Clinical trial NCT00440687: Withdrawal of Inhaled Corticosteroids in Patients With COPD in Primary Care
Official title: Phase 4 Withdrawal of Inhaled Corticosteroids in Patients With Chronic Obstructive Pulmonary Disease in Primary Care: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: chronic obstructive pulmonary disease
primary care
randomised trials
therapeutic interventions
Lead sponsor: Queen Mary University of London
Sponsor class: OTHER
Collaborators: name: British Lung Foundation
name: GlaxoSmithKline
First posted: 2007-02-27
Enrollment: 256
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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)

Primary outcomes:
measure: the frequency of exacerbations compared to a control group
Secondary outcomes:
measure: differences in time to first exacerbation compared to control group
measure: differences in health status compared to a control group
measure: differences in lung function compared to a control group
measure: changes in unscheduled care compared to a control group
measure: direct and indirect costs compared to a control group
measure: comparison of side effects between groups
Other outcomes:
Locations:
city: London and Essex
country: United Kingdom
facility: Centre for Health Sciences, Queen Mary's School of Medicine and Dentistry, Barts and The London, 2 Newark Street,.
state: London
Study officials:
affiliation: Centre for Health Sciences, Queen Mary's School of Medicine and Dentistry
name: Aklak B Choudhury, MRCP
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre for Health Sciences, Queen Mary's School of Medicine and Dentistry
name: Gene S Feder, MRCGP MD
role: STUDY_CHAIR
affiliation: Academic Unit of Respiratory Medicine, Royal Free and University College Medical School
name: Jadwiga A Wedzicha, MRCP MD
role: STUDY_CHAIR
affiliation: Centre for Health Sciences, Queen Mary's School of Medicine and Dentistry
name: Chris J Griffiths, MRCP MRCGP MD
role: STUDY_DIRECTOR
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