BRONCHODUAL(R) IN THE LONG-TERM TREATMENT OF CHILDREN WITH ASTHMA

Bronchodual(R) is a combination of two bronchodilators, a beta-2 adren ergic substance (fenoterol, 50 mu g per dose), and an anticholinergic substance (ipratropium bromide, 20 mu g per dose), administered by met ered aerosol. According to different studies carried out with adults a nd children, the bronchodilating action of this combination is greatly superior to that obtained with each substance individually; the beta- 2 adrenergic substance can be spared; its action is longer and involve s a decrease in the number of drug intake and lastly its tolerance is excellent. A French multicentre study was performed with 74 children ( 7 to 15 years old, mean : 11.8 +/- 2.6 years), 53 boys and 21 girls wi th allergic or non-allergic asthma: 41 children presented a moderate a sthma (one crisis per month) and 33 children moderatly severe asthma ( one crisis per week). These children had been given no corticosteroid therapy (per os or inhaled) for at least 15 days, their usual long-ter m treamtent (cromoglycate, anti H1, theophylline LP, antibiotics) was given as normal. Their FVC was greater than or equal to 80% of predict ed values and they presented an intercritical airway obstruction. Hypo xemia was noted in 41.2% of the children. A reversibility test was per formed with Bronchodual(R): 68 of 74 children (i e 91.9%) were respond ers, ie after two doses of Bronchodual(R) at least one of the FEFs had increased by at least 15% when compared with the initial values. The responders were given a 2 month treatment with two inhalations 3 times /day with a sparer. Fifty-seven patients were considered for the final evaluation. From a clincal point of view the efficacy of rite treatme nt was ''very good'' in 41.1% of the cases, rather good'' in 46.6% and low or without any benefit in 12% of the cases. On D60 there was sign ificant improvement in FEV1, PEFR, MEF50 and MEF25 and particularly a positive reaction to the inhalation of two doses of Bronchodual(R) thu s showing a lasting present action of the substance. Side effects were mild and transient In no case the treatment was discontinued because of adverse effects. As a conclusion, the efficacy of Bronchodual(R) wa s demonstrated in the long-term treatment of children with allergic or non-allergic asthma. Its combination is recommended with either disod ium cromoglycate -for moderate asthma- or an inhaled steroid -for more severe asthma. Bronchodual(R) actually meets the two major criterions for a drug: efficacy and safety.