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Withdrawal of Inhaled Corticosteroids in Patients With COPD in Primary Care

NCT00440687 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 256

Last updated 2007-02-27

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Fluticasone 500mcg BD via accuhaler or identical placebo

Sponsors & Collaborators

  • British Lung Foundation

    collaborator OTHER

  • GlaxoSmithKline

    collaborator INDUSTRY

  • Queen Mary University of London

    lead OTHER

Principal Investigators

  • Aklak B Choudhury, MRCP · Centre for Health Sciences, Queen Mary's School of Medicine and Dentistry

  • Gene S Feder, MRCGP MD · Centre for Health Sciences, Queen Mary's School of Medicine and Dentistry

  • Jadwiga A Wedzicha, MRCP MD · Academic Unit of Respiratory Medicine, Royal Free and University College Medical School

  • Chris J Griffiths, MRCP MRCGP MD · Centre for Health Sciences, Queen Mary's School of Medicine and Dentistry

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-01-31
Completion
2004-03-31

Countries

  • United Kingdom

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00440687 on ClinicalTrials.gov