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

doi:10.1136/bmj.320.7245.1297

BMJ 2000;320:1297-1303 ( 13 May )

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

P S Burge, consultant chest physician, ^a P M A Calverley, professor of respiratory medicine, ^b P W Jones, professor of respiratory medicine, ^c S Spencer, research fellow, ^c J A Anderson, senior statistician, ^d T K Maslen, clinical project manager, ^d on behalf of the ISOLDE study investigators.

^a Department of Respiratory Medicine, Birmingham Heartlands Hospital, Birmingham B9 5SS, ^b Department of Medicine, University Hospital Aintree, Liverpool L9 7AL, ^c Department of Physiological Medicine, St George's Hospital Medical School, London SW17 0RE, ^d GlaxoWellcome Research and Development, Stockley Park West, Uxbridge, Middlesex UB11 1BT

Correspondence to: P S Burge burgeps{at}aol.com

Objectives: To determine the effect of long term inhaledcorticosteroids on lung function, exacerbations, and health statusin patients with moderate to severe chronic obstructive pulmonarydisease.
Design: Double blind, placebo controlledstudy.
Setting: Eighteen UKhospitals.
Participants: 751 men and women aged between 40 and 75 yearswith mean forced expiratory volume in one second (FEV₁) 50% ofpredictednormal.
Interventions: Inhaled fluticasone propionate 500 µg twicedaily from a metered dose inhaler or identicalplacebo.
Main outcome measures: Efficacy measures: rate of decline in FEV₁after the bronchodilator and in health status, frequency of exacerbations,respiratory withdrawals. Safety measures: morning serum cortisolconcentration, incidence of adverseevents.
Results: There was no significant difference in theannual rate of decline in FEV₁(P=0.16). Mean FEV₁ after bronchodilatorremained significantly higher throughout the study with fluticasonepropionate compared with placebo (P<0.001). Median exacerbationrate was reduced by 25% from 1.32 a year on placebo to 0.99 ayear on with fluticasone propionate (P=0.026). Health status deterioratedby 3.2 units a year on placebo and 2.0 units a year on fluticasonepropionate (P=0.0043). Withdrawals because of respiratory diseasenot related to malignancy were higher in the placebo group (25%v 19%, P=0.034).
Conclusions: Fluticasone propionate 500 µg twice dailydid not affect the rate of decline in FEV₁ but did produce a smallincrease in FEV₁. Patients on fluticasone propionate had fewerexacerbations and a slower decline in health status. These improvementsin clinical outcomes support the use of this treatment in patientswith moderate to severe chronic obstructive pulmonarydisease.

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