← Back to Search

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

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 below

Select...

I am 40 years old or older.

Select...

I am not pregnant or breastfeeding and agree not to become pregnant during the study.

Select...

I am 40 years old or older.

Select...

I am not pregnant or breastfeeding and agree to avoid pregnancy during the study.

Select...

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.

Select...

I have asthma according to the latest GINA guidelines.

Select...

I have a lung condition not related to COPD that is the main cause of my symptoms.

Select...

I have severe lung damage causing cough and thick mucus most days.

Select...

I have been diagnosed with high blood pressure in the lungs.

Select...

I haven't had a severe heart attack or dangerous heart issues in the last 6 months.

Select...

I had surgery on my stomach, esophagus, or pancreas within the last 2 years or have had related symptoms in the past year.

Select...

I have severe stomach or swallowing problems.

Select...

I am taking more than 10 mg of prednisone or its equivalent daily.

Select...

I take more than 40 mg of opioid medication daily.

Select...

I am allergic to common anesthesia or bronchoscopy drugs that can't be managed.

Select...

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and randomization to 12 months, 3 to 12 months for reporting.

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 more

Other study objectives

Adverse event rates

Changes in dyspnea

Changes in lung function

+3 more

Trial 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.

0 / 17Eligibility criteria met