Asthma Clinical Research Network (ACRN)
Macrolides In Asthma (MIA)
Asthmatics with chronic Mycoplasma pneumoniae or Chlamydia pneumoniae airway infection and suboptimal asthma control despite inhaled corticosteroid therapy will not exhibit an improvement in asthma control with the addition of a macrolide antibiotic compared with placebo. Non-infected asthmatics with suboptimal asthma control despite inhaled corticosteroid therapy will not exhibit an improvement in asthma control with the addition of a macrolide antibiotic compared with placebo.
MIA is an exploratory, stratified, randomized, controlled, double-blind, parallel-arm study designed as a test of the effect on asthma control of 16 weeks of clarithromycin or placebo added to fluticasone in subjects between the ages of 18 and 60 years with suboptimally-controlled asthma both with and without chronic mycoplasma or chlamydia airway infection. The primary outcome variable is the difference in the Asthma Control Questionnaire score between values obtained at the end of the characterization period and the end of the intervention period.
Enrollment for the MIA trial will begin in July 2006 and the last patient visits are anticipated to occur in July 2007. The target sample size is a minimum of 72 randomized PCR+ patients and 72 randomized PCR– patients.
