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

Assistance Publique - Hôpitaux de Paris

Status and phase

Completed

Phase 4

Conditions

Pulmonary Disease

Chronic Obstructive (MeSH)

Treatments

Drug: Placebo

Drug: Prednisone

Study type

Interventional

Funder types

Other

Identifiers

NCT02330952

AOM13195

Details and patient eligibility

About

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.

Full 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.

Enrollment

189 patients

Sex

All

Ages

40+ years old

Volunteers

No 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