Metered Cryospray for the Treatment of Patients With Chronic Obstructive Pulmonary Disease With Chronic Bronchitis

This is an interventional treatment trial for COPD Read More

Inclusion Criteria:

Each Subject must meet the following criteria to be enrolled in the study:

1. Males and females ≥40 to <80 years of age.
2. Subject is able to read, understand, and sign a written Informed Consent in order to participate in the study.
3. Subject has a diagnosis of CB and COPD and has been symptomatic 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).
4. Subject is classified as having moderate or severe (GOLD stage 2-3) airflow obstruction defined by a post-bronchodilator of =>30% FEV1 to <80% predicted with a baseline FEV1/FVC of <0.70.
5. Subject has a COPD assessment tool (CAT) score of ≥10.
6. Subject is being treated according to current medically accepted treatment guidelines without successful resolution of chronic bronchitis and agrees to continue maintenance pulmonary/COPD medications (as defined per GOLD Standard for medications) for the duration of the study (subject must be on a regime of pulmonary medications for a minimum of 2 weeks prior to enrolment into the study).
7. Smoking history of at least 10 pack years.
8. Non-smoking for a minimum of 2 months prior to consent and agrees to continue not smoking for the duration of the study.
9. Subject is able to adhere to and undergo 4 bronchoscopic procedures (5 for control subjects accepting cross over option), in the opinion of the investigator or per hospital guidelines.
10. For women of childbearing potential: non-pregnant, non-lactating, and agree to practice an adequate birth control method (abstinence, combination barrier and spermicide, or hormonal) for the duration of the study.

Exclusion Criteria:

A potential subject who meets any of the following criteria will be excluded from participation in this study:

1. Subject has had an acute pulmonary infection, exacerbation or pneumonia requiring medical treatment (with antibiotics and/or steroids) within 6 weeks of initially planned study bronchoscopy.
2. Diagnosis of asthma with an onset before 30 years of age.
3. Subject has Alpha-1 antitrypsin deficiency.
4. Subject has other origins of respiratory disease aside from chronic bronchitis and COPD.
5. Subject is using e-cigarettes, vaping or taking any oral or inhaled substances not prescribed by a physician.
6. Subject has untreatable or life-threatening arrhythmias, or history of inability to adequately oxygenate during a bronchoscopy, or has acute respiratory failure with hypercapnia.
7. Subject has bullous emphysema characterized as large bullae >30 millimetres on HRCT; or subject has stenosis in the tracheobronchial system, tracheobronchomegaly, trachea-bronchomalacia, amyloidosis or cystic fibrosis.
8. Subject has clinically significant bronchiectasis
9. Subject has had a transplant procedure (any).
10. Subject has a known mucosal tear, has undergone prior lung surgery such as pneumonectomy, lobectomy, bullectomy, or lung volume reduction surgery, bronchial thermoplasty, rheoplasty or cryotherapy.
11. Subject has had a prior lung device procedure, including emphysema stent(s) implanted, lung coils, valves, lung denervation or other devices for emphysema.
12. Subject is unable to temporarily discontinue use of anticoagulant therapy: warfarin, Coumadin, LMWH, heparin, clopidrogel (or equal).
13. 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.
14. 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.
15. Subject is or has been in another clinical investigational study within 6 weeks of enrolment.
16. Subject has known sensitivity to medication required to perform bronchoscopy (such as lidocaine, atropine, and benzodiazepines).