NL-OMON55018
Completed
Not Applicable
Characterizing the Mechanism of Action of Metered Cryospray for the Treatment of Patients with Chronic Obstructive Pulmonary Disease with Chronic Bronchitis - REJUVENAIR MCS MOA
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Bronchitis
- Sponsor
- CSA MEDICAL, INC.
- Enrollment
- 16
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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\.
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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