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Procedure
RejuvenAir System for Chronic Bronchitis (SPRAY-CB Trial)
N/A
Waitlist Available
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
Must not have
Subject has 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
Current diagnosis of Asthma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
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.
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.
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I've been treated for a lung infection or pneumonia with medication in the last 4 weeks.
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I have been diagnosed with asthma.
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My Alpha-1 antitrypsin levels are below 59 mg/dL.
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My lung issues are not due to chronic bronchitis or COPD.
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I use e-cigarettes, vape, or inhale substances not prescribed by a doctor.
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I have severe heart rhythm problems or breathing issues that make certain lung procedures unsafe for me.
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I have severe lung issues, such as large lung blisters or specific airway diseases.
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I have a serious lung condition that affects my airways.
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I have had an organ transplant.
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I have had surgery on my lungs or have a known tear in the lining of my body cavities.
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I have had a procedure done on my lungs, such as stents, coils, or other therapies.
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I cannot stop taking my blood thinner medication temporarily.
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I do not have any uncontrolled serious health conditions like heart failure or diabetes.
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I am currently undergoing or have recently completed chemotherapy or radiation therapy.
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I am allergic to medications used in lung exams.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
St. George's Respiratory Questionnaire
Secondary study objectives
Acute Exacerbation Rate (AECOPD)
Chronic Obstructive Airway Disease
Coughing
+2 moreTrial 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
3 Trials studying Bronchitis
62 Patients Enrolled for Bronchitis
Gerard Criner, MDPrincipal InvestigatorTemple University Health System
9 Previous Clinical Trials
5,651 Total Patients Enrolled
1 Trials studying Bronchitis
2,981 Patients Enrolled for Bronchitis
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am allergic to medications used in lung exams.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.I am willing and able to undergo up to 4 bronchoscopic procedures.Your initial SGRQ score is 50 or higher.I use e-cigarettes, vape, or inhale substances not prescribed by a doctor.I have been diagnosed with asthma.I cough daily and produce a lot of mucus.My Alpha-1 antitrypsin levels are below 59 mg/dL.I cough daily and produce a lot of mucus.I do not have any uncontrolled serious health conditions like heart failure or diabetes.I have been following treatment for chronic bronchitis for at least 3 months and agree to continue my COPD medications during the study.I have severe heart rhythm problems or breathing issues that make certain lung procedures unsafe for me.I've been treated for a lung infection or pneumonia with medication in the last 4 weeks.I have a serious lung condition that affects my airways.I cannot stop taking my blood thinner medication temporarily.I am currently undergoing or have recently completed chemotherapy or radiation therapy.I am between 40 and 80 years old.I have had an organ transplant.My lung issues are not due to chronic bronchitis or COPD.I have severe lung issues, such as large lung blisters or specific airway diseases.I have had surgery on my lungs or have a known tear in the lining of my body cavities.I have had a procedure done on my lungs, such as stents, coils, or other therapies.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment
- Group 2: Sham Control
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.