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

Peter Creticos*, John Burk, Lewis Smith, Robert Comp, Philip Norman, Steven Findlay

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

25 Scopus citations


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 All maintenance bronchodilators were withdrawn before the baseline period, and patients entered the treatment period only after demonstrating a specified level of asthma symptoms.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 β2-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 ALLERGY C LIN IMMUNOL 1995;95:829-36.).

Original languageEnglish (US)
Pages (from-to)829-836
Number of pages8
JournalThe Journal of allergy and clinical immunology
Issue number4
StatePublished - Apr 1995


  • Asthma
  • antiinflammatory
  • nedocromil sodium
  • pyranoquinoline
  • twice daily dosing

ASJC Scopus subject areas

  • Immunology and Allergy
  • Immunology


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