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Drug Investigation

, Volume 3, Issue 2, pp 76–81 | Cite as

A Double-Blind Comparison of RU-41740 (‘Biostim’) and Placebo in Recurrent Upper Respiratory Tract Infections in Children with Cystic Fibrosis

  • G. Lenoir
  • D. Sommelet Olive
  • J. Derelle
  • J. P. Chazalette
  • M. Jehanne
  • F. Douchain
  • M. Loeuil
  • I. Ounis
Original Research Article

Summary

This study was designed to evaluate the prophylactic action of RU-41740 (‘Biostim’) on upper respiratory tract (URT) infections in a group of children with mild cystic fibrosis. RU-41740 is an immunomodulator of biological origin used against recurrent respiratory infections in adults and children over 1 year of age.

49 children aged 2 to 8 years were followed for 12 months. The RU-41740 patients (n = 25) were older, taller and more ill (lower Shwachmann score) than the control group (n = 24). However, the RU-41740 group had significantly fewer URT infections (2.16) than the placebo group (3.63) over the 12 months (p = 0.05). The total infection time was shorter (17.12 vs 25.54 days, p = 0.12) and the duration of antibiotic treatment significantly shorter (12.28 vs 23.5 days, p = 0.03). The clinical (particularly gastrointestinal) and laboratory tolerability of RU-41740 were good.

RU-41740 provided prophylactic treatment against URT infections in these cystic fibrosis patients in whom infection is a serious threat. Further investigations with this drug are warranted.

Keywords

Cystic Fibrosis Cystic Fibrosis Patient Nasal Polyp Drug Invest Recurrent Respiratory Infection 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

