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Efficacy of Corticosteroids to Treat Outpatients With Acute Exacerbations of COPD

Phase 4
Completed
Conditions
Pulmonary Disease
Chronic Obstructive (MeSH)
Interventions
Drug: Placebo
Drug: Prednisone
Registration Number
NCT02330952
Lead Sponsor
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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
189
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
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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
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
PlaceboPlacebo-
PrednisonePrednisone-
Primary Outcome Measures
NameTimeMethod
Treatment failure8 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
NameTimeMethod
MYMOP (Measure Yourself Medical Outcome Profile)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)

Dyspnea Medical Research Council (MRC) score8 weeks

5-level dyspnea scale

Occurrence of each event8 weeks

Rate of occurrence of each component of the primary endpoint within 8 weeks after inclusion

Treatment Failure related to respiratory status8 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

Self-managed relapse or recurrence8 weeks

antibiotics and / or oral corticosteroids or other treatment taken after a consultation or on early prescription

COPD Assessment Test (CAT)8 weeks

Questionnaire assessing the impact of COPD on quality of life

Adverse events8 weeks

All reported adverse events

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

Trial Locations

Locations (1)

Assistance Publique - Hopitaux Paris

🇫🇷

Paris, France

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