KEYSTONE, COLO. — Clinically meaningful indicators of asthma control in children with mild to moderate persistent asthma improved significantly more with an inhaled corticosteroid than with a leukotriene inhibitor in a randomized, double-blind crossover study, Dr. Joseph D. Spahn reported at a meeting sponsored by the National Jewish Medical and Research Center.
The number of days per week in which asthma was under control was significantly greater and the need for supplemental albuterol less with fluticasone compared with montelukast in the 16-week trial.
Greater improvement also was found in morning peak expiratory flow and other measures of pulmonary response during fluticasone therapy, as well as in levels of inflammatory biomarkers, said Dr. Spahn of the Denver center.
He presented highlights of an analysis of key secondary end points in a National Heart, Lung, and Blood Institute-sponsored study involving 126 children aged 6–17 years. The primary study end point—the percentage of patients who responded to 8 weeks of therapy with at least a 7.5% increase in forced expiratory volume in 1 second (FEV1)—was previously reported (J. Allergy Clin. Immunol. 2005;115:233–42).
The study has come under considerable criticism—legitimately, in Dr. Spahn's view, and he was a study coauthor—for this choice of a primary end point. Because the mean baseline FEV1 was already 96% of predicted, a child had to have an on-treatment FEV1 in excess of 100% to be classified as significantly improved. That's setting the bar very high, he said.
In all, 23% of the children met the primary end point while on fluticasone only, 5% on montelukast only, and 17% on both drugs.
The more recent analysis by Dr. Spahn and his colleagues looked at a broader range of clinical, pulmonary, and inflammatory responses to therapy (see box). Fluticasone consistently came out ahead, providing the first solid evidence-based support for current national and international guidelines that relied on expert opinion in recommending inhaled corticosteroids as the preferred first-line therapy for mild to moderate persistent asthma in children.
Predictors of a greater therapeutic response to fluticasone than to montelukast in terms of asthma control days per week included greater baseline albuterol use, more positive skin test responses, and higher levels of exhaled nitric oxide, a marker of airway inflammation (J. Allergy Clin. Immunol. 2006;117:45–52).