• Lower Respiratory Infections
• Pulmonary Clinical Trials

• Lower Respiratory Infections
• Pulmonary Clinical Trials
• Pulmonary & Critical Care

A study of a nonsurgical lung volume reduction (LVR) approach using an emphysematous lung sealant (ELS) demonstrated that >50% of treated patients experienced minimal, clinically important differences in health status and respiratory measures compared with patients treated only with optimal medical therapy. However, the rate of serious adverse events (SAEs) was higher in patients who responded to ELS treatment. The Study of the AeriSeal System for Hyperinflation Reduction in Emphysema [ASPIRE; NCT01449292; Washko GR et al. Am J Respir Crit Care Med 2014] was terminated early for financial reasons. George Washko, MD, Brigham and Women's Hospital, Boston, Massachusetts, USA, presented data on the 90 patients who completed the 3- and the 6-month follow-up.

The multicenter, multinational, randomized, controlled trial used ELS, a synthetic polymer that targets the alveolar compartment of the lung to block the distal airways and collateral ventilation, to achieve nonresectional inflation in patients with hyperinflation. The goal was to achieve the clinical and physiologic benefit of LVR without the morbidity and mortality associated with surgery. In ASPIRE, 2 subsegments each in the right and upper left lobes were treated endoscopically with ELS, and patients were hospitalized overnight for observation.

The study patients had upper lobe–predominant emphysema, with forced expiratory volume in 1 second (FEV₁) <50%, total lung capacity >100%, and a diffusing capacity of the lungs for carbon monoxide of 20% to 60%. In total, 95 patients were randomized to optimal medical therapy plus ELS (ELS treated; n=61) or optimal medical therapy alone (control; n=34). Their mean age was 65 years, most were men (∼60%), and they had smoking histories of >20 pack-years. Patients with a₁ antitrypsin deficiency, a genetic risk factor for emphysema, and those who had prior LVR were excluded.

The primary outcome was change in FEV₁ at 12 months from baseline. Data were available at 3 months for 34 ELS-treated and 23 control patients and at 6 months for 21 ELS-treated and 13 control patients. The changes in FEV₁ in the ELS-treated patients were +11% and +19% at 3 and 6 months, compared with −2% and +1% in the control patients, respectively. The change in health status as measured by the St. George's Respiratory Questionnaire, a secondary end point, was −11 and −12 at 3 and 6 months in the ELS-treated patients and −4 and −3, respectively, in the control patients. The change in the Modified Medical Research Council dyspnea scale was small: −1 at 3 and 6 months in the ELS-treated and 0 at both time points in the control patients.

The rate of all SAEs was higher for the ELS-treated than for control patients, with 43% and 16%, respectively, requiring hospitalization, primarily for respiratory SAEs (39% of treatment and 15% of control patients). Two patients in the treatment group died (1 treatment related).

The individual patient data at 6 months showed that the improvement in FEV₁ ranged from a nearly 25% reduction to an approximately 120% increase in the ELS-treated patients. The median change in FEV₁ was approximately 19% and the mean change was approximately 28% in the ELS-treated patients, which is comparable with surgical LVR outcomes, stated Dr. Washko.

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