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17 May 2012
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| [ Print-friendly version ] |
| Short versus conventional term glucocorticoid therapy in acute exacerbations of chronic obstructive pulmonary disease. The reduce trial. |
| ISRCTN | ISRCTN19646069 |
| ClinicalTrials.gov identifier | |
| 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 | |
| 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 | |
| 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 |
| 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 | 12/04/2006 |
| Date ISRCTN assigned | 08/03/2006 |
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| © 2012 ISRCTN unless otherwise stated. | |
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