Chronic Obstructive (MeSH), Pulmonary Disease
Conditions
Keywords
Double-blind method, Randomized Controlled trials
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.
Interventions
DRUGPrednisone
40mg/day per os for 5 days
DRUGPlacebo
40mg/day per os for 5 days
Sponsors
URC-CIC Paris Descartes Necker Cochin
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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 * Untreated peptic ulcer * Unhealed wound * Ulcerative Colitis * Allergy to steroids * Any severe or uncontrolled infections who are not specified as therapeutic indication in the SPC (Summary of Product Characteristics) * Hepatitis, acute genital herpes, varicella, acute zoster * Live attenuated vaccine, recent or planned * Psychoses not controlled by treatment * Hypersensitivity to prednisone or any of the excipients of Cortancyl®, including lactose intolerance * Patients who have already been included in BECOMEG * Patients who have to move within 8 weeks after inclusion in the study * Patients who are not affiliated to the national health insurance
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment failure | 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
| Measure | Time frame | Description |
|---|---|---|
| MYMOP (Measure Yourself Medical Outcome Profile) | 8 weeks | 4 items assessed by the patient on a 7-level Likert scale from 1 (poor quality of life) to 7 (good quality of life) |
| COPD Assessment Test (CAT) | 8 weeks | Questionnaire assessing the impact of COPD on quality of life |
| Dyspnea Medical Research Council (MRC) score | 8 weeks | 5-level dyspnea scale |
| Quality of life-adjusted survival (Q-TWIST) | 8 weeks | 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). |
| Treatment Failure related to respiratory status | 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 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 |
| Self-managed relapse or recurrence | 8 weeks | antibiotics and / or oral corticosteroids or other treatment taken after a consultation or on early prescription |
| Adverse events | 8 weeks | All reported adverse events |
| Occurrence of each event | 8 weeks | Rate of occurrence of each component of the primary endpoint within 8 weeks after inclusion |
Countries
France
Outcome results
None listed