Abstract | OBJECTIVE: METHODS: The speed and length of bronchodilation with 20 mg bambuterol and 50 microg inhaled salmeterol were compared in 16 patients with partially reversible COPD. The investigation and designed as a double-blind, double-dummy, cross-over, placebo controlled and randomised study. Lung function (FEV1, FVC) and systemic variables (subjective tremor, heart rate, blood pressure) were monitored prior to the administration of the drug and for 12 h after each agent on 3 non-consecutive days. RESULTS: Inhalation of salmeterol induced a significant (P < 0.05) increase of lung function when compared with placebo. In addition, oral bambuterol elicited good bronchodilation, with its maximum slightly later than for salmeterol. The mean (+/- SE) AUC(0-12h)S for all patients were 3.134 1 +/- 0.553 for salmeterol and 1963 1 +/- 0.573 for bambuterol. Both AUC(0-12h)S were significantly greater than for placebo (P < 0.05), but there was no significant difference (P = 0.077) between the salmeterol and bambuterol AUC(0-12h)S. Bambuterol, but not salmeterol, caused tremor in four patients. Moreover, it induced a higher heart rate when compared with salmeterol at each considered time after the administration of the drug; differences after 9 and 12 h were statistically significant (P < 0.05). CONCLUSION:
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Authors | M Cazzola, F Calderaro, C Califano, F Di Pema, A Vinciguerra, C F Donner, M G Matera |
Journal | European journal of clinical pharmacology
(Eur J Clin Pharmacol)
Vol. 54
Issue 11
Pg. 829-33
(Jan 1999)
ISSN: 0031-6970 [Print] Germany |
PMID | 10027655
(Publication Type: Clinical Trial, Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Bronchodilator Agents
- Salmeterol Xinafoate
- Terbutaline
- Albuterol
- bambuterol
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Topics |
- Administration, Inhalation
- Administration, Oral
- Adult
- Aged
- Albuterol
(administration & dosage, adverse effects, analogs & derivatives, therapeutic use)
- Arrhythmias, Cardiac
(chemically induced)
- Bronchodilator Agents
(adverse effects, therapeutic use)
- Cross-Over Studies
- Double-Blind Method
- Forced Expiratory Flow Rates
(drug effects)
- Forced Expiratory Volume
(drug effects)
- Heart Rate
(drug effects)
- Humans
- Lung Diseases, Obstructive
(drug therapy, physiopathology)
- Male
- Middle Aged
- Salmeterol Xinafoate
- Terbutaline
(administration & dosage, adverse effects, analogs & derivatives, therapeutic use)
- Time Factors
- Tremor
(chemically induced)
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