Efficacy of Corticosteroids to Treat Outpatients With Acute Exacerbations of COPD

• Status: Completed
• Trial end date: 2017-05-23
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Prednisone

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