Skip to main content
Clinical Trials/NL-OMON55018
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

CSA MEDICAL, INC.0 sites16 target enrollmentTBD

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.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional

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

Similar Trials