Prophylactic management of children at risk for recurrent upper respiratory infections: the Preventia I Study

  1. A. Grimfeld1,
  2. S. T. Holgate2,
  3. G. W. Canonica3,
  4. S. Bonini4,
  5. M. P. Borres5,
  6. D. Adam6,
  7. C. Canseco Gonzalez7,
  8. P. Lobaton8,
  9. P. Patel9,
  10. A. Szczeklik10,
  11. M. R. Danzig11,
  12. I. Roman12,
  13. H. Bismut13,
  14. W. Czarlewski14

Article first published online: 12 NOV 2004

DOI: 10.1111/j.1365-2222.2004.02098.x

Issue

Clinical & Experimental Allergy

Clinical & Experimental Allergy

Volume 34, Issue 11, pages 1665–1672, November 2004

Additional Information

How to Cite

Grimfeld, A., Holgate, S. T., Canonica, G. W., Bonini, S., Borres, M. P., Adam, D., Canseco Gonzalez, C., Lobaton, P., Patel, P., Szczeklik, A., Danzig, M. R., Roman, I., Bismut, H. and Czarlewski, W. (2004), Prophylactic management of children at risk for recurrent upper respiratory infections: the Preventia I Study. Clinical & Experimental Allergy, 34: 1665–1672. doi: 10.1111/j.1365-2222.2004.02098.x

Author Information

  1. 1

    Hôpital Armand Trousseau, Paris, France,

  2. 2

    School of Medicine, University of Southampton, Southampton, UK,

  3. 3

    University of Genoa, Genoa, Italy,

  4. 4

    Italian National Research Council, Rome, Italy,

  5. 5

    University of Gothenburg, Gothenburg, Sweden,

  6. 6

    Kinderklinik der Universität, Munchen, Germany,

  7. 7

    Hospital Universitario, Monterrey, Mexico,

  8. 8

    University of Cadiz, Cadiz, Spain,

  9. 9

    Allied Clinical, Toronto, Canada,

  10. 10

    Jagellonian University, Krakow, Poland,

  11. 11

    Schering-Plough Corp., Kenilworth, NJ, USA,

  12. 12

    Target Research Associates, New Providence, NJ, USA,

  13. 13

    Strategik & Numerik, Paris, France

  14. 14

    Schering-Plough, Levallois Perret, France

* Pr Alain Grimfeld, Centre de l'Asthme, Hôpital Armand – Trousseau, 26, Avenue du Dr Arnold Netter, 75571 Paris cedex 12, France. E-mail: alain.grimfeld@trs.ap-hop-paris.fr

  1. This study was co-ordinated by Alain Grimfeld and Stephen T. Holgate.

  2. See † for participating investigators and centres.

Publication History

  1. Issue published online: 12 NOV 2004
  2. Article first published online: 12 NOV 2004
  3. Submitted 3 September 2003; revised 22 June 2004; accepted 29 June 2004

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Keywords:

  • airway hyper-reactivity;
  • asthma;
  • child;
  • ENT infections;
  • ICAM-1;
  • loratadine;
  • prevention;
  • psychomotor development;
  • rhinovirus;
  • wheezing

Summary

Background Given the morbidity and mortality of asthma and the recent dramatic increase in its prevalence, pharmacologic prophylaxis of this disease in children at risk would represent a major medical advance.

Objectives The Preventia I Study was designed to evaluate the efficacy and long-term safety of loratadine in reducing the number of respiratory infections in children at 24 months. A secondary objective was to investigate the benefit of loratadine treatment in preventing the onset of respiratory exacerbations.

Methods Preventia I was a randomized placebo-controlled study involving 22 countries worldwide. The children were 12–30 months of age at enrolment and had experienced at least five episodes of ENT infections, and no more than two episodes of wheezing during the previous 12 months. Phase I was a 12-month double-blind period during which the children were treated with loratadine 5 mg/day (2.5 mg/day for childrenleqslant R: less-than-or-eq, slant24 months of age) or placebo. Phase II was a double-blind follow-up period without study medication.

Results Of the 412 children enrolled, 342 and 310 completed Phase I and Phase II, respectively. The results showed a significant decrease in the number of infections in the whole population of children. However, no difference was observed between the loratadine and placebo group. When considering secondary end-points, loratadine was shown to reduce the number of respiratory exacerbations during the treatment phase. None of the 204 children who received loratadine discontinued the study because of drug-related events. Loratadine treatment was not more sedative than placebo and was not associated with cardiovascular events.

Conclusion The strong decrease in the rate of infections in the children at risk of recurrent infections, while not being influenced by loratadine treatment, should encourage future reflection in terms of prophylactic management. This study also confirms the long-term safety of loratadine and its metabolites in young children.

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