A Double-Blind Multicenter Group Comparative Study of the Efficacy and Safety of Nedocromil Sodium in the Management of Asthma
The pharmacologic management of asthma is based on the appropriate use of bronchodilator drugs which act on airway smooth muscle, and drugs believed to have an effect on aspects of airway inflammation and mediator release. For many years, the mainstay of asthma therapy in the United States has been the concomitant use of xanthine-based oral bronchodilators and inhaled beta-adrenergic broncho-dilators, as required, to control symptoms.-2 Greater use is now being made of cromolyn sodium as a first-line maintenance therapy and of inhaled corticosteroids for more intractable disease, the rationale being that the anti-inflammatory and mast cell stabilizing properties of these drugs* have an influence on the underlying disease process.
Nedocromil sodium, a pyranoquinoline dicarboxylic acid derivative, is a new drug which has been shown to possess pharmacologic properties likely to be influential in the prevention and treatment of asthma. In addition to activity in the classical models of immediate hypersensitivity, the inhibition by nedocromil sodium of antigen-induced bronchoconstriction in the macaque monkey model and of the activation of mucosal type (atypical) mast cells and neutrophils has raised the possibility of nonsteroid based antiinflammatory properties for this compound. It was, therefore, of great interest to study the effects of this agent in long-term adult asthmatic patients already stabilized on sustained release theophylline preparations. This study also represents the first large scale, placebo controlled trial of nedocromil sodium carried out over a 16-week period.