Condition category
Respiratory
Date applied
21/02/2006
Date assigned
08/03/2006
Last edited
23/05/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jonas Rutishauser

ORCID ID

Contact details

University Hospital Basel
Department of Internal Medicine
Petersgraben 4
Basel
4031
Switzerland
+41 (0)61 265 4665
j.rutishauser@unibas.ch

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

REDUCE

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

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

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Acute Exacerbation of Chronic Obstructive Pulmonary Disease (AECOPD)

Intervention

Comparison of 5-day to 14-day systemic glucocorticoid
therapy

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Time to next COPD exacerbation

Secondary outcome measures

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)

Overall trial start date

27/02/2006

Overall trial end date

27/02/2009

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

390

Participant 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)

Recruitment start date

27/02/2006

Recruitment end date

27/02/2009

Locations

Countries of recruitment

Switzerland

Trial participating centre

University Hospital Basel
Basel
4031
Switzerland

Sponsor information

Organisation

University Hospital Basel, Department of Internal Medicine (Switzerland)

Sponsor details

c/o Prof. J. Schifferli (Head)
Petersgraben 4
Basel
4031 Basel
Switzerland

Sponsor type

University/education

Website

http://www.kantonsspital-basel.ch/

Funders

Funder type

University/education

Funder name

In-house grant from the Department of Medicine, University Hospital Basel, Switzerland

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23695200

Publication citations

  1. Results

    Leuppi JD, Schuetz P, Bingisser R, Bodmer M, Briel M, Drescher T, Duerring U, Henzen C, Leibbrandt Y, Maier S, Miedinger D, Müller B, Scherr A, Schindler C, Stoeckli R, Viatte S, von Garnier C, Tamm M, Rutishauser J, Short-term vs conventional glucocorticoid therapy in acute exacerbations of chronic obstructive pulmonary disease: the REDUCE randomized clinical trial., JAMA, 2013, 309, 21, 2223-2231, doi: 10.1001/jama.2013.5023.

Additional files

Editorial Notes