COPD Emphysema
Conditions
Interventions
Subjects will undergo two bronchoscopy procedures two months apart and will be
treated with AeriSeal unilaterally, in two sub-segments during each
bronchoscopy (4 segments treated in total).
Bronchoscopy
COPD
Emphysema
Sponsors
Pulmonx International Sarl
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Subject is willing and able to provide informed consent and to participate in the study. 2. Subject is >= 40 years of age. 3. Subject has a diagnosis of homogenous or heterogeneous upper lobe predominant emphysema confirmed by CT scan. 4. Subject has at least 2 non-adjacent subsegments appropriate for treatment based upon CT scan in 2 different upper lobe segments in each lung (total 4 available subsegments) 5. Subject has clinically significant dyspnea scoring >= 1 on the mMRC scale of 0 - 4 6. Subject has a Six-Minute Walk Test (6MWT) distance >= 250 meters 7. Subject has post-bronchodilator FEV1 100% predicted 9. Subject has Residual Volume >= 175% predicted 10. Subject has stopped smoking for at least 8 weeks prior to entering the study as confirmed by carboxyhemoglobin or cotinine levels. 11. Subject has received preventive vaccinations against potential respiratory infections consistent with local recommendations or policy.
Exclusion criteria
Exclusion criteria: 1. Subject has severe bullous emphysema as judged by the Investigator. 2. Subject has prior lung volume reduction surgery, prior lobectomy or pneumonectomy, prior lung transplantation, prior airway stent placement, prior pleurodesis, or prior endobronchial lung volume reduction therapy of any type 3. Subject has evidence of active respiratory infection 4. Subject has an ongoing COPD exacerbation or bronchospasm 5. Subject has a known allergy to the device components: a. Polyether block amide - PEBAX® b. Polyvinyl Alcohol c. Glutaraldehyde 6. Subject requires ventilatory support (invasive or non-invasive) 7. Subject has DLco 55 mm Hg b. PaO2 = 4 L/min supplemental O2, at rest 13. Subject has Pulmonary hypertension, defined as peak systolic pressure > 45 mm Hg on echocardiogram or right heart catheterization. 14. Subject use of systemic steroids > 20 mg/day or equivalent, immunosuppressive agents, heparins, oral anticoagulants (e.g., warfarin, dicumarol; note: antiplatelet drugs including aspirin and clopidogrel are permitted) within 4 weeks of entering the study. 15. Subject has alpha1 -antitrypsin serum level of 35 kg/m2 23. Female subject pregnant or breast-feeding. 24. Abnormal screening laboratory test results as compared to reference lab normals at individual sites as follows: a. Blood urea nitrogen > 1.5 x upper limit of normal b. Creatinine > 1.5 x upper limit of normal c. Aspartate aminotransf
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The primary endpoint will be safety of AeriSeal System treatment. Safety will be assessed by monitoring the incidence of Serious Adverse Events (SAEs), during the 3*months post treatment period. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Percent mean change relative to baseline at 3-months, 6-months and 12-months for: a. Forced Expiratory Volume in one second (FEV1) b. Residual volume (RV) 2. Absolute change relative to baseline at 3-months, 6-months and 12-months for: a. Exercise capacity as assessed by six*minute walk test (6MWT) b. Quality of life as assessed by the St George*s Respiratory Questionnaire (SGRQ) c. Dyspnea as assessed by the Modified Medical Research Council Dyspnea Score (mMRC) 3. Lobar volume reduction of the treated lobes as quantified by CT scans at 3-months. 4. Radiological signs on CT scans of complications including but not limited to pneumonias, pleural effusions and consolidation at, and outside the treatment sites and formation of lung abscesses at 3-months following the second placement of AeriSeal foam. | — |
Countries
Austria, Germany, Netherlands
Outcome results
None listed