Childhood Asthma Research and Education (CARE) Network

Montelukast or Azithromycin for Reduction of Inhaled Corticosteroids in Childhood Asthma (MARS)

NULL HYPOTHESIS

In children with moderate to severe persistent asthma, a macrolide (Mac) or a leukotriene receptor antagonist (LTRA) will provide the same steroid-sparing effect when compared to placebo as the dose of inhaled corticosteroid (ICS) is reduced.  This will be tested following achievement of control of symptoms with moderate to high dose ICS in combination with a long acting bronchodilator agonist (LABA).  Use of these ICS doses will be based on NHLBI step-up guidelines to achieve asthma control. 

DESIGN

MARS is designed as a randomized, double-blind parallel group that compares the capacity of azithromycin or montelukast to placebo as effective adjunctive therapy that allows ICS reduction in children ages 6 to 17 years with moderate to severe persistent asthma.

RESULTS

Enrollment for MARS will began in February 2006 with a target sample size of 210 randomized children (70 on placebo, 70 on montelukast, 70 on azithromycin).