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Procedure
TLD for COPD (AIRFLOW-3 Trial)
N/A
Waitlist Available
Led By Frank Sciurba, MD
Research Sponsored by Nuvaira, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subject ≥40 years of age at the time of consent;
Women of child bearing potential must not be pregnant, evidenced by a negative pregnancy test (blood or urine) pre-treatment, or lactating and agree not to become pregnant for the duration of the study;
Must not have
Malignancy treated with radiation or chemotherapy within 1 year of consent
Asthma as defined by the current Global Initiative for Asthma (GINA) guidelines
Timeline
Screening 3 weeks
Treatment Varies
Follow Up randomization to 12 months, 3 to 12 months
Awards & highlights
Summary
This trial is testing a new device to treat COPD. The device is safe and effective.
Who is the study for?
Adults over 40 with COPD who've had at least 2 moderate or 1 severe exacerbation in the past year, despite optimal medical care. They must not smoke, have a CAT score ≥10, FEV1 between 25-80% predicted, and agree to flu vaccinations. Excluded are those with certain other diseases or conditions that could affect study participation or those on high doses of steroids.
What is being tested?
The trial is testing the Nuvaira Lung Denervation System's safety and effectiveness for treating COPD compared to optimal medical care alone. It involves a procedure called Targeted Lung Denervation (TLD) which aims to reduce nerve signals that cause airway constriction.
What are the potential side effects?
Potential side effects may include reactions related to bronchoscopy or general anesthesia such as sore throat, coughing, shortness of breath; complications from lung denervation like chest discomfort; and risks associated with medications used during the procedure.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 40 years old or older.
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I am not pregnant or breastfeeding and agree not to become pregnant during the study.
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I am 40 years old or older.
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I am not pregnant or breastfeeding and agree to avoid pregnancy during the study.
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I have COPD with specific lung function test results.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I've had cancer treatment with radiation or chemotherapy in the last year.
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I have asthma according to the latest GINA guidelines.
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I have a lung condition not related to COPD that is the main cause of my symptoms.
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I have severe lung damage causing cough and thick mucus most days.
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I have been diagnosed with high blood pressure in the lungs.
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I haven't had a severe heart attack or dangerous heart issues in the last 6 months.
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I had surgery on my stomach, esophagus, or pancreas within the last 2 years or have had related symptoms in the past year.
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I have severe stomach or swallowing problems.
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I am taking more than 10 mg of prednisone or its equivalent daily.
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I take more than 40 mg of opioid medication daily.
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I am allergic to common anesthesia or bronchoscopy drugs that can't be managed.
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My CT scan shows severe lung issues or a mass needing treatment that can't be addressed with standard catheters.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ randomization to 12 months, 3 to 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~randomization to 12 months, 3 to 12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Moderate or severe COPD exacerbations
Secondary study objectives
CAT responders
Change in FEV1
Change in FVC
+7 moreOther study objectives
Adverse event rates
Changes in dyspnea
Changes in lung function
+3 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active TreatmentExperimental Treatment2 Interventions
Target Lung Denervation (TLD) with the Nuvaira Lung Denervation System (RF energy delivered) and optimal medical care for COPD.
Group II: Sham ControlPlacebo Group1 Intervention
Sham Targeted Lung Denervation (TLD) procedure with the Nuvaira Lung Denervation System (catheter placement and balloon deployment in all treatment locations, no RF energy delivered) and optimal medical care for COPD.
Find a Location
Who is running the clinical trial?
Nuvaira, Inc.Lead Sponsor
5 Previous Clinical Trials
167 Total Patients Enrolled
Frank Sciurba, MDPrincipal InvestigatorUniversity of Pittsburgh Medical Center
4 Previous Clinical Trials
2,307 Total Patients Enrolled
Dirk-Jan Slebos, MD, PhDPrincipal InvestigatorUniversity Medical Center Groningen
4 Previous Clinical Trials
98 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with high blood pressure in the lungs.I had a lung or chest surgery less than a year ago, with any metal placed at least 5cm away from where I'll be treated.I have COPD with specific lung function test results.I can stop taking blood thinners for a lung exam.I am 40 years old or older.You are not currently smoking or using any other inhaled substance (e.g., cigarettes, vaping, cannabis, pipes) for a minimum of 2 months prior to consent and agrees to not start for the duration of the study.I have severe stomach or swallowing problems.I am not pregnant or breastfeeding and agree not to become pregnant during the study.I have a lung condition not related to COPD that is the main cause of my symptoms.I have asthma according to the latest GINA guidelines.I don't have any health issues that could stop me from completing this study.I am taking more than 10 mg of prednisone or its equivalent daily.I am allergic to common anesthesia or bronchoscopy drugs that can't be managed.My CT scan shows severe lung issues or a mass needing treatment that can't be addressed with standard catheters.Your diabetes is not well managed, according to the doctor.I have had 2 or more moderate or at least 1 severe COPD flare-ups in the last year despite being on optimal medication.I take more than 40 mg of opioid medication daily.I have had 2 or more moderate or at least 1 severe COPD flare-ups in the last year despite being on optimal medication.I am not pregnant or breastfeeding and agree to avoid pregnancy during the study.I finished a lung rehab program over 3 months ago or will continue my current program.I have signed a consent form approved by the ethics committee.I've had cancer treatment with radiation or chemotherapy in the last year.Your body weight is either too low or too high for this study.I am 40 years old or older.I have had a flu shot in the last year or agree to get one and continue annually during the study.I agree to follow all study requirements, including tests and taking specific medications.I haven't had a severe heart attack or dangerous heart issues in the last 6 months.I had surgery on my stomach, esophagus, or pancreas within the last 2 years or have had related symptoms in the past year.You have smoked the equivalent of at least 10 packs of cigarettes over your lifetime.I have severe lung damage causing cough and thick mucus most days.You have smoked the equivalent of at least 10 packs of cigarettes in your lifetime.You have smoked the equivalent of 10 packs of cigarettes a year for at least one year.
Research Study Groups:
This trial has the following groups:- Group 1: Sham Control
- Group 2: Active Treatment
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.
Chronic Obstructive Pulmonary Disease Patient Testimony for trial: Trial Name: NCT03639051 — N/A
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