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 |
| Secondary identifying numbers | N/A |
- 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
Not provided at time of registration
Contact information
Dr Jonas Rutishauser
Scientific
Scientific
University Hospital Basel
Department of Internal Medicine
Petersgraben 4
Basel
4031
Switzerland
| Phone | +41 (0)61 265 4665 |
|---|---|
| j.rutishauser@unibas.ch |
Study information
| Study design | Prospective, randomized, double-blind, placebo-controlled, non-inferiority trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study 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(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. |
| Condition | 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 | 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 study start date | 27/02/2006 |
| Overall study end date | 27/02/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 390 |
| 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 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
Study participating centre
University Hospital Basel
Basel
4031
Switzerland
4031
Switzerland
Sponsor information
University Hospital Basel, Department of Internal Medicine (Switzerland)
University/education
University/education
c/o Prof. J. Schifferli (Head)
Petersgraben 4
Basel
4031 Basel
Switzerland
| Website | http://www.kantonsspital-basel.ch/ |
|---|---|
"ROR" |
https://ror.org/04k51q396 |
Funders
Funder type
University/education
In-house grant from the Department of Medicine, University Hospital Basel, Switzerland
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
