Two-month comparative study of tulobuterol aerosol versus fenoterol aerosol in patients with chronic obstructive lung disease.

In this two month, double-blind, crossover study, the efficacy and safety of tulobuterol aerosol (400 micrograms qid) was compared to fenoterol aerosol (400 micrograms qid) in patients with chronic obstructive lung disease. Thirty-six (36) adults with reversible bronchospasm were enrolled. All patients were evaluable. On set of response was within 5 minutes for both drugs. Mean increases in FEV1 were greater after tulobuterol than fenoterol at every time interval. Increases peaked at 30-60 minutes postdose. Duration of response was longer after tulobuterol with mean FEV1 remaining greater than 15% over baseline for at least 6 hours postdose. Mean predose FEV1 values were significantly greater after 2 and 4 weeks of tulobuterol treatment compared with fenoterol. Despite these large increases, changes in mean FEV1 from predose to 1 hour postdose at these visits were not significantly different between treatment groups. Results of plethysmography testing also indicated greater improvement after tulobuterol. In addition, improvement in pulmonary symptoms was more pronounced during tulobuterol therapy. Small changes in mean blood pressure occurred, with greater changes after fenoterol than after tulobuterol. Changes in mean pulse rate were significantly greater following fenoterol administration. No adverse reactions were reported during tulobuterol treatment; however, one patient experienced severe tremor, tachycardia, and sweating during fenoterol treatment and withdrew from the study prematurely. The results in this study indicate that tulobuterol aerosol is more effective than fenoterol aerosol in the treatment of patients with chronic obstructive lung disease, with fewer cardiovascular effects and no adverse reactions.

RCT Entities:   Population Interventions Outcomes