Withdrawal of Inhaled Corticosteroids in Patients With COPD in Primary Care

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Drug: Fluticasone 500mcg BD via accuhaler or identical placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Fluticasone 500mcg BD via accuhaler or identical placebo|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the frequency of exacerbations compared to a control group |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic obstructive pulmonary disease, primary care, randomised trials, therapeutic interventions