Withdrawal of Inhaled Corticosteroids in Patients With COPD in Primary Care

NCT00440687 | Completed Phase 4 DMC

• 2 other identifiers: QMUL - WISP 01British Lung Foundation P00/8
• Study Type: interventional
• Target: 256
• Locations: 1 country
• Sites: 1

Brief 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

Chronic Obstructive Pulmonary Disease

Keywords

chronic obstructive pulmonary disease; primary care; randomised trials; therapeutic interventions

Outcome Measures

Primary Outcomes (1)

• the frequency of exacerbations compared to a control group

Secondary Outcomes (6)

• 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

Interventions

Fluticasone 500mcg BD via accuhaler or identical placebo DRUG

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• patients to be included in trial of which 196 must have had a precious exacerbation of COPD in the last year

You may not qualify if:

• 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)

Sponsors & Collaborators

• Queen Mary University of London: lead
• British Lung Foundation: collaborator
• GlaxoSmithKline: collaborator

Study Sites (1)

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

Location

Related Publications (28)

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• Choudhury AB, Dawson CM, Kilvington HE, Eldridge S, James WY, Wedzicha JA, Feder GS, Griffiths CJ. Withdrawal of inhaled corticosteroids in people with COPD in primary care: a randomised controlled trial. Respir Res. 2007 Dec 27;8(1):93. doi: 10.1186/1465-9921-8-93.

  PMID: 18162137 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Fluticasone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Aklak B Choudhury, MRCP

  Centre for Health Sciences, Queen Mary's School of Medicine and Dentistry

  PRINCIPAL INVESTIGATOR

• 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 CHAIR

• Chris J Griffiths, MRCP MRCGP MD

  Centre for Health Sciences, Queen Mary's School of Medicine and Dentistry

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 26, 2007
• First Posted: February 27, 2007
• Study Start: January 1, 2001
• Study Completion: March 1, 2004
• Last Updated: February 27, 2007

Record last verified: 2007-02

Locations

GB (1)