Design of the Lung Health Study: a randomized clinical trial of early intervention for chronic obstructive pulmonary disease

Control Clin Trials. 1993 Apr;14(2 Suppl):3S-19S. doi: 10.1016/0197-2456(93)90021-5.


The Lung Health Study is a multicenter randomized clinical trial. Participants are smokers aged 35-60 with spirometric evidence of moderate lung function impairment. The objective of the trial is to determine whether a program of smoking intervention and use of an inhaled bronchodilator can slow the rate of decline in pulmonary function over a 5-year follow-up period. This paper describes the background, design, sample size (approximately 6000 participants), and power estimates for the trial, as well as the treatment program and the rationale for the choice of inhaled bronchodilator. Plans for analysis of changes in pulmonary function parameters and for analysis of participants' survival and smoking-related morbidity are also discussed.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Administration, Inhalation
  • Adult
  • Airway Resistance / drug effects
  • Clinical Trials as Topic / methods*
  • Female
  • Follow-Up Studies
  • Forced Expiratory Volume / drug effects
  • Humans
  • Ipratropium / administration & dosage*
  • Lung Diseases, Obstructive / mortality
  • Lung Diseases, Obstructive / therapy*
  • Male
  • Middle Aged
  • Smoking Cessation*
  • Survival Rate


  • Ipratropium