A Double-Blind Group Comparative Trial of Nedocromil Sodium and Placebo in the Management of Bronchial Asthma

Abstract

A 3-month double-blind group comparative trial of nedocromil sodium (4 mg twice daily) and placebo was carried out in 30 adult asthmatic patients maintained on bronchodilator therapy. Fifteen patients received each treatment. Subjective (asthma symptoms and severity) and objective (lung function and use of concomitant medication) variables were measured to monitor the response to trial treatments. Significant differences in favour of nedocromil sodium for night-time asthma, daytime asthma, cough, daytime bronchodilator use and clinic assessment of forced expiratory volume during the first second of expiration were observed by week 4 of the trial. The diurnal variation in peak expiratory flow rate was reduced in the nedocromil sodium treated patients. There were no serious adverse reactions and no treatment related changes in haematological findings, blood biochemistry or urinalysis.

Quality of life, symptoms and pulmonary function in asthma: long-term treatment with nedocromil sodium examined in a controlled multicentre trial. Nedocromil Sodium Quality of Life Study Group

“…Despite the large improvements in standard measures of therapeutic efficacy in the placebo treated patients, nedocromil sodium achieved levels of improvement similar to [12], and in many areas better than previously reported [25,26]. A positive response occurred within the first period of assessment, and improvement continued over the whole treatment period.…”

Mechanisms of Action of Central and Peripheral Antitussive Drugs

“…These laryngeal afferents had rapidly adapting acid-induced cough in the dog 31 and cough in asthmatics. 32,33 This drug has no effect on pulmonary discharge patterns. 17,18 Whether or not other types of laryngeal afferents have a modulatory effect on the RARs, slowly adapting receptors, or pulmonary Cfibres.…”

The pharmacokinetics of nedocromil sodium, a new drug for the treatment of reversible obstructive airways disease, in human volunteers and patients with reversible obstructive airways disease.

“…Nedocromil sodium is the disodium salt of a 1985; Shaw & Kay, 1985;Youngchaiyud & Lee, pyranoquinoline dicarboxylic acid which has been 1986) as well as being active in therapeutic trials developed as a new treatment (Tilade9, (Lal et al, 1984;Ruffin, 1986;Fairfax & Allbeson registered trade mark of Fisons plc) for reversible 1986). obstructive airways disease (Auty, 1986; A sensitive radioimmunoassay for nedocromil al., 1986).…”