Efficacy of Corticosteroids to Treat Outpatients With Acute Exacerbations of COPD

NCT02330952 | Completed Phase 4 DMC

• 1 other identifier: AOM13195
• Study Type: interventional
• Target: 189
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Disease; Chronic Obstructive (MeSH)

Keywords

Double-blind method; Randomized Controlled trials

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Quality of life-adjusted survival (Q-TWIST)

  8 weeks

• MYMOP (Measure Yourself Medical Outcome Profile)

  8 weeks

• COPD Assessment Test (CAT)

  8 weeks

• Dyspnea Medical Research Council (MRC) score

  8 weeks

• Occurrence of each event

  8 weeks

Study Arms (2)

Prednisone

EXPERIMENTAL

Drug: Prednisone

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Prednisone DRUG

40mg/day per os for 5 days

Prednisone

Placebo DRUG

40mg/day per os for 5 days

Placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Known or suspected chronic respiratory disease other than COPD (asthma, bronchiectasis ...)
• Suspected pneumonia or pulmonary oedema
• Decision of hospitalization
• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Assistance Publique - Hopitaux Paris

Paris, 75014, France

Location

Related Publications (6)

• 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.

  PMID: 37701369 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.

  PMID: 20965408 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.

  PMID: 8756814 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.

  PMID: 21975757 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.

  PMID: 19160195 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.

  PMID: 12844030 BACKGROUND

MeSH Terms

Conditions

Lung Diseases

Interventions

Prednisone

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 1, 2015
• First Posted: January 5, 2015
• Study Start: February 10, 2015
• Primary Completion: May 23, 2017
• Study Completion: May 23, 2017
• Last Updated: September 11, 2025

Record last verified: 2025-09

Locations

FR (1)