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Randomised placebo controlled trial of low dose prednisolone for 3-years in subjects with chronic obstructive pulmonary disease with a sputum eosinophilia - Randomised trial of long term prednisolone in COPD with eosinophilia

Randomised placebo controlled trial of low dose prednisolone for 3-years in subjects with chronic obstructive pulmonary disease with a sputum eosinophilia - Randomised trial of long term prednisolone in COPD with eosinophilia

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2005-002138-36-GB
Enrollment
130
Registered
2006-02-01
Start date
2006-02-24
Completion date
Unknown
Last updated
2020-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic obstructive pulmonary disease with sputum eosinophilia>3%

Interventions

Trade Name: Prednisolone Tablets BP 5mg Product Name: Prednisolone Product Code: Not applicable Pharmaceutical Form: Tablet INN or Proposed INN: Prednisolone CAS Number: N/A Current Sponsor code: not

Sponsors

University Hospital of Leicester NHS Trust
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Subjects will be >45yrs old and have COPD FEV1=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Subjects with significant co-morbidity will be excluded including: bronchiectasis, lung cancer, heart failure, osteoporosis

Design outcomes

Primary

MeasureTime frame
Main Objective: To reduce decline in lung function & rate of annual exacerbation rate in patients with COPD & sputum eosinophilia on oral prednisolone versus placebo;Secondary Objective: To observe safety issues of long term low dose oral prednisolone, visual analogue scores for respiratory symptoms;Primary end point(s): Primary outcomes 1. Lung function Post-bronchodilator FEV1 2. Exacerbations-Moderate 7severe—

Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026