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References

  1. Abman SH, Ogle JW, Butler-Simon N, Rumack CM, Accurso FJ. Role of respiratory syncytial virus in early hospitalisations for respiratory distress of young infants with cystic fibrosis. Journal of Pediatrics 113: 826–830, 1988PubMedCrossRefGoogle Scholar
  2. Andreux JP, Renard M, Andreux MH. Modulation of murine hemopoiesis by repeated injection of glycoprotein extract from Klebsiella pneumoniae. International Journal of Immunopharmacology 8: 147–154, 1986PubMedCrossRefGoogle Scholar
  3. Bonfils P. Prophylaxie des infections des voies respiratoires chez l’enfant par le RU 41740. Presse Médicale 28: 1450–1452, 1988Google Scholar
  4. Durandy A, Smets P, Zalisz R, Griscelli C. The effects of RU 41740 on the in vitro maturation of human B cells. International Journal of Immunopharmacology 10: 851–854, 1988PubMedCrossRefGoogle Scholar
  5. Fietta A, Bersani C, De Rose V, Mangiarotti P, Merlini C, et al. Double-blind trial RU 41740 vs. placebo: immunological and clinical effects in a group of patients with chronic bronchitis. Respiration 54: 145–152, 1988PubMedCrossRefGoogle Scholar
  6. Fisher-Szafarz B, Rommain M, Brossard C, Smets P. Hyaluronic acid-degrading enzymes in rat alveolar macrophages and in alveolar fluid: stimulation of enzyme activity after oral treatment with the immunomodulator RU 41740. Biology of the Cell 63: 355–360, 1988Google Scholar
  7. Gepner P. Immunotolérance du RU 41740. Presse Médicale 17: 1458–1460, 1988Google Scholar
  8. Guenounou M, Vacheron F, Zalisz R, Smets P, Agneray J. Immunological activities of RU 41740, a glycoprotein extract from Klebsiella pneumoniae. I. Activation of murine B cells and induction of interleukin-1 production by macrophages. Annales d’Immunologie 135D: 59–69, 1984PubMedGoogle Scholar
  9. Kerem BS, Rommens JM, Buchanan JA, et al. Identification of the cystic fibrosis gene: genetic analysis. Science 245: 1073–1080, 1989PubMedCrossRefGoogle Scholar
  10. Lenoir G. Mucoviscidose. Encyclopédie Medico-Chirurgicale 6039 A96, 9: 1–22, 1988Google Scholar
  11. Nielsen H. Augmentation of human blood monocyte microbicidal activity by RU 41740 a glycoprotein extract from Klebsiella pneumoniae. European Journal of Clinical Pharmacology 30: 99–104, 1986PubMedCrossRefGoogle Scholar
  12. Nielsen H, Bonde J. Immunostimulation of blood monocyte function by RU 41740 (Biostim) in patients with chronic bronchitis. International Journal of Immunopharmacology 8: 589–592, 1986PubMedCrossRefGoogle Scholar
  13. Pacheco Y, Fonlupt P, Dubois M, Biot N, Perrin-Fayolle M, et al. La méthylation des phospholipides membranaires du macrophage alvéolaire dans la sacoïdose pulmonaire et les fibroses pulmonaires interstitielles diffuses. Pathologie et Biologie 34: 1067–1073, 1986PubMedGoogle Scholar
  14. Petersen NT, Hoiry N, Mordhorst CH, Lind K, Flensburg EW, et al. Respiratory infections in cystic fibrosis patients caused by virus, chlamydia and mycoplasma possible synergism with Pseudomonas aeruginosa. Acta Paediatrica Scandinavica 70: 623–628, 1981PubMedCrossRefGoogle Scholar
  15. Profeta ML, Meroni PL, Guidi G, Palmieri R, Palladino G, et al. Influenza vaccination with adjuvant RU 41740 in the elderly. Lancet 1: 973, 1987PubMedCrossRefGoogle Scholar
  16. Rubio TT. Infection in patients with cystic fibrosis. American Journal of Medicine 81: 73–77, 1986PubMedCrossRefGoogle Scholar
  17. Rudent A, Zalisz R, Quero AM, Smets P. Enhanced resistance of mice against influenza virus infection after local administration of glycoprotein extracts from Klebsiella pneumoniae. International Journal of Immunopharmacology 7: 525–531, 1985PubMedCrossRefGoogle Scholar
  18. Shwachmann H, Redmond A, Khaw KT. Studies in cystic fibrosis: report of 130 patients diagnosed under three months of age over a 20 year period. Pediatrics 46: 335–343, 1970Google Scholar
  19. Smets P, Salles MF, Rommain M, Zalisz R, Yagello M, et al. RU 41740 (K pneumoniae glycoprotein) enhances resistance to experimental candidiasis and stimulates phagocytic functions. Annales de l’Institut Pasteur, Immunologie 138: 425–436, 1987CrossRefGoogle Scholar
  20. Smets P, Zalisz R, Boisnic F. Biostim (RU 41740), immune functions and infection. Advances in the Biosciences 68: 85–102, 1988Google Scholar
  21. Stern RC, Boat TF, Orenstein DM, et al. Treatment and prognosis of nasal polyps in cystic fibrosis. American Journal of Diseases of Children 136: 1067–1070, 1982PubMedGoogle Scholar
  22. Sozzani S, Luini W, Braceschi L, Spreafico F. The effect of Biostim (RU 41740) on natural killer activity in different mouse organs. International Journal of Immunopharmacology 8: 845–853, 1986PubMedCrossRefGoogle Scholar
  23. Wang EL, Prober CG, Manson B, et al. Association of respiratory viral infections with pulmonary deterioration in patients with cystic fibrosis. New England Journal of Medicine 311: 1653–1658, 1984PubMedCrossRefGoogle Scholar

Copyright information

© Adis International Limited 1991

Authors and Affiliations

  • G. Lenoir
    • 1
  • D. Sommelet Olive
    • 1
  • J. Derelle
    • 1
  • J. P. Chazalette
    • 1
  • M. Jehanne
    • 1
  • F. Douchain
    • 1
  • M. Loeuil
    • 1
  • I. Ounis
    • 2
  1. 1.Hôpital NeckerFrance
  2. 2.Laboratoires CassenneParisFrance

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