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| Name | Class |
|---|---|
| URC-CIC Paris Descartes Necker Cochin | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prednisone | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prednisone | Drug | 40mg/day per os for 5 days |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment failure | Occurrence of one of the following events within 8 weeks after inclusion:
| 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christian Ghasarossian, MD | Département de Médecine Générale Faculté de Médecine Paris Descartes | Principal Investigator |
| Nicolas Roche, MD, PhD | Assistance Publique - Hôpitaux de Paris | Study Chair |
| Thomas Similowski, MD, PhD | Université Paris 6, Inserm, APHP | Study Chair |
| Jean-Laurent Thebault, MD | Département de Médecine Générale Faculté de Médecine Paris Descartes | Study Chair |
| Alain Lorenzo, MD | Département de Médecine Générale Faculté de Médecine Paris Descartes | Study Chair |
| François Bloede, MD | Département de Médecine Générale Faculté de Médecine Paris Descartes | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assistance Publique - Hopitaux Paris | Paris | 75014 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20965408 | Background | Rabbat A, Guetta A, Lorut C, Lefebvre A, Roche N, Huchon G. [Management of acute exacerbations of COPD]. Rev Mal Respir. 2010 Oct;27(8):939-53. doi: 10.1016/j.rmr.2010.08.003. French. | |
| 8756814 | Background | Thompson WH, Nielson CP, Carvalho P, Charan NB, Crowley JJ. Controlled trial of oral prednisone in outpatients with acute COPD exacerbation. Am J Respir Crit Care Med. 1996 Aug;154(2 Pt 1):407-12. doi: 10.1164/ajrccm.154.2.8756814. |
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| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D011241 | Prednisone |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| Drug |
40mg/day per os for 5 days |
|
| 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) | 8 weeks |
| COPD Assessment Test (CAT) | Questionnaire assessing the impact of COPD on quality of life | 8 weeks |
| Dyspnea Medical Research Council (MRC) score | 5-level dyspnea scale | 8 weeks |
| Occurrence of each event | Rate of occurrence of each component of the primary endpoint within 8 weeks after inclusion | 8 weeks |
| Treatment Failure related to respiratory status | Occurrence of one of the following events within 8 weeks after inclusion:
| 8 weeks |
| Self-managed relapse or recurrence | antibiotics and / or oral corticosteroids or other treatment taken after a consultation or on early prescription | 8 weeks |
| Adverse events | All reported adverse events | 8 weeks |
| 21975757 | Background | Walters JA, Wang W, Morley C, Soltani A, Wood-Baker R. Different durations of corticosteroid therapy for exacerbations of chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2011 Oct 5;(10):CD006897. doi: 10.1002/14651858.CD006897.pub2. |
| 19160195 | Background | Walters JA, Gibson PG, Wood-Baker R, Hannay M, Walters EH. Systemic corticosteroids for acute exacerbations of chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2009 Jan 21;(1):CD001288. doi: 10.1002/14651858.CD001288.pub3. |
| 12844030 | Background | Societe de Pneumologie de Langue Francaise. [Updated guidelines of the Societe de Pneumologie de Langue Francaise for the management of chronic obstructive pulmonary disease: essential points]. Rev Mal Respir. 2003 Apr;20(2 Pt 1):294-9. No abstract available. French. |
| 37701369 | Result | Thebault JL, Roche N, Abdoul H, Lorenzo A, Similowski T, Ghasarossian C. Efficacy and safety of oral corticosteroids to treat outpatients with acute exacerbations of COPD in primary care: a multicentre pragmatic randomised controlled study. ERJ Open Res. 2023 Sep 11;9(5):00057-2023. doi: 10.1183/23120541.00057-2023. eCollection 2023 Sep. |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |