Childhood Asthma Research and Education (CARE) Network

Maintenance vs Intermittent Inhaled Steroids in Wheezing Toddlers (MIST)

NULL HYPOTHESIS

In preschool children 12-53 months of age, with recurrent wheezing, +API and at least one asthma/wheezing exacerbation in the prior year, the following two therapies will not differ with respect to the rate of wheezing/asthma exacerbations requiring systemic corticosteroids during one year of treatment:

  1) Maintenance low-dose ICS (Pulmicort Respules0.5 mg)

  2) Intermittent high-dose ICS BID x 7 days with RTI (Pulmicort Respules1 mg BID).

DESIGN

MIST is a randomized, double-blind, double-dummy placebo- controlled parallel multicenter comparison of two strategies (maintenance daily low-dose ICS compared to intermittent high-dose ICS for 7 days during RTI) directed at reducing risk (exacerbations requiring systemic corticosteroids, primary outcome) and reducing impairment (EFD, severity of symptoms during RTI, albuterol use, and QOL) in preschool children 12-53 months of age with the following phenotypic characteristics: recurrent wheezing, +API and history of severe exacerbation in the year prior to enrollment. There will be a 2-week observation period to qualify and characterize the participants with respect to baseline demographic, atopic/asthma and genetic factors followed by a 52-week treatment phase. 

RESULTS

Enrollment for MIST will begin in August 2008 with a target sample size of 250 randomized children and the final patient visits will occur in August 2010.