The orally administered anti-allergic agent, sodium nivimedone (BRL 10833); efficacy in bronchial asthma and effects on IgE, complement and eosinophils

Abstract

1 Sodium nivimedone (BRL 10833) which acts similarly to disodium cromoglycate (DSCG), given at an oral dose of 200 mg thrice daily, was compared, after a preliminary standardization week, with placebo in a 6-week double-blind cross-over trial. Twenty-four non-smoking, atopic, asthmatic out-patients aged between 16 and 32 years, who were not taking corticosteroids took part. Subjects recorded symptoms and bronchodilator use each day and measured peak expiratory flow rate (PEFR) thrice daily.

2 Data was analysed separately for the twelve subjects who received placebo followed by sodium nivimedone (Group I) and those who took the treatments in the reverse order (Group II).

3 In Group I subjects, with sodium nivimedone, bronchodilator use decreased, symptom scores improved and there was a significant improvement in overall PEFR as well as the separated morning and evening values. When symptom scores were expressed as a percentage of the placebo disability index, wheezing, chest tightness, cough and asthma on activity showed significant improvement.

4 Subjects in Group II showed no improvement in any of these variables when drug was compared to placebo.

5 Sodium nivimedone did not appear to have any effect on circulating eosinophil levels, and concentrations of serum IgE, C3 and C4.

6 There was no clinical or laboratory evidence that sodium nivimedone had any untoward effect in the doses given.

7 Sodium nivimedone appeared to be of benefit in the subjects studied. The importance of appreciating the order of treatments and the value of frequent serial objective and subjective measures of disability backed up by appropriate data processing is stressed.