Reduction of corticosteroid use in outpatient treatment of exacerbated COPD - Study protocol for a randomized, double-blind, non-inferiority study, (The RECUT-trial).
Administration, Oral
Adrenal Cortex Hormones
/ administration & dosage
Ambulatory Care
Disease Progression
Double-Blind Method
Drug Administration Schedule
Equivalence Trials as Topic
Female
Forced Expiratory Volume
Humans
Lung
/ drug effects
Male
Prednisone
/ administration & dosage
Prospective Studies
Pulmonary Disease, Chronic Obstructive
/ diagnosis
Switzerland
Time Factors
Treatment Outcome
AECOPD
COPD
Corticosteroids
Exacerbation
Primary care
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
16 Dec 2019
16 Dec 2019
Historique:
received:
13
08
2019
accepted:
25
10
2019
entrez:
18
12
2019
pubmed:
18
12
2019
medline:
1
9
2020
Statut:
epublish
Résumé
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. 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. 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. ClinicalTrials.gov, NCT02386735. Registered on 12 March 2015.
Sections du résumé
BACKGROUND
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
METHODS
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
CONCLUSIONS
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
BACKGROUND
ClinicalTrials.gov, NCT02386735. Registered on 12 March 2015.
Identifiants
pubmed: 31842993
doi: 10.1186/s13063-019-3856-8
pii: 10.1186/s13063-019-3856-8
pmc: PMC6916452
doi:
Substances chimiques
Adrenal Cortex Hormones
0
Prednisone
VB0R961HZT
Banques de données
ClinicalTrials.gov
['NCT02386735']
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
727Subventions
Organisme : Schweizerischer Nationalfonds zur Förderung der Wissenschaftlichen Forschung
ID : 32003B_160072
Organisme : Lungenliga Schweiz
ID : 2015-08
Références
Respiration. 2010;79(6):469-74
pubmed: 19786731
Lancet. 2007 Sep 1;370(9589):741-50
pubmed: 17765523
Am J Emerg Med. 1996 Mar;14(2):139-43
pubmed: 8924134
Am J Respir Crit Care Med. 2002 Sep 1;166(5):691-5
pubmed: 12204867
Biom J. 2007 Dec;49(6):903-16
pubmed: 17726715
Ann Intern Med. 1987 Feb;106(2):196-204
pubmed: 3492164
Eur Respir J. 2010 Dec;36(6):1259-69
pubmed: 20413537
Am J Respir Crit Care Med. 2007 Sep 15;176(6):532-55
pubmed: 17507545
N Engl J Med. 1999 Jun 24;340(25):1941-7
pubmed: 10379017
Chest. 1997 Mar;111(3):732-43
pubmed: 9118715
JAMA. 2013 Jun 5;309(21):2223-31
pubmed: 23695200
Respir Med. 1999 Mar;93(3):173-9
pubmed: 10464874
Stat Med. 2006 May 30;25(10):1628-38
pubmed: 16639773
Chest. 2000 May;117(5 Suppl 2):398S-401S
pubmed: 10843984
Swiss Med Wkly. 2012 Apr 05;142:w13567
pubmed: 22481636
Am J Respir Crit Care Med. 1994 Jul;150(1):11-6
pubmed: 8025735
Chest. 1989 Mar;95(3):563-7
pubmed: 2920584
Swiss Med Wkly. 2010 Apr 21;140:
pubmed: 20407960
N Engl J Med. 2003 Jun 26;348(26):2618-25
pubmed: 12826636
Lancet. 1999 Aug 7;354(9177):456-60
pubmed: 10465169
Swiss Med Wkly. 2010 Oct 18;140:w13109
pubmed: 21136333
Am J Respir Crit Care Med. 1996 Aug;154(2 Pt 1):407-12
pubmed: 8756814
Ann Intern Med. 1980 Jun;92(6):753-8
pubmed: 6770731