Open cross-over comparison of tulobuterol and fenoterol in asthmatic adult patients.
The objective of this open randomized cross-over study was to compare the clinical efficacy and safety of a recently introduced beta-2 mimetic, tulobuterol, with fenoterol in asthma patients. The study length was four weeks with each drug, with a seven-day washout period between treatment courses. Spirometric tests were carried out every 14 days; laboratory tests and an electrocardiograph were performed at the beginning and end of each treatment course, and a daily diary of salbutamol aerosol use and adverse reactions was kept. Pulmonary function tests and registration of pulse rate and arterial pressure were performed on days 1, 14 and 28 of both treatment courses, before the morning dose and 3 h after administration of the drug. No statistically significant changes were detected in laboratory tests, pulse rate or arterial pressure. The only adverse reaction noted was transient tremor which appeared in three cases with tulobuterol and in two cases with fenoterol. Spirometric tests revealed increases in all parameters with both drugs, although in the comparison between groups no overall statistically significant differences were found. All patients required inhaled salbutamol with both of the drug treatments, and there was a significant increase (p less than 0.05) in its use during the fenoterol treatment course. With both tulobuterol and fenoterol, inhaled salbutamol was mainly used within 2 h before and 1 h after each dose. It is concluded that tulobuterrol (2 mg, twice daily) was at least as effective as fenoterol (2.5 mg, thrice daily), while its clinical effect was longer-lasting. It is doubtful, however, that it provides coverage for 12 h in the type of patients selected.
Sanchez
J
J
Department of Internal Medicine, Virgen del Camio Hospital, Pamplona, Spain.
Rivero
A
A
Dal-Re
R
R
Azanza
J R
JR
D000328:Adult; D000420:Albuterol / Q000627:therapeutic use; D001249:Asthma / Q000188:drug therapy*; D004341:Drug Evaluation; D005280:Fenoterol / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008875:Middle Aged; D011897:Random Allocation; D012129:Respiratory Function Tests; D013726:Terbutaline / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use
D005280:Fenoterol; C010809:tulobuterol; D013726:Terbutaline; D000420:Albuterol