Conclusion: Nedocromil sodium, 4 mg twice daily, conferred significant benefit when added to sustained-release theophylline therapy. The results suggest that nedocromil sodium may permit a reduction in theophylline dosage and possibly substitute for theophylline in previously dependent patients.
N edocromil sodium (Tilade), a pyranoquinoline derivative, is a unique topical antiasthma agent that possesses both antiallergic and anti-inflammatory properties but has no acute bronchodilator activity. In bronchial challenge studies, nedocromil sodium has been shown to protect against bronchoconstriction induced by specific (allergic) and nonspecific airway stimuli, and to be more potent than cromolyn sodium (Intal) following cold air,2 fog, adenosine, and sulfur dioxide challenge. In previous therapeutic trials in adult patients with chronic asthma, the addition of 4 mg of nedocromil sodium, two or four times daily, to existing maintenance therapy has been reported to reduce the requirement for the current medication while maintaining or improving control of asthma. contraceptive pills
More recent research has shown no significant difference between four times daily nedocromil sodium (4 mg) and beclomethasone dipropionate (100 |xg) therapy and significant improvements in asthma symptoms despite a greater than 60 percent decrease in maintenance theophylline therapy. The objectives of this trial, however, were to assess the efficacy and safety of nedocromil sodium 4 mg given twice daily as an adjunct to sustained-release theophylline in the management of chronic asthma and further to examine the ability of nedocromil sodium to substitute for theophylline in these theophylline-dependent patients.Methods
Thirty-five adult outpatients (tertiary care) with a diagnosis of chronic asthma and receiving regular treatment with sustained-release theophyllines (^ four months’ stable dose) plus inhaled 02-bronchodilators on demand were recruited into the study. At the time of admission into the study, all patients demonstrated reversibility in airflow obstruction (^15 percent increase in forced expiratory volume in 1 s [FEV,] following a standard dose of an inhaled p2-bronchodilator) and, despite at least three months’ stability, all had experienced an acute exacerbation of asthma in the past 12 months, severe enough to warrant hospital admission or oral corticosteroid therapy. Patients receiving oral or inhaled corticosteroids or cromolyn sodium were not included in the study. All the patients gave their written informed consent to participate in the trial.