RejuvenAir System for Chronic Bronchitis

(SPRAY-CB Trial)

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

210 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

How does the RejuvenAir System treatment for chronic bronchitis differ from other treatments?

The RejuvenAir System is unique because it uses a cryospray (a method of applying cold therapy) to treat chronic bronchitis, which is different from traditional medications or inhalers that focus on reducing inflammation or opening airways. This approach targets the underlying tissue to potentially rejuvenate the airways, offering a novel method compared to standard treatments. ^{1 2 3 4 5}

Research Team

Gerard J Criner

Principal Investigator

Temple University Health System

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. Italy pubmed.ncbi.nlm.nih.gov

Broncalt®, class II medical device, in patients with chronic relapsed upper airways disease: a survey in clinical practice. [2020]

2. Italy pubmed.ncbi.nlm.nih.gov

Broncalt®, class II medical device, in patients with chronic upper airways disease: a survey in clinical practice. [2020]

3. Ukraine pubmed.ncbi.nlm.nih.gov

[The immune system indices of patients with acute recurrent bronchitis]. [2006]

4. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Experience with the Chinese therapeutic gymnastics in the complex treatment of patients with bronchial asthma]. [2006]

5. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Interrelation of the immunological parameters of healthy donors and of persons frequently ill with acute respiratory diseases and bronchitis in the remission stage (a new approach to assessing immune status)]. [2020]