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

John E. Connett, John W. Kusek, William C. Bailey, Peggy O'Hara, Margaret Wu

Research output: Contribution to journalArticlepeer-review

97 Scopus citations

Abstract

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.

Original languageEnglish (US)
Pages (from-to)3-19
Number of pages17
JournalControlled clinical trials
Volume14
Issue number2 SUPPL.
DOIs
StatePublished - Apr 1993

Bibliographical note

Funding Information:
Supported by funding from the Division of Lung Diseases of the National Heart, Lung and Blood Institute.

Copyright:
Copyright 2014 Elsevier B.V., All rights reserved.

Keywords

  • Clinical trial
  • behavioral intervention
  • inhaled bronchodilator
  • pulmonary function

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