A modified staged treatment algorithm using the AeriSeal System

Introduction: Bronchoscopic lung volume reduction with a total 80mL dose of AeriSeal in patients with severe emphysema can improve lung function and quality of life. A staged treatment may attenuate the intensity of the inflammatory response. Objectives: To assess the impact of a staged and lower dosed AeriSeal treatment on adverse events and radiologic response. Methods: Prospective, multicenter feasibility study. AeriSeal administered during two sequential bronchoscopies: 2 subsegments of a lobe treated with two 5mL doses, followed by two 10mL doses in a contralateral lobe after 6 weeks. Results: Fourteen patients (9F/5M, FEV1 28±7%pred) were enrolled. Ten were treated at both sides, 4 unilaterally. Mean target lobar volume reduction was 98.7±95.1mL (p=0.005) after Treatment 1 and 167.8±189.0mL (p=0.002) after Treatment 2, see Figure. There were no deaths, four subjects (28.6%) experienced 5 COPD exacerbations and 2 subjects (14.3%) a post-treatment acute inflammatory reaction (fever, dyspnea, cough, chest pain) in the 3-months after Treatment 2. Three patients (21.5%) had a COPD exacerbation during the 3 to 12 month follow up period. Conclusions: Lower dosed, staged delivery of AeriSeal induces a significant, but not yet clinically relevant, dose-dependent volume reduction, with an adverse event rate similar to prior single-staged higher dose treatment. This study indicates that AeriSeal does not need to be administered at a lower dose in staged procedures.