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. 2018 Mar 19;2018(3):CD006897. doi: 10.1002/14651858.CD006897.pub4

Leuppi 2017.

Trial name or title Reduction of Corticosteroid Use in Outpatient Treatment of Exacerbated COPD (RECUT)
Methods Prospective, randomized, double‐blind, placebo‐controlled, non‐inferiority trial in an out‐patient setting
Participants Inclusion Criteria:

  1. Informed Consent as documented by signature

  2. Age ≥40 years

  3. History of ≥10 pack‐years of smoking (past or present smokers)

  4. Airway obstruction, defined as FEV1/FVC≤70%

  5. Current acute exacerbation of COPD by clinical criteria, defined by the presence of at least two of the following: Change of baseline dyspneaChange of coughChange of sputum quantity or purulence


Exclusion Criteria:

  1. Diagnosis of asthma

  2. Initial necessity of hospitalisation

  3. Women who are pregnant or breast feeding

  4. Premenopausal women with insufficient contraception and anamnestic risk for pregnancy

  5. Severe coexisting disease with life expectancy <6 months

  6. Diagnosis of tuberculosis

  7. Known severe immunosuppression or immunosuppression after solid organ or stem cell transplantation

  8. Inability to follow study procedures, e.g. due to language problems, psychological disorders, dementia, etc. of the participant

  9. Participation in another study involving an investigational drug

  10. Previous enrolment into the current study
Interventions Intervention group 1: Three days prednisolone 40mg, two days placebo
Intervention group 2: Five days prednisolone 40mg
Outcomes Primary:

  1. Time to next exacerbation [ Time Frame: Six month follow‐up period after index exacerbation. ]


Secondary:

  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. ]
Starting date March 2015 (Recruiting)
Contact information Prof. Joerg Leuppi. +41 61 925 21 80 joerg.leuppi@ksbl.ch
Kantonsspital Baselland, Liestal, BL, Switzerland, 4410
Notes