Peter S. Creticos, MD Journal of Allergy and Clinical Immunology

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Presentation transcript:

Effects of nedocromil sodium on inflammation and symptoms in therapeutic studies Peter S. Creticos, MD Journal of Allergy and Clinical Immunology Volume 98, Issue 5, Pages S143-S150 (November 1996) DOI: 10.1016/S0091-6749(96)70030-1 Copyright © 1996 Mosby, Inc. Terms and Conditions

FIG. 1 Effect of nedocromil sodium, 4 mg, administered four times daily (solid line); beclomethasone dipropionate, 100 μg, administered four times daily (dashed line), and placebo (dotted line) on methacholine responsiveness in 25 adults with nonatopic asthma. + represents p < 0.05, +++ represents p < 0.001 versus baseline; * represents p < 0.05, ** represents p < 0.01 versus placebo. There were no significant differences between active treatments at any time. (From Bel EH, Timmers MC, Hermans J, Dijkman JH, Sterk PJ. The long-term effects of nedocromil sodium and beclomethasone dipropionate on bronchial responsiveness to methacholine in nonatopic asthmatic subjects. Am Rev Respir Dis 1990;141:21-8.) Journal of Allergy and Clinical Immunology 1996 98, S143-S150DOI: (10.1016/S0091-6749(96)70030-1) Copyright © 1996 Mosby, Inc. Terms and Conditions

FIG. 2 Effect of nedocromil sodium, 4 mg, administered four times daily (solid line) and albuterol, 200 μg, administered four times daily (dashed line) on peak expiratory flow and diurnal variation. * p < 0.05 between treatments. This was a crossover study in 29 adults with allergic asthma. (From de Jong JW, Teengs JP, Postma DS, Vander Mark TW, Koeter GH, de Monchy JGR. Nedocromil sodium versus albuterol in the management of allergic asthma. Am J Respir Crit Care Med 1994;149:91-7.) Journal of Allergy and Clinical Immunology 1996 98, S143-S150DOI: (10.1016/S0091-6749(96)70030-1) Copyright © 1996 Mosby, Inc. Terms and Conditions

FIG. 3 Effect of nedocromil sodium, 4 mg, administered twice daily on peak expiratory flows in adult patients with asthma who were theophylline dependent (n = 18 on active treatment, n = 17 on placebo). Baseline treatment with sustained-release theophylline was halved after 4 weeks and withdrawn completely for the final 2 weeks. ** p < 0.01, *** p < 0.001 versus placebo. Journal of Allergy and Clinical Immunology 1996 98, S143-S150DOI: (10.1016/S0091-6749(96)70030-1) Copyright © 1996 Mosby, Inc. Terms and Conditions

FIG. 4 Diary card symptom scores during treatment (results for weeks 4 to 6) with nedocromil sodium, 4 mg, administered four times daily (open bars; n = 69), beclomethasone, 100 μg, administered four times daily (solid bars; n = 68), or placebo (shaded bars; n = 65). * represents p < 0.05, ** represents p < 0.01 versus placebo. There were no significant differences between active treatments. (From Bergmann K-C, Bauer C-P, Overlack A. A placebo-controlled, blind comparison of nedocromil sodium and beclomethasone dipropionate in bronchial asthma. Curr Med Res Opin 1989;11:533-42.) Journal of Allergy and Clinical Immunology 1996 98, S143-S150DOI: (10.1016/S0091-6749(96)70030-1) Copyright © 1996 Mosby, Inc. Terms and Conditions

FIG. 5 Onset of effect of nedocromil sodium, 4 mg four times daily (n = 60), and placebo (n = 61) on asthma symptoms (summary score for daytime and nighttime asthma). The difference was significant (p < 0.05) from day 3 onwards. (From Cherniak RM, Wasserman SI, Ramsdell JW, Selner JC, Koepke JW, Rogers RM, et al. A double-blind multicenter group comparative study of the efficacy and safety of nedocromil sodium in the management of asthma. Chest 1990;97:1299-306.) Journal of Allergy and Clinical Immunology 1996 98, S143-S150DOI: (10.1016/S0091-6749(96)70030-1) Copyright © 1996 Mosby, Inc. Terms and Conditions

FIG. 6 Cumulative mean scores for cough recorded by patients on daily diary cards during the first 14 days of treatment with nedocromil sodium, 4 mg four times daily (solid line) or placebo (dashed line) in clinical studies in patients with mild and mild-to-moderate asthma. (a), nedocromil sodium (n = 60) or placebo (n = 61) was added to bronchodilator treatment comprising daily sustained-release theophylline (SRT) and as-needed inhaled or oral β2-agonist; SRT was withdrawn after 2 weeks of test treatment. (From Cherniak RM, et al. A double-blind multicenter group comparative study of the efficacy and safety of nedocromil sodium in the management of asthma. Chest 1990;97:1299-306.) (b), Nedocromil sodium (n = 102) or placebo (n = 98) replaced daily SRT that was overdrawn at the start of the preceding 2-week baseline. (From Schwartz HJ, et al. Highlights of the nedocromil sodium clinical presentations. J Allergy Clin Immunol 1993;92:204-9.) (C), Overview analysis pooling results from all studies with at least 50 patients per treatment group and in which nedocromil sodium (n = 380) or placebo (n = 405) was added to or replaced regular bronchodilator treatment. + p = 0.06 or 0.07 vs. placebo; *p < 0.05; **p < 0.01; ***p < 0.001 vs. placebo. Journal of Allergy and Clinical Immunology 1996 98, S143-S150DOI: (10.1016/S0091-6749(96)70030-1) Copyright © 1996 Mosby, Inc. Terms and Conditions