Short versus conventional term glucocorticoid therapy in acute exacerbations of chronic obstructive pulmonary disease: the REDUCE trial

ISRCTN	ISRCTN19646069
DOI	https://doi.org/10.1186/ISRCTN19646069
Protocol serial number	N/A
Sponsor	University Hospital Basel, Department of Internal Medicine (Switzerland)
Funder	In-house grant from the Department of Medicine, University Hospital Basel, Switzerland

Submission date: 21/02/2006
Registration date: 08/03/2006
Last edited: 23/05/2013

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Jonas Rutishauser
Scientific

University Hospital Basel
Department of Internal Medicine
Petersgraben 4
Basel
4031
Switzerland

Phone	+41 (0)61 265 4665
Email	j.rutishauser@unibas.ch

Study information

Primary study design	Interventional
Study design	Prospective, randomized, double-blind, placebo-controlled, non-inferiority trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	REDUCE
Study objectives	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(s)	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.
Health condition(s) or problem(s) studied	Acute Exacerbation of Chronic Obstructive Pulmonary Disease (AECOPD)
Intervention	Comparison of 5-day to 14-day systemic glucocorticoid therapy
Intervention type	Other
Primary outcome measure(s)	Time to next COPD exacerbation
Key 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)
Completion date	27/02/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	390
Key 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
Key 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)
Date of first enrolment	27/02/2006
Date of final enrolment	27/02/2009

Locations

Countries of recruitment

Switzerland

Study participating centre

University Hospital Basel

Basel
4031
Switzerland

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	05/06/2013		Yes	No