Reduction of Corticosteroid Use in Outpatient Treatment of Exacerbated COPD (RECUT)
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|ClinicalTrials.gov Identifier: NCT02386735|
Recruitment Status : Recruiting
First Posted : March 12, 2015
Last Update Posted : May 6, 2019
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.
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.
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.
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.
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Disease, Chronic Obstructive Adverse Effect of Glucocorticoids and Synthetic Analogues Disease Exacerbation||Drug: Placebo Drug: Prednisone||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||470 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Reduction of Corticosteroid Use in Outpatient Treatment of Exacerbated COPD - a Randomized, Double-blind, Non-inferiority Study (The "RECUT"-Trial)|
|Study Start Date :||March 2015|
|Estimated Primary Completion Date :||September 2020|
|Estimated Study Completion Date :||March 2021|
Experimental: Investigational treatment
Patients included in the placebo group are receiving systemic corticosteroid treatment (equivalent of 40mg prednisone daily) for three days followed by two days of placebo.
Three days prednisone 40mg, two days placebo
Active Comparator: Standard treatment
Patients included in the control group are receiving systemic corticosteroid treatment (equivalent of 40mg prednisone daily) for five days as recommended in current guidelines.
Five days prednisone 40mg.
- Time to next exacerbation [ Time Frame: Six month follow-up period after index exacerbation. ]
- Cumulative glucocorticoid dose [ Time Frame: Six month follow-up period after index exacerbation. ]
- Glucocorticoid side effects and complications [ Time Frame: Six month follow-up period after index exacerbation. ]
- Change in FEV1 [ Time Frame: 7 days follow-up period after index exacerbation. ]
- Hospitalization rate during index exacerbation [ Time Frame: Six month follow-up period after index exacerbation. ]
- Overall mortality [ Time Frame: Six month follow-up period after index exacerbation. ]
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): NCT02386735
|Contact: Joerg Leuppi, Prof. Dr. med.||+41 61 925 21 firstname.lastname@example.org|
|Liestal, BL, Switzerland, 4410|
|Contact: Joerg Leuppi, Prof. Dr. med. +41 61 925 21 80 email@example.com|