A DOUBLE-BLIND-STUDY OF THE EFFICACY OF NEDOCROMIL SODIUM IN THE MANAGEMENT OF ASTHMA IN PATIENTS USING HIGH-DOSES OF BRONCHODILATORS

The effects of nedocromil sodium were assessed in 110 patients with as thma who experienced asthma symptoms despite the use of high doses of inhaled bronchodilators. During the baseline period antiinflammatory a gents were not permitted, and patients were treated with inhaled beta- agonists on an as-needed basis. Patients who required 12 or more puffs of albuterol and experienced continuing asthma symptoms for 7 of the 14 baseline days were randomized to treatment groups. Subjects receive d either nedocromil sodium (4 mg) or placebo four times a day for to w eeks. Statistically significant (p < 0.05) between-treatment differenc es (weeks 3 to 10), favoring nedocromil sodium, were determined for th e asthma summary score, daytime asthma severity asthmatic cough, morni ng peak flow rates, reduction of as-needed bronchodilator use, physici an's assessment of asthma severity and patient and physician opinions of treatment effectiveness. By trial end (week 10), sleep difficulty c aused by asthma decreased 29% in the nedocromil sodium group and 4% in the placebo group (p = 0.006). Nedocromil sodium was well tolerated a nd improved asthma control while reducing the inhaled bronchodilator l oad of these patients with moderately severe asthma.