The use of twice daily nedocromil sodium in the treatment of asthma

Abstract

The efficacy and safety of nedocromil sodium inhalation aerosol (4 mg * * * Each actuation delivers 2 mg ex-valve and 1.75 mg from the mouthpiece. of Tilade administered by metered-dose inhaler) given twice daily was compared with placebo in 112 patients with mild-to-moderate asthma who had been receiving maintenance therapy with oral or inhaled bronchodilators or both. After a 2-week run-in period and a subsequent 2-week baseline period, patients were randomized to active treatment ( n = 56) or placebo ( n = 56) for 8 weeks. All maintenance bronchodilators were withdrawn before the baseline period, and patients entered the treatment period only after demonstrating a specified level of asthma symptoms. Twice daily administration of nedocromil sodium improved all asthma symptoms in these patients who had symptoms as a result of the withdrawal of their maintenance theophylline and/or oral and inhaled β 2-agonist bronchodilators. During the primary time period (treatment weeks 5 to 8), statistically significant between-group differences favored nedocromil sodium for the asthma summary score (primary variable, p = 0.001), daytime asthma ( p = 0.001), and sleep difficulty caused by asthma ( p = 0.006). Furthermore, significant reductions in the use of as-needed rescue medications were reported in the nedocromil sodium group ( p = 0.003) compared with the placebo group. Final overall opinions of treatment effectiveness expressed by physicians ( p = 0.016) and patients ( p = 0.002) strongly favored nedocromil sodium. (J A LLERGY C LIN I MMUNOL 1995;95:829-36.)