Nedocromil sodium

To summarize the available pharmacokinetic and pharmacologic data on nedocromil sodium and to present representative clinical trials of this new agent in both mild-to-moderate and severe chronic asthma and allergic rhinitis. Adverse effects are reviewed.

A MEDLINE search was used to identify pertinent literature, excluding reviews and foreign-language articles. All available English-language studies were reviewed.

Pivotal and representative studies are discussed relating to the following issues: pharmacology and pharmacokinetics, management of patients with non-steroid-dependent and steroid-dependent asthma, comparison with sodium cromoglycate (cromolyn), comparison with inhaled beclomethasone dipropionate, management of exercise-induced asthma, use in children with asthma, and use in allergic rhinitis.

Nedocromil sodium is chemically grossly unrelated to cromolyn but has similar pharmacology, pharmacokinetics, and therapeutic benefits. Although ineffective in relieving acute asthma attacks, nedocromil appears to be superior to placebo in lessening the severity of chronic asthma and protecting against allergen-induced asthma when taken as chronic prophylaxis. Single doses attenuate exercise-induced asthma. It is also effective in the management of allergic rhinitis. Results have varied when nedocromil has been compared with cromolyn or inhaled beclomethasone. Studies to date indicate that, overall, nedocromil is not significantly better than cromolyn and is no better than or is inferior to inhaled beclomethasone, although individual response appears to be variable, with no identifiable predictive factors.

Individual patients may receive marked improvement from nedocromil therapy, but there are no factors that identify which patients will respond. Nedocromil may be particularly useful in adults who frequently fail to respond to cromolyn.