Objectives: To determine whether chronic therapy with theophylline or ipratropium has an adverse effect on cognition and psychomotor skills in geriatric patients with chronic obstructive pulmonary disease.
Design: The study design was a randomized, repeated measures, double-blind, double-dummy, placebo-controlled comparison of theophylline and ipratropium treatments.
Setting: Ambulatory patients were tested at the Clinical Trials Center of the University of California, San Diego, Medical Center.
Patients: Ambulatory patients with chronic obstructive pulmonary disease aged 65 years or more with FEV1 less than 60% predicted, FEV1/FVC less than 70%, and post bronchodilator FEV1 less than 70%.
Interventions: Patients received either theophylline or ipratropium for 2 weeks, followed by a 1-week placebo control period, then a 2-week treatment period of the alternative drug therapy. A standard therapy of albuterol MDI, 2 puffs (180 microg) qid was given throughout the study.
Measurements: The main response level was an 11-part battery of psychometric tests. Tests were administered at the end of each treatment period and at the end of the washout period. Covariates were sequence of treatment, pulmonary function tests, age, and baseline psychometric test scores.
Results: There was no difference in performance scores on the cognitive tests among the three treatment periods.
Conclusions: We were unable to detect a harmful effect of treatment with either theophylline or ipratropium on the performance of elderly patients with chronic obstructive pulmonary disease on a battery of psychometric tests, suggesting that significant cognitive impairment in the elderly is not commonly associated with treatment with either theophylline or ipratropium.