Azithromycin for episodes with asthma-like symptoms in young children aged 1-3 years

Setting: Birth cohort of general population of Zealand region, Denmark. Patients At the age of 1 week, 700 infants were recruited and observed via daily parental diaries until the age of 3 years. Included in the trial were children who developed recurrent troublesome lung symptoms, defined as: 5 episodes in 6 months of cough, dyspnoea or wheeze severely affecting the well-being of the child; 4 weeks of continuous symptoms; severe episode requiring admission or treatment with oral steroids. Three months of inhaled fluticasone was given at the diagnosis of recurrent troublesome lung symptoms and continued for another 6 months if symptoms recurred. Intervention Children older than 1 year of age were assessed by a study physician at each acute episode (≥3 consecutive days of cough, dyspnoea or wheeze severely affecting the well-being of the child) and randomly allocated to azithromycin (10 mg/kg/day for 3 days) or placebo. Hypopharyngeal aspirates were analysed by viral PCR and bacterial culture. Additional treatment, including montelukast, β2 agonist therapy or prednisolone, was given at the clinician’s discretion. Parents and investigators were blinded. Exclusion criteria Macrolide allergy, heart, liver, neurological or kidney disease; evidend of pneumonia (C reactive protein level of >50 mg/L; respiratory rate ≥50 breaths/min or fever ≥39° C). Primary outcome Duration of respiratory symptoms after treatment, measured by parental diary cards.Secondary outcomes: The time from treatment to the next episode, the number of episodes that turned into severe exacerbations and the duration of β2 agonist use after treatment. Secondary outcomes The time from treatment to thenext episode, the number of episodes that turned intob severe exacerbations and the duration of β2 agonist use after treatment.