Comparing two methods of lung volume reduction for severe emphysema

Randomized Trial Evaluating the Rate of Pneumothorax in Severe Emphysema Secondary to Endoscopic Volume Reduction With Two-stage ZEPHYR® Valves Versus Endoscopic Volume Reduction With One-stage ZEPHYR® Valves

This study is testing which of two methods for lung volume reduction is safer and better for people with severe emphysema using special valves.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 244 (estimated)
• Ages: 35 Years to 80 Years
• Sex: All
• Sponsor: University Hospital, Limoges (Academic / other)
• Locations: 15 sites (Bordeaux and 14 other locations)
• Trial ID: NCT06181357 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the rate of pneumothorax in patients with severe emphysema undergoing endoscopic lung volume reduction using either a two-stage or one-stage approach with Zephyr® valves. A total of 244 patients will be randomized to receive one of the two treatment methods under general anesthesia, with both groups receiving standard care as per COPD guidelines. The study aims to determine which method is safer and more effective in reducing lung volume and improving respiratory function. Participants will be monitored for one year post-procedure to assess outcomes and complications.

Who should consider this trial

Good fit: Ideal candidates are adults aged 35 to 80 with severe emphysema and specific lung function criteria.

Not a fit: Patients with asthma as a primary diagnosis or those with recurrent exacerbations may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to safer and more effective treatment options for patients with severe emphysema.

How similar studies have performed: Previous studies have shown clinical superiority of Zephyr® valves compared to standard care, indicating a promising approach.

Eligibility criteria

Inclusion Criteria:

Patient able to give informed consent and participate in the study

* Age ≥ 35 years old and ≤ 80 years old at the time of signing the consent
* Emphysema (homogeneous or heterogeneous) on a recent CT scan (\< 6 months). Heterogeneous emphysema defined by a difference of at least 15% destruction (threshold 910HU) between two adjacent lobes.
* Destruction ≥ 50% (threshold 910 HU) of the target lobe on the chest scanner
* Smoking quit for 3 months
* Dyspnea ≥ 2 according to the modified Medical Research Council (mMRC) questionnaire)
* Post-bronchodilator FEV between 15 and 50% theoretical
* Post-bronchodilator total lung capacity ≥ 100% theoretical and post-bronchodilator residual volume ≥ 175% theoretical
* Distance traveled during the TM6M ≥ 100m
* Member of or beneficiary of a social security scheme

Exclusion Criteria:

* Asthma considered as main diagnosis
* Recurrent exacerbations: (\>3 over the last year or 2 requiring hospitalization)
* Myocardial infarction or stroke in the 6 months prior to inclusion
* Symptoms of heart failure in the 6 months prior to inclusion
* Chest CT abnormalities: giant bulla (occupying more than a third of the pulmonary field), paraseptal emphysema, pulmonary nodule greater than 0.8cm (not applicable pulmonary nodules known for more than a year and stable), fibrosing interstitial pneumonitis, dilated bronchi
* Pulmonary tomoscintigraphy:

  * Patients for whom the least perfused lobe is not the one with the highest emphysema destruction score
  * Patients with homogeneous emphysema for whom the perfusion delta (difference in perfusion between the ipsilateral lung and the treated lobe) is less than 10%
* Arterial blood gas analysis in ambient air: Hypoxemia in ambient air (PaO2 \< 45 mmHg). Hypercapnia (PaCO2 \> 55 mmHg)
* Echocardiography:

  * Left Ventricular Ejection Function \< 45%
  * Systolic pulmonary arterial pressure \> 45 mmHg
* History of pneumonectomy, lung surgery homolateral to the lobe targeted for endoscopic lung volume reduction
* History of pneumothorax homolateral to the lobe targeted for endoscopic lung volume reduction
* History of endoscopic volume reduction
* Oral corticosteroid therapy \> 20 mg/day within the 4 weeks preceding inclusion
* Symptomatic bronchial dilatations, bronchial colonization with pseudomonas aeruginosa, multi-resistant bacteria or aspergillus origin
* Metastatic cancer undergoing treatment or whose treatments ended less than 5 years ago
* Pregnant or breastfeeding women
* Nickel allergy
* Patient under guardianship, curatorship or under judicial protection
* Participation in another interventional clinical research
* Any other condition which, in the opinion of the investigator, could interfere with the objective of the study or would cause the subject's participation in the study to be suboptimal, in particular (non-exhaustive list) unweaned alcoholism, substance abuse, non-compliance with usual follow-up visits)

secondary exclusion criteria:

\- Evidence of collateral ventilation measured by the Chartis system

Where this trial is running

Bordeaux and 14 other locations

• CHU de Bordeaux — Bordeaux, France (Recruiting)
• CHU de Brest — Brest, France (Recruiting)
• CHU de Dijon — Dijon, France (Recruiting)
• chu de Grenoble — Grenoble, France (Recruiting)
• CHU de Lille — Lille, France (Recruiting)
• CHU de Limoges — Limoges, France (Recruiting)
• Aphm — Marseille, France (Recruiting)
• Hopital Saint Joseph — Marseille, France (Recruiting)
• CHU de Nice — Nice, France (Not_yet_recruiting)
• Aphp — Paris, France (Recruiting)
• Aphp — Paris, France (Not_yet_recruiting)
• CHU de Rouen — Rouen, France (Not_yet_recruiting)
• chu de Strasbourg — Strasbourg, France (Recruiting)
• Hopital Foch — Suresnes, France (Recruiting)
• chu de Toulouse — Toulouse, France (Recruiting)

Study contacts

• Study coordinator: Thomas EGENOD, MD

Conditions COPD; Endobronchial Zephyr® valves; Endoscopic lung volume reduction; Pneumothorax; Emphysema