title: Secondary outcomes of a pilot randomized trial of azithromycin treatment for asthma.
abstract: OBJECTIVE
  The respiratory pathogen Chlamydia pneumoniae (C. pneumoniae) produces acute and chronic lung infections and is associated with asthma. Evidence for effectiveness of antichlamydial antibiotics in asthma is limited. The primary objective of this pilot study was to investigate the feasibility of performing an asthma clinical trial in practice settings where most asthma is encountered and managed. The secondary objectives were to investigate (1) whether azithromycin treatment would affect any asthma outcomes and (2) whether C. pneumoniae serology would be related to outcomes. This report presents the secondary results.
  
  
  METHODS
  Randomized, placebo-controlled, blinded (participants, physicians, study personnel, data analysts), allocation-concealed parallel group clinical trial.
  
  
  METHODS
  Community-based health-care settings located in four states and one Canadian province.
  
  
  METHODS
  Adults with stable, persistent asthma.
  
  
  METHODS
  Azithromycin (six weekly doses) or identical matching placebo, plus usual community care.
  
  
  METHODS
  Juniper Asthma Quality of Life Questionnaire (Juniper AQLQ), symptom, and medication changes from baseline (pretreatment) to 3 mo posttreatment (follow-up); C. pneumoniae IgG and IgA antibodies at baseline and follow-up.
  
  
  RESULTS
  Juniper AQLQ improved by 0.25 (95% confidence interval; -0.3, 0.8) units, overall asthma symptoms improved by 0.68 (0.1, 1.3) units, and rescue inhaler use decreased by 0.59 (-0.5, 1.6) daily administrations in azithromycin-treated compared to placebo-treated participants. Baseline IgA antibodies were positively associated with worsening overall asthma symptoms at follow-up (p = 0.04), but IgG was not (p = 0.63). Overall asthma symptom improvement attributable to azithromycin was 28% in high IgA participants versus 12% in low IgA participants (p for interaction = 0.27).
  
  
  CONCLUSIONS
  Azithromycin did not improve Juniper AQLQ but appeared to improve overall asthma symptoms. Larger community-based trials of antichlamydial antibiotics for asthma are warranted.
authors.affiliation: Dean Medical Center, East Clinic, Madison, Wisconsin, United States of America. dlhahn@wisc.edu
authors.forename: David L
authors.initials: DL
authors.lastname: Hahn
authors.forename: Mary Beth
authors.initials: MB
authors.lastname: Plane
authors.forename: Olaimatu S
authors.initials: OS
authors.lastname: Mahdi
authors.forename: Gerald I
authors.initials: GI
authors.lastname: Byrne