Clinical trial NCT02330952: Efficacy of Corticosteroids to Treat Outpatients With Acute Exacerbations of COPD
Official title: Efficacy and Safety of Oral Corticosteroids for the Treatment of Acute Exacerbations of COPD in General Practice
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pulmonary Disease
Chronic Obstructive (MeSH)
Keywords: Double-blind method
Randomized Controlled trials
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2015-01-05
Enrollment: 189
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Treatment failure
timeFrame: 8 weeks
Secondary outcomes:
measure: Quality of life-adjusted survival (Q-TWIST)
timeFrame: 8 weeks
measure: MYMOP (Measure Yourself Medical Outcome Profile)
timeFrame: 8 weeks
measure: COPD Assessment Test (CAT)
timeFrame: 8 weeks
measure: Dyspnea Medical Research Council (MRC) score
timeFrame: 8 weeks
measure: Occurrence of each event
timeFrame: 8 weeks
measure: Treatment Failure related to respiratory status
timeFrame: 8 weeks
measure: Self-managed relapse or recurrence
timeFrame: 8 weeks
measure: Adverse events
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Paris
country: France
facility: Assistance Publique - Hopitaux Paris
Study officials:
affiliation: Département de Médecine Générale Faculté de Médecine Paris Descartes
name: Christian Ghasarossian, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Assistance Publique - Hôpitaux de Paris
name: Nicolas Roche, MD, PhD
role: STUDY_CHAIR
affiliation: Université Paris 6, Inserm, APHP
name: Thomas Similowski, MD, PhD
role: STUDY_CHAIR
affiliation: Département de Médecine Générale Faculté de Médecine Paris Descartes
name: Jean-Laurent Thebault, MD
role: STUDY_CHAIR
affiliation: Département de Médecine Générale Faculté de Médecine Paris Descartes
name: Alain Lorenzo, MD
role: STUDY_CHAIR
affiliation: Département de Médecine Générale Faculté de Médecine Paris Descartes
name: François Bloede, MD
role: STUDY_CHAIR
References:
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.
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.
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.
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.
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.
citation: 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.