Study Results

• What We Learned:

  Study results show that while there was no improvement in lung function in the treatment group compared to the placebo group; treatment with azithromycin did improve other measures including the rate of pulmonary exacerbations. Treatment with azithromycin did not increase the risk of adverse events.

• Primary Findings:

  Effectiveness:

  This study was conducted between February 2007 and July 2009. A total of 260 patients were randomized to receive either azithromycin (N=131) or placebo (N= 129); the vast majority of participants completed the study (126 in each treatment group). The researchers found that treatment with azithromycin for 24 weeks, compared with placebo, did not result in improved pulmonary function, as measured by the change in FEV1 (the volume of air that can be forced out in one second after taking a deep breath).

   

  Analyses of exploratory end points demonstrated that when compared with the placebo group, the azithromycin group had a 50 percent reduction in pulmonary exacerbations, 27 percent reduction in the initiation of new oral antibiotics (other than azithromycin), 1.3 lbs. weight gain, and a 0.34-unit increase in body mass index. There were no differences in treatment groups in the use of intravenous or inhaled antibiotics or hospitalizations.

  Safety:

  Participants in the azithromycin group had no increased risk of adverse events, but had less cough and less productive cough compared with placebo participants.

• Citation:

  JAMA 2010;303(17):1707-1715

For current information about the overall development status of this drug, please check the Drug Development Pipeline.