The plasma half-life of theophylline was determined during and 1 month after serologically confirmed upper-respiratory-tract viral illness in six children with chronic asthma. In this group the plasma-theophylline half-life (mean = 419.8 min) was significantly longer during the acute stage of their illness than 1 month later (mean 249.9 min). There was no appreciable change in half-life in 4 patients who were febrile but in whom seroconversion did not occur. These preliminary results suggest that certain upper-respiratory-tract viral infections may affect theophylline metabolism.
The objective of this double-blind trial was to evaluate the corticosteroid-sparing effect of azelastine in patients with chronic bronchial asthma. A total of 193 subjects received either 6 mg of azelastine twice per day or placebo (in a 2:1 ratio) in combination with beclomethasone dipropionate (6 to 16 inhalations per day). The number of daily inhalations of the corticosteroid was reduced until maximum reduction or elimination was achieved. Patients then entered a 12-wk maintenance period, during which patients were maintained on their lowest possible dose of inhaled corticosteroid. Compared with placebo, the azelastine group had a statistically significantly greater overall median reduction in inhaled corticosteroids (4.9 puffs/day for azelastine versus 3.1 puffs/day for placebo; p < or = 0.010) during the maintenance period. The azelastine group also had a statistically significantly higher percentage of patients with reductions of > or = 50% and > or = 75% from the baseline level (53 and 31%, respectively, for azelastine versus 34 and 14%, respectively, for placebo; p < or = 0.028). The results demonstrated that azelastine, 6 mg twice per day, can reduce the need for inhaled corticosteroids in patients with chronic bronchial asthma and not lead to a deterioration in pulmonary function.
The efficacy of continuous, around-the-clock sustained-release (S-R) theophylline therapy, adjusted to approximate serum or plasma steady state theophylline concentrations (Tc) of 15 µg/ml three hours following the last dose, was assessed in 18 children suffering from moderately severe chronic asthma. Two of the three formulations studied, Slo-Phyllin Gyrocaps and Theo-Dur, had excellent bioavailability and produced stable therapeutic Tc, throughout an eight-hour dosing interval, using average doses of 8.7 ± 0.5 and 8.4 ± 0.6 (SE) mg/kg/dose, respectively. Pulmonary function responses paralleled Tc and were also stable throughout the dosing interval. Aerolate provided comparatively less stability, and higher doses (11.3 ± 0.7 mg/kg) were necessary to produce therapeutic Tc. Toxicity was not evident when dosage was adjusted to avoid Tc exceeding 20 µg/ ml. S-R theophylline therapy, with the use of formulations of acceptable bioavailability, provides excellent control of chronic childhood asthma, offers the advantage of extended dosing intervals, and encourages improved patient cooperation in drug compliance.
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