Effectiveness of low-dose theophylline for the management of biomass-associated COPD (LODOT-BCOPD): study protocol for a randomized controlled trial.
Effectiveness of low-dose theophylline for the management of biomass-associated COPD (LODOT-BCOPD): study protocol for a randomized controlled trial.
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DOI：
10.1186/s13063-021-05163-2
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发表时间：
2021-03-16
期刊：
影响因子：
2.5
通讯作者：
Kirenga B
中科院分区：
文献类型：
--
作者：
Siddharthan T;Pollard SL;Jackson P;Robertson NM;Wosu AC;Rahman N;Padalkar R;Sekitoleko I;Namazzi E;Alupo P;Hurst JR;Kalyesubula R;Dowdy D;Wise R;Barnes PJ;Checkley W;Kirenga B
慢性阻塞性肺病是全球主要的死亡原因，大多数发病率和死亡率发生在低收入和中等收入国家。虽然烟草烟雾暴露是高收入环境中COPD的最重要风险因素，但生物质烟雾燃烧造成的家庭空气污染是LMIC中COPD的主要风险因素。尽管生物质烟雾相关的COPD负担很高，但很少有研究在这一背景下评估药物治疗的有效性。目前推荐的基于吸入器的COPD治疗在大多数资源有限的情况下既得不到，也负担不起。低剂量茶碱是一种口服疗法，每天一次，在高收入国家(HICs)长期使用，已被提议用于在没有吸入类固醇和/或支气管扩张剂的LMICs中治疗COPD。低剂量茶碱治疗生物质相关COPD(LODOT-BCOPD)试验研究了低剂量茶碱在低收入环境下治疗生物质相关COPD的临床疗效和成本效益。LOOT-BCOPD是一项随机、双盲、安慰剂对照试验，旨在测试小剂量茶碱在改善乌干达中部110名中到重度COPD参与者的呼吸道症状方面的有效性。入选标准如下：(1)40至80 岁，(2)研究区域的全职居民，(3)每日生物量暴露，(4)服用支气管扩张剂后的第一秒用力肺活量/用力肺活量低于全球肺倡议混合种族参考人口的第5百分位数，(5)金级B-D慢性阻塞性肺病。参与者将被随机分配，每天接受一次低剂量茶碱(200mgER，Uncontin-E)或安慰剂，为期52 周。所有参与者都将接受有关慢性阻塞性肺疾病自我管理和抢救沙丁胺醇吸入器的教育。我们将在基线和每6个月使用圣乔治呼吸问卷(SGRQ)和EuroQol-5D(EQ-5D)来衡量健康状况和生活质量。此外，我们将在基线、1个月和6个 月评估家庭空气污染水平、血清炎症生物标志物(纤维蛋白原，hs-CRP)和茶碱水平。主要结果是在12个 月时SGRQ评分的变化。最后，我们将通过计算EQ-5D的质量调整寿命年(QALY)来评估干预措施的成本效益。ClinicalTrials.gov：NCT03984188。2019年6月12日注册的治疗生物质相关COPD的小剂量茶碱(LODOT-BCOPD)
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 FEV1/FVC below the 5th percentile of the Global Lung Initiative mixed ethnic reference population, and (5) GOLD Grade B-D COPD. Participants will be randomly assigned to receive once daily low-dose theophylline (200 mg ER, Unicontin-E) or placebo for 52 weeks. All participants will receive education about self-management of COPD and rescue salbutamol inhalers. We will measure health status using the St. George’s Respiratory Questionnaire (SGRQ) and quality of life using the EuroQol-5D (EQ-5D) at baseline and every 6 months. In addition, we will assess household air pollution levels, serum inflammatory biomarkers (fibrinogen, hs-CRP), and theophylline levels at baseline, 1 month, and 6 months. The primary outcome is change in SGRQ score at 12 months. Lastly, we will assess the cost-effectiveness of the intervention by calculating quality-adjusted life years (QALYs) from the EQ-5D. ClinicalTrials.gov NCT03984188. Registered on June 12, 2019 Low-dose Theophylline for the Management of Biomass-Associated COPD (LODOT-BCOPD)
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影响因子：
2.5
作者：
Devereux G;Cotton S;Barnes P;Briggs A;Burns G;Chaudhuri R;Chrystyn H;Davies L;De Soyza A;Fielding S;Gompertz S;Haughney J;Lee AJ;McCormack K;McPherson G;Morice A;Norrie J;Sullivan A;Wilson A;Price D
通讯作者：
Price D
影响因子：
10.4
作者：
Bonjour S;Adair-Rohani H;Wolf J;Bruce NG;Mehta S;Prüss-Ustün A;Lahiff M;Rehfuess EA;Mishra V;Smith KR
通讯作者：
Smith KR
影响因子：
9.6
作者：
Hankinson, John L.;Kawut, Steven M.;Barr, R. Graham
通讯作者：
Barr, R. Graham
DOI：
10.1513/pats.200504-024sr
发表时间：
2005-01-01
期刊：
Proceedings of the American Thoracic Society
影响因子：
--
作者：
Barnes, Peter J
通讯作者：
Barnes, Peter J
影响因子：
3.3
作者：
Brooks, R
通讯作者：
Brooks, R