Lancaster EPrints

Randomised, double blind, placebo controlled study of fluticasone propionate in patients with moderate to severe chronic obstructive pulmonary disease: the ISOLDE trial.

Burge, P Sherwood and Calverley, Peter MA and Jones, Paul W and Spencer, Sally and Anderson, Julie A and Maslen, T K (2000) Randomised, double blind, placebo controlled study of fluticasone propionate in patients with moderate to severe chronic obstructive pulmonary disease: the ISOLDE trial. BMJ (British Medical Journal), 320 (7245). pp. 1297-303. ISSN 0959-8138

[img]
Preview
PDF - Published Version
Available under License Creative Commons Attribution Non-commercial.

Download (309Kb) | Preview

    Abstract

    To determine the effect of long term inhaled corticosteroids on lung function, exacerbations, and health status in patients with moderate to severe chronic obstructive pulmonary disease. DESIGN: Double blind, placebo controlled study. SETTING: Eighteen UK hospitals. Participants: 751 men and women aged between 40 and 75 years with mean forced expiratory volume in one second (FEV(1)) 50% of predicted normal. Interventions: Inhaled fluticasone propionate 500 microgram twice daily from a metered dose inhaler or identical placebo. Main outcome measures: Efficacy measures: rate of decline in FEV(1) after the bronchodilator and in health status, frequency of exacerbations, respiratory withdrawals. Safety measures: morning serum cortisol concentration, incidence of adverse events. RESULTS: There was no significant difference in the annual rate of decline in FEV(1 )(P=0.16). Mean FEV(1) after bronchodilator remained significantly higher throughout the study with fluticasone propionate compared with placebo (P<0.001). Median exacerbation rate was reduced by 25% from 1.32 a year on placebo to 0.99 a year on with fluticasone propionate (P=0.026). Health status deteriorated by 3.2 units a year on placebo and 2.0 units a year on fluticasone propionate (P=0.0043). Withdrawals because of respiratory disease not related to malignancy were higher in the placebo group (25% v 19%, P=0.034). CONCLUSIONS: Fluticasone propionate 500 microgram twice daily did not affect the rate of decline in FEV(1) but did produce a small increase in FEV(1). Patients on fluticasone propionate had fewer exacerbations and a slower decline in health status. These improvements in clinical outcomes support the use of this treatment in patients with moderate to severe chronic obstructive pulmonary disease.

    Item Type: Article
    Journal or Publication Title: BMJ (British Medical Journal)
    Subjects: R Medicine > R Medicine (General)
    Departments: Faculty of Health and Medicine
    ID Code: 55054
    Deposited By: ep_importer_pure
    Deposited On: 13 Jun 2012 14:33
    Refereed?: Yes
    Published?: Published
    Last Modified: 09 Apr 2014 23:39
    Identification Number:
    URI: http://eprints.lancs.ac.uk/id/eprint/55054

    Actions (login required)

    View Item