About this trial
This study is being conducted to determine the safety of repeat metered cryospray (MCS) treatment in patients with COPD with chronic bronchitis previously treated with MCS.
Eligibility criteria
Qualifiers
Subject has completed a previous MCS study, including both treatments (treatment day 1 and treatment day 2)
Males and females <80 years of age
Subject is able to read, understand, and sign a written informed consent form in order to participate in the study
Subject has a diagnosis of chronic obstructive pulmonary disease (COPD) with chronic bronchitis (CB) for a minimum of two years. (CB 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)
Disqualifiers
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
Subject has other origins of respiratory disease aside from CB and COPD
Subject is using e-cigarettes, vaping or 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
Trial design
Treatments tested in this trial
- Metered cryospray (MCS)