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Withdrawal of Inhaled Corticosteroids in Patients With COPD in Primary Care

This study has been completed.
Sponsor:
Collaborators:
British Lung Foundation
GlaxoSmithKline
Information provided by:
Queen Mary University of London
ClinicalTrials.gov Identifier:
NCT00440687
First received: February 26, 2007
Last updated: NA
Last verified: February 2007
History: No changes posted

February 26, 2007
February 26, 2007
January 2001
Not Provided
the frequency of exacerbations compared to a control group
Same as current
No Changes Posted
  • 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
Same as current
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Chronic Obstructive Pulmonary Disease
Drug: Fluticasone 500mcg BD via accuhaler or identical placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
256
March 2004
Not Provided

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)
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00440687
QMUL - WISP 01, British Lung Foundation P00/8
Yes
Not Provided
Queen Mary University of London
  • British Lung Foundation
  • GlaxoSmithKline
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
Queen Mary University of London
February 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP