Objectives

To test the hypothesis that clarithromycin would improve asthma control in individuals with mild-to-moderate persistent asthma that was not well-controlled despite treatment with low-dose inhaled corticosteroids (ICS).

Background

Research has shown that in some individuals, respiratory airway infections may play a role in the onset and severity of asthma. Inhaled corticosteroids are commonly used to treat asthma; however, they do not effectively control symptoms for everyone. Clarithromycin, an antibiotic medication used to treat bacterial infections, may be an effective asthma treatment for individuals who do not respond well to inhaled corticosteroids.

Participants

Participants were eligible if they had a clinical diagnosis of asthma and either bronchodilator responsiveness, defined as an increase of 12% or greater in the forced expiratory volume in one second (FEV1) 15 minutes after the administration of two puffs of albuterol, or airway hyperresponsiveness, measured by the PC20 FEV1 to methacholine (the concentration of methacholine inducing a 20% fall in FEV1) of ≤ 16 mg/mL. Participants also were required to demonstrate suboptimally-controlled asthma at the time of enrollment, as defined by threshold scores on the Juniper Asthma Control Questionnaire (ACQ) of ≥ 1.5 in those not receiving inhaled corticosteroid (ICS)-containing treatments. Participants receiving ICS-containing treatments could be enrolled with an ACQ score ≥ 1.25 at enrollment or if in the opinion of the investigator the ACQ score was likely to be ≥ 1.25 at the end of the run-in period.

Ninety-two participants were randomized. Twelve (13%) subjects demonstrated PCR evidence of M. pneumoniae or C. pneumoniae in endobronchial biopsies; 80 were PCR negative for both organisms.

Design

Adults with an Asthma Control Questionnaire (ACQ) score ≥1.5 after a 4 week period of treatment with fluticasone propionate were entered into a PCR-stratified randomized trial to evaluate the effect of 16 weeks of either clarithromycin or placebo, added to fluticasone, on asthma control in individuals with or without lower airway PCR evidence of M. pneumoniae or C. pneumoniae.

Conclusions

Adding clarithromycin to fluticasone in adults with mild-to-moderate persistent asthma that was suboptimally-controlled by low-dose ICS alone did not further improve asthma control. Although there was an improvement in airway hyperresponsiveness with clarithromycin, this benefit was not accompanied by improvements in other secondary outcomes. (J Allergy Clin Immunol, 2010; 126(4): 747–753)

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