The REDUCE EU Study - Endobronchial Thermal Liquid Ablation (ETLA) for the Treatment of Emphysema

Korábbi kezelés

• Greater than two hospitalizations for COPD exacerbations and/or pneumonia in the 12 months prior to enrollment
• Prior lung volume reduction via endobronchial valves(s), coil(s), vapor and/or polymer. Patients whose valves have been removed > 3 months previously can be treated if a baseline bronchoscopy reveals no airway obstruction or obvious tissue granulation and the reason for valve removal was not for complications e.g., Pneumonia, severe exacerbation, or pneumothorax.
• Prior heart or lung transplant
• Heart failure requiring hospitalization, within 6 months prior to enrollment
• Daily systemic steroids equivalent to > 15mg prednisolone
• Concomitant illnesses or medications that may pose a significant increased risk for complications following treatment with ETLA
• Prior Lung Volume Reduction Surgery (LVRS), bullectomy, or lobectomy
• Active respiratory infection or recent respiratory infection with resolution < 4 weeks prior to screening or procedure
• Recent COPD exacerbation within < 6 weeks prior to screening or procedure

Más betegség

• Chronic bronchitis as defined by cough and sputum production for at least 3 months per year for two consecutive years, in the absence of other conditions that can explain these symptoms
• Pulmonary hypertension
• Uncontrolled diabetes mellitus
• Myocardial infarction or stroke within the 12 months of enrollment
• Diagnosis of heart failure
• History of bleeding disorders or enhanced predisposition to bleeding
• History of severe/massive hemoptysis defined as >200ml of blood loss in < 24 hours
• Immunosuppressive drugs, such as for the treatment of cancer, autoimmune disease, or prevention of tissue/organ rejection
• Any disease or condition likely to limit survival to less than one year
• Any condition that would interfere with evaluation or completion of the study including study assessments and procedures, including bronchoscopy.
• Active aspergillus infection

Laborértékek

• Unable to discontinue anti-coagulants or platelet inhibitors (acetylsalicylic acid [ASA]and non-ASA, including low dose) for at least 7 days prior to each procedure (or as per physician discretion based on the specific agent) and for at least 6 weeks after each procedure

Egyéb

• Body mass index (BMI) < 16 kg/m\^2 or ≥ 33 kg/m\^2
• DLCO < 20% predicted
• 75ml or greater sputum production per day most days of the week
• Diagnosis of asthma that is confirmed according to the Global Initiative for Asthma (GINA) guidelines
• Alpha-1 antitrypsin deficiency
• Pregnant, lactating, or women of childbearing potential that plan to become pregnant within the study duration
• Currently enrolled in another trial studying an experimental treatment
• Clinically significant bronchiectasis as determined by the Investigator
• Radiological evidence of bronchiectasis in target region(s) and/or cystic radiological bronchiectasis in any region of the lungs
• Clinically significant pulmonary fibrosis
• Lung nodule not proven stable unless proven to have benign pathology
• Large bulla (defined as > 1/3 volume of a lung)
• The remaining lung tissue NOT targeted for ETLA treatment is too highly diseased

• Age ≥ 40 years old
• Diagnosis of COPD with FEV1/FVC less than 0.7 post-bronchodilation
• Post-bronchodilator Forced Expiratory Volume (FEV1) ≥ 20% and ≤ 49% of predicted value
• Total lung capacity (TLC) ≥ 100% predicted
• Residual volume (RV) ≥ 175% predicted
• 6 Minute Walk Distance (6MWD) ≥ 140 meters
• Dyspnea scoring ≥ 1 on the modified Medical Research Council scale (mMRC)
• Blood gas values of PCO2 ≤ 55 mmHg; PO2 ≥ 45 mmHg on room air
• Optimized medical management (consistent with GOLD guidelines) as confirmed by the Investigator
• Non-smoking for 3 months prior to study enrollment, as confirmed by lab testing
• Participant must engages in physical exercise beyond activities of daily living (i.e., a walking program, pulmonary rehabilitation) on n a regular basis for more than 6 weeks prior to enrollment and agree to continue the activity throughout study participation
• Participant must live within approximately 1 hour of the study hospital, or live within 1 hour of adequate regional care, or be willing to remain in the hospital for at least five days post-procedure
• Vaccinated for COVID-19, pneumococcus, and influenza (per European Union and Member State guidelines) or documented clinical intolerance or documented patient refusal
• Cognitively able to provide written informed consent and willing to comply with study requirements
• Severe emphysematous lung subsegments eligible for ETLA treatment