Azithromycin for acute bronchitis: a randomised, double-blind, controlled trial

Lancet. 2002 May 11;359(9318):1648-54. doi: 10.1016/S0140-6736(02)08597-5.


Background: The value of azithromycin for treatment of acute bronchitis is unknown, even though this drug is commonly prescribed. We have investigated this question in a randomised, double-blind, controlled trial.

Methods: Adults diagnosed with acute bronchitis, without evidence of underlying lung disease, were randomly assigned azithromycin (n=112) or vitamin C (n=108) for 5 days (total dose for each 1.5 g). All individuals were also given liquid dextromethorphan and albuterol inhaler with a spacer. The primary outcome was improvement in health-related quality of life at 7 days; an important difference was defined as 0.5 or greater. Analysis was by intention to treat.

Findings: The study was stopped by the data-monitoring and safety committee when 220 patients had been recruited. On day 7, the adjusted difference in health-related quality of life was small and not significant (difference 0.03 [95% CI -0.20 to 0.26], p=0.8). 86 (89%) of 97 patients in the azithromycin group and 82 (89%) of 92 in the vitamin C group had returned to their usual activities by day 7 (difference 0.5% [-10% to 9%], p>0.9). There were no differences in the frequency of adverse effects; three patients in the vitamin C group discontinued the study medicine because of perceived adverse effects, compared with none in the azithromycin group. Most patients (81%) reported benefit from the albuterol inhaler.

Interpretation: Azithromycin is no better than low-dose vitamin C for acute bronchitis. Further studies are needed to identify the best treatment for this disorder.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Acute Disease
  • Adult
  • Aged
  • Aged, 80 and over
  • Analysis of Variance
  • Anti-Bacterial Agents / therapeutic use*
  • Ascorbic Acid / therapeutic use
  • Azithromycin / therapeutic use*
  • Bronchitis / drug therapy*
  • Chi-Square Distribution
  • Double-Blind Method
  • Female
  • Humans
  • Male
  • Middle Aged
  • Quality of Life
  • Surveys and Questionnaires
  • Treatment Outcome


  • Anti-Bacterial Agents
  • Azithromycin
  • Ascorbic Acid