PURPOSE OF THE STUDY.
The aim of this pilot study was to assess the effect of a 3-week course of clarithromycin as an add-on to regular treatment, on symptom-free days and lung function, in asthmatic children experiencing an acute exacerbation.
Participants included 40 children, ages 6 to 14 years, followed by the Allergy Department at the second pediatric clinic of the University of Athens with intermittent or mild persistent asthma, who presented with an acute asthma exacerbation during a predefined 2-year period.
This was a prospective, open-label, randomized pilot study. Participants were randomized to 2 groups. The first group received 15 mg/kg of clarithromycin for 3 weeks in addition to their regular exacerbation treatment. The second received only their regular exacerbation treatment. Children were followed with diary cards for 12 weeks. Lung function was assessed at study entry, and 3 and 12 weeks after the index exacerbation. Nasal wash samples were collected at study entry and reverse transcriptase polymerase chain reaction was performed for respiratory viruses and atypical bacteria.
Of the 40 children enrolled, 18 were treated with clarithromycin. The children in the clarithromycin treatment group had significantly more symptom-free days (78 vs 69 days, P < .0001) and fewer periods with loss of asthma control (9 vs 19, P = .013) compared with controls. Also, time to first period of loss of control was prolonged in the clarithromycin group (67.5 vs 26.5 days, P = .003). Furthermore, the severity of symptoms was lower in the clarithromycin treatment group versus the control group during the first period with loss of control, but not during subsequent periods of loss of control. The duration of the index episode of asthma exacerbation was significantly shorter in the clarithromycin group compared with the control group (5.0 vs 7.5 days, P < .00001) as well. There were no significant differences in lung function between the groups and detection of respiratory syncytial virus did not modify the outcomes in either the clarithromycin group or the control group. The participants in the clarithromycin group were slightly more likely to receive concurrent oral corticosteroids (16/18 vs 14/22, P = .067); however, even after adjusting for corticosteroid use, clarithromycin administration was associated with 10.9 more symptom-free days than in the control group.
In this unblinded study, the addition of a 3-week course of clarithromycin to regular treatment of an acute asthma exacerbation was associated with decreased duration of the asthma exacerbation, increase in symptom-free days after the exacerbation, and reductions in the number and severity of days with loss of control after the initial exacerbation. Addition of clarithromycin had no effect on lung function.
This study showed that a 3-week course of clarithromycin, added to usual therapy for an acute asthma exacerbation in children, is effective in reducing the duration of the exacerbation as well as in reducing subsequent symptoms, both in severity and in number of days with symptoms, over a 3-month follow-up period. However, the study was unblinded and beneficial effects of clarithromycin were observed for self-reported outcomes and not for lung function, so it is possible that the observed treatment effects were a result of bias. Further studies using blinded, randomized control trials should be performed to assess for the efficacy and safety of clarithromycin add-on therapy for acute asthma exacerbations in children.
- Copyright © 2013 by the American Academy of Pediatrics