An open assessment study of the acceptability, tolerability and safety of nedocromil sodium in long-term clinical use in patients with perennial asthma.

Fifty-one patients (22 male, 29 female) aged 22-60 years (mean age 41.2 years), predominantly extrinsic asthmatics, took part in this study, a follow-up to a 28-day, double-blind trial (Lal et al., Thorax 1984: 39: 809). Forty-four patients completed 12 months of treatment after a 4-week baseline; seven withdrew. A number of symptoms (e.g. coughing, wheezing, sore throat) were reported but none appeared particularly frequently; most were attributable to the technique of inhalation. After 4 weeks of treatment with nedocromil sodium (Tilade 4 mg q.i.d.), patients were encouraged to reduce use of inhaled corticosteroids (48 patients) and sodium cromoglycate (16). Inhaled bronchodilators were to be used as required and other medication was to continue as before. At the end of the study, 28 patients had stopped using inhaled steroids and 10 had significantly reduced the dosage (p less than 0.001, week 5 to end). Ten patients had stopped using sodium cromoglycate. Inhaled bronchodilator use was significantly reduced (p less than 0.001, weeks 1-8; p less than 0.05, weeks 9-12) early in the study but returned to baseline as inhaled steroid usage was reduced. Diary card assessments of wheezing and shortness of breath showed significant improvement, particularly in the early part of the study. Diary card PEFRs showed no marked changes but significant decreases, though small, were found in FEV1, FVC and PEFR on clinic visits. Clinical assessment showed improvement in the first half of the study; the differences were less marked as inhaled steroid usage declined. Final opinions of treatment effectiveness significantly favoured nedocromil sodium. This study demonstrates the acceptability, tolerability and safety of nedocromil sodium.(ABSTRACT TRUNCATED AT 250 WORDS)

RCT Entities:   Population Interventions Outcomes