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document
Randomised , double blind , placebo controlled study of fluticasone propionate in patients with moderate to severe chronic obstructive pulmonary disease : the ISOLDE trial . 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 ( 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 .
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Intervention_Control
placebo
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Intervention_Pharmacological
fluticasone propionate
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Intervention_Pharmacological
corticosteroids
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Intervention_Control
placebo
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Intervention_Pharmacological
fluticasone propionate 500 microgram twice daily from a metered dose inhaler
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Outcome_Physical
lung function , exacerbations , and health status
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Outcome_Other
Efficacy
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Outcome_Physical
rate of decline in FEV ( 1 ) after the bronchodilator and in health status , frequency of exacerbations
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Outcome_Other
respiratory withdrawals
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Outcome_Physical
morning serum cortisol concentration
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Outcome_Adverse-effects
incidence of adverse events
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Outcome_Physical
annual rate of decline in FEV ( 1 )
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Outcome_Physical
Mean FEV ( 1 )
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Outcome_Physical
significantly higher
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Outcome_Physical
Median exacerbation rate
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Outcome_Physical
Health status deteriorated
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Outcome_Other
Withdrawals
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Outcome_Physical
rate of decline in FEV ( 1 )
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Outcome_Physical
produce a small increase in FEV ( 1 ) .
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Outcome_Physical
exacerbations
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Outcome_Physical
slower decline in health status
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Participant_Condition
moderate to severe chronic obstructive pulmonary disease
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Participant_Condition
moderate to severe chronic obstructive pulmonary disease
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Participant_Sex
men
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Participant_Sex
women
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Participant_Age
aged between 40 and 75 years
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Participant_Condition
moderate to severe chronic obstructive pulmonary disease