - Subject has Alpha-1 antitrypsin deficiency - 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 transplant procedure (any) - 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, autoimmune disease 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 clinical investigational 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) |
Исход
Примарне мере исхода
1. Acute Exacerbation Rate (AECOPD) [12 months]
2. St. George's Respiratory Questionnaire [12 months]
Секундарне мере исхода
1. 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]
2. Reduction of cough [Treatment 1 through 12 months]
3. Reduction of sputum [Treatment 1 through 12 months]
4. Rate and time to first mild/moderate/severe/very severe AECOPD [12 months]
5. Time to next AECOPD exacerbation (mild/moderate/severe/very severe) [12 months]
