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RejuvenAir® System Trial for COPD With Chronic Bronchitis

NCT03893370 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2024-06-03

No results posted yet for this study

Summary

Chronic Obstructive Pulmonary Disease (COPD) is defined as an impaired ability to move air within the lungs and is a major public health problem that is projected to rank fifth worldwide in terms of disease burden and third in terms of mortality. Chronic bronchitis (CB) is a common clinical phenotype within the umbrella of a COPD diagnosis and is classically defined as chronic cough and sputum production for 3 months a year for 2 consecutive years2, but many studies have used different definitions to define it- chronic cough and sputum production for one year or cough and sputum production on most days of the week. CB is associated with multiple clinical consequences, including; the worsening of lung function decline, increasing risk of acute exacerbations of COPD, increased risk of developing pneumonia, reduced health related quality of life, and an increase in all-cause mortality.

Conditions

  • Chronic Bronchitis

Interventions

DEVICE

RejuvenAir System

RejuvenAir Metered CryoSpray

DEVICE

Sham Control Procedure

Sham Control Procedure

Sponsors & Collaborators

  • CSA Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • Gerard Criner, MD · Temple University Health System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-09
Primary Completion
2025-05-31
Completion
2026-09-30
FDA Device
Yes

Countries

  • United States
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03893370 on ClinicalTrials.gov