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
  Purpose

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.


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease
Drug: Fluticasone 500mcg BD via accuhaler or identical placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Phase 4 Withdrawal of Inhaled Corticosteroids in Patients With Chronic Obstructive Pulmonary Disease in Primary Care: a Randomised Controlled Trial

Resource links provided by NLM:


Further study details as provided by Queen Mary University of London:

Primary Outcome Measures:
  • the frequency of exacerbations compared to a control group

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 256
Study Start Date: January 2001
Estimated Study Completion Date: March 2004
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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00440687

Locations
United Kingdom
Centre for Health Sciences, Queen Mary’s School of Medicine and Dentistry, Barts and The London, 2 Newark Street,.
London and Essex, London, United Kingdom, E1 2AT
Sponsors and Collaborators
Queen Mary University of London
British Lung Foundation
GlaxoSmithKline
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
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00440687     History of Changes
Other Study ID Numbers: QMUL - WISP 01, British Lung Foundation P00/8
Study First Received: February 26, 2007
Last Updated: February 26, 2007
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Queen Mary University of London:
chronic obstructive pulmonary disease
primary care
randomised trials
therapeutic interventions

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 23, 2014