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Procedure
Bronchial Rheoplasty for Chronic Bronchitis (RheSolve Trial)
N/A
Waitlist Available
Led By Frank Sciurba, MD
Research Sponsored by Gala Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient is at least 35 years of age.
Patient has chronic bronchitis, defined as productive cough for three months in each of two successive years, whereas other causes of productive cough have been ruled out.
Must not have
Patient has a steroid-dependent condition requiring >10 mg of oral corticosteroid per day.
Patient has known unresolved lower respiratory tract infection (e.g., pneumonia, mycobacterium avium-intracellulare infection (MAI), fungus, tuberculosis).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 and 12 months
Summary
This trial will assess the safety and effectiveness of a new treatment for chronic bronchitis called Bronchial Rheoplasty. A total of 270 patients will be randomized and followed for 2 years at up to 40 study centers.
Who is the study for?
Adults over 35 with moderate to severe chronic bronchitis, a history of smoking, and specific scores on respiratory health questionnaires. They must be on stable medication for at least 8 weeks and able to walk more than 225 meters. Excluded are those with emphysema, asthma, certain heart conditions or devices that can't be turned off during procedures, unresolved lung cancer, recent smokers or other serious medical issues.
What is being tested?
The trial is testing the RheOx Bronchial Rheoplasty System against a sham procedure to see if it's safe and effective in treating symptoms of chronic bronchitis in COPD patients. It's randomized and double-blind meaning neither the participants nor the researchers know who receives which treatment until after the results are collected.
What are the potential side effects?
While not explicitly listed here, potential side effects may include complications from bronchoscopy such as sore throat, coughing or infection; reactions to anesthesia; and any specific risks associated with manipulating airways during rheoplasty like tissue damage.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 35 years old or older.
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I have had a cough with mucus for 3 months each year for 2 years, and other causes have been ruled out.
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I have smoked the equivalent of 10 packs of cigarettes a year.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I need more than 10 mg of oral steroids daily for my condition.
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I have an ongoing lung infection that hasn't healed.
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I cannot walk more than 225 meters in 6 minutes.
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I do not have any serious health conditions that could affect my safety or the study results.
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I have been diagnosed with asthma.
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I have severe lung damage that affects my cough and mucus production.
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My CT scan shows I have significant emphysema.
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I have been diagnosed with severe pulmonary hypertension.
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My lung cancer has not been cured.
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I have severe acid reflux that isn't managed by my current treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 and 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 and 12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
COPD Assessment Test (CAT) Score
Secondary study objectives
COPD Exacerbations
Cough Frequency
Distal Airway Volume
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: RheOx TreatmentExperimental Treatment1 Intervention
Group II: Sham ProcedurePlacebo Group1 Intervention
Find a Location
Who is running the clinical trial?
Gala Therapeutics, Inc.Lead Sponsor
4 Previous Clinical Trials
149 Total Patients Enrolled
4 Trials studying Bronchitis
149 Patients Enrolled for Bronchitis
Frank Sciurba, MDPrincipal InvestigatorUPMC; Division of Pulmonary and Critical Care Medicine
4 Previous Clinical Trials
2,501 Total Patients Enrolled
Arschang Valipour, MDPrincipal InvestigatorKarl-Landsteiner-Institute for Lung Research and Pulmonary Oncology; Vienna, Austria
3 Previous Clinical Trials
162 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a lung spot that might need treatment during the study.I need more than 10 mg of oral steroids daily for my condition.I am 35 years old or older.I have an ongoing lung infection that hasn't healed.You have a CAT score of 10 or higher.I have been on long-term lung medication or tried it in the past year without improvement.I cannot walk more than 225 meters in 6 minutes.I do not have any serious health conditions that could affect my safety or the study results.I have been diagnosed with asthma.Your lung function is at least 30% of what is expected for someone of your age and size after using a bronchodilator.I have severe lung damage that affects my cough and mucus production.My CT scan shows I have significant emphysema.I have had lung surgery or procedures but no lung resection.I have had a cough with mucus for 3 months each year for 2 years, and other causes have been ruled out.Your lung function test shows a certain ratio is too low.I have been diagnosed with severe pulmonary hypertension.I had a serious heart rhythm problem in the last 2 years but it's treated now.Your SGRQ score is 25 or higher.I have smoked the equivalent of 10 packs of cigarettes a year.My lung cancer has not been cured.You have used any kind of smoking or vaping, including tobacco and marijuana, in the last 6 months.I have severe acid reflux that isn't managed by my current treatment.Your answers to the first two questions add up to at least 7 points, or they add up to 6 points and your total score is more than 20 points.
Research Study Groups:
This trial has the following groups:- Group 1: RheOx Treatment
- Group 2: Sham Procedure
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.
Bronchitis Patient Testimony for trial: Trial Name: NCT04677465 — N/A
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