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New treatment option for Emphysema or COPD
Official title The REDUCE EU Study - Endobronchial Thermal Liquid Ablation (ETLA) for the Treatment of Emphysema
ClinicalTrials.gov ID: NCT06655428
What this study is testing
- What it's testing
- The goal of this clinical trial is to learn if bronchoscopic lung volume reduction with endobronchial thermal liquid ablation (ETLA) works to treat severe emphysema in terms of feasibility and safety. Participants will: Have up to two ETLA procedures Complete five clinic follow-up visits and two virtual follow-up visits.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 and older
You may be able to join if
- 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
You likely can't join if
- Body mass index (BMI) \< 16 kg/m\^2 or ≥ 33 kg/m\^2
- DLCO \< 20% predicted
- 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...
- 75ml or greater sputum production per day most days of the week
- Greater than two hospitalizations for COPD exacerbations and/or pneumonia in the 12 months prior to enrollment
- Diagnosis of asthma that is confirmed according to the Global Initiative for Asthma (GINA) guidelines
See the full eligibility criteria
Who can join
- 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...
- 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
What rules you out
- Body mass index (BMI) \< 16 kg/m\^2 or ≥ 33 kg/m\^2
- DLCO \< 20% predicted
- 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
- 75ml or greater sputum production per day most days of the week
- Greater than two hospitalizations for COPD exacerbations and/or pneumonia in the 12 months prior to enrollment
- Diagnosis of asthma that is confirmed according to the Global Initiative for Asthma (GINA) guidelines
- 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...
- Pulmonary hypertension
- Alpha-1 antitrypsin deficiency
- Uncontrolled diabetes mellitus
- Prior heart or lung transplant
- Myocardial infarction or stroke within the 12 months of enrollment
- Diagnosis of heart failure
- Heart failure requiring hospitalization, within 6 months prior to enrollment
- History of bleeding disorders or enhanced predisposition to bleeding
- History of severe/massive hemoptysis defined as \>200ml of blood loss in \< 24 hours
- 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...
- Daily systemic steroids equivalent to \> 15mg prednisolone
- Immunosuppressive drugs, such as for the treatment of cancer, autoimmune disease, or prevention of tissue/organ rejection
- 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
- Any disease or condition likely to limit survival to less than one year
- Concomitant illnesses or medications that may pose a significant increased risk for complications following treatment with ETLA
- Any condition that would interfere with evaluation or completion of the study including study assessments and procedures, including bronchoscopy.
- Active aspergillus infection
- 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)
- Prior Lung Volume Reduction Surgery (LVRS), bullectomy, or lobectomy
- The remaining lung tissue NOT targeted for ETLA treatment is too highly diseased
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Vienna, Austria, Austria
- Berlin, Germany, Germany
- Gauting, Germany, Germany
- Hamburg, Germany, Germany
- Heidelberg, Germany, Germany
- Groningen, The Netherlands, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Vienna, Austria, Austria; Berlin, Germany, Germany; Gauting, Germany, Germany; Hamburg, Germany, Germany; Heidelberg, Germany, Germany; Groningen, The Netherlands, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.