A Phase 4 interventional study of Prednisone and Placebo in Pulmonary Disease and Chronic Obstructive (MeSH), sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2025-09-11.
Sponsored by Assistance Publique - Hôpitaux de Paris · Phase 4, Interventional, and Treatment
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.
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.
3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.
This study's enrollment of 189 is above the median of 72 across 2,118 interventional studies indexed under Lung Diseases.
Browse Lung Diseases studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Prednisone
Drug: Placebo
40mg/day per os for 5 days
40mg/day per os for 5 days
Treatment failure
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
Time frame: 8 weeks
Quality of life-adjusted survival (Q-TWIST)
The Q-TWiST method (Quality-adjusted Time Without Symptoms or Toxicity) takes into account the survival times during which patients are asymptomatic and / or show signs of toxicity, affecting each of these periods a weighting coefficient between 0 (life without quality) and 1 (best possible quality of life).
Time frame: 8 weeks
MYMOP (Measure Yourself Medical Outcome Profile)
4 items assessed by the patient on a 7-level Likert scale from 1 (poor quality of life) to 7 (good quality of life)
Time frame: 8 weeks
COPD Assessment Test (CAT)
Questionnaire assessing the impact of COPD on quality of life
Time frame: 8 weeks
Dyspnea Medical Research Council (MRC) score
5-level dyspnea scale
Time frame: 8 weeks
Occurrence of each event
Rate of occurrence of each component of the primary endpoint within 8 weeks after inclusion
Time frame: 8 weeks
Treatment Failure related to respiratory status
Occurrence of one of the following events within 8 weeks after inclusion: * emergency visit (s) or consultation (s) (use of unscheduled care) related the respiratory status of the patient * visit (s) to the emergency department, related to respiratory status * hospitalization (s), related to respiratory status * death, related to the respiratory status
Time frame: 8 weeks
Self-managed relapse or recurrence
antibiotics and / or oral corticosteroids or other treatment taken after a consultation or on early prescription
Time frame: 8 weeks
Adverse events
All reported adverse events
Time frame: 8 weeks
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Assistance Publique - Hôpitaux de Paris