Comparison of a lactose-free formulation of sodium cromoglycate and sodium cromoglycate plus lactose in the treatment of asthma.
A double-blind, parallel group, 7-centre trial was carried out to compare the clinical efficacy and patient acceptability of two formulations of sodium cromoglycate for inhalation in patients suffering from asthma. Each single-dose capsule for use in a breath-actuated inhaler contained either a blend of sodium cromoglycate (20 mg) plus lactose (20 mg) or a lactose-free pelletized formulation of sodium cromoglycate (20 mg). Data were summarized from 529 asthmatic patients who had been using the blend formulation for at least 3 months previously. Two hundred and sixty-five patients then received pelletized sodium cromoglycate and 264 patients remained on sodium cromoglycate plus lactose for at least 3 months. Regular assessments were made by patients and clinicians during the trial period of treatment effectiveness. No clinically significant differences were observed between the two formulations after 3 months on test treatment. After a treatment period of 6 months, the pelletized formulation was shown to have some advantages over the blend formulation which were not observed at 3 months, with a significantly higher proportion of 'very effective' assessments being recorded by both patients and clinicians. The capsules of pelletized sodium cromoglycate required significantly less inhalations to empty compared to the capsules of the blend. No differences were observed between the two formulations with regard to the incidence of transient cough and throat irritation after inhalation.
Edwards
A M
AM
Department of Clinical Investigations, Fisons plc, Pharmaceutical Division, Loughborough, England.
Chambers
A
A
D000293:Adolescent; D000328:Adult; D001249:Asthma / Q000188:drug therapy*; D002648:Child; D002986:Clinical Trials as Topic; D004205:Cromolyn Sodium / Q000009:adverse effects / Q000627:therapeutic use*; D004304:Dosage Forms; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D006801:Humans; D007785:Lactose / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged
D004304:Dosage Forms; D004338:Drug Combinations; D007785:Lactose; D004205:Cromolyn Sodium