Effect of nedocromil sodium on bronchial hyperreactivity in children with nonatopic asthma.
Author(s): Fiocchi A, Riva E, Santini I, Bernardo L, Sala M, Mirri GP
Affiliation(s): University of Milan, Department of Pediatrics, San Paolo Biomedical Institute, Italy.
Publication date & source: 1997-12, Ann Allergy Asthma Immunol., 79(6):503-6.
Publication type: Clinical Trial; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
BACKGROUND AND OBJECTIVES: Although cromones inhibit immediate bronchial responses to both allergen and nonspecific challenge, their effectiveness in treating nonatopic childhood asthma is unknown. We therefore investigated a possible effect of nedocromil sodium on bronchial hyperreactivity and asthmatic symptoms in a group of children receiving this drug for nonatopic asthma. STUDY DESIGN AND METHODS: A double-blind, placebo-controlled, randomized trial of two parallel groups was carried out in our pediatric respiratory disease clinic. Twenty children with mild, nonatopic asthma hyperreactive to fog-induced challenge were treated with inhaled nedocromil sodium 16 mg each day for 6 weeks (group N) or with a placebo (group P). Five girls and five boys (7 to 13 years of age) were randomly assigned to group N, and three girls and seven boys (aged 6 to 16 years) to group P. Symptoms and bronchodilator use were reported on diary cards. Ultrasonic nebulized distilled water PD10 was measured administering increasing doses of nebulized distilled water (2.5, 5, 10, 20, and 40 L). RESULTS: Symptom scores were significantly affected by the active treatment. Baseline lung function was normal and remained unaltered after treatment with nedocromil sodium. Nonspecific reactivity was significantly reduced over time only in the active treatment group. CONCLUSIONS: Nedocromil sodium can reduce the severity of asthmatic symptoms and nonspecific bronchial hyperreactivity at fog-induced challenge in children with stable, nonatopic asthma.