This study was designed to measure improvement in quality of life of patients with
asthma, using a standardized disease-specific questionnaire, the St George's Respiratory Questionnaire, in a year long double-blind, placebo-controlled, group comparative study with
nedocromil sodium. Two other questionnaires were used: the Sickness Impact Profile (a measure of general health) and the Hospital Anxiety and Depression Scale. Measurements were made at baseline and following 24 and 48 weeks of treatment. Response to
therapy was also evaluated using daily diary card and peak flow measurements, clinic assessments and spirometry. Following a 4 week baseline, 719 adult asthmatics were randomized to treatment with 4 mg
nedocromil sodium or placebo. Patients currently maintained on inhaled
corticosteroids received treatments four times daily, those on
bronchodilator alone received treatments twice daily. The Impacts component of the St George's Respiratory Questionnaire was significantly improved in patients receiving
nedocromil sodium, as were night-time
asthma,
asthma severity at clinic, and daytime inhaled
bronchodilator use. In patients receiving placebo, most of the traditional variables improved, and all three questionnaires recorded significant improvements in health. Patients and clinicians judged
nedocromil sodium more effective than placebo. The improvement in St George's Questionnaire score in the
nedocromil sodium treated patients was approximately double the change considered to be clinically significant. The study has shown that improvements in health with prophylactic
therapy for
asthma may be quantified by the use of a standardized disease-specific questionnaire.