Effects of the Addition of Nedocromil Sodium to Maintenance Bronchodilator rherapy in the Management of Chronic Asthma (Part 7)Safety

Unusual Symptoms: Both treatments were well tolerated. After two weeks of placebo treatment, one patient experienced nausea for one day during a three-day period of moderate taste loss. No other adverse reactions or unusual symptoms were recorded.

Laboratory Data: Statistically significant treatment group differences were detected for changes from baseline for hemoglobin (p<0.01) and hematocrit (p<0.05). These changes were small (hemoglobin: nedocromil sodium —0.26 ±0.28 g*dl_1, placebo + 0.11 ±0.45 g’dl; and hematocrit: nedocromil sodium — 0.01±0.02 percent x 10-2, placebo -I- 0.00±0.02 percent X10-2) in relation to the normal ranges of the laboratory concerned and were not clinically significant. natural asthma inhaler


In this study, the addition of nedocromil sodium 4 mg twice daily to maintenance bronchodilator therapy led to significant improvements in all diary card variables (symptom scores, PEF, use of inhaled p2″ bronchodilator) compared with little or no change in the placebo group. When the dose of theophylline was substantially reduced, these variables remained improved from the baseline in the nedocromil sodium group but deteriorated in the placebo group. After withdrawal of theophylline therapy, the variables returned to the baseline in the nedocromil sodium group. In the placebo group, there was further deterioration—symptom scores and requirements for inhaled bronchodilator doubled. Patient and clinician assessment of the efficacy of treatment significantly favored nedocromil sodium during the period when the theophylline dosage was unchanged and during the period when it was reduced and withdrawn.

Category: asthma / Tags: Bronchodilator therapy, Chronic Asthma, Nedocromil Sodium