Treatment of Advanced Emphysema with Emphysematous Lung Sealant (AeriSeal (R))

Background: This report summarizes initial tests of an
emphysematous lung synthetic polymer sealant (ELS) designed to
reduce lung volume in patients with advanced emphysema. Objectives:
The primary study objective was to define a therapeutic strategy to
optimize treatment safety and effectiveness. Methods: ELS therapy
was administered bronchoscopically to 25 patients with
heterogeneous emphysema in an open-label, noncontrolled study at 6
centers in Germany. Treatment was performed initially at 2-4
subsegments. After 12 weeks, patients were eligible for repeat
therapy to a total of 6 sites. Safety and efficacy were assessed
after 6 months. Responses were evaluated in terms of changes from
baseline in lung physiology, functional capacity, and
health-related quality of life. Follow-up is available for 21 of 25
patients. Results: Treatment was well tolerated. There were no
treatment-related deaths (i.e. within 90 days of treatment), and an
acceptable short-and long-term safety profile. Physiological and
clinical benefits were observed at 24 weeks. Efficacy responses
were better among Global Initiative for Chronic Obstructive Lung
Disease (GOLD) stage III patients {[}n = 14; change in residual
volume/total lung capacity (Delta RV/TLC) = -7.4 +/- 10.3%; Delta
forced expiratory volume in 1 s (Delta FEV(1)) = +15.9 +/- 22.6%;
change in forced vital capacity (Delta FVC) = +24.1 +/- 22.7%;
change in carbon monoxide lung diffusion capacity (Delta DLCO) =
+19.3 +/- 34.8%; change in 6-min walk test (Delta 6MWD) = +28.7 +/-
59.6 m; change in Medical Research Council Dyspnea (Delta MRCD)
score = -1.0 +/- 1.04 units; change in St. George's Respiratory
Questionnaire (Delta SGRQ) score = -9.9 +/- 15.3 units] than for
GOLD stage IV patients (n = 7; Delta RV/TLC = -0.5 +/- 6.4%; Delta
FEV 1 = +2.3 +/- 12.3%; Delta FVC = +2.6 +/- 21.1%; Delta DLCO =
-2.8 +/- 17.2%; Delta 6MWD = +28.3 +/- 58.4 m; Delta MRCD = 0.3 +/-
0.81 units; Delta SGRQ = -6.7 +/- 7.0 units). Conclusions: ELS
therapy shows promise for treating patients with advanced
heterogeneous emphysema. Additional studies to assess responses in
a larger cohort with a longer follow-up are warranted. Copyright
(C) 2011 S. Karger AG, Basel