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

Primary Purpose

Pulmonary Disease, Chronic Obstructive (MeSH)

Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Prednisone
Placebo
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Disease focused on measuring Double-blind method, Randomized Controlled trials

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Assistance Publique - Hopitaux Paris

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Prednisone

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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).
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)
COPD Assessment Test (CAT)
Questionnaire assessing the impact of COPD on quality of life
Dyspnea Medical Research Council (MRC) score
5-level dyspnea scale
Occurrence of each event
Rate of occurrence of each component of the primary endpoint within 8 weeks after inclusion
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
Self-managed relapse or recurrence
antibiotics and / or oral corticosteroids or other treatment taken after a consultation or on early prescription
Adverse events
All reported adverse events

Full Information

First Posted
January 1, 2015
Last Updated
May 9, 2018
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT02330952
Brief Title
Efficacy of Corticosteroids to Treat Outpatients With Acute Exacerbations of COPD
Acronym
BECOMEG
Official Title
Efficacy and Safety of Oral Corticosteroids for the Treatment of Acute Exacerbations of COPD in General Practice
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
February 10, 2015 (Actual)
Primary Completion Date
May 23, 2017 (Actual)
Study Completion Date
May 23, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive (MeSH)
Keywords
Double-blind method, Randomized Controlled trials

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
189 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prednisone
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Prednisone
Intervention Description
40mg/day per os for 5 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
40mg/day per os for 5 days
Primary Outcome Measure Information:
Title
Treatment failure
Description
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
Secondary Outcome Measure Information:
Title
Quality of life-adjusted survival (Q-TWIST)
Description
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
Title
MYMOP (Measure Yourself Medical Outcome Profile)
Description
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
Title
COPD Assessment Test (CAT)
Description
Questionnaire assessing the impact of COPD on quality of life
Time Frame
8 weeks
Title
Dyspnea Medical Research Council (MRC) score
Description
5-level dyspnea scale
Time Frame
8 weeks
Title
Occurrence of each event
Description
Rate of occurrence of each component of the primary endpoint within 8 weeks after inclusion
Time Frame
8 weeks
Title
Treatment Failure related to respiratory status
Description
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
Title
Self-managed relapse or recurrence
Description
antibiotics and / or oral corticosteroids or other treatment taken after a consultation or on early prescription
Time Frame
8 weeks
Title
Adverse events
Description
All reported adverse events
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Ghasarossian, MD
Organizational Affiliation
Département de Médecine Générale Faculté de Médecine Paris Descartes
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nicolas Roche, MD, PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Thomas Similowski, MD, PhD
Organizational Affiliation
Université Paris 6, Inserm, APHP
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jean-Laurent Thebault, MD
Organizational Affiliation
Département de Médecine Générale Faculté de Médecine Paris Descartes
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Alain Lorenzo, MD
Organizational Affiliation
Département de Médecine Générale Faculté de Médecine Paris Descartes
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
François Bloede, MD
Organizational Affiliation
Département de Médecine Générale Faculté de Médecine Paris Descartes
Official's Role
Study Chair
Facility Information:
Facility Name
Assistance Publique - Hopitaux Paris
City
Paris
ZIP/Postal Code
75014
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
20965408
Citation
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.
Results Reference
background
PubMed Identifier
8756814
Citation
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.
Results Reference
background
PubMed Identifier
21975757
Citation
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.
Results Reference
background
PubMed Identifier
19160195
Citation
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.
Results Reference
background
PubMed Identifier
12844030
Citation
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.
Results Reference
background

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Efficacy of Corticosteroids to Treat Outpatients With Acute Exacerbations of COPD

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