The Journal of Allergy and Clinical Immunology
Volume 126, Issue 5 , Pages 942-949, November 2010

Steroid-sparing effects with allergen-specific immunotherapy in children with asthma: A randomized controlled trial

  • Stefan Zielen, MD

      Affiliations

    • Pediatric Clinic, Frankfurt University, Frankfurt, Germany
    • ,
  • Peter Kardos, MD

      Affiliations

    • Group Practice and the Center for Pneumology, Allergy, Somnology, Maingau Clinic, Frankfurt, Germany
    • ,
  • Enzo Madonini, MD

      Affiliations

    • Pneumology Unit, San Carlo Hospital, Milan, Italy
    • Corresponding Author InformationReprint requests: Enzo Madonini, MD, Via Cicognara 6, 20129 Milan, Italy.

Received 13 October 2009; received in revised form 3 June 2010; accepted 7 June 2010. published online 12 July 2010.

Background

Asthma control is now recognized as the main goal of asthma therapy. Guidelines recommend finding the lowest effective dose of inhaled corticosteroids in children with persistent asthma.

Objective

The aim of this study was to investigate the efficacy of an allergen-specific immunotherapy with a high-dose hypoallergenic mite preparation (allergoid) as steroid-sparing agent in children with allergic asthma.

Methods

Sixty-five children with asthma (Global Initiative for Asthma treatment levels II and III; 6-17 years old), after reaching asthma control with inhaled steroids during a 5-month baseline period, were randomized for subcutaneous mite allergoid immunotherapy (SCIT) plus fluticasone propionate (FP) or FP therapy alone for 2 years. During 2 subsequent 5-month winter periods, steroid therapy was adjusted according to predefined dose steps, determining and comparing the changes in FP dosages and the lowest FP dose sufficient to maintain asthma control. Immunologic and functional investigations were also carried out.

Results

Children treated with house dust mite SCIT plus FP were able to significantly reduce the FP dose by more steps (P < .05), compared with the control group on FP alone. The mean daily dose in the immunotherapy group decreased from 330.3 μg in the baseline period to 151.5 μg after 2 treatment years, whereas in the control group the dose decreased from 290.6 μg to 206.3 μg. Compared with the control group, significant improvement was also observed in morning peak expiratory flow (P = .0315). Significantly increased levels of specific IgG1 (P = .0001) and IgG4 (P < .0001) were also observed.

Conclusion

Adding a mite allergoid SCIT to pharmacologic treatment is an effective and safe strategy to reduce corticosteroid doses while maintaining disease control in children with mite-induced allergic asthma.

Key words: Subcutaneous immunotherapy, allergoid, house dust mite, asthma control, children, hypoallergenic preparation, controlled trial, efficacy, safety, Dermatophagoides pteronyssinus

Abbreviations used: FP, Fluticasone propionate, GINA, Global Initiative for Asthma, ICS, Inhaled corticosteroid, PEF, Peak expiratory flow, SCIT, Subcutaneous immunotherapy, SIT, Allergen-specific immunotherapy, SLIT, Sublingual immunotherapy, SPT, Skin prick test, TU, Therapeutic unit

 

 Supported by Allergopharma Joachim Ganzer KG, Reinbek, Germany.

 Disclosure of potential conflict of interest: S. Zielen has received research support from Allergopharma, MSD, and Bencard. P. Kardos has received research support from Boehringner Ingelheim and AstraZeneca, is on the QAB and Omalizumab Advisory Board for Novartis and the Mundipharma Advisory Board, and has given presentations for GlaxoSmithKline, Mundipharma, AstraZeneca, Novartis, Bionorica, Cefalon, and Janssen-Cilag. E. Madonini is a consultant for Allergopharma SPA.

 Trial registration: Clinical Trials.gov identifier: NCT00263640.

PII: S0091-6749(10)00898-5

doi:10.1016/j.jaci.2010.06.002

The Journal of Allergy and Clinical Immunology
Volume 126, Issue 5 , Pages 942-949, November 2010

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