Prophylactic treatment with loratadine versus cromolyn sodium in children with mild-to-moderate perennial allergic asthma

Abstract Although new antihistamines exert additional antiallergic properties besides blocking histamine 1 (H 1 ) receptors, their potential for prophylactic treatment of asthma has not been thoroughly investigated. This study compared the efficacy and tolerability of loratadine with those of cromolyn sodium, the nonsteroidal prophylactic treatment of choice for mild-to-moderate childhood perennial allergic asthma. A total of 122 children (mean age, 10 ± 2 years) with mild-to-moderate perennial allergic asthma were enrolled in a multicenter, double-masked, double-dummy, randomized, parallel-group study. They received either cromolyn sodium (two 5-mg puffs four times daily) or loratadine (10 mg if body weight was ⩽30 kg or 20 mg if >30 kg) for 8 weeks. The efficacy was assessed by wheezing, cough, and asthma symptom scores, overall assessment of asthma severity, peak expiratory flow recordings, forced expiratory volume in 1 second (FEV 1 ) measurements, and use of inhaled beta 2 -agonists. Tolerability was assessed by recording possible adverse reactions and blood test results. Wheezing decreased significantly in patients in both groups from day 0 to day 56; cough decreased significantly only in the loratadine group. Similarly, asthma score decreased significantly only in the loratadine group. Physicians and parents reported a highly significant reduction in asthma severity and in the number of patients using beta 2 -agonists in both groups. Peak-flow and FEV 1 values remained constant in both groups throughout the study. No statistically significant difference was observed between the treatment groups in any variable. In addition, tolerability was similar and satisfactory for both groups. Results of this study suggest that loratadine could be an alternative to cromolyn sodium in the treatment of mild-to-moderate childhood perennial allergic asthma.