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Abstract
Mepyramine-theophylline-acetate (MTA), a theophylline derivative combined with an
antihistamine, is used to treat patients with asthma. A double-blind, randomized,
prospective, parallel-group study was conducted to evaluate the efficacy and safety
of MTA in the treatment of asthmatic crisis in children 2 to 6 years of age. Forty
patients with mild-to-moderate asthma were admitted to the study. The MTA group received
8 mg/kg per day of MTA by mouth in three divided doses for 7 days. The other group
received 50 μL/kg per day of placebo in three divided doses for 7 days. Salbutamol
(albuterol) syrup was used as the rescue drug if manifestations of asthma persisted.
Both the MTA group and the placebo group had similar demographic characteristics at
baseline. Both groups showed improvement of the asthma symptoms (cough, dyspnea, hypoventilation,
and wheezing), as evaluated by the investigators at days 3 and 7. Patient diary scores
showed earlier improvements in the MTA groups than in the placebo group. Both groups
showed improvement in peak flow at days 3 and 7 (P = 0.005). The control group used more doses of salbutamol than the MTA group on days
2 through 6 and globally (mean ± SD, 6.79 ± 9.11 doses vs 1.29 ± 2.23 doses). The
improvements in the placebo group were thought to be due to salbutamol. Three MTA
patients dropped out of the trial, one because the parents felt that the treatment
was not effective and two because of gastrointestinal manifestations (epigastric discomfort
and vomiting). In the placebo group, two patients dropped out. One patient had epigastric
discomfort and the other had to be treated in the emergency department for an exacerbation
of the asthma. We conclude that MTA may be a good therapeutic option for the treatment
of asthmatic crisis in children 2 to 6 years of age.
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© 1995 Published by Elsevier Inc.
