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 microL/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 group 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.