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临床试验/NCT03984188
NCT03984188已完成3 期

Effectiveness of Low-Dose Theophylline for the Management of Biomass-Associated COPD

University of Miami2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年2月23日最近更新:
适应症
干预措施

试验速览

阶段
3 期
状态
已完成
入组人数
100
试验地点
2
主要终点
Change in St. George Respiratory Questionnaire (SGRQ) Scores

研究概览

简要总结

Chronic obstructive pulmonary disease (COPD) is the fourth leading cause of death worldwide, and over 90% of COPD-related deaths occurring in low- and middle-income countries (LMICs). Household air pollution (HAP) - from burning solid fuels such as wood, dung, agricultural crop waste, and coal for energy - is the primary risk factor for COPD in these settings. Biomass-related COPD has a distinct histopathology, phenotype and inflammatory profile when compared to tobacco mediated COPD. Despite the high global burden of biomass-related disease, little is known about the effectiveness of pharmacotherapies for biomass-related COPD; to date, no clinical trials have focused specifically on treatment of biomass-related COPD. This study proposes to assess the health impact of biomass-related COPD and test the effectiveness of low dose theophylline compared to standard therapy among adults with biomass-related COPD in Uganda with the aim to assess whether low-dose theophylline improves respiratory symptoms, decreases the inflammatory profile of serum biomarkers and whether administration attenuates the effect of HAP on lung function. The study additionally aims to assess whether low-dose theophylline is a cost-effective intervention based on the incremental cost-effectiveness ratio and a range of willingness to pay thresholds.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 40 years
  • Full-time resident of study area
  • Post-bronchodilator FEV1/FVC < the lower limit of normal of the Global Lung Initiative Mixed Ethnic reference population
  • Grade B-D COPD
  • Daily biomass exposure

排除标准

  • Plans to move within one year
  • Uncontrolled hypertension
  • Pregnancy (assessed by urine pregnancy test among women of childbearing age/menstrual history)
  • Current use of chronic respiratory medications (Long acting Beta 2 Antagonists (LABA), Long-acting muscarinic antagonist (LAMA), inhaled corticosteroid (ICS))
  • History of post-treatment pulmonary tuberculosis
  • ≥10 pack year tobacco smoking history
  • Known intolerance or contraindication to theophylline.

研究组 & 干预措施

Low-dose Theophylline Group

Experimental

Participant in this group will receive low-dose theophylline in addition to standard care, per World Health Organization (WHO) guidelines for management of Chronic Obstructive Pulmonary Disease (COPD) treatment, over a one year period.

干预措施: Theophylline ER (Drug)

Low-dose Theophylline Group

Experimental

Participant in this group will receive low-dose theophylline in addition to standard care, per World Health Organization (WHO) guidelines for management of Chronic Obstructive Pulmonary Disease (COPD) treatment, over a one year period.

干预措施: Standard of Care Treatment (Other)

Placebo Group

Placebo Comparator

Participant in this group will receive a placebo in addition to standard care, per World Health Organization (WHO) guidelines for management of Chronic Obstructive Pulmonary Disease (COPD) treatment.

干预措施: Placebo oral tablet (Drug)

Placebo Group

Placebo Comparator

Participant in this group will receive a placebo in addition to standard care, per World Health Organization (WHO) guidelines for management of Chronic Obstructive Pulmonary Disease (COPD) treatment.

干预措施: Standard of Care Treatment (Other)

结局指标

主要结局

Change in St. George Respiratory Questionnaire (SGRQ) Scores

时间窗: Baseline, 1 year

The SGRQ comprises of 50 items and consists of two parts. The first part pertains to symptoms and the second pertains to functional status as well as social and psychological impact of disease. Overall scores ranges between 0 and 100 with higher scores indicating more limitations.

次要结局

  • Change in Forced Expiratory Volume in One Second (FEV1)(Baseline, 6 months)
  • Change in Forced Vital Capacity (FVC)(Baseline, 6 months)
  • Change in St. George Respiratory Questionnaire (SGRQ) Scores(Baseline, 6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Trishul Siddharthan

Assistant Professor of Clinical

University of Miami

研究点 (2)

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