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

AOM13195

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.

2015-02-10

2017-05-23

2017-05-23

Completed

Early phase I

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 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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 189, 'type': 'ACTUAL'}}

2024-01-10