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First clinical studies on mabuterol. A summarizing report.
Arzneimittel-Forschung
|January 1, 1984
Summary
The optimal dose for mabuterol (dl-1-(4-amino-3-chloro-5-trifluoromethyl-phenyl)-2-tert.-butylamino-ethanol hydrochloride) in asthma patients was found to be 50 micrograms. This dose demonstrated the best effectiveness and tolerability in both single and twice-daily treatment regimens.
Area of Science:
- Pharmacology
- Pulmonology
- Clinical Trials
Background:
- Asthma management requires effective and well-tolerated bronchodilators.
- Determining optimal dosing is crucial for maximizing therapeutic benefits while minimizing adverse effects.
Purpose of the Study:
- To identify the optimal single and multiple dose regimens of mabuterol for asthma patients.
- To evaluate the effectiveness and tolerability of different mabuterol dosages.
Main Methods:
- A dose-finding study involving 245 asthmatic patients receiving single doses of mabuterol (30-80 micrograms).
- A subsequent multicenter comparative study treating patients with 50 or 75 micrograms of mabuterol twice daily for six weeks.
Main Results:
- The optimal single dose of mabuterol was determined to be 50 micrograms based on effectiveness and tolerability.
- In the comparative study, 50 micrograms of mabuterol twice daily was found to be optimally effective and tolerable.
Conclusions:
- A twice-daily regimen of 50 micrograms of mabuterol is recommended for the effective and tolerable treatment of asthma.
- The 50-microgram dose of mabuterol provides a favorable balance of efficacy and safety in asthmatic patients.