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Background We conducted a double-blind, randomized, placebo-controlled study to evaluate the efficacy of telithromycin in patients with acute exacerbations of asthma.
Methods A total of 278 adults with diagnosed asthma were enrolled within 24 hours after an acute exacerbation of asthma requiring short-term medical care. The patients were randomly assigned to receive 10 days of oral treatment with telithromycin (at a dose of 800 mg daily) or placebo in addition to usual care. Primary efficacy end points were a change from baseline over the treatment period in symptoms (as recorded by patients in a diary card) and in the peak expiratory flow in the morning at home. The presence of Chlamydophila pneumoniae or Mycoplasma pneumoniae was ascertained by serologic analysis, polymerase chain reaction, and culture.
Results Of the two prespecified primary outcomes, only asthma symptoms showed a significantly greater reduction among patients receiving telithromycin than among those receiving placebo. Mean (±SD) scores on a test of asthma symptoms (on a 7-point scale, with 0 denoting no symptoms and 6 denoting severe symptoms) were 3.0±1.4 at baseline and 1.7±1.1 at the end of treatment for the telithromycin group and 2.8±1.3 at baseline and 2.0±1.0 at the end of treatment for the placebo group. The mean decrease in symptom scores during the treatment period was 1.3 for telithromycin and 1.0 for placebo (mean difference, –0.3; 95 percent confidence interval, –0.5 to –0.1; P=0.004). There was no significant treatment effect on the other primary outcome measure, a change in morning peak expiratory flow. Nausea was more common among patients in the telithromycin group than in the placebo group (P=0.01). Although 61 percent of patients had evidence of infection with C. pneumoniae, M. pneumoniae, or both, there was no relationship between bacteriologic status and the response to asthma treatment.
Conclusions This study provides evidence of the benefit of telithromycin in patients with acute exacerbations of asthma; the mechanisms of benefit remain unclear. (ClinicalTrials.gov number, NCT00273520
[ClinicalTrials.gov]
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Source Information
From the National Heart and Lung Institute, Imperial College London (S.L.J.); and G.R. Micro (D.J.F.) — both in London; the University of Milan, Istituto di Ricovero e cura a Carattere Scientifico Policlinico, Milan (F.B.); the University of Auckland, Auckland, New Zealand (P.N.B.); the National Jewish Medical and Research Center, Denver (R.J.M.); and Sanofi-Aventis, Bridgewater, N.J. (R.B.N.).
Address reprint requests to Dr. Johnston at the Department of Respiratory Medicine, National Heart and Lung Institute and Wright Fleming Institute of Infection and Immunity, Imperial College London, Norfolk Pl., London W2 1PG, United Kingdom, or at s.johnston{at}imperial.ac.uk.
Related Letters:
Telithromycin in Acute Exacerbations of Asthma
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