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Short versus conventional term glucocorticoid therapy in acute exacerbations of chronic obstructive pulmonary disease: the REDUCE trial
ISRCTN ISRCTN19646069
DOI 10.1186/ISRCTN19646069
ClinicalTrials.gov identifier
EudraCT number
Public title Short versus conventional term glucocorticoid therapy in acute exacerbations of chronic obstructive pulmonary disease: the REDUCE trial
Scientific title
Acronym REDUCE
Serial number at source N/A
Study hypothesis Our hypothesis is that in exacerbated Chronic Obstructive Pulmonary Disease (COPD), a 5-day glucocorticoid treatment course will result in the same clinical outcome as a standard 14-day regimen
Lay summary Not provided at time of registration
Ethics approval This trial was approved by the Ethics Committee of Basel (EKBB), reference number 167/0, the amendment dates from 16/01/2006. This trial was also approved by the Swiss Federal Authority (Swiss Agency for Therapeutic Products [SWISSMEDIC]) on 23/01/2006, protocol reference number: 2006DR4021.
Study design Prospective, randomized, double-blind, placebo-controlled, non-inferiority trial
Countries of recruitment Switzerland
Disease/condition/study domain Acute Exacerbation of Chronic Obstructive Pulmonary Disease (AECOPD)
Participants - inclusion criteria 1. Clinical diagnosis of exacerbated COPD, defined by the presence of at least two of the following:
a. Change in baseline dyspnoea
b. Cough
c. Sputum (levels I III according to American Thoracic Society [ATS] or European Respiratory Society [ERS] criteria)
2. Age ≥40 years
3. History of ≥20 pack-years of cigarette smoking
Participants - exclusion criteria 1. Inability to give informed consent
2. Diagnosis of asthma
3. Forced expiratory volume in one second (FEV1) or Forced Vital Capacities (FVC) (Tiffenau) >70% (bedside post-bronchodilator)
4. Radiological diagnosis of pneumonia
5. Coexisting disease making survival of >6 months unlikely
6. Pregnancy or lactation (pregnancy test mandatory for pre-menopausal women)
Anticipated start date 27/02/2006
Anticipated end date 27/02/2009
Status of trial Completed
Patient information material
Target number of participants 390
Interventions Comparison of 5-day to 14-day systemic glucocorticoid
therapy
Primary outcome measure(s) Time to next COPD exacerbation
Secondary outcome measure(s) 1. Cumulative steroid dose
2. Time to open-label standard-dose glucocorticoid therapy during the index exacerbation
3. Need for invasive or non-invasive mechanical ventilation
4. Change in FEV1
5. Clinical outcome at discharge and during follow-up as assessed by a standardized worksheet and questionnaire. Dyspnoea will be assessed according to the ATS consensus statement.
6. Duration of hospital stay
7. Death from any cause
8. Steroid-associated side-effects and complications:
a. Development or exacerbation of hyperglycemia (defined as fasting plasma glucose ≥5.6mmol/l or random plasma glucose ≥7.8 mmol/l or rise by ≥20% in daily doses of insulin or oral anti-diabetic drugs or initiation of one or more anti-diabetic therapeutic principle) respectively
b. Development or worsening of hypertension (defined as blood pressure ≥140 mmHg systolic and/or ≥90 mmHg diastolic; or the addition of one or more antihypertensive drugs to previous treatment regimens
c. Suppression of the adrenal function at study entry and during follow-up as assessed with the low dose (1 ug) adrenocorticotropic hormone (ACTH) stimulation test
d. Secondary infections
e. Effects on bone turnover, assessed by specific biochemical markers (endpoint updated in April 2006)
f. Other potential steroid-related adverse events (e.g. gastrointestinal bleeding or psychiatric disease)
Sources of funding In-house grant from the Department of Medicine, University Hospital Basel, Switzerland
Trial website
Publications 1. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23695200
Contact name Dr  Jonas  Rutishauser
  Address University Hospital Basel

Department of Internal Medicine

Petersgraben 4
  City/town Basel
  Zip/Postcode 4031
  Country Switzerland
  Tel +41 (0)61 265 4665
  Fax +41 (0)61 265 5390
  Email j.rutishauser@unibas.ch
Sponsor University Hospital Basel, Department of Internal Medicine (Switzerland)
  Address c/o Prof. J. Schifferli (Head)

Petersgraben 4
  City/town Basel
  Zip/Postcode 4031 Basel
  Country Switzerland
  Sponsor website: http://www.kantonsspital-basel.ch/
Date applied 21/02/2006
Last edited 23/05/2013
Date ISRCTN assigned 08/03/2006
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