Efficacy of Corticosteroids to Treat Outpatients With Acute Exacerbations of COPD

Pulmonary Disease Clinical Trial

— BECOMEG  

Official title:

Efficacy and Safety of Oral Corticosteroids for the Treatment of Acute Exacerbations of COPD in General Practice

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02330952
• Other study ID #: AOM13195
• Status: Completed
• Phase: Phase 4
• Start date: February 10, 2015
• Est. completion date: May 23, 2017

Study information

• Verified date: January 2024
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 189
• Est. completion date: May 23, 2017
• Est. primary completion date: May 23, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive (MeSH)
• Lung Diseases
• Pulmonary Disease

Intervention

Drug:
• Prednisone
40mg/day per os for 5 days
• Placebo
40mg/day per os for 5 days

Locations

Country	Name	City	State
France	Assistance Publique - Hopitaux Paris	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

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