Efficacy of sustained release theophylline given at three different evening intake times in addition to a baseline medication.
In this randomized crossover study of 26 outpatients with bronchial asthma the efficacy of a new once-daily theophylline formulation given in addition to a baseline medication was investigated; moreover, under steady state conditions, the effect of three evening intake times (6, 8 and 10 p.m.) on 24 h pharmacokinetics and peak-expiratory flow profiles was evaluated. The theophylline dose had been individually titrated. The pharmacodynamic results show a marked improvement of 24 h peak expiratory flow values after adding theophylline to a drug therapy including inhalative beta 2-agonists and corticosteroids in nearly all and inhalative anticholinergics in 50% of the treated outpatients. No significant differences between the pharmacokinetic characteristics and the 24 hr averages (mesors) of peak expiratory flow at the three different intake times 6, 8 and 10 p.m. were found; however, intake at 10 p.m. resulted in the highest nocturnal excess of serum theophylline concentrations and the highest peak expiratory flow during the early morning hours between 2 and 6 a.m.
Siebert
B
B
Department for Clinical Immunology and Asthma, Policlinic of the Free University Berlin, Germany.
Kunkel
G
G
Borner
K
K
Staudinger
H W
HW
Steinijans
V W
VW
D001249:Asthma / Q000188:drug therapy*; D003692:Delayed-Action Preparations; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010366:Peak Expiratory Flow Rate / Q000187:drug effects; D016032:Randomized Controlled Trials as Topic; D013806:Theophylline / Q000008:administration & dosage* / Q000493:pharmacokinetics / Q000627:therapeutic use
D003692:Delayed-Action Preparations; D013806:Theophylline