Chest
Clinical Investigations: DrugsA Comparative Study of the Clinical Efficacy of Nedocromil Sodium and Placebo: How Does Cromolyn Sodium Compare as an Active Control Treatment?
Section snippets
Study Design
From 12 different treatment centers, patients participated in a 14-week, double-blind, placebo-controlled trial that included a 2-week run-in, 2-week baseline, 8-week treatment phase, followed by a 2-week follow-up (washout) period. Prior to run-in, the reversibility of airway obstruction was determined (at least a 15% improvement in FEV1 after a short-acting β2-agonist aerosol). After the 2-week run-in, patients were randomized to one of three treatments groups: (1) nedocromil sodium, 4 mg
Results
Of the 306 patients randomized to treatment, no between-group differences were observed among the three groups of patients (Table 1). Most patients in all three treatment groups had allergic asthma: nedocromil sodium, 86%; placebo, 86%; and cromolyn sodium, 85%. As also shown in Table 1, 13 patients withdrew from the study: none in the nedocromil sodium group, 10 in the placebo group, and 3 in the cromolyn sodium group. Reasons for patient withdrawals in the placebo group included the
Discussion
The results from this study demonstrate the efficacy and safety of nedocromil sodium for treatment of mild-to-moderate allergic asthma as compared with placebo treatment. When comparing nedocromil sodium with the active control, cromolyn sodium, the two agents appeared clinically similar. Statistically, 3 of 13 variables favored cromolyn sodium over nedocromil sodium when analyses utilized the pooled data for treatment weeks 3 through 8 (the protocol defined primary time period). The clinical
Appendix
Howard J. Schwartz, MD, Clinical Professor of Medicine, Case Western Reserve University, Cleveland.
Malcolm N. Blumenthal, MD, Clinical Professor, University of Minnesota, Minneapolis.
Raymond Brady, MD, Clinical Professor of Allergy/Immunology, University of Oregon Health Science Center, Vancouver.
Sheldon R. Braun, MD, Department of Pulmonology, University of Missouri Medical Center, Columbia.
Richard F. Lockey, MD, Director, Division of Allergy and Immunology, University of South Florida
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Cited by (46)
Managing Chronic Cough Due to Asthma and NAEB in Adults and Adolescents: CHEST Expert Panel Report
2020, ChestCitation Excerpt :In our three systematic reviews, we performed a comprehensive search of several databases with the exception of studies not in English. We are confident these systematic reviews accurately reflect the lack of good quality trials on the role of non-invasive measures of airway inflammation in chronic cough due to asthma, and the treatment for chronic cough in asthma and NAEB.32-91 In contrast, there is a wealth of trials with high quality evidence for treatment in asthma overall1,9 and moderate-to-good evidence for the role of biomarkers of eosinophilic inflammation in supporting the diagnosis23,24,92 and directing therapy in asthma.9,23,93
The Chromones: Cromolyn Sodium and Nedocromil Sodium
2014, Middleton's Allergy: Principles and Practice: Eighth EditionClinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, FDA and ICH Guidelines
2011, Clinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, FDA and ICH GuidelinesPharmacopeial methodologies for determining aerodynamic mass distributions of ultra-high dose inhaler medicines
2010, Journal of Pharmaceutical and Biomedical AnalysisAsthma: Diagnosis and management
2006, Medical Clinics of North AmericaCitation Excerpt :In vitro studies have shown that they prevent release of potent inflammatory mediators, including histamine, leukotrienes, and prostaglandins. Several clinical studies have demonstrated modest benefit with the use of cromolyn or nedocromil for asthma [64]. However, the efficacy of nedocromil was markedly inferior to that observed for ICS in a head-to-head trial conducted in children [65].
6. Asthma
2003, Journal of Allergy and Clinical Immunology
A complete list of the authors and their institutions is located in the Appendix.