A double-blind, placebo-controlled comparison of sodium cromoglycate and ketotifen in the treatment of childhood asthma.

We compared three treatments: sodium cromoglycate 5 mg aerosol and placebo syrup (39 patients), placebo aerosol and ketotifen syrup (39 patients), and placebo aerosol and syrup (36 patients). The patients (mean age 11.7 years) had mostly allergic, moderately severe asthma. Treatments were added to current therapy (mostly bronchodilators only) for 3 months. Aerosols were taken four times daily and syrups twice daily. The following results were significant at a level of 5%. At the final clinic visit, the changes from baseline in lung function favored sodium cromoglycate over the other treatments. During month 3, sodium cromoglycate was superior to ketotifen for night symptoms, morning tightness, daytime symptoms, and cough. Bronchodilator use decreased more with sodium cromoglycate than ketotifen. Patients' and clinicians' overall opinions of treatment effectiveness favored sodium cromoglycate over ketotifen and placebo. In these patients, sodium cromoglycate was both effective and superior to ketotifen.

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.