Double-blind comparative trial of Nuelin Depot and TheoDur with adjusted dosage in asthmatic adults.
Equivalent doses of two sustained release preparations of theophylline, Nuelin Depot and TheoDur, were compared in a double blind, cross-over study. Twenty adult outpatients with COLD were given adjusted doses of the two preparations to reach a peak value of theophylline in steady state within the therapeutic range. The study consisted of two 14-day periods and airway function parametres, plasma concentrations, asthma symptoms, and side effects were recorded the last day in each period. In addition morning PEFR, use of beta 2 stimulant aerosol and number of nightly attacks were recorded daily. As judged from the peak-trough variation of 24.8 mumol for Nuelin Depot and 26.3 mumol/l for TheoDur as well as the tmax of 4.3 hours for Nuelin and 3.6 hours for TheoDur, both products produced a similar plasma profile. No statistically significant differences were found between the two preparations with respect to airway function parameters, relief of asthma symptoms, need for beta 2-stimulant aerosol or side effects. In conclusion these two sustained release preparations should be considered equivalent for practical use.
D000318:Adrenergic beta-Agonists / Q000627:therapeutic use; D000328:Adult; D000336:Aerosols; D000368:Aged; D001249:Asthma / Q000175:diagnosis / Q000188:drug therapy*; D001993:Bronchodilator Agents / Q000627:therapeutic use*; D002986:Clinical Trials as Topic; D003692:Delayed-Action Preparations; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007700:Kinetics; D008297:Male; D008875:Middle Aged; D012129:Respiratory Function Tests; D013806:Theophylline / Q000009:adverse effects / Q000097:blood / Q000378:metabolism / Q000627:therapeutic use*
D000318:Adrenergic beta-Agonists; D000336:Aerosols; D001993:Bronchodilator Agents; D003692:Delayed-Action Preparations; D013806:Theophylline