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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

BMJ 2000; 320 doi: https://doi.org/10.1136/bmj.320.7245.1297 (Published 13 May 2000) Cite this as: BMJ 2000;320:1297
  1. P S Burge, consultant chest physician (burgeps{at}aol.com)a,
  2. P M A Calverley, professor of respiratory medicineb,
  3. P W Jones, professor of respiratory medicinec,
  4. S Spencer, research fellowc,
  5. J A Anderson, senior statisticiand,
  6. T K Maslen, clinical project manager the ISOLDE study investigatorsd
  1. a Department of Respiratory Medicine, Birmingham Heartlands Hospital, Birmingham B9 5SS
  2. b Department of Medicine, University Hospital Aintree, Liverpool L9 7AL
  3. c Department of Physiological Medicine, St George's Hospital Medical School, London SW17 0RE
  4. d GlaxoWellcome Research and Development, Stockley Park West, Uxbridge, Middlesex UB11 1BT
  1. Correspondence to: P S Burge
  • Accepted 7 February 2000

Abstract

Objectives: 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 (FEV1) 50% of predicted normal.

Interventions: Inhaled fluticasone propionate 500 μg twice daily from a metered dose inhaler or identical placebo.

Main outcome measures: Efficacy measures: rate of decline in FEV1 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 FEV1 (P=0.16). Mean FEV1 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 μg twice daily did not affect the rate of decline in FEV1 but did produce a small increase in FEV1. 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.

Footnotes

  • Funding GlaxoWellcome Research and Development.

  • Competing interests PSB has received financial support for research and attending meetings and has received fees for speaking and consulting. He also has shares in GlaxoWellcome. PMAC has received grant support and has spoken at several meetings financially supported by GlaxoWellcome. PWJ has received funds for research and members of staff from GlaxoWellcome. SS has received funds for research and members of staff from GlaxoWellcome. JAA and TKM are both employed by GlaxoWellcome. Fluticasone propionate is manufactured by Allen and Hanburys, which is owned by GlaxoWellcome.

  • Accepted 7 February 2000
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