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Ann Allergy Asthma Immunol. 2012 Jul;109(1):65-70. doi: 10.1016/j.anai.2012.05.006. Epub 2012 Jun 1.

Salmeterol and fluticasone in young children with multiple-trigger wheeze.

Author information

1
Department of Allergy, Helsinki University Central Hospital, Finland. mika.makela@hus.fi

Abstract

BACKGROUND:

Treatment guidelines recommend using an inhaled corticosteroid (ICS) plus a long-acting β(2)-agonist (LABA) for childhood asthma when the symptoms are not controlled by ICS alone, but the appropriate use of LABAs in children continues to be debated.

OBJECTIVE:

To compare the efficacy of an inhaled salmeterol and fluticasone propionate combination, 50/100 μg twice daily, with fluticasone propionate, 100 μg twice daily, or salmeterol, 50 μg twice daily, in children with multiple-trigger wheeze.

METHODS:

A total of 105 children 4 to 7 years of age with multiple-trigger wheezing based on respiratory symptoms and bronchodilator responsiveness and/or exercise-induced bronchoconstriction without a viral cold were randomized to salmeterol-fluticasone, fluticasone propionate alone, or salmeterol alone via a metered-dose inhaler and a spacer device for 8 weeks. The primary efficacy outcome was exhaled nitric oxide level. Secondary outcomes were lung function measurements via impulse oscillometry, respiratory symptoms, and rescue medication use.

RESULTS:

The exhaled nitric oxide levels decreased after all treatments, significantly more so after salmeterol-fluticasone and fluticasone than with salmeterol (adjusted geometric means at 8 weeks: salmeterol-fluticasone, 9.4 ppb; fluticasone, 9.3 ppb; salmeterol, 13.9 ppb; salmeterol-fluticasone vs salmeterol, P = .02; fluticasone vs salmeterol, P = .01). No treatment differences were found with respect to respiratory symptoms or median rescue use. Salmeterol-fluticasone resulted in a small but statistically significant improvement in baseline lung function compared with fluticasone. All treatments were equally well tolerated.

CONCLUSION:

The effects of salmeterol-fluticasone and fluticasone were comparable, although lung function improvement was better with salmeterol-fluticasone than with fluticasone alone. There is no obvious benefit in initiation therapy with salmeterol-fluticasone rather than fluticasone alone in the treatment of steroid-naive children with multiple-trigger wheeze.

TRIAL REGISTRATION:

Pathway of clinical trial registry of Helsinki University:http://www.hus.fi/?Path=1;28;2530;9899;9900;23618;23903;33578.

PMID:
22727160
DOI:
10.1016/j.anai.2012.05.006
[Indexed for MEDLINE]
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