Nedocromil sodium is a pyranoquinoline dicarboxylic acid derivative, formulated in a metered-dose inhaler. Because nedocromil sodium has in vitro and in vivo anti-inflammatory properties, it was evaluated in a group of steroid-dependent patients with asthma to observe how well it might be tolerated and for evidence of any beneficial effects. In a double-blind, group-comparative study, 127 patients received nedocromil sodium and 61 received placebo, administered as two puffs of 2 mg, four times per day, for 12 weeks. Ten patients developed adverse reactions, seven receiving active drug and three patients receiving placebo. Two patients of each group withdrew because of worsening asthma. Despite selecting patients whose asthma was stable, when they were receiving established therapeutic regimens that included steroids and bronchodilators, it was found that diary-card symptom scores, morning and evening peak expiratory flow rate values, and inhaled beta-agonist usage all demonstrated slight but significant benefit with addition of nedocromil sodium. It is concluded that the inhaled, anti-inflammatory agent, nedocromil sodium, may be added to asthma-treatment regimens with the reasonable expectation of further modest symptomatic benefit.
A double-blind parallel group study was undertaken during May and June 1985 to compare the effect of nedocromil sodium (1% nasal spray) and placebo, taken twice daily, in relieving the symptoms of rhinitis caused by birch pollen. Two centres were involved. The 54 patients studied had a history of rhinitis in 2 previous birch pollen seasons and positive skin tests to birch pollen. Patients were treated for 4 weeks, but to compare the effects of the 2 treatments the peak pollen periods were used. For dairy card symptoms, results in the 2 centres differed: in Tampere, there were trends in favour of nedocromil sodium with respect to itching (P = 0.04, sneezing (P = 0.06) and total symptoms (P = 0.09); in Oulu no significant differences were seen. Nasal peak expiratory flow rates were slightly better in the nedocromil sodium group. In respect of antihistamine usage, results in the 2 centres were similar and significantly more were used in the placebo group (P less than 0.01). At the end of the trial, both the patients' and the investigators' opinions of treatment effect favoured nedocromil sodium. There were no serious side effects. The results suggest that nedocromil sodium 1% nasal spray, when given twice daily, is effective in the treatment of seasonal allergic rhinitis.
A retrospective analysis of patient charts was performed for a single, multioffice pulmonary practice in Toronto, Ontario. Canada, to assess hospital care utilization and associated cost reductions after asthma prophylaxis with nedocromil sodium inhalation aerosol. Data were obtained from 310 adult patients with mild, moderate, or severe asthma who were treated in the practice between January 1988 and June 1994 and who had been placed on nedocromil sodium for at least 1 year. The number of office visits increased with nedocromil sodium therapy due to initial surveillance of the new medication, but no other changes were made in the usual protocol for each visit. After initiation of nedocromil sodium therapy, patients showed better asthma control as measured by improvements in pulmonary function scores and by reduced hospital utilization (both emergency department visits and hospital admissions). It is likely that the improvements in asthma control could result in cost savings, and savings projections for the Canadian health care system were made using the retrospective data collected for asthma-related hospital services. Prospective data are needed to confirm our findings.