Steroid sparing effect of nedocromil sodium in asthmatic patients on high doses of inhaled steroids

Abstract

Nedocromil sodium is a non-steroidal prophylactic agent developed for the management of asthma. We have assessed the steroid sparing potential of inhaled nedocromil sodium 4 mg four times daily in a randomized, double blind, placebo controlled study in 69 asthmatic subjects controlled on inhaled beclomethasone dipropionate in the dose range 1000-2000 micrograms daily. Following a 4 week run-in period subjects added nedocromil sodium or placebo by metered dose inhaler to their usual medication for a further 4 weeks. The dose of inhaled steroid was then reduced at fortnightly intervals according to a predetermined schedule, with monitoring of asthma severity, symptom scores, bronchodilator use and peak flow recordings. Sixty subjects entered the steroid reduction phase and achieved median (range) % decreases in steroid dose of 80 (17-100)% with nedocromil sodium compared to 65 (0-100)% with placebo (P = 0.34) with 14 patients in the nedocromil sodium group and 10 in the placebo group being withdrawn completely from inhaled steroids. Subjective global assessment scores were significantly better with nedocromil sodium (mean 2.14) than with placebo (2.93; P < 0.02) though there was no difference between individual daily symptom scores. In this study therefore in asthmatic patients controlled on high doses of inhaled steroids, nedocromil sodium was well tolerated but the small differences in steroid sparing effect between nedocromil and placebo were not statistically significant.

Leukotriene antagonists and Churg-Strauss syndrome: the smoking gun

“…Systemic steroid therapy was, however, used by all subjects within 6-12 months before the onset of CSS. More forcefully, there have been very few reports of CSS following the introduction of other asthma treatments including inhaled corticosteroids, 16 theophylline, and cromolyns, [17][18][19] all of which have shown some steroid sparing eVect. [20][21][22][23] Notably, no cases of CSS have been reported in association with the use of the 5-lipoxygenase inhibitor zileuton.…”

North of England evidence based guidelines development project: summary version of evidence based guideline for the primary care management of asthma in adults

“…Though nedocromil is more effective than placebo as a first line anti-inflammatory agent, its effect is not large and it has a questionable effect as a second line anti-inflammatory drug (I) 41 42 43 44 45 46. Sodium cromoglycate is more effective than placebo as a first line anti-inflammatory drug and is effective delivered in either a metered dose inhaler or a spinhaler (I) 47.…”

What is the future for inhaled steroids in adult asthma care?

“…Several shortterm studies suggest that many patients can achieve large reductions in inhaled steroid dosage without asthma control deteriorating. [5][6][7] A major concern is whether the dose of inhaled steroid can be reduced in the long-term with the same effect. Furthermore, greater use of oral corticosteroids to treat exacerbations may override any attempt to minimise steroid-induced side-effects by the reduction of inhaled steroids.…”

“…[1][2][3][4][5][6] Guidelines for the management of chronic obstructive pulmonary disease (COPD) have also been published, [6][7][8][9][10][11][12][13] but these are mainly drawn up by thoracic societies and some parts are less relevant for patients with milder forms of COPD or those treated in primary care. The aim of this paper is to provide recommendations (evidence-based where possible) to guide primary care professionals in their management of adult patients with COPD.…”