Active not recruitingNAINTERVENTIONAL

RejuvenAir® System Trial for COPD With Chronic Bronchitis

This study is looking for people between 40 and 80 years old who have chronic bronchitis, a common lung condition often linked to COPD. Chronic bronchitis causes a long-lasting cough and a lot of mucus. This new treatment, called the RejuvenAir System, uses a special cold spray to target damaged areas in the airways. The idea is to help these areas heal and grow new, healthy lining, which could make breathing easier, reduce coughing, and cut down on mucus production. The study wants to see if this treatment can improve quality of life for those with chronic bronchitis. Participants will either receive the RejuvenAir treatment or a dummy procedure.

At a glance

Status

Active not recruiting

Phase

Sponsor

CSA Medical, Inc.

Enrolment target

210

Start

09 Jul 2020

Estimated completion

01 Sep 2026

Chronic Bronchitis

What is this study about?

Chronic bronchitis is a lung condition where your airways, the tubes that carry air in and out of your lungs, become irritated and swollen. This often leads to a persistent cough and a lot of mucus, making it hard to breathe. It's a type of Chronic Obstructive Pulmonary Disease (COPD), which is a larger group of lung illnesses that make it difficult to move air in and out of your lungs properly. For people with chronic bronchitis, this can mean more flare-ups of their condition, a greater risk of lung infections like pneumonia, and generally feeling unwell.

The RejuvenAir System is a new approach being tested to help people with chronic bronchitis. It uses a very cold liquid nitrogen spray, delivered through a thin tube, to gently treat the inside lining of your airways. The goal is to remove the damaged cells that produce too much mucus and allow new, healthier cells to grow. These new cells should be better at clearing mucus, reducing swelling, and making the airways wider, which could make breathing much easier.

By helping the airways to heal and improving how they work, the researchers hope this treatment will reduce the ongoing cough and mucus, lessen inflammation both in the lungs and potentially throughout the body, and ultimately improve the daily lives of people living with chronic bronchitis.

Key takeaways

This study is for adults aged 40-80 with chronic bronchitis.
It tests a new cold spray treatment to help airways heal.
Participants will receive either the new treatment or a dummy procedure.
It involves procedures using a thin tube (bronchoscopy).
You must have stopped smoking and continue to do so.

Who may be eligible?

This study is looking for adult men and women, specifically those aged between 40 and 80 years old.

You might be able to join if you've been diagnosed with chronic bronchitis or COPD for at least two years and have daily cough and significant mucus. Your lung function needs to be in a moderate to severe range, and you should also be feeling the effects of your condition on your quality of life. Importantly, you must have stopped smoking for at least two months before the study starts and agree not to smoke throughout the study period.

There are also some reasons you wouldn't be able to join. For example, if you've had a recent lung infection, pneumonia, or a flare-up of your condition in the last month. You also can't have asthma, a specific genetic condition called Alpha-1 antitrypsin deficiency, or other serious lung diseases beyond chronic bronchitis/COPD. People who use e-cigarettes or other inhaled substances not prescribed by a doctor are also not eligible.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 40 and 80 years old?
Do you have chronic bronchitis or COPD diagnosed for at least 2 years?
Do you experience daily cough and significant mucus?
Have you stopped smoking for at least the past 2 months?
Are you able to attend follow-up appointments and use an e-diary?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll need to sign a consent form to make sure you understand everything. You'll then be assigned to either receive the RejuvenAir treatment or a 'sham' (dummy) procedure. The sham procedure is designed to look and feel similar to the real procedure but without the active treatment.

Both procedures involve a 'bronchoscopy,' where a thin tube is passed into your airways while you are sedated. You will likely have at least two of these procedures over the course of the study. You will also need to continue taking your regular COPD medications as prescribed. Throughout the study, you'll be asked to use an electronic diary every day to record your symptoms. The study duration will vary depending on your group, but it will involve several follow-up visits to check on your progress.

Potential risks and benefits

Taking part in this study could potentially offer benefits, such as an improvement in your chronic bronchitis symptoms like coughing and mucus, and a better quality of life. However, there's no guarantee the treatment will work for everyone, and it's also possible you may receive the sham procedure. As with any medical procedure, there are potential risks, including those associated with bronchoscopies, such as discomfort, temporary breathing problems, or in very rare cases, more serious complications. The study will carefully monitor you for any side effects. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (27)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Honor Health
Verified postcode
Scottsdale, United States
El Camino Hospital
Verified postcode
Mountain View, United States
University of California, Davis Medical Center
Verified postcode
Sacramento, United States
Advanced Pulmonary Research Institute
Verified postcode
Loxahatchee Groves, United States
Sarasota Memorial Hospital
Verified postcode
Sarasota, United States
Northwestern University
Verified postcode
Chicago, United States
Louisiana State University Medical Center
Verified postcode
Shreveport, United States
University of Maryland
Verified postcode
Baltimore, United States
Johns Hopkins Universtiy
Verified postcode
Baltimore, United States
Beth Israel Deaconess Medical Center
Verified postcode
Boston, United States
Henry Ford Health System
Verified postcode
Detroit, United States
Spectrum Health
Verified postcode
Grand Rapids, United States

Common questions

What is chronic bronchitis?

It's a long-term lung condition that causes a persistent cough and a lot of mucus, often making breathing difficult. It's a type of COPD.

What is the RejuvenAir System?

It's a new treatment being tested that uses a cold spray inside your airways to help damaged areas heal and grow new, healthier cells.

Will I definitely get the new treatment?

No, you'll either receive the RejuvenAir treatment or a 'sham' (dummy) procedure, which looks and feels similar but isn't the active treatment.

What does a bronchoscopy involve?

It's a procedure where a thin tube is passed into your airways, usually while you are sedated, to perform the treatment or sham procedure.

Can I still smoke if I join the study?

No, you must have quit smoking at least two months before the study starts and agree not to smoke for the entire duration of the study.