Reduction of Corticosteroid Use in Outpatient Treatment of Exacerbated COPD
Status:
Recruiting
Trial end date:
2022-12-01
Target enrollment:
Participant gender:
Summary
Background
Chronic obstructive pulmonary disease (COPD) is a major public health issue with no curative
treatment. In Switzerland estimated 5-7% of the total population are suffering from this
chronic disease. According to current guidelines corticosteroids are part of treatment of
acute exacerbations in COPD patients. Several studies suggest that corticosteroids accelerate
the recovery of forced expiratory volume in 1 second (FEV1), decrease duration of
hospitalization, reduce treatment failure rate and improve clinical outcome. The additional
therapeutic benefit on FEV1-recovery tough seems only to last for three to five days. The
investigators recently published a hospital-based study showing that in patients presenting
to emergency departments with acute exacerbation of COPD, a short five day treatment with
systemic steroids was not inferior to a conventional 14 day treatment with regard to
re-exacerbation. Cumulative corticosteroid dose could be reduced in this trial. To the
investigators knowledge no data is available about the minimal necessary corticosteroid dose
in an outpatient treatment setting so far.
Aim
The primary aim of this study is to investigate in an outpatient setting, whether a three day
treatment with orally administered systemic corticosteroids is non-inferior to a five day
treatment in acute exacerbation of COPD and if total glucocorticoid exposure can be reduced
by shorter therapy.
Hypothesis
The investigators postulate, that in an outpatient setting, where generally less severe
exacerbations are being treated, a three day treatment duration of systemic corticosteroids
should be non-inferior to a five day treatment duration with regard to treatment benefits but
decrease cumulative corticosteroid exposure.
Design and Setting
This study is going to be performed as a prospective, randomized, double-blind,
placebo-controlled, non-inferiority trial in an outpatient setting. Randomization will be
performed as block randomization with a 1:1 allocation. The investigators are going to
recruit GPs in northwestern and central Switzerland.
Methods
The investigators are going to include patients presenting to GP's with acute exacerbation of
COPD. When matching the investigators eligibility criteria and written informed consent is
given, patients included in the study are receiving systemic corticosteroid treatment
(equivalent of 40mg prednisone daily) for either five days (conventional arm) or three days
(interventional arm) followed by two days of placebo for the interventional group.
Pre-randomized, identically looking, numbered blisters are given to all patients included in
the study. Antibiotic treatment (Amoxicillin/Clavulanic acid, 625mg 3/d, for ten days) is
given to all patients with a CRP ≥50mg/l, COPD and known diagnosis of bronchiectasis, as well
as patients presenting with all three of the following symptoms: change of baseline dyspnea,
change of sputum quantity and sputum purulence. Further initial treatment and steroid
treatment after inclusion is determined and documented by the GP. Patients will undergo
follow-up visits at day three and seven by their GP as well as follow-up phone calls executed
by the study center at day 30, 90 and 180.
Phase:
N/A
Details
Lead Sponsor:
Prof. Dr. Jörg Leuppi
Collaborators:
Institut für Hausarztmedizin Basel Kantonsspital Baselland Bruderholz