Unpredictability of deception in compliance with physician-prescribed bronchodilator inhaler use in a clinical trial

Objective: To identify subject characteristics that may be predictive of in tentional dumping of metered-dose inhalers (MDIs) during a clinical trial, Design: Nebulizer Chronologs (NCs; Medtrac Technologies; Lakewood, CO), whi ch record the date and time of each MDI actuation, were attached to the MDI s of participants who were given a prescribed medication schedule to follow in a clinical trial. Participants were not informed of the function of the NC or that their medication use was being monitored. Setting: The Lung Health Study, a 5-year clinical trial to evaluate the eff ect of intensive smoking cessation counseling and regular use of an inhaled bronchodilator on the progression of COPD, Participants: One hundred one smokers, 35 to 60 years of age, with mild to moderate airways obstruction enrolled in The Lung Health Study. Measurements and results: Thirty of these 101 participants (30%) actuated t heir inhalers > 100 times within a 3-h interval on at least one occasion du ring the first year of this 5-year trial. Only 1 of an additional 135 parti cipants who had full foreknowledge of the MDI monitoring capability of the NC did so. Most of these dumping episodes occurred shortly before a clinic follow-up visit, suggesting an active attempt to hide noncompliance from th e clinic staff. Whereas self-reported inhaler usage and canister weights we re similar for the "dumpers" and "nondumpers," NC data indicated significan tly lower compliance rates for dumpers (chi(2); p < 0.05), When demographic variables, treatment and clinic assignments, smoking status, pulmonary fun ction test results, respiratory symptoms, and disease history of dumpers an d nondumpers were analyzed, no predictors of dumping could be found, Conclusions: Deception among noncompliers occurs frequently in clinical tri als, is often not revealed by the usual methods of monitoring, and cannot b e predicted by data readily available in clinical trials.