A Multicenter, Randomized, Sham-controlled Study to Evaluate Safety and Efficacy After Treatment with the Nuvaira* Lung Denervation System in Subjects with Chronic Obstructive Pulmonary Disease (COPD)

Recruiting

• Conditions: chronic bronchitis; COPD; 10038716

• Registration Number: NL-OMON55508
• Lead Sponsor: VAIRA inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 65

Inclusion Criteria

1) Subject >=40 years of age at the time of consent;
2) 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;
3) Smoking history of at least 10 pack years;
4) Not 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;
5)Subject has received a flu vaccination within the 12 months prior to the
procedure or agrees to obtain vaccination once it becomes available and agrees
to annual vaccinations for the duration of the study;
6) SpO2 >=89% on room air at the time of screening;
7) CAT score >=10 at the time of screening;
8) Diagnosis of COPD with 25% <= FEV1 <=80% of predicted, PaCO2 < 50 (if FEV1
<30%) and FEV1/FVC <70% (post-bronchodilator);
9) Documented history of >= 2 moderate COPD exacerbations or >= 1 severe COPD
exacerbation leading to hospitalization in the 12 months prior to consent with
at least one exacerbation occurring
while the subject was on optimal medical care (taking a LAMA and a LABA, or
scheduled SABA or SAMA instead of either a LAMA or a LABA, not both, as regular
respiratory maintenance
medication);
10)Subject is on optimal medical care at the time of consent;
11) If subject has participated in a formal pulmonary rehabilitation program
recently, program completion must have occurred >=3 months prior to consent; if
in a maintenance program, subject agrees to continue their current program
through their 12-month follow-up visit;
NOTE: Prior participation in a pulmonary rehabilitation program is not required
for inclusion in the study.
12) Subject is a candidate for bronchoscopy in the opinion of the physician
investigator or per hospital guidelines and is able to discontinue blood
thinning medication peri-procedurally;
13) The subject is able and agrees to complete all protocol required baseline
and follow up tests and assessments including taking certain medications (e.g.,
azithromycin, prednisolone / prednisone);
14) Subject has provided written informed consent using a form that has been
reviewed and approved by the Institutional Review Board (IRB) / Ethics
Committee (EC).

Exclusion Criteria

1) Body Mass Index <18 or >35;
2) Subject has an implantable electronic device and has not received
appropriate medical clearance;;
3) Uncontrolled diabetes in the opinion of the investigator;
4) Malignancy treated with radiation or chemotherapy within 1 years of consent;
5) Asthma as defined by the current Global Initiative for Asthma (GINA)
guidelines;
6)Subject diagnosed with a dominant non-COPD lung disease or condition
affecting the lungs which is the main driver of the subjects clinical symptoms
(e.g., cystic fibrosis, paradoxical vocal cord motion, eosinophilic
granulomatosis with polyangiitis (EGPA), allergic bronchopulmonary
aspergillosis, interstitial lung disease or active tuberculosis) or has a
documented medical history of pneumothorax within 1 years of consent;
7) Clinically relevant bronchiectasis, defined as severe single lobe or
multilobar bronchial wall thickening associated with airway dilation on CT scan
leading to cough and tenacious sputum on most days;
8) Pre-existing diagnosis of pulmonary hypertension, clinical evidence of
pulmonary hypertension,
(cardiovascular function impairment including peripheral edema) and mPAP >=25
mmHg at rest by right heart catheterization (or estimated right ventricular
systolic pressure >50 mmHg by
echocardiogram if no previous right heart catheterization)
9) Myocardial infarction within last 6 months, EKG with evidence of life
threatening arrhythmias or acute ischemia, pre-existing documented evidence of
a LVEF <40%, stage C or D (ACC/AHA) or Class III or IV (NYHA) congestive heart
failure, or any other past or present cardiac findings that make the subject an
unacceptable candidate for a bronchoscopic procedure utilizing general
anesthesia;
10) Surgical procedures(s) on the stomach, esophagus or pancreas performed <=2
years prior to consent or ongoing related symptoms within the past year;
11)Symptomatic gastric motility disorder(s) (e.g. gastroparesis) as evidenced
by GCSI score >=18.0, severe uncontrolled GERD (e.g., refractory heartburn,
endoscopic esophagitis) or severe dysphagia (e.g., esophageal stricture,
achalasia, esophageal spasm); NOTE: Subjects with a hiatal hernia are allowed
if subject meets all other enrollment criteria.
12) Any disease or condition that might interfere with completion of a
procedure or this study (e.g., structural esophageal disorder, life expectancy
<3 years);
13) Prior lung or chest procedure (e.g., lung transplant, LVRS, BLVR, lung
implant, metal stent, valves, median sternotomy, bullectomy, lobectomy,
segmentectomy or other interventional lung or chest procedure) performed <=1
year of consent);
14) Daily use of >10 mg of prednisone or its equivalent at the time of consent;
15) Chronic use of *40 mg MEDD opioid only medication per day;
16) Known contraindication or allergy to medications required for bronchoscopy
or general anesthesia (e.g., lidocaine, atropine, propofol, sevoflurane) that
cannot be medically controlled;
17) Baseline chest CT scan reveals bronchi anatomy cannot be fully treated with
available catheter sizes, presence of severe emphysema >50% lobar attenuation
area or severe bullous disease (>1/3 hemithorax) (as determined by the CT core
lab using a single density mask threshold of -950 HU) or discovery of a mass
that requires trea

Study & Design

• Study Type: Interventional
• Study Design: Not specified