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Procedure

RejuvenAir System for Chronic Bronchitis (SPRAY-CB Trial)

N/A
Recruiting
Led By Gerard Criner, MD
Research Sponsored by CSA Medical, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject demonstrates daily cough and significant mucus
Males and females ≥40 to ≤80 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

SPRAY-CB Trial Summary

This trial is testing if a medicine can help people with CB.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects may include discomfort from the bronchoscopy procedure such as sore throat or coughing. There's also a risk of bleeding and infection from the intervention itself.

SPRAY-CB Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I cough daily and produce a lot of mucus.
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I am between 40 and 80 years old.
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I have been diagnosed with chronic bronchitis or COPD for at least two years.
Select...
I have moderate to severe lung obstruction based on my breathing test results.
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I cough daily and produce a lot of mucus.
Select...
I have been following treatment for chronic bronchitis for at least 3 months and agree to continue my COPD medications during the study.

SPRAY-CB Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
St. George's Respiratory Questionnaire
Secondary outcome measures
Acute Exacerbation Rate (AECOPD)
Chronic Obstructive Airway Disease
Coughing
+2 more

SPRAY-CB Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: TreatmentActive Control1 Intervention
RJA MCS
Group II: Sham ControlPlacebo Group1 Intervention
Sham

Find a Location

Who is running the clinical trial?

CSA Medical, Inc.Lead Sponsor
19 Previous Clinical Trials
743 Total Patients Enrolled
2 Trials studying Chronic Bronchitis
32 Patients Enrolled for Chronic Bronchitis
Gerard Criner, MDPrincipal InvestigatorTemple University Health System
9 Previous Clinical Trials
5,604 Total Patients Enrolled
1 Trials studying Chronic Bronchitis
2,981 Patients Enrolled for Chronic Bronchitis

Media Library

RejuvenAir System (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT03893370 — N/A
Chronic Bronchitis Research Study Groups: Treatment, Sham Control
Chronic Bronchitis Clinical Trial 2023: RejuvenAir System Highlights & Side Effects. Trial Name: NCT03893370 — N/A
RejuvenAir System (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03893370 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research allow for the participation of geriatric patients?

"The present clinical trial is searching for participants aged 40 to 80. Meanwhile, 36 trials are available specifically designed for people younger than 18 while 59 exist targeting those over 65 years old."

Answered by AI

What is the upper limit of subjects who have enrolled in this medical experiment?

"This trial necessitates 210 individuals with suitable inclusion criteria. Patients can access this medication at Medical University of South carolina in Charleston, SC and El Camino Hospital in Mountain View, CA."

Answered by AI

Do I qualify to partake in this experiment?

"This medical trial is searching for 210 adults aged between 40 and 80 to participate. Participants must have been diagnosed with chronic bronchitis or COPD for two years and display a baseline SGRQ score of 50 or greater, as well as daily coughing and mucus production. Furthermore, they must be following medically accepted guidelines regarding the treatment of their condition whilst also adhering to rules such as having not smoked in 2 months before joining the study and continuing this abstinence throughout its duration. Finally, eligible patients should demonstrate an ability to undergo up to 4 bronchoscopic procedures (2 if not crossing over) while utilising an e-d"

Answered by AI

Are there various healthcare facilities conducting this experiment within the state?

"For this trial, Medical University of South carolina in Charleston, El Camino Hospital in Mountain View and St. Vincent Hospital in Santa Fe are among the 25 clinical sites recruiting patients."

Answered by AI

Are there any opportunities for volunteers to participate in this investigation?

"According to the details found on clinicaltrials.gov, this research project is now actively enrolling participants from its inception date of July 9th 2020 and the most recent update made on June 13th 2022."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
What site did they apply to?
Sarasota Memorial Hospital
Temple University - Of the Commonwealth System of Higher Education
Honor Health

Why did patients apply to this trial?

The medicine that I'm on, doesn't seem to help with the COPD.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
RejuvenAir® System Trial for COPD With Chronic Bronchitis
2020. "RejuvenAir® System Trial for COPD With Chronic Bronchitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03893370.
~44 spots leftby Apr 2025
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