Inhaled Steroids Best For Kids' Asthma, Trial Finds

MADISON, Wis., Jan. 23 -- Inhaled corticosteroids are the most effective therapy for children with mild to moderate persistent asthma, found a randomized controlled trial.

A combination of steroids and beta-agonists -- aimed at reducing the steroid dose -- was less effective than steroids in controlling clinical measures of asthma, according to Christine Sorkness, PharmD., of the University of Wisconsin here.

Least effective was monotherapy with an oral leukotriene receptor antagonist, Dr. Sorkness and colleagues reported in the January issue of the Journal of Allergy and Clinical Immunology.

The multi-center Pediatric Asthma Controller Trial (PACT) was testing the hypothesis that lower doses of steroids, combined with a long-acting beta-agonist, would outperform steroids alone.

The primary outcome was the number of asthma control days in which there was no need for rescue medication, oral corticosteroids, or non-study asthma medications and there were no daytime symptoms, nighttime awakenings, unscheduled health care visits, emergency department visits, hospitalizations for asthma, or school absenteeism for asthma.

The study assigned 285 children between the ages of six and 14 to:

• Inhaled Flovent Diskus (fluticasone) at 100 micrograms twice daily, with an oral placebo in the evening - the so-called fluticasone monotherapy arm.
• Inhaled Advair Diskus (100 micrograms of fluticasone and 50 micrograms of salmeterol) in the morning and 50 micrograms of inhaled Serevent (salmeterol) in the evening plus a placebo oral drug. This was the so-called PACT combination.
• Or placebo Diskus in the morning and evening, plus five milligrams of Singulair (montelukast) in the evening.

The study found:

• The fluticasone monotherapy and PACT combination were comparable in many patient-measured outcomes, including percent of asthma control days (64.2% versus 59.6%).
• Fluticasone monotherapy was superior to PACT for clinic-measured outcomes such as one-second forced expiratory volume over forced vital capacity, maximum bronchodilator response, and exhaled nitric oxide. The differences were statistically significant at P=0.015, P=0.009 and P<0.001, respectively.
• Fluticasone monotherapy was superior to Singulair for asthma control days (64.2% versus 52.5%, P=0.004) and for all other outcomes.
• Growth over the 48 week-study was not statistically different among the arms.

The bottom line, Dr. Sorkness and colleagues concluded, is that despite the similarity in patient-measured outcomes, Flovent Diskus "provided significantly more improvement in lung function and in bronchial hyperresponsiveness and greater reduction in (exhaled nitric oxide) than PACT combination."

Also, they said, "for several of these other outcomes, PACT combination was not superior to montelukast, which in turn was inferior to fluticasone monotherapy for all assessed asthma control outcomes."

The trial does not support the use of a steroid-sparing strategy in these children, they said.