Reduction of Corticosteroid Use in Outpatient Treatment of Exacerbated COPD (RECUT)

September 5, 2023 updated by: Prof. Dr. Jörg Leuppi

Reduction of Corticosteroid Use in Outpatient Treatment of Exacerbated COPD - a Randomized, Double-blind, Non-inferiority Study (The "RECUT"-Trial)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

470

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Switzerland
    • BL
      • Liestal, BL, Switzerland, 4410
        • Recruiting
        • Kantonsspital Baselland
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Informed Consent as documented by signature
  • Age ≥40 years
  • History of ≥10 pack-years of smoking (past or present smokers)
  • Airway obstruction, defined as FEV1/FVC≤70%

  • Current acute exacerbation of COPD by clinical criteria, defined by the presence of at least two of the following:

    • Change of baseline dyspnea
    • Change of cough
    • Change of sputum quantity or purulence

Exclusion Criteria:

  • Diagnosis of asthma
  • Initial necessity of hospitalization
  • Women who are pregnant or breast feeding
  • Premenopausal women with insufficient contraception and anamnestic risk for pregnancy
  • Severe coexisting disease with life expectancy <6 months
  • Diagnosis of tuberculosis
  • Known severe immunosuppression or immunosuppression after solid organ or stem cell transplantation
  • Inability to follow study procedures, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
  • Participation in another study involving an investigational drug
  • Previous enrolment into the current study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: 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.
Drug: Prednisone
Five days prednisone 40mg.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to next exacerbation
Time Frame: Six month follow-up period after index exacerbation.
Six month follow-up period after index exacerbation.

Secondary Outcome Measures

Outcome Measure
Time Frame
Cumulative glucocorticoid dose
Time Frame: Six month follow-up period after index exacerbation.
Six month follow-up period after index exacerbation.
Glucocorticoid side effects and complications
Time Frame: Six month follow-up period after index exacerbation.
Six month follow-up period after index exacerbation.
Change in FEV1
Time Frame: 7 days follow-up period after index exacerbation.
7 days follow-up period after index exacerbation.
Hospitalization rate during index exacerbation
Time Frame: Six month follow-up period after index exacerbation.
Six month follow-up period after index exacerbation.
Overall mortality
Time Frame: Six month follow-up period after index exacerbation.
Six month follow-up period after index exacerbation.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prof. Dr. Jörg Leuppi

Collaborators

Kantonsspital Baselland Bruderholz
Institut für Hausarztmedizin Basel

Investigators

  • Principal Investigator: Joerg D. Leuppi, Prof., Kantonsspital Basleland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

February 11, 2015

First Submitted That Met QC Criteria

March 11, 2015

First Posted (Estimated)

March 12, 2015

Study Record Updates

Last Update Posted (Actual)

September 6, 2023

Last Update Submitted That Met QC Criteria

September 5, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KSBL2015-017

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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