The clinical development of a new agent for the treatment of airway inflammation, nedocromil sodium (Tilade)

Abstract

Nedocromil sodium is the disodium salt of a novel pyranoquinoline dicarboxylic acid which has physicochemical and pharmacokinetic properties which make it suitable for delivery to the respiratory tract by inhalation. Its biological properties suggest that it will display anti-allergic effects in man and that it will also have anti-inflammatory activity in chronic reversible obstructive airways disease. The clinical development of nedocromil sodium has been influenced by its anticipated effects in man and also by the knowledge that preclinical and early clinical tests are poor predictors of efficacy for agents of this type. Thus, although nedocromil sodium prevents immediate and delayed reactions to bronchial antigen challenge, and also prevents exercise-induced bronchoconstriction, the clinical development programme of this drug was designed to provide therapeutic double-blind trials of 1 month's treatment with the drug at the earliest opportunity, because this was thought to be the definitive test for activity. Studies on a larger scale and of longer duration followed the positive outcome of the first therapeutic trials. This series of studies, conducted to different designs, demonstrated the safety and efficacy of nedocromil sodium. They also permitted a view to be gained of the place of nedocromil sodium in the management of patients with airways inflammation.