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, 320 (7245). pp. 1297-303. ISSN 0959-8138

[thumbnail of 1297.full.pdf]
Preview
PDF
1297.full.pdf - Published Version
Available under License Creative Commons Attribution-NonCommercial-NoDerivs.

Download (316kB)

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:
Journal Article
Journal or Publication Title:
BMJ
Uncontrolled Keywords:
/dk/atira/pure/researchoutput/libraryofcongress/r1
Subjects:
?? MEDICAL EDUCATIONMEDICINE(ALL)R MEDICINE (GENERAL) ??
ID Code:
55054
Deposited By:
Deposited On:
13 Jun 2012 13:33
Refereed?:
Yes
Published?:
Published
Last Modified:
17 Sep 2023 01:05