A Study Using the RejuvenAir® System for the Treatment of Moderate to Severe Chronic Obstructive Pulmonary Disease with Chronic Bronchitis (SPRAY-CB)

Lungs and Breathing
Official Title A Sham Controlled Prospective Randomized Clinical Trial of the RejuvenAir® System for the Treatment of Moderate to Severe Chronic Obstructive Pulmonary Disease with Chronic Bronchitis (SPRAY-CB)

Purpose

The purpose of this study is to determine the safety and effectiveness of a device called the RejuvenAir® System, developed for patients with chronic bronchitis. The primary objective of this trial is to demonstrate the safety and effectiveness of the RejuvenAir® System for the treatment of adult subjects with a diagnosis of CB defined as COPD with classic 3 months of cough and sputum production for a minimum of 2 years who demonstrate ongoing symptoms of cough and significant mucus production. You will be in the study for approximately 36 months, including the screening period.

Could this study be right for you?

Inclusion Criteria:

  1. Males and females 40-80 years of age
  2. Must demonstrate daily cough and significant mucus production
  3. Have had a diagnosis of chronic bronchitis (CB) and chronic obstructive pulmonary disease (COPD) 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)
  4. Smoking history of at least 10 pack years
  5. Non-smoking for a minimum of 2 months prior to consent and agrees to continue not smoking for the duration of the study

Exclusion Criteria:

  1. Have 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
  2. Diagnosis of Asthma
  3. You have had any type of transplant procedure
  4. Use e-cigarettes, vaping or inhaled substances not prescribed by a physician RejuvenAir® System
  5. You are pregnant, nursing, or planning to get pregnant during study

* This is not a complete list of either inclusion or exclusion criteria

Age Range

40 and up