Efficacy of Corticosteroids to Treat Outpatients With Acute Exacerbations of COPD (BECOMEG)

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

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Disease; Chronic Obstructive (MeSH)
• Intervention / Treatment: Drug: Prednisone; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 189
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Paris, France, 75014
    • Assistance Publique - Hopitaux Paris

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; 40mg/day per os for 5 days
Experimental: Prednisone	Drug: Prednisone; 40mg/day per os for 5 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	8 weeks

Secondary Outcome Measures

Outcome Measure	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
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: 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	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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Christian Ghasarossian, MD, Département de Médecine Générale Faculté de Médecine Paris Descartes; Study Chair: 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

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2015
• Primary Completion (Actual): May 23, 2017
• Study Completion (Actual): May 23, 2017

Study Registration Dates

• First Submitted: January 1, 2015
• First Submitted That Met QC Criteria: January 2, 2015
• First Posted (Estimated): January 5, 2015

Study Record Updates

• Last Update Posted (Actual): January 10, 2024
• Last Update Submitted That Met QC Criteria: January 8, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Double-blind method; Randomized Controlled trials
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antineoplastic Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Prednisone
• Other Study ID Numbers: AOM13195