Efficacy of Corticosteroids to Treat Outpatients With Acute Exacerbations of COPD

NCT ID: NCT02330952

Last Updated: 2025-09-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 189 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-10
• Study Completion Date: 2017-05-23

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.

Conditions

Pulmonary Disease; Chronic Obstructive (MeSH)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Prednisone

Group Type: EXPERIMENTAL

Prednisone

Intervention Type: DRUG

40mg/day per os for 5 days

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

40mg/day per os for 5 days

Interventions

Prednisone

40mg/day per os for 5 days

Intervention Type: DRUG

Placebo

40mg/day per os for 5 days

Intervention Type: DRUG

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

URC-CIC Paris Descartes Necker Cochin

OTHER

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christian Ghasarossian, MD

Role: PRINCIPAL_INVESTIGATOR

Département de Médecine Générale Faculté de Médecine Paris Descartes

Nicolas Roche, MD, PhD

Role: STUDY_CHAIR

Assistance Publique - Hôpitaux de Paris

Thomas Similowski, MD, PhD

Role: STUDY_CHAIR

Université Paris 6, Inserm, APHP

Jean-Laurent Thebault, MD

Role: STUDY_CHAIR

Département de Médecine Générale Faculté de Médecine Paris Descartes

Alain Lorenzo, MD

Role: STUDY_CHAIR

Département de Médecine Générale Faculté de Médecine Paris Descartes

François Bloede, MD

Role: STUDY_CHAIR

Département de Médecine Générale Faculté de Médecine Paris Descartes

Locations

Assistance Publique - Hopitaux Paris

Paris, , France

Countries

France

References

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.

Reference Type: BACKGROUND

PMID: 37701369 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20965408 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 8756814 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21975757 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19160195 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12844030 (View on PubMed)

Other Identifiers

AOM13195

Identifier Type: -

Identifier Source: org_study_id