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Clinical Trial
. 1995 Apr;95(4):829-36.
doi: 10.1016/s0091-6749(95)70126-5.

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

P Creticos  1 , J Burk, L Smith, R Comp, P Norman, S Findlay
Affiliations
Clinical Trial

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

P Creticos et al. J Allergy Clin Immunol. 1995 Apr.

Abstract

The efficacy and safety of nedocromil sodium inhalation aerosol (4 mg 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 All maintenance bronchodilators were withdrawn before the baseline period, and patients entered the treatment period only after demonstrating a specified level of asthma symptoms.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 beta 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.

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