Reduction of corticosteroid use in outpatient treatment of exacerbated COPD - Study protocol for a randomized, double-blind, non-inferiority study, (The RECUT-trial)
Abstract Background Chronic obstructive pulmonary disease (COPD) is a major public health issue affecting approximately 4% to 7% of the Swiss population. According to current inpatient guidelines, systemic corticosteroids are important in the treatment of acute COPD exacerbations and should be given...
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| Format: | Article |
| Language: | English |
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BMC
2019-12-01
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| Series: | Trials |
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| Online Access: | https://doi.org/10.1186/s13063-019-3856-8 |
| _version_ | 1819077048651481088 |
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| author | Pascal Urwyler Maria Boesing Kristin Abig Marco Cattaneo Thomas Dieterle Andreas Zeller Herbert Bachler Stefan Markun Oliver Senn Christoph Merlo Stefan Essig Elke Ullmer Jonas Rutishauser Macé M Schuurmans Joerg Daniel Leuppi |
| author_facet | Pascal Urwyler Maria Boesing Kristin Abig Marco Cattaneo Thomas Dieterle Andreas Zeller Herbert Bachler Stefan Markun Oliver Senn Christoph Merlo Stefan Essig Elke Ullmer Jonas Rutishauser Macé M Schuurmans Joerg Daniel Leuppi |
| author_sort | Pascal Urwyler |
| collection | DOAJ |
| description | Abstract Background Chronic obstructive pulmonary disease (COPD) is a major public health issue affecting approximately 4% to 7% of the Swiss population. According to current inpatient guidelines, systemic corticosteroids are important in the treatment of acute COPD exacerbations and should be given for 5 to 7 days. Several studies suggest that corticosteroids accelerate the recovery of FEV1 (forced expiratory volume in 1 second), enhance oxygenation, decrease the duration of hospitalization, and improve clinical outcomes. However, the additional therapeutic benefit regarding FEV1 recovery appears to be most apparent in the first 3 to 5 days. No data are available on the optimum duration of corticosteroid treatment in primary-care patients with acute COPD exacerbations. Given that many COPD patients are treated as outpatients, there is an urgent need to improve the evidence base on COPD management in this setting. The aim of this study is to investigate whether a 3-day treatment with orally administered corticosteroids is non-inferior to a 5-day treatment in acute exacerbations of COPD in a primary-care setting. Methods/design This study is a prospective double-blind randomized controlled trial conducted in a primary-care setting. It is anticipated that 470 patients with acutely exacerbated COPD will be recruited. Participants are randomized to receive systemic corticosteroid treatment of 40 mg prednisone daily for 5 days (conventional arm, n = 235) or for 3 days followed by 2 days of placebo (experimental arm, n = 235). Antibiotic treatment for 7 days is given to all patients with CRP ≥ 50 mg/l, those with a known diagnosis of bronchiectasis, or those presenting with Anthonisen type I exacerbation. Additional treatment after inclusion is left at the discretion of the treating general practitioner. Follow-up visits are performed on days 3 and 7, followed by telephone interviews on days 30, 90, and 180 after inclusion in the study. The primary endpoint is the time to next exacerbation during the 6-month follow-up period. Discussion The study is designed to assess whether a 3-day course of corticosteroid treatment is not inferior to the conventional 5-day treatment course in outpatients with exacerbated COPD regarding time to next exacerbation. Depending on the results, this trial may lead to a reduction in the cumulative corticosteroid dose in COPD patients. Trial registration ClinicalTrials.gov, NCT02386735. Registered on 12 March 2015. |
| first_indexed | 2024-12-21T18:51:00Z |
| format | Article |
| id | doaj.art-12655cd23da94f5bbe996953bb518c52 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-21T18:51:00Z |
| publishDate | 2019-12-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-12655cd23da94f5bbe996953bb518c522022-12-21T18:53:45ZengBMCTrials1745-62152019-12-012011710.1186/s13063-019-3856-8Reduction of corticosteroid use in outpatient treatment of exacerbated COPD - Study protocol for a randomized, double-blind, non-inferiority study, (The RECUT-trial)Pascal Urwyler0Maria Boesing1Kristin Abig2Marco Cattaneo3Thomas Dieterle4Andreas Zeller5Herbert Bachler6Stefan Markun7Oliver Senn8Christoph Merlo9Stefan Essig10Elke Ullmer11Jonas Rutishauser12Macé M Schuurmans13Joerg Daniel Leuppi14University Department of Medicine, Cantonal Hospital BasellandUniversity Department of Medicine, Cantonal Hospital BasellandUniversity Department of Medicine, Cantonal Hospital BasellandDepartment of Clinical Research, University of BaselUniversity Department of Medicine, Cantonal Hospital BasellandFaculty of Medicine, University of BaselTyrolean Society of General MedicineInstitute of Primary Care, University and University Hospital of ZurichInstitute of Primary Care, University and University Hospital of ZurichInstitute of Primary and Community CareInstitute of Primary and Community CareCentre for Lung Diseases BernFaculty of Medicine, University of BaselDepartment of Medicine, Cantonal Hospital WinterthurUniversity Department of Medicine, Cantonal Hospital BasellandAbstract Background Chronic obstructive pulmonary disease (COPD) is a major public health issue affecting approximately 4% to 7% of the Swiss population. According to current inpatient guidelines, systemic corticosteroids are important in the treatment of acute COPD exacerbations and should be given for 5 to 7 days. Several studies suggest that corticosteroids accelerate the recovery of FEV1 (forced expiratory volume in 1 second), enhance oxygenation, decrease the duration of hospitalization, and improve clinical outcomes. However, the additional therapeutic benefit regarding FEV1 recovery appears to be most apparent in the first 3 to 5 days. No data are available on the optimum duration of corticosteroid treatment in primary-care patients with acute COPD exacerbations. Given that many COPD patients are treated as outpatients, there is an urgent need to improve the evidence base on COPD management in this setting. The aim of this study is to investigate whether a 3-day treatment with orally administered corticosteroids is non-inferior to a 5-day treatment in acute exacerbations of COPD in a primary-care setting. Methods/design This study is a prospective double-blind randomized controlled trial conducted in a primary-care setting. It is anticipated that 470 patients with acutely exacerbated COPD will be recruited. Participants are randomized to receive systemic corticosteroid treatment of 40 mg prednisone daily for 5 days (conventional arm, n = 235) or for 3 days followed by 2 days of placebo (experimental arm, n = 235). Antibiotic treatment for 7 days is given to all patients with CRP ≥ 50 mg/l, those with a known diagnosis of bronchiectasis, or those presenting with Anthonisen type I exacerbation. Additional treatment after inclusion is left at the discretion of the treating general practitioner. Follow-up visits are performed on days 3 and 7, followed by telephone interviews on days 30, 90, and 180 after inclusion in the study. The primary endpoint is the time to next exacerbation during the 6-month follow-up period. Discussion The study is designed to assess whether a 3-day course of corticosteroid treatment is not inferior to the conventional 5-day treatment course in outpatients with exacerbated COPD regarding time to next exacerbation. Depending on the results, this trial may lead to a reduction in the cumulative corticosteroid dose in COPD patients. Trial registration ClinicalTrials.gov, NCT02386735. Registered on 12 March 2015.https://doi.org/10.1186/s13063-019-3856-8COPDAECOPDExacerbationPrimary careCorticosteroids |
| spellingShingle | Pascal Urwyler Maria Boesing Kristin Abig Marco Cattaneo Thomas Dieterle Andreas Zeller Herbert Bachler Stefan Markun Oliver Senn Christoph Merlo Stefan Essig Elke Ullmer Jonas Rutishauser Macé M Schuurmans Joerg Daniel Leuppi Reduction of corticosteroid use in outpatient treatment of exacerbated COPD - Study protocol for a randomized, double-blind, non-inferiority study, (The RECUT-trial) Trials COPD AECOPD Exacerbation Primary care Corticosteroids |
| title | Reduction of corticosteroid use in outpatient treatment of exacerbated COPD - Study protocol for a randomized, double-blind, non-inferiority study, (The RECUT-trial) |
| title_full | Reduction of corticosteroid use in outpatient treatment of exacerbated COPD - Study protocol for a randomized, double-blind, non-inferiority study, (The RECUT-trial) |
| title_fullStr | Reduction of corticosteroid use in outpatient treatment of exacerbated COPD - Study protocol for a randomized, double-blind, non-inferiority study, (The RECUT-trial) |
| title_full_unstemmed | Reduction of corticosteroid use in outpatient treatment of exacerbated COPD - Study protocol for a randomized, double-blind, non-inferiority study, (The RECUT-trial) |
| title_short | Reduction of corticosteroid use in outpatient treatment of exacerbated COPD - Study protocol for a randomized, double-blind, non-inferiority study, (The RECUT-trial) |
| title_sort | reduction of corticosteroid use in outpatient treatment of exacerbated copd study protocol for a randomized double blind non inferiority study the recut trial |
| topic | COPD AECOPD Exacerbation Primary care Corticosteroids |
| url | https://doi.org/10.1186/s13063-019-3856-8 |
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