The Journal of clinical pharmacology and the journal of new drugs · 1967
A comprehensive evaluation of metaproterenol, a new bronchodilator.
Клиническое исследованиеКонтролируемое клиническое исследованиеСтатьяНазвание и аннотация: Перевод в очереди
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Miller J
Аннотация
Metaproterenol (Alupent), a new bronchodilator, was administered in oral and metered aerosol forms to 134 patients with bronchial asthma in three separate studies: (1) a placebo-controlled trial of single doses of aerosol, (2) a long-term uncontrolled clinical trial of the aerosol, and (3) a long-term uncontrolled clinical trial of the oral tablet. In the first study, statistical analysis of results in 31 patients showed that a single dose of metaproterenol aerosol was significantly superior to placebo aerosol in improving the pulmonary function as measured by forced expiratory volume (P less than 0.01) and maximum mid-expiratory flow rate (P less than 0.05). In the two uncontrolled, long-term clinical trials, 37 patients were treated with metaproterenol aerosol for an average of about four months, and 66 other patients received the drug orally for an average of about three weeks, respectively. The daily dose was one or two doses of aerosol, approximately 0.65 mg. per dose, taken as required several times daily; or 20 to 80 mg. of metaproterenol tablets daily orally. Satisfactory clinical response was seen in 29 (78.4 per cent) of the patients on aerosol and in 45 (68.2 per cent) of the patients on oral therapy. On the aerosol, nine patients (24.3 per cent) experienced mild tachycardia. On oral medication, side effects developed in 16 patients (24.2 per cent). Reactions, mostly nervousness and tachycardia, were mild and usually could be controlled by reducing the dosage. Only two patients (3 per cent) discontinued the drug. Laboratory tests carried out during the aerosol trial and at the end of the oral study revealed no drug-related abnormalities.(ABSTRACT TRUNCATED AT 250 WORDS)