A placebo-controlled trial of procaterol: a new long-acting oral beta 2-agonist in bronchial asthma.

Abstract

Procaterol hydrochloride, a potent beta 2-adrenergic bronchodilator developed in Japan, was evaluated in a double-blind, placebo-controlled study for efficacy and safety in 45 patients (ages 18 to 55 yr) with chronic documented reversible airway disease. After a 1-week placebo washout period, patients were administered either 0.05 mg or 0.10 mg of procaterol or placebo twice daily for 2 wk. Spirometric determinations, vital signs, and ECGs were obtained at 1/2, 1, 2, 4, 6, and 8 hr after the first dose and at the same time intervals after 1 and 2 wk of treatment. Patients recorded on a daily basis peak flow rates, asthma symptoms, need for supplemental aerosol, concurrent medications, and side effects. Spirometry results indicated significant improvement in pulmonary function with both doses of procaterol compared with placebo (P less than 0.05). The larger dose was generally more effective. Bronchodilatation was evident 1/2 hr after dosing and peaked at 2 hr. At 8 hr after 0.10 mg of procaterol, FEV1 was still above predose values. Daily peak flow rates were significantly higher with 0.10 mg than with 0.05 mg (P less than 0.05) and placebo (P less than 0.001). Tremor and nervousness were the most frequent side effects. They occurred in a dose-related frequency, were mild and transient, and occurred early in treatment. No significant drug-related changes were noted in ECGs, heart rate, blood pressure, or clinical laboratory data. Procaterol was found to be an effective, well-tolerated oral bronchodilator with a long duration of action, especially at 0.10 mg twice daily.

• Authors: S C Siegel, R M Katz, G S Rachelefsky, M L Brandon, L A Borgen
• Journal: The Journal of allergy and clinical immunology (J Allergy Clin Immunol) Vol. 75 Issue 6 Pg. 698-705 (Jun 1985) ISSN: 0091-6749 [Print] United States
• PMID: 2861219 (Publication Type: Clinical Trial, Controlled Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Adrenergic beta-Agonists
• Bronchodilator Agents
• Ethanolamines
• Placebos
• Procaterol

Topics

• Adolescent
• Adrenergic beta-Agonists (therapeutic use)
• Adult
• Asthma (drug therapy, physiopathology)
• Bronchodilator Agents (therapeutic use)
• Clinical Trials as Topic
• Double-Blind Method
• Ethanolamines (adverse effects, therapeutic use)
• Female
• Humans
• Male
• Medical Records
• Middle Aged
• Patient Compliance
• Placebos
• Procaterol
• Pulmonary Ventilation (drug effects)
• Time Factors