Distribution of blood eosinophils in patients with chronic obstructive pulmonary disease (COPD) living in areas of endemic helminth infections:a cross-sectional study in South East Asia (Helminth study)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 500
- 试验地点
- 4
- 主要终点
- Primary outcome will include circulating blood eosinophil count; for each patient two
研究概览
简要总结
The study will consist of a single clinic visit during which data will be collected by spirometry, blood, stool and urine tests, review of medical history, review of COPD exacerbation history, and review of concomitant or recent medications. Participants’ self-report will be used to complement medical records and to collect information on previous exposure to dust, fumes and biomass smoke.
This study aims to recruit a total of 500 participants with COPD from India. COPD symptoms must have started after 30 years of age. Areas