title: Changing patterns in long-acting bronchodilator trials in chronic obstructive pulmonary disease.
abstract: Chronic obstructive pulmonary disease (COPD) is a major cause of morbidity and mortality worldwide. Developments in the understanding of COPD have led to standard guidelines for diagnosis, treatment, and spirometry assessments, which have in turn influenced trial designs and inclusion criteria. Substantial clinical evidence has been gained from clinical trials and supports a positive approach to COPD management. However, there appear to be changing trends in recent trials. Large bronchodilator studies have reported lower improvements in trough forced expiratory volume in 1 second (FEV(1)) values versus placebo than were observed in earlier studies, while the rate of FEV(1) decline seems to be lower in more recent trials. In addition, recent evidence has called into question the usefulness of bronchodilator reversibility testing as a trial inclusion criterion. Baseline patient populations and use of concomitant medications have also changed over recent years due to increased treatment options. The impact of these many variables on clinical trial results is explored, with a particular focus on changes in inclusion criteria and patient baseline demographics.
authors.affiliation: Division of Pulmonary Disease and Critical Care Medicine, School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC 27599, USA. jdonohue@med.unc.edu
authors.forename: James F
authors.initials: JF
authors.lastname: Donohue
authors.forename: Paul W
authors.initials: PW
authors.lastname: Jones
mesh_terms: D000368:Aged; D001993:Bronchodilator Agents / Q000627:therapeutic use*; D002986:Clinical Trials as Topic / Q000639:trends*; D019317:Evidence-Based Medicine / Q000639:trends; D005541:Forced Expiratory Volume; D006801:Humans; D008168:Lung / Q000187:drug effects* / Q000503:physiopathology; D008875:Middle Aged; D018579:Patient Selection; D029424:Pulmonary Disease, Chronic Obstructive / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D012129:Respiratory Function Tests; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D001993:Bronchodilator Agents