Withdrawal of Inhaled Corticosteroids in Patients With COPD in Primary Care

February 26, 2007 updated by: Queen Mary University of London

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

256

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • London
      • London and Essex, London, United Kingdom, E1 2AT
        • Centre for Health Sciences, Queen Mary's School of Medicine and Dentistry, Barts and The London, 2 Newark Street,.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Smoker or ex smoker of at least 10 pack years
  • Age 40 or above
  • Prior and current use of inhaled corticosteroids for at least 6 months duration (Used for at least 75% of time on direct questioning)
  • FEV1 <80% of predicted, FEV1/FVC ratio <70%.
  • Less than 15% change and <200 mls change in FEV1 20 minutes after 5 mg nebulised salbutamol.
  • 256 patients to be included in trial of which 196 must have had a precious exacerbation of COPD in the last year

Exclusion Criteria:

  • Clear history of asthma, bronchiectasis, carcinoma of bronchus or other significant respiratory disease
  • Inability to give informed consent (severe mental illness, mental handicap or brain damage).
  • Recorded exacerbation within last month that has required antibiotics or steroids (delayed randomisation)
  • Classification as a never smoker
  • Strongly positive skin allergy result (>10mm skin weal greater then negative control) to house dust mite, grass, tree, aspergillus, cat, dog or weed (irrespective of asthma/atopy status)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
the frequency of exacerbations compared to a control group

Secondary Outcome Measures

Outcome Measure
differences in time to first exacerbation compared to 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
comparison of side effects between groups

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Queen Mary University of London

Collaborators

GlaxoSmithKline
British Lung Foundation

Investigators

  • Principal Investigator: Aklak B Choudhury, MRCP, Centre for Health Sciences, Queen Mary's School of Medicine and Dentistry
  • Study Chair: Gene S Feder, MRCGP MD, Centre for Health Sciences, Queen Mary's School of Medicine and Dentistry
  • Study Chair: Jadwiga A Wedzicha, MRCP MD, Academic Unit of Respiratory Medicine, Royal Free and University College Medical School
  • Study Director: Chris J Griffiths, MRCP MRCGP MD, Centre for Health Sciences, Queen Mary's School of Medicine and Dentistry

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2001

Study Completion

March 1, 2004

Study Registration Dates

First Submitted

February 26, 2007

First Submitted That Met QC Criteria

February 26, 2007

First Posted (Estimate)

February 27, 2007

Study Record Updates

Last Update Posted (Estimate)

February 27, 2007

Last Update Submitted That Met QC Criteria

February 26, 2007

Last Verified

February 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QMUL - WISP 01
  • British Lung Foundation P00/8

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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