Table 1. Inclusion, Exclusion, and Outcome Criteria
Criteria
Inclusions
  • Adults ≥18 years of age with physician-diagnosed asthma (symptomatic ≥2 days per week and/or ≥2 nights per month or in exacerbation)

  • Objective evidence for reversible airway obstruction (≥12% and ≥200 mL change in FEV18 and/or a 25% and 60 L/min change in PEFR9) either spontaneously or after treatment

  • Asthma for at least 6 months before enrollment

Exclusions
  • Not English literate or has no email address or Internet access

  • Macrolide allergy

  • Pregnant or lactating

  • ≥4 weeks of continuous use of macrolides, tetracyclines, or quinolones within 6 months of randomization

  • Asthma symptoms less than 6 months' duration

  • Unstable asthma requiring immediate emergency care

  • Comorbidities likely to interfere with study assessments or follow-up (eg, cystic fibrosis, obstructive sleep apnea requiring CPAP, cardiomyopathy, congestive heart failure, terminal cancer, alcohol or other drug abuse, or any other serious medical condition that, in the opinion of the study physician, would seriously interfere with or preclude assessment of study outcomes or completion of study assessments)

  • Medical conditions for which macrolide administration may possibly be hazardous (eg, acute or chronic hepatitis, cirrhosis, or other liver disease; chronic kidney disease; or history of prolonged cardiac repolarization and QT interval or torsades de pointes).

  • Specified medications for which close monitoring has been recommended in the setting of macrolide administration (digoxin, theophylline, warfarin, ergotamine or dihydroergotamine, triazolam, carbamazepine, cyclosporine, hexobarbital, or phenytoin)

Outcomes
  • Asthma symptom scores (0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = worst ever) within the past 24 hours; every 1.5 months

  • AQL (Juniper AQL questionnaire)10 within the past 2 weeks; every 3 months

  • Asthma control (mini-Juniper Asthma Control Questionnaire, without pulmonary function)11,12 within the past week; every 3 months

  • Exacerbations (a steroid burst, an unscheduled or emergency visit and/or a hospitalizations for asthma) within the past 1.5 months; every 1.5 months

  • Other respiratory illnesses within the past 1.5 months; every 1.5 months

  • Off-study antibiotic use within the past 1.5 months; every 1.5 months

  • Adverse events within the past 1.5 months; every 1.5 months

  • Use of asthma-controller medications (oral or inhaled steroids, LABAs, or antileukotriene agents) within the past 3 months; every 3 months

  • Self-reported improvement in asthma (compared with baseline) within the past 3 months; every 3 months

  • AQL, asthma quality of life; CPAP, continuous positive airway pressure; FEV1, forced expiratory volume in 1 second; LABA, long-acting bronchodilators; PEFR, peak expiratory flow rate.