Repeat Treatment With Metered Cryospray in Patients With Chronic Obstructive Pulmonary Disease With Chronic Bronchitis

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 80
SponsorCSA Medical, Inc.

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)

Treatment groups

10 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators