Effectiveness of low-dose theophylline for the management of biomass-associated COPD (LODOT-BCOPD): study protocol for a randomized controlled trial.
Biomass
COPD
Theophylline
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
16 Mar 2021
16 Mar 2021
Historique:
received:
02
09
2020
accepted:
28
02
2021
entrez:
17
3
2021
pubmed:
18
3
2021
medline:
22
6
2021
Statut:
epublish
Résumé
COPD is a leading cause of death globally, with the majority of morbidity and mortality occurring in low- and middle-income country (LMIC) settings. While tobacco-smoke exposure is the most important risk factor for COPD in high-income settings, household air pollution from biomass smoke combustion is a leading risk factor for COPD in LMICs. Despite the high burden of biomass smoke-related COPD, few studies have evaluated the efficacy of pharmacotherapy in this context. Currently recommended inhaler-based therapy for COPD is neither available nor affordable in most resource-limited settings. Low-dose theophylline is an oral, once-a-day therapy, long used in high-income countries (HICs), which has been proposed for the management of COPD in LMICs in the absence of inhaled steroids and/or bronchodilators. The Low-dose Theophylline for the Management of Biomass-Associated COPD (LODOT-BCOPD) trial investigates the clinical efficacy and cost-effectiveness of low-dose theophylline for the management of biomass-related COPD in a low-income setting. LODOT-BCOPD is a randomized, double-blind, placebo-controlled trial to test the efficacy of low-dose theophylline in improving respiratory symptoms in 110 participants with moderate to severe COPD in Central Uganda. The inclusion criteria are as follows: (1) age 40 to 80 years, (2) full-time resident of the study area, (3) daily biomass exposure, (4) post-bronchodilator FEV ClinicalTrials.gov NCT03984188 . Registered on June 12, 2019 TRIAL ACRONYM: Low-dose Theophylline for the Management of Biomass-Associated COPD (LODOT-BCOPD).
Sections du résumé
BACKGROUND
BACKGROUND
COPD is a leading cause of death globally, with the majority of morbidity and mortality occurring in low- and middle-income country (LMIC) settings. While tobacco-smoke exposure is the most important risk factor for COPD in high-income settings, household air pollution from biomass smoke combustion is a leading risk factor for COPD in LMICs. Despite the high burden of biomass smoke-related COPD, few studies have evaluated the efficacy of pharmacotherapy in this context. Currently recommended inhaler-based therapy for COPD is neither available nor affordable in most resource-limited settings. Low-dose theophylline is an oral, once-a-day therapy, long used in high-income countries (HICs), which has been proposed for the management of COPD in LMICs in the absence of inhaled steroids and/or bronchodilators. The Low-dose Theophylline for the Management of Biomass-Associated COPD (LODOT-BCOPD) trial investigates the clinical efficacy and cost-effectiveness of low-dose theophylline for the management of biomass-related COPD in a low-income setting.
METHODS
METHODS
LODOT-BCOPD is a randomized, double-blind, placebo-controlled trial to test the efficacy of low-dose theophylline in improving respiratory symptoms in 110 participants with moderate to severe COPD in Central Uganda. The inclusion criteria are as follows: (1) age 40 to 80 years, (2) full-time resident of the study area, (3) daily biomass exposure, (4) post-bronchodilator FEV
TRIAL REGISTRATION
BACKGROUND
ClinicalTrials.gov NCT03984188 . Registered on June 12, 2019 TRIAL ACRONYM: Low-dose Theophylline for the Management of Biomass-Associated COPD (LODOT-BCOPD).
Identifiants
pubmed: 33726828
doi: 10.1186/s13063-021-05163-2
pii: 10.1186/s13063-021-05163-2
pmc: PMC7962083
doi:
Substances chimiques
Bronchodilator Agents
0
Theophylline
C137DTR5RG
Banques de données
ClinicalTrials.gov
['NCT03984188']
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
213Subventions
Organisme : NHLBI NIH HHS
ID : K23 HL146946
Pays : United States
Organisme : NHLBI NIH HHS
ID : K23HL146946
Pays : United States
Références
Chronic Obstr Pulm Dis. 2019 Jan 4;6(1):17-28
pubmed: 30775421
Chronic Obstr Pulm Dis. 2015 Sep 2;2(4):281-289
pubmed: 28848850
Trials. 2015 Jun 10;16:267
pubmed: 26058585
Thorax. 2009 May;64(5):424-9
pubmed: 19158122
BMJ Open Respir Res. 2018 Jul 11;5(1):e000276
pubmed: 30018764
Thorax. 2015 Sep;70(9):822-9
pubmed: 26048404
Environ Health Perspect. 2013 Jul;121(7):784-90
pubmed: 23674502
Am Rev Respir Dis. 1992 Jun;145(6):1321-7
pubmed: 1595997
Proc Natl Acad Sci U S A. 2014 Sep 9;111(36):13229-34
pubmed: 25157159
Chest. 2010 Jan;137(1):138-45
pubmed: 19741060
Lancet Respir Med. 2015 Feb;3(2):159-170
pubmed: 25680912
Value Health. 2009 Jan-Feb;12(1):118-23
pubmed: 19911444
Am J Respir Crit Care Med. 2020 Jul 15;202(2):171-172
pubmed: 32396738
Chest. 2011 Apr;139(4):752-763
pubmed: 20884729
Lancet. 2007 Sep 1;370(9589):741-50
pubmed: 17765523
Chest. 2010 Jun;137(6):1338-44
pubmed: 20299628
Nutr Clin Pract. 2006 Jun;21(3):312-9
pubmed: 16772549
Respirology. 2006 Sep;11(5):603-10
pubmed: 16916334
Stat Methods Med Res. 1995 Sep;4(3):187-96
pubmed: 8548102
BMJ. 2012 Mar 02;344:e608
pubmed: 22389338
J R Stat Soc Ser A Stat Soc. 2015 Feb;178(2):425-443
pubmed: 27695203
Am J Respir Crit Care Med. 2018 Mar 1;197(5):611-620
pubmed: 29323928
Clin Ther. 1999 Jun;21(6):1074-90; discussion 1073
pubmed: 10440628
Chronic Obstr Pulm Dis. 2014 May 6;1(1):23-32
pubmed: 28848808
Respirology. 2017 Apr;22(3):575-601
pubmed: 28150362
Trials. 2018 Oct 19;19(1):571
pubmed: 30340648
Qual Life Res. 2013 Sep;22(7):1717-27
pubmed: 23184421
Respir Res. 2015 Mar 18;16:40
pubmed: 25889777
Thorax. 2013 Jul;68(7):670-6
pubmed: 22744884
COPD. 2012 Aug;9(4):359-66
pubmed: 22489912
Stat Med. 2014 Dec 10;33(28):4919-33
pubmed: 25164949
Am J Respir Crit Care Med. 2013 Oct 15;188(8):901-6
pubmed: 23672674
Health Policy. 1996 Jul;37(1):53-72
pubmed: 10158943
Proc Am Thorac Soc. 2005;2(4):334-9; discussion 340-1
pubmed: 16267358
Eur Respir J. 2004 Jun;23(6):932-46
pubmed: 15219010
Eur Respir J. 2005 Aug;26(2):319-38
pubmed: 16055882
Am J Respir Crit Care Med. 2017 Mar 1;195(5):557-582
pubmed: 28128970
Eur Respir J. 2012 Dec;40(6):1324-43
pubmed: 22743675
J Clin Epidemiol. 2013 Feb;66(2):197-201
pubmed: 23195919
Eur Respir J. 2009 Sep;34(3):648-54
pubmed: 19720809
Chronic Obstr Pulm Dis. 2015;2(1):23-34
pubmed: 25685850