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, G. Gauthier, A. Beaupré, P. Grégoire, P. Jacquemin, F. Plante, Y. Lachance, G. Provost, P. Hernandez, R. Jean-François, Charbonneau, N. Inhaber, J. Braidy, A. Jeanneret, P. BolducP. P. Leblanc, R. Olivenstein, S. Mannix, B. Chrysler, N. Wolkove, H. Kreisman, Frank, J. Fox, N. Colman, J. Gruber, Zidulka, A. Gursahaney, Matouk, D. Eidelman, M. Julien, J. Malo, R. Dandurand, E. Skamene, S. Suissa, S. Choi, J. Martin, G. Dankoff, M. Enjalbert, P. A. Lauener

Research output: Contribution to journalArticlepeer-review

207 Citations (Scopus)

Abstract

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.

Original languageEnglish
Pages (from-to)1719-1724
Number of pages6
JournalAmerican Journal of Respiratory and Critical Care Medicine
Volume156
Issue number6
DOIs
Publication statusPublished - 1997
Externally publishedYes

ASJC Scopus Subject Areas

  • Pulmonary and Respiratory Medicine
  • Critical Care and Intensive Care Medicine

PubMed: MeSH publication types

  • Clinical Trial
  • Journal Article
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

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