Early use of inhaled nedocromil sodium in children following an acute episode of asthma

Background-Current guidelines on the treatment of childhood asthma recommen d the introduction of an antiinflammatory drug in children who have persist ent symptoms and require regular treatment with a bronchodilator. The effic acy and safety of inhaled nedocromil sodium (Tilade Mint aerosol) administe red using a Fisonair spacer at a dose of 4 mg three times daily was compare d with placebo in the treatment of asthmatic children aged 6-12 years who a re symptomatic and recovering from an acute exacerbation of asthma. Methods-A group comparative, double blind, placebo controlled trial was per formed in children who were recovering from an acute episode of asthma foll owing treatment in the emergency department of the hospital or in children referred from their general practitioner following a wheezing episode and d ocumented evidence of at least two previous episodes of wheezing. A two wee k baseline period on existing bronchodilator treatment was followed by a 12 week treatment period on either nedocromil sodium (2 mg/puff) or placebo. Both treatments were administered using a Fisonair spacer at a dose of two puffs three times daily. Changes from baseline values in daytime asthma and night time asthma symptom scores, usage of rescue bronchodilators, mean pe ak expiratory flow (PEF) recorded twice daily on diary cards, patients' opi nion of treatment, and withdrawals due to treatment failure were measured d uring the primary treatment period (last six weeks of treatment). Results-One hundred and forty two children aged 6-12 years entered the base line period. Sixty three were withdrawn due to failure to meet the entry cr iteria (18) or the criteria for asthma symptom severity (15) or reversibili ty (9), because they developed uncontrolled asthma (2), because they took d isallowed treatment (2), or for other non-trial related reasons (17). Seven ty nine patients (46 boys) of mean age 8.8 years entered the treatment peri od. There were significant differences in the changes from baseline values during the last six weeks of treatment in favour of nedocromil sodium compa red with placebo in the primary variables of daytime asthma and night time asthma, morning and evening PEF, and the usage of rescue inhaled bronchodil ators; 53% of patients reported nedocromil sodium to be very or moderately effective compared with 44% placebo. improvement in asthma symptoms, PEF, a nd reduction in use of rescue bronchodilators did not reach statistical sig nificance until after six weeks of treatment. Twenty two patients were with drawn or dropped out during the treatment phase, 12 due to uncontrolled ast hma or persistence of asthma symptoms, four due to suspected adverse drug r eactions (nedocromil sodium 3 (headaches 2, angio-oedema/urticaria 1), plac ebo 1 (persistent cough)), and six due to non-treatment related reasons. Se venty one adverse events were reported by 27 patients in the nedocromil gro up and 75 by 30 patients in the placebo group. Conclusions-Asthma symptoms, use of bronchodilators, and lung function can be improved significantly in children recovering from an acute exacerbation of asthma or wheeze and currently receiving treatment with bronchodilators alone by the addition of inhaled nedocromil sodium at a dose of 4 mg three times daily administered using a Fisonair holding chamber.