A multicentre double-blind group comparative trial of two dose levels of nedocromil sodium and placebo in the management of perennial extrinsic asthma.

The efficacy of nedocromil sodium 4 mg or 2 mg q.i.d. in the management of perennial extrinsic asthma was evaluated in a double-blind, placebo-controlled, multicentre trial. Nedocromil sodium, especially at the dose of 4 mg q.i.d., was consistently rated higher than placebo on clinical assessment and diary card measurement. Compared with placebo, there were significant improvements for nedocromil sodium (4 X 4 mg) in asthma severity scores (p less than 0.05 after 1 and 2 weeks of treatment) and clinician's opinion of treatment (p less than 0.001). The results suggest that nedocromil sodium is effective in the maintenance treatment of patients with perennial extrinsic asthma and further studies with longer-term treatment periods are suggested.

RCT Entities:   Population Interventions Outcomes