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|Title: ||Randomised, double blind, placebo controlled study of fluticasone propionate in patients with moderate to severe chronic obstructive pulmonary disease: The ISOLDE trial|
|Authors: ||Burge, PS|
|Publication Date: ||2000|
|Publisher: ||BMJ Publishing Group|
|Citation: ||BMJ. 320;1297-1303|
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.
Double blind, placebo controlled study.
Eighteen UK hospitals.
751 men and women aged between 40 and 75 years with mean forced expiratory volume in one second (FEV1) 50% of predicted normal.
Inhaled fluticasone propionate 500mg 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.
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).
Fluticasone propionate 500 mg 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.|
|Appears in Collections:||School of Health Sciences and Social Care Research Papers|
Community Health and Public Health
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