NCT00440687

Withdrawal of Inhaled Corticosteroids in Patients With COPD in Primary Care

Phase 4 Withdrawal of Inhaled Corticosteroids in Patients With Chronic Obstructive Pulmonary Disease in Primary Care: a Randomised Controlled Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 256 (planned)
• Sponsor: Queen Mary University of London · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

Guidelines recommend inhaled corticosteroids (ICS) for patients with moderate to severe chronic obstructive pulmonary disease (COPD). Most COPD patients are managed in primary care and receive ICS long-term and irrespective of severity. The effect of withdrawing ICS from COPD patients in primary care is unknown.This randomised double-blind placebo-controlled trial will evaluate the effect of withdrawal of inhaled corticosteroids in patients with COPD recruited from general practice. Participants will have a clinical and spirometric diagnosis of COPD and will have been prescribed inhaled steroids for the 6 months before entry to the trial. They will be randomised to taking a fixed dose steroid inhaler (Flixotide Accuhaler) or an identical placebo inhaler. Patients will be monitored using diary cards for a year with 3 monthly follow-up visits at their general practice. The primary outcome measures will be exacerbation frequency and severity. Other outcomes are time to first exacerbation, costs, health status, lung function and unscheduled care. We tested the hypothesis that withdrawal of ICS in this population would lead to an increased number of exacerbations, earlier onset of exacerbation, and a worsening of symptoms.

Detailed description

To determine whether withdrawal of inhaled corticosteroids in patients with COPD in general practice effects: * the frequency of exacerbations compared to a control group * differences in health status compared to a control group * differences in lung function compared to a control group * changes in unscheduled care compared to a control group * Direct and indirect costs compared to a control group Hypothesis The withdrawal of inhaled corticosteroids from patients with COPD identified in primary care will cause an increase in frequency and severity of exacerbations and is not cost-effective.

Conditions

• Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
DRUG	Fluticasone 500mcg BD via accuhaler or identical placebo

Timeline

• Start date: 2001-01-01
• Completion: 2004-03-01
• First posted: 2007-02-27
• Last updated: 2007-02-27

Locations

1 site across 1 country: United Kingdom