Multicenter comparison of once-daily Uniphyl tablets administered in the morning or evening with baseline twice-daily theophylline therapy in patients with nocturnal asthma.

Ninety-six patients with reversible airways disease and a history of nocturnal asthma completed a four-week open-label study that compared the effectiveness of Uniphyl tablets (The Purdue Frederick Company, Norwalk, Connecticut) administered once daily in the morning or the evening with twice-daily baseline theophylline therapy. All patients transferred easily from their previous twice-daily theophylline regimen to once-daily Uniphyl therapy. Predose serum theophylline levels and pulmonary function values were similar for the twice-daily and once-daily theophylline regimens. However, both the morning and evening once-daily Uniphyl regimens were judged by the investigators to control the asthmatic symptoms of more patients than did the prestudy twice-daily theophylline. In addition, patient acceptance of the two once-daily Uniphyl regimens was significantly (p less than 0.01) greater than that of the previous twice-daily theophylline therapy. During the fourth week of the study, the evening Uniphyl dosing schedule resulted in significantly (p less than 0.01) higher home-monitored morning peak expiratory flow rates and fewer nighttime awakenings than the pre-study twice-daily theophylline regimen. The morning regimen was not associated with such an improvement. The results of the study suggest that a once-daily evening dosage regimen with Uniphyl tablets provides greater control of nocturnal asthma.