Annals of Long Term Care

Stockholm, Sweden
September 15-19, 2007

The European Respiratory Society’s Annual Congress is the largest international gathering of health professionals and researchers involved in respiratory medicine in the world. This year, over 15,000 persons attended the meeting held in Stockholm, Sweden. This forum has increasingly become the preferred venue for the presentation of important new research findings and landmark clinical trials in the field of respiratory medicine. Some highlights from the scientific sessions are listed below, with abstracts from the entire proceedings available online by going to www.ersnet.org, click on “Congresses,” click on “Stockholm 2007 Highlights,” and then on “Abstracts.”

Chronic Obstructive Pulmonary Disease
VENT
Several important clinical trials on interventions in chronic obstructive pulmonary disease (COPD) were presented at this year’s Congress. The endobronchial Valve for Emphysema palliatioN Trial (VENT) was an eagerly awaited international study of the use of an endobronchial valve for palliation in emphysema. The VENT concept is to reduce the need for lung volume reduction surgery in patients with severe COPD by bronchoscopically placing a one-way valve in the bronchus of an emphysematous lobe of the lung. The one-way valve prevents inspired air from entering the severely diseased lobe, yet allows trapped air to escape on expiration. This results in collapse of the emphysematous lobe. It is intended to accomplish the same improvement in pulmonary mechanics and ventilation perfusion that is seen with lung volume reduction surgery without the high perioperative morbidity and mortality associated with that surgery. Candidates for the study were carefully screened with chest computerized tomography and selected on the basis of a high heterogeneity score. In other words, there had to be both severely involved lobes, but also areas of lung less involved that could benefit from the volume reduction.

Safety and efficacy endpoints were studied at 6 months, and the results were quite promising. There was a significant improvement in the primary efficacy measures (FEV₁, 6-minute walk test) in the treatment versus control arms (P < 0.025). There was also a significant improvement in secondary measures (maximum workload, quality-of-life questionnaire, and dyspnea scale) in the treatment group (P < 0.025). Use of supplemental oxygen did not change between groups. The study also met the primary safety endpoint with no increased mortality in the treatment arm; however, there were increased adverse events associated with the valve placement. Complications included obstruction of the valve with secretions, infection in the lobe with the valve, misplacement of the valve, poor tolerance of the procedure, and granuloma formation at the site of the valve. The researchers did demonstrate that the valve can be safely removed in the event of a complication, and concluded that the endobronchial valve is a beneficial procedure in selected patients.

INSPIRE
Another major clinical trial in COPD presented was the Investigating New Standards for Prophylaxis In Reduction of Exacerbations (INSPIRE) study. This study reported the results of the first major head-to-head comparison of the two primary drugs commonly used for the clinical management of COPD (tiotropium bromide 18 mcg/day vs salmeterol 50 mcg/day plus fluticasone 500 mcg/day). The study involved over 600 subjects in each treatment arm with moderately severe COPD (mean FEV₁, 39% predicted) who were followed on treatment for a two-year period. Baseline characteristics including age, gender, smoking history, and previous history of exacerbations were very similar in both groups. The primary study endpoint for a measurement of efficacy was the rate of exacerbations that required healthcare utilization.