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Am. J. Respir. Crit. Care Med., Volume 156, Number 6, December 1997, 1719-1724

Effects of an Immunostimulating Agent on Acute Exacerbations and Hospitalizations in Patients with Chronic Obstructive Pulmonary Disease

J. P. COLLET, S. SHAPIRO, P. ERNST, P. RENZI, T. DUCRUET, A. ROBINSON, and the PARI-IS Study Steering Committee and Research Group

Randomized Clinical Trial Unit, SMBD Jewish General Hospital; Department of Epidemiology and Biostatistics, McGill University; Department of Respirology, Montreal General Hospital; and Département de Pneumologie, Hôpital Notre Dame, Université de Montréal, Québec, Canada

The PARI-IS Study is a double-blind placebo-controlled randomized clinical trial to study the effect of an immunostimulating agent to prevent acute respiratory exacerbation in patients with COPD. Three hundred eighty-one ambulatory patients (190 placebo and 191 immunostimulant) were followed at home for 6 mo by experienced research nurses. The risk of having at least one episode of acute exacerbation (primary outcome) was similar in the two groups (p = 0.872). In contrast, the total number of days of hospitalization for a respiratory problem was 55% less in the group treated with OM-85 BV (287 d) than in the group treated with placebo (642 d). Patients treated with OM-85 BV spent an average of 1.5 d in hospital compared with 3.4 d for patients treated with placebo (p = 0.037). The risk of being hospitalized for a respiratory problem was 30% lower in the treated group (16.2%) than in the placebo group (23.2%); p = 0.089. Eight deaths were observed: two in patients treated with OM-85 BV and six in patients treated with placebo (p = 0.153). During the course of the study dyspnea improved slightly in patients treated with OM-85 BV, whereas it deteriorated slightly in patients receiving placebo (p = 0.028). These results suggest that this immunostimulating agent may be beneficial for patients with COPD by reducing the likelihood of severe respiratory events leading to hospitalization.




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