Pulmonary DiseasePhase 4BECOMEGNCT02330952
Efficacy of Corticosteroids to Treat Outpatients With Acute Exacerbations of COPD
A Phase 4 study testing Prednisone in people with Pulmonary Disease and Chronic Obstructive (MeSH), run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive (MeSH)
- What is being tested?
- Prednisone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 189 participants
- Where
- 1 siteFrance
- Study dates
- 10 Feb 2015to 23 May 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 22Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Oral Corticosteroids for the Treatment of Acute Exacerbations of COPD in General Practice
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.
Read the 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)
- Being tested
- Prednisone, Placebo
- Keywords
- Double-blind method, Randomized Controlled trials
- Medical subject headings
- Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrednisoneDrug
40mg/day per os for 5 days
PlaceboDrug
40mg/day per os for 5 days
| Study group | Role | What they receive |
|---|---|---|
| Prednisone | Experimental | Not described Receives: Drug: Prednisone |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 8 weeks
Secondary outcomes (8)
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).
Measured: 8 weeks
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)
Measured: 8 weeks
COPD Assessment Test (CAT)
Questionnaire assessing the impact of COPD on quality of life
Measured: 8 weeks
Dyspnea Medical Research Council (MRC) score
5-level dyspnea scale
Measured: 8 weeks
Occurrence of each event
Rate of occurrence of each component of the primary endpoint within 8 weeks after inclusion
Measured: 8 weeks
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
Measured: 8 weeks
Self-managed relapse or recurrence
antibiotics and / or oral corticosteroids or other treatment taken after a consultation or on early prescription
Measured: 8 weeks
Adverse events
All reported adverse events
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2015 (estimated)
- Study start10 Feb 2015
- Primary completion23 May 2017
- Study completion23 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 189 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Christian Ghasarossian, MD, Principal investigator, Département de Médecine Générale Faculté de Médecine Paris DescartesNicolas Roche, MD, PhD, Study chair, Assistance Publique - Hôpitaux de ParisThomas Similowski, MD, PhD, Study chair, Université Paris 6, Inserm, APHPJean-Laurent Thebault, MD, Study chair, Département de Médecine Générale Faculté de Médecine Paris DescartesAlain Lorenzo, MD, Study chair, Département de Médecine Générale Faculté de Médecine Paris DescartesFrançois Bloede, MD, Study chair, Département de Médecine Générale Faculté de Médecine Paris Descartes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02330952
- Sponsor's protocol ID
- AOM13195
- Acronym
- BECOMEG
- Status last verified
- Sep 2025
- First submitted
- 1 Jan 2015
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 20965408Thompson 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.
PubMed 8756814Walters 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.
PubMed 21975757Walters 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.
PubMed 19160195Societe 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.
PubMed 12844030Thebault 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.
PubMed 37701369
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Oral Corticosteroids for the Treatment of Acute Exacerbations of COPD in General Practice
- ClinicalTrials.gov ID
- NCT02330952
- Acronym / sponsor ID
- BECOMEG / AOM13195
- Conditions
- Pulmonary Disease, Chronic Obstructive (MeSH)
- Keywords
- Double-blind method, Randomized Controlled trials
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 189 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 10 Feb 2015 (actual)
- Primary completion
- 23 May 2017 (actual)
- Study completion
- 23 May 2017 (actual)
- First posted
- 5 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prednisone | Experimental | Drug: Prednisone |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prednisone40mg/day per os for 5 days | Drug | Prednisone |
| Placebo40mg/day per os for 5 days | Drug | Placebo |
Primary outcome
Treatment failure
Time frame: 8 weeks
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 secondary outcomes
Quality of life-adjusted survival (Q-TWIST)
Time frame: 8 weeks
MYMOP (Measure Yourself Medical Outcome Profile)
Time frame: 8 weeks
COPD Assessment Test (CAT)
Time frame: 8 weeks
Dyspnea Medical Research Council (MRC) score
Time frame: 8 weeks
Occurrence of each event
Time frame: 8 weeks
Treatment Failure related to respiratory status
Time frame: 8 weeks
Self-managed relapse or recurrence
Time frame: 8 weeks
Adverse events
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.
- Background: PubMed 20965408Rabbat 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.
- Background: PubMed 8756814Thompson 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.
- Background: PubMed 21975757Walters 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.
- Background: PubMed 19160195Walters 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.
- Background: PubMed 12844030Societe 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.
- Results publication: PubMed 37701369Thebault 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Ghasarossian, MD principal investigator
Département de Médecine Générale Faculté de Médecine Paris Descartes
Nicolas Roche, MD, PhD study chair
Assistance Publique - Hôpitaux de Paris
Thomas Similowski, MD, PhD study chair
Université Paris 6, Inserm, APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Prednisone in people with Pulmonary Disease and Chronic Obstructive (MeSH), run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment failure (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02330952, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2025.