RejuvenAir System for Chronic Bronchitis

(SPRAY-CB Trial)

Not currently recruiting at 27 trial locations

Overseen By Kamran Mahmood, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: CSA Medical, Inc.

Must be taking: Pulmonary/COPD medications

Must not be taking: Anticoagulants, Chemotherapy

Disqualifiers: Asthma, Alpha-1 deficiency, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: Up to 30 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called the RejuvenAir System to assist people with chronic bronchitis, a type of COPD (Chronic Obstructive Pulmonary Disease) characterized by a long-term cough and excessive mucus. The trial compares this treatment to a placebo (a treatment with no active effect) to determine if it can improve lung function and quality of life. It seeks participants who have experienced a chronic cough and mucus for at least two years and are already receiving standard treatment for their condition. Participants should not have smoked for at least two months before joining and must be prepared to undergo certain medical procedures as part of the trial. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could lead to new treatment options for chronic bronchitis.

Will I have to stop taking my current medications?

The trial requires that you continue taking your current maintenance medications for chronic bronchitis or COPD throughout the study.

What prior data suggests that the RejuvenAir System is safe for chronic bronchitis?

Research has shown that the RejuvenAir System is generally safe for people with chronic bronchitis. Several studies have found that patients tolerate this treatment well. For example, one study found no device-related problems over a year. Another study noted significant improvements in quality of life without serious side effects. Overall, the RejuvenAir System has been used safely in clinical settings and may offer relief for those with chronic bronchitis. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The RejuvenAir System stands out in the treatment of chronic bronchitis because it uses a unique approach called metered cryospray (MCS). Unlike standard treatments that often rely on medications like bronchodilators and steroids to manage symptoms, the RejuvenAir System delivers a precise spray of cold mist directly to the airways, aiming to reduce inflammation and improve lung function. Researchers are excited about this method because it represents a non-pharmacological option with the potential for quick symptom relief and improved quality of life for patients.

What evidence suggests that the RejuvenAir System is effective for chronic bronchitis?

Research has shown that the RejuvenAir System, which participants in this trial may receive, could benefit people with chronic bronchitis, a condition often associated with COPD. Studies have found that this treatment can enhance the airways' structure and function, potentially reducing symptoms such as persistent cough and mucus production. Patients who used the RejuvenAir System reported feeling better and experiencing fewer symptoms. Moreover, these benefits appear to last for up to two years, indicating long-lasting positive effects. ^{1 4 5 6 7}

Who Is on the Research Team?

Gerard J Criner

Principal Investigator

Temple University Health System

Are You a Good Fit for This Trial?

This trial is for adults aged 40-80 with chronic bronchitis or COPD, who have had symptoms like daily cough and mucus for at least two years. They must not smoke, be able to use an eDiary, and agree to maintain their current lung medications. People can't join if they vape, had a recent lung infection, certain blood deficiencies or serious medical conditions, are pregnant, or have been in another study recently.

Inclusion Criteria

I have been diagnosed with chronic bronchitis or COPD for at least two years.

I have moderate to severe lung obstruction based on my breathing test results.

Your initial SGRQ score is 50 or higher.

Exclusion Criteria

I am allergic to medications used in lung exams.

I use e-cigarettes, vape, or inhale substances not prescribed by a doctor.

I have been diagnosed with asthma.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive cryotherapy treatment with the RejuvenAir® System to induce regenerative endobronchial tissue effects

Up to 30 days

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness, including changes in respiratory questionnaire scores and reduction of symptoms

12 months

What Are the Treatments Tested in This Trial?

Interventions

• RejuvenAir System
• Sham Control Procedure

Trial Overview The RejuvenAir System trial is testing a new procedure against a sham (fake) procedure to see if it helps people with chronic bronchitis within COPD. Participants will undergo bronchoscopy where the actual treatment or sham will be applied to compare effectiveness.

How Is the Trial Designed?

Group I: Treatment Active Control 1 Intervention

RJA MCS

Group II: Sham Control Placebo Group 1 Intervention

Sham

Who Is Running the Clinical Trial?

CSA Medical, Inc.

Lead Sponsor

Trials

20

Recruited

950+

Citations

1. rejuvenair.com rejuvenair.com/data-presented-at-the-american-college-of-chest-physicians-correlates-airway-remodeling/

Data Presented at the American College of Chest ... Data correlating the positive clinical outcomes following Metered CryoSpray (MCS), using the RejuvenAir System, with evidence of airway tissue remodeling in ...

2. rejuvenair.com rejuvenair.com/csa-medical-announces-new-scientific-data-utilizing-metered-cryospray/

CSA Medical Announces New Scientific Data Utilizing ... Research reveals rejuvenative changes in cellular populations indicative of airway remodeling correspond with clinical efficacy and improved quality of life.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7744607/

A prospective safety and feasibility study of metered ... Conclusions. Treatment with the RejuvenAir system in individuals with chronic bronchitis in COPD is safe, feasible, well tolerated, and resulted ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03893370

RejuvenAir® System Trial for COPD With Chronic Bronchitis CB is associated with multiple clinical consequences, including; the worsening of lung function decline, increasing risk of acute exacerbations of COPD, ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10875532/

Retreatment of symptomatic chronic bronchitis with bronchial ... However, the available data demonstrate a durable effect up to 2 years, and thus instances of the clinical recurrence of symptoms remain rather ...

6. publications.ersnet.org publications.ersnet.org/content/erj/54/suppl63/oa5172

Safety and Feasibility of Metered CryoSpray (MCS) for ... These data indicate MCS treatment is safe, feasible and associated with clinically significant improvements in health-related quality of life in COPD patients ...

7. rejuvenair.com rejuvenair.com/first-randomized-controlled-study-clinically-significant/

First Randomized Controlled Study with ... RejuvenAir® Metered Cryospray is both safe and effective in a patient population with multiple co-morbidities, in a disease with no established ...