BACKGROUND: There is insufficient evidence for the efficacy of a transdermal tulobuterol patch (TP), although combination therapy with bronchodilators is recommended for chronic obstructive pulmonary disease (COPD). OBJECTIVE: A randomized, controlled crossover study was conducted to evaluate the clinical efficacy and safety of the TP in 16 patients with COPD. Slow-release theophylline was used as a control drug. METHODS: Following a 2-week run-in period, patients were randomly allocated to two groups by the envelope method; they then received the TP and theophylline for 4 weeks each by the crossover method. Pulmonary function tests, peripheral blood examination, and electrocardiography were performed before and after each treatment period. Patients recorded in diaries their symptom scores, numbers of administrations of inhaled beta(2) agonists, and presence/absence of adverse reactions. RESULTS: Patients receiving TP exhibited significant improvement in the number and ease of sputum expectoration and in cough frequency score and wheezing severity score compared with baseline (p<0.05); the corresponding improvement in patients receiving theophylline was non-significant. Assessment of quality of life by the St. George's Hospital Respiratory Questionnaire revealed that treatment with TP was associated with significant improvement in symptoms, impact, and total scores compared with baseline (p<0.05); theophylline gave only a non-significant improvement in total score. Neither drug caused significant changes in the results of physiological examinations or in pulse or blood pressure. There was no difference in safety between the treatments. CONCLUSION: Treatment of COPD patients withTP is more effective than with theophylline.
RCT Entities:
BACKGROUND: There is insufficient evidence for the efficacy of a transdermal tulobuterol patch (TP), although combination therapy with bronchodilators is recommended for chronic obstructive pulmonary disease (COPD). OBJECTIVE: A randomized, controlled crossover study was conducted to evaluate the clinical efficacy and safety of the TP in 16 patients with COPD. Slow-release theophylline was used as a control drug. METHODS: Following a 2-week run-in period, patients were randomly allocated to two groups by the envelope method; they then received the TP and theophylline for 4 weeks each by the crossover method. Pulmonary function tests, peripheral blood examination, and electrocardiography were performed before and after each treatment period. Patients recorded in diaries their symptom scores, numbers of administrations of inhaled beta(2) agonists, and presence/absence of adverse reactions. RESULTS:Patients receiving TP exhibited significant improvement in the number and ease of sputum expectoration and in cough frequency score and wheezing severity score compared with baseline (p<0.05); the corresponding improvement in patients receiving theophylline was non-significant. Assessment of quality of life by the St. George's Hospital Respiratory Questionnaire revealed that treatment with TP was associated with significant improvement in symptoms, impact, and total scores compared with baseline (p<0.05); theophylline gave only a non-significant improvement in total score. Neither drug caused significant changes in the results of physiological examinations or in pulse or blood pressure. There was no difference in safety between the treatments. CONCLUSION: Treatment of COPDpatients with TP is more effective than with theophylline.