Clinical efficacy of the transdermal tulobuterol patch in patients with chronic obstructive pulmonary disease: a comparison with slow-release theophylline.
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.


CONCLUSIONS
Treatment of COPD patients with TP is more effective than with theophylline.
Minami
Shuwa
S
Division of Respirology, Neurology, and Rheumatology, Department of Medicine, Kurume University School of Medicine.
Kawayama
Tomotaka
T
Ichiki
Masao
M
Nishiyama
Mamoru
M
Sueyasu
Yoshiko
Y
Gohara
Rumi
R
Kinoshita
Masaharu
M
Koga
Hideyuki
H
Iwanaga
Tomoaki
T
Aizawa
Hisamichi
H
D000203:Activities of Daily Living; D000279:Administration, Cutaneous; D000368:Aged; D000369:Aged, 80 and over; D001993:Bronchodilator Agents / Q000008:administration & dosage* / Q000009:adverse effects; D003371:Cough / Q000139:chemically induced; D018592:Cross-Over Studies; D003692:Delayed-Action Preparations; D004417:Dyspnea / Q000139:chemically induced; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D029424:Pulmonary Disease, Chronic Obstructive / Q000188:drug therapy* / Q000503:physiopathology; D011788:Quality of Life; D012129:Respiratory Function Tests; D013726:Terbutaline / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D013806:Theophylline / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome
D001993:Bronchodilator Agents; D003692:Delayed-Action Preparations; C010809:tulobuterol; D013806:Theophylline; D013726:Terbutaline