Airway inflammation is consistently present in patients with severe asthma. The combination of inhaled steroids and bronchodilators may be useful both for treating symptoms and improving the underlying inflammatory condition. We have compared the effect of beclomethasone dipropionate (BDP) combined with salbutamol (S), BDP alone, and placebo, on the severity of bronchial responsiveness in 30 children with allergic asthma during the period of specific allergen exposure. In children treated with BDP alone, PC20-FEV1 methacholine was 0.66 +/- 0.54 at the beginning and 1.91 +/- 2.11 at the end of the study period (p greater than 0.05). In children treated with BDP + S PC20, methacholine was 1.21 +/- 1.43 at the beginning and 4.22 +/- 3.88 at the end of the study (p less than 0.05). The group of children treated with placebo had a PC20-FEV1 methacholine of 0.79 +/- 0.61 at the beginning of the study and 0.80 +/- 0.46 at the end of the study. The results of the present study show that maintenance treatment with inhaled beclomethasone combined with salbutamol may lead to greater improvement in bronchial hyperreactivity than treatment with inhaled beclomethasone dipropionate alone.
The dose-response activity of clenbuterol, a new long-acting beta 2-agonist, was evaluated in 12 children aged 5 to 11 years with moderate to severe asthma. The study was a double-blind cross-over comparison of three oral dose levels: 0.5, 1.0, and 1.5 micrograms/kg and placebo all in the form of syrup. Pulmonary function, heart rate, blood pressure, and tremor were evaluated at 30, 60, 90, and 120 min, then hourly for 8 hr, following the ingestion of the drug. The bronchodilating effect of clenbuterol, evaluated as percentage changes in expiratory flow rates was significantly different from placebo. The overall fall-off in the effect of 1.0 micrograms/kg and 1.5 micrograms/kg doses after 8 hr was small. The results of the 1.0 micrograms/kg dose often overlapped those of the 1.5 micrograms/kg dose, suggesting that a single 1.0 micrograms/kg dose of clenbuterol is most advisable in children, assuring the most favorable risk/benefit ratio. Even the highest dose of clenbuterol caused only a marginal increase in tremor, not statistically different from that induced by placebo.
Fifteen healthy volunteers took part in a study to investigate the effect of food on the bioavailability of a slow-release formulation of theophylline. Serum theophylline levels were measured every two hours for ten hours after a single oral dose of 500 mg of theophylline. Serum levels were significantly higher after the dose was taken on an empty stomach; however, serum levels were significantly higher 10 hours later when the dose was taken after a standard meal. Despite these differences, eating had no overall effect on theophylline bioavailability. Two analytic methods for measuring serum levels of theophylline were compared, and it was found that fluorometry could measure lower levels and was therefore more precise than an enzyme immunoassay method, which is probably due to the complete automation and reduced interference of bilirubin and hemoglobin.
Two slow-release preparations of theophylline have been compared in an open crossover trial in the treatment of 20 asthmatic children. Theophylline concentrations were measured in both serum and saliva. Although the treatment preference of both patients and clinicians was for Somofillina Ritardo, there was no significant difference between the two treatments in respect to either serum and salivary concentrations. Nor did their mean bioavailabilities differ significantly. The results indicated that concentration in saliva was not a useful indicator of the serum concentration.
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