NCT02330952

Efficacy of Corticosteroids to Treat Outpatients With Acute Exacerbations of COPD

Efficacy and Safety of Oral Corticosteroids for the Treatment of Acute Exacerbations of COPD in General Practice

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 189 (actual)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

Primary objective: The aim of this study is to determine the efficacy and safety of five days of oral corticosteroids (40 mg / day) for the treatment of acute exacerbations of COPD (AECOPD) in outpatients.

Detailed description

COPD is a major and growing public health issue. The vast majority of cases are cared for in primary care, both for follow-up in stable state and for treatment of exacerbations, which represent major events in the natural history of the disease. Systemic corticosteroid treatment is often proposed for exacerbations treatment, although guidelines in this area are heterogeneous regarding precise indications of this treatment. The latest data from the literature, seems to show efficacy of oral corticosteroids but involved only patients seen at the hospital. General practitioners need evidence-base informations to choose whether or not they have to give oral corticosteroids to their patients ; therefore it is very important to better define the benefit-risk ratio and precise indications of oral corticosteroids as part of the care for COPD exacerbations. The investigators built a randomized double-blind controlled trial to answer this question.

Conditions

• Pulmonary Disease
• Chronic Obstructive (MeSH)

Interventions

Type	Name	Description
DRUG	Prednisone	40mg/day per os for 5 days
DRUG	Placebo	40mg/day per os for 5 days

Timeline

• Start date: 2015-02-10
• Primary completion: 2017-05-23
• Completion: 2017-05-23
• First posted: 2015-01-05
• Last updated: 2025-09-11

Locations

1 site across 1 country: France