Safe withdrawal of inhaled steroids in mild or moderate COPD
- Conditions
- COPDRespiratory
- Registration Number
- ISRCTN65344386
- Lead Sponsor
- King's College London
- Brief Summary
2019 preliminary research in https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6978678/ (added 17/06/2020) 2019 qualitative results in https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6566471/ (added 17/06/2020)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 106
1. Known diagnosis of mild or moderate COPD (forced expiratory volume in first second (FEV1) =50% predicted and FEV1/forced vital capacity (FVC) <0.7) obtained from spirometry within the past 12 months and confirmed at interview
2. Prescribed and have used high-dose ICS (alone or in combination with a long-acting bronchodilator) at a dose of fluticasone propionate =250mcg/day, fluticasone furoate =92mcg/day, budesonide >400mcg/day or beclomethasone dipropionate >400mcg/day on most days for at least 3 months
3. Age = 45 years
4. <2 exacerbations in the previous year and no admissions to hospital with an exacerbation since the diagnosis of COPD was made
5. BMI of less than 35
1. Patients with a BMI greater than 35
2. History of asthma
3. Lung cancer
4. Breathlessness secondary to cardiac disease
5. Moderate or severe osteoarthritis limiting mobility
6. Current severe mental illness (severe depression or psychosis)
7. Current alcohol dependence
8. Dementia
9. Patients who use continuous oral corticosteroids
10. Pregnant females or females of childbearing age not using effective contraception
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The principle outcome measure of the feasibility of a trial of withdrawal of high-dose ICS will be the proportion of patients who attend the baseline interview who find the invitation to participate acceptable and are willing to submit to randomisation.
- Secondary Outcome Measures
Name Time Method