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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
Sponsor:
Collaborators:
Institut für Hausarztmedizin Basel
Kantonsspital Baselland Bruderholz
Information provided by (Responsible Party):
Prof. Dr. Jörg Leuppi, Cantonal Hosptal, Baselland

Brief 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.


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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 470 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Steroids
Drug Information available for: Prednisone

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.




Primary Outcome Measures :
  1. Time to next exacerbation [ Time Frame: Six month follow-up period after index exacerbation. ]

Secondary Outcome Measures :
  1. Cumulative glucocorticoid dose [ Time Frame: Six month follow-up period after index exacerbation. ]
  2. Glucocorticoid side effects and complications [ Time Frame: Six month follow-up period after index exacerbation. ]
  3. Change in FEV1 [ Time Frame: 7 days follow-up period after index exacerbation. ]
  4. Hospitalization rate during index exacerbation [ Time Frame: Six month follow-up period after index exacerbation. ]
  5. Overall mortality [ Time Frame: Six month follow-up period after index exacerbation. ]


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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Joerg Leuppi, Prof. Dr. med. +41 61 925 21 80 joerg.leuppi@ksbl.ch

Locations
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Switzerland
Kantonsspital Baselland Recruiting
Liestal, BL, Switzerland, 4410
Contact: Joerg Leuppi, Prof. Dr. med.    +41 61 925 21 80    joerg.leuppi@ksbl.ch   
Sponsors and Collaborators
Prof. Dr. Jörg Leuppi
Institut für Hausarztmedizin Basel
Kantonsspital Baselland Bruderholz

Additional Information:
Publications:

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Responsible Party: Prof. Dr. Jörg Leuppi, Prof. Dr. med., Cantonal Hosptal, Baselland
ClinicalTrials.gov Identifier: NCT02386735     History of Changes
Other Study ID Numbers: KSBL2015-017
First Posted: March 12, 2015    Key Record Dates
Last Update Posted: May 6, 2019
Last Verified: May 2019

Keywords provided by Prof. Dr. Jörg Leuppi, Cantonal Hosptal, Baselland:
Corticosteroid treatment
COPD
Primary Health Care
Randomized controlled trial

Additional relevant MeSH terms:
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Lung Diseases
Chronic Disease
Pulmonary Disease, Chronic Obstructive
Disease Progression
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Lung Diseases, Obstructive
Prednisone
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents