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Efficacy of Corticosteroids to Treat Outpatients With Acute Exacerbations of COPD (BECOMEG)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02330952
Recruitment Status : Completed
First Posted : January 5, 2015
Last Update Posted : May 15, 2018
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.


Condition or disease Intervention/treatment Phase
Pulmonary Disease Chronic Obstructive (MeSH) Drug: Prednisone Drug: Placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 189 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Oral Corticosteroids for the Treatment of Acute Exacerbations of COPD in General Practice
Actual Study Start Date : February 10, 2015
Actual Primary Completion Date : May 23, 2017
Actual Study Completion Date : May 23, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Steroids
Drug Information available for: Prednisone

Arm Intervention/treatment
Experimental: Prednisone Drug: Prednisone
40mg/day per os for 5 days

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Quality of life-adjusted survival (Q-TWIST) [ Time Frame: 8 weeks ]
    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).

  2. MYMOP (Measure Yourself Medical Outcome Profile) [ Time Frame: 8 weeks ]
    4 items assessed by the patient on a 7-level Likert scale from 1 (poor quality of life) to 7 (good quality of life)

  3. COPD Assessment Test (CAT) [ Time Frame: 8 weeks ]
    Questionnaire assessing the impact of COPD on quality of life

  4. Dyspnea Medical Research Council (MRC) score [ Time Frame: 8 weeks ]
    5-level dyspnea scale

  5. Occurrence of each event [ Time Frame: 8 weeks ]
    Rate of occurrence of each component of the primary endpoint within 8 weeks after inclusion

  6. Treatment Failure related to respiratory status [ 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 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

  7. Self-managed relapse or recurrence [ Time Frame: 8 weeks ]
    antibiotics and / or oral corticosteroids or other treatment taken after a consultation or on early prescription

  8. Adverse events [ Time Frame: 8 weeks ]
    All reported adverse events



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02330952


Locations
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France
Assistance Publique - Hopitaux Paris
Paris, France, 75014
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Christian Ghasarossian, MD Département de Médecine Générale Faculté de Médecine Paris Descartes
Study Chair: 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
Publications:
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02330952    
Other Study ID Numbers: AOM13195
First Posted: January 5, 2015    Key Record Dates
Last Update Posted: May 15, 2018
Last Verified: March 2018
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Double-blind method
Randomized Controlled trials
Additional relevant MeSH terms:
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Lung Diseases
Respiratory Tract Diseases
Prednisone
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents