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Completed

NCT Number: NCT00440687

Withdrawal of Inhaled Corticosteroids in Patients With COPD in Primary Care

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Centre for Health Sciences, Queen Mary's School of Medicine and Dentistry, Barts and The London, 2 Newark Street,.

London and Essex, London, E1 2AT, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Fluticasone 500mcg BD via accuhaler or identical placebo

Drug

Primary outcomes

  1. the frequency of exacerbations compared to a control group

Secondary outcomes

  1. differences in time to first exacerbation compared to control group

  2. differences in health status compared to a control group

  3. differences in lung function compared to a control group

  4. changes in unscheduled care compared to a control group

  5. direct and indirect costs compared to a control group

  6. comparison of side effects between groups

Sponsors and collaborators

Lead sponsor

Queen Mary University of London

Other

Collaborators

  • British Lung Foundation
  • GlaxoSmithKline

Registry information

Official study title

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

Important dates

Study start
2001
Study completion
2004
First posted
Feb 27, 2007
Registry last updated
Feb 27, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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