Withdrawal of Inhaled Corticosteroids in Patients With COPD in Primary Care
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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 |
- the frequency of exacerbations compared to a control group
- 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 |
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 |
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| 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 | |
| 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 Respiration Disorders Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Respiratory Tract Diseases Fluticasone Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Pharmacologic Actions Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses Dermatologic Agents Anti-Allergic Agents Anti-Inflammatory Agents |
ClinicalTrials.gov processed this record on May 16, 2013