A double-blind study of the efficacy of nedocromil sodium in the management of asthma in patients using high doses of bronchodilators. J Allergy Clin Immunol 1994 Sep;94(3 Pt 1):473-81
Date
09/01/1994Pubmed ID
8083452DOI
10.1016/0091-6749(94)90203-8Scopus ID
2-s2.0-0028131249 (requires institutional sign-in at Scopus site) 14 CitationsAbstract
The effects of nedocromil sodium were assessed in 110 patients with asthma who experienced asthma symptoms despite the use of high doses of inhaled bronchodilators. During the baseline period, antiinflammatory agents 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 received either nedocromil sodium (4 mg) or placebo four times a day for 10 weeks. Statistically significant (p < 0.05) between-treatment differences (weeks 3 to 10), favoring nedocromil sodium, were determined for the asthma summary score, daytime asthma severity, asthmatic cough, morning peak flow rates, reduction of as-needed bronchodilator use, physician's assessment of asthma severity, and patient and physician opinions of treatment effectiveness. By trial end (week 10), sleep difficulty caused by asthma decreased 29% in the nedocromil sodium group and 4% in the placebo group (p = 0.006). Nedocromil sodium was well tolerated and improved asthma control while reducing the inhaled bronchodilator load of these patients with moderately severe asthma.
Author List
Fink JN, Forman S, Silvers WS, Soifer MM, Tashkin DP, Wilson AFMESH terms used to index this publication - Major topics in bold
AdolescentAdult
Asthma
Bronchodilator Agents
Double-Blind Method
Drug Evaluation
Female
Humans
Male
Medical Records
Middle Aged
Nebulizers and Vaporizers
Nedocromil
Respiratory Function Tests
