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 bronchodiiator 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.

Keywords

Nedocromil sodium asthma adult

Get full access to this article

View all access options for this article.

References

Eady

Greenwood

Jackson

: The effect of nedocromil sodium and sodium cromoglycate on antigen-induced bronchoconstriction in the Ascaris-sensitive monkey. Br J Pharmacol 1985; 85: 323–325.

Joseph

Capron

Thorel

: Nedocromil sodium inhibits IgE-dependent activation of rat macrophages and platelets as measured by schistosome killing, chemiluminescence and enzyme release. Eur J Respir Dis 1986; 69 (suppl 147): 220–222.

Moqbel

Walsh

Kay

: Inhibition of human granulocyte activation by nedocromil sodium. Eur J Respir Dis 1986; 69 (suppl 147): 227–229.

Auty

: The clinical development of a new agent for the treatment of airway inflammation, nedocromil sodium (Tilade). Eur J Respir Dis 1986; 69 (suppl 147): 120–131.

Youngchaiyud

Lee

: The effect of nedocromil sodium on the immediate response to allergen challenge in asthmatic patients. Clin Allergy 1986; 16: 129–134.

Dixon

CMS

Fuller

Barnes

: The action of nedocromil sodium on sulphur dioxide induced bronchoconstriction. Thorax 1986; 41: 246.

Cua-Lim

Agbayani

Lachica

: A double-blind comparative trial of nedocromil sodium and placebo in the management of bronchial asthma. Phil J Int Med 1985; 23: 181–190.

Hetzel

Clark

TJH

: Comparison of normal and asthmatic circadian rhythms in peak expiratory flow rate. Thorax 1980; 35: 732–738.

Lal

Malhotra

Gribben

: An open assessment study of the acceptability, tolerability and safety of nedocromil sodium in long-term clinical use in patients with perennial asthma. Eur J Respir Dis 1986; 69 (suppl 147): 136–142.

10.

Carrasco

Sepulveda

: The acceptability, tolerability and safety of nedocromil sodium in long-term clinical use. Eur J Respir Dis 1986; 69 (suppl 147): 311–313.

11.

Dorow

: A double-blind group comparative trial of nedocromil sodium and placebo in the management of bronchial asthma in steroid-dependent patients. Eur J Respir Dis 1986; 69 (suppl 147): 317–319.

12.

Chadwick

Lane

: A double-blind comparative trial of nedocromil sodium versus placebo as replacement therapy for inhaled corticosteroids in patients with bronchial asthma. Eur J Respir Dis 1986; 69 (suppl 147): 327–329.

13.

Williams

Stableforth

: The addition of nedocromil sodium to maintenance therapy in the management of patients with bronchial asthma. Eur J Respir Dis 1986; 69 (suppl 147): 340–343.

14.

Gonzalez

Brogden

: Nedocromil sodium. A preliminary review of its pharmacodynamic and pharmacokinetic properties, and therapeutic efficacy in the treatment of reversible obstructive airways disease. Drugs 1987; 34: 560–577.

15.

Ryan

Latimer

Dolovich

: Bronchial responsiveness to histamine; relationship to diurnal variation of peak flow rate, improvement after bronchodilator, and airway calibre. Thorax 1982; 37: 423–429.