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* From the Department of Medicine (Drs. Kraft and Martin, and Mr. Pak), National Jewish Medical and Research Center and the University of Colorado Health Sciences Center, Denver, CO; and Department of Microbiology (Dr. Cassell), University of Alabama at Birmingham, Birmingham, AL.
Correspondence to: Richard J. Martin, MD, FCCP, National Jewish Medical and Research Center, 1400 Jackson St, Room J115, Denver, CO 80206; e-mail: martinr{at}njc.org
Study objectives: To determine the effect of clarithromycin therapy in patients with asthma.
Design: Randomized, double blind, placebo-controlled trial.
Setting: A tertiary referral center.
Patients or participants: Fifty-five subjects with chronic, stable asthma recruited from the general Denver, CO, community.
Interventions: Patients underwent airway evaluation for Mycoplasma pneumoniae and Chlamydia pneumoniae by polymerase chain reaction (PCR) and culture, followed by treatment with clarithromycin, 500 bid, or placebo for 6 weeks.
Measurements and results: Outcome variables were lung function, sinusitis as measured by CT, and the inflammatory mediators tumor necrosis factor (TNF)-
, interleukin (IL)-2, IL-4, IL-5, and IL-12 messenger RNA (mRNA) measured via in situ hybridization, in airway biopsies, and BAL. Mycoplasma or chlamydia were detected by PCR in 31 of 55 asthmatics. Treatment resulted in a significant improvement in the FEV1, but only in the PCR-positive subjects (2.50 ± 0.16 to 2.69 ± 0.19 L, mean ± SEM; p = 0.05). This was not appreciated in the PCR-negative subjects (2.59 ± 0.24 to 2.54 ± 0.18 L, p = 0.85) or the PCR-positive or PCR-negative subjects who received placebo. Sinus CTs revealed no change in sinusitis with clarithromycin treatment. In situ hybridization revealed no significant difference in baseline airway tissue or BAL-mediator expression between the PCR-positive and PCR-negative subjects. However, the PCR-positive subjects who received clarithromycin demonstrated a reduction in TNF- (p = 0.006), IL-5 (p = 0.007), and IL-12 (p = 0.004) mRNA in BAL and TNF- mRNA in airway tissue (p = 0.0009). The PCR-negative subjects who received clarithromycin only demonstrated a reduction in TNF- (p = 0.01) and IL-12 (p = 0.002) mRNA in BAL and TNF- mRNA in airway tissue (p = 0.004). There were no significant differences in cytokine expression in those subjects who received placebo.
Conclusions: These observations support the hypothesis that clarithromycin therapy improves lung function, but only in those subjects with positive PCR findings for M pneumoniae or C pneumoniae.
Key Words: airway • asthma • bronchoscopy • chlamydia • mycoplasma
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