Efficacy and Safety of Oral Corticosteroids for the Treatment of Acute Exacerbations of COPD in General Practice
Overview
- Phase
- Phase 4
- Intervention
- Prednisone
- Conditions
- Pulmonary Disease
- Sponsor
- Assistance Publique - Hôpitaux de Paris
- Enrollment
- 189
- Locations
- 1
- Primary Endpoint
- Treatment failure
- Status
- Completed
- Last Updated
- 7 months ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Adults aged 40 years and over
- •Smoking ≥ 10 pack-years
- •Patients with suspected acute exacerbation of COPD
- •Patients who gave their written informed consent to participate in the study
Exclusion Criteria
- •Known or suspected chronic respiratory disease other than COPD (asthma, bronchiectasis ...)
- •Suspected pneumonia or pulmonary oedema
- •Decision of hospitalization
- •Patients taking oral corticosteroids running or stopped for less than a week before inclusion
- •Pathology compromising compliance
- •Fever unexplained by the current AECOPD
- •Uncontrolled hypertension
- •Uncontrolled diabetes
- •Deep infectious disease
- •History of ancient untreated tuberculosis
Arms & Interventions
Prednisone
Intervention: Prednisone
Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Treatment failure
Time Frame: 8 weeks
Occurrence of one of the following events within 8 weeks after inclusion: * emergency visit (s) or consultation (s) (use of unscheduled care) related or not to the respiratory status of the patient * visit (s) to the emergency department, related or not to respiratory status * hospitalization (s), related or not to respiratory status * death, related or not to the respiratory status
Secondary Outcomes
- MYMOP (Measure Yourself Medical Outcome Profile)(8 weeks)
- Dyspnea Medical Research Council (MRC) score(8 weeks)
- Occurrence of each event(8 weeks)
- Treatment Failure related to respiratory status(8 weeks)
- Self-managed relapse or recurrence(8 weeks)
- COPD Assessment Test (CAT)(8 weeks)
- Adverse events(8 weeks)
- Quality of life-adjusted survival (Q-TWIST)(8 weeks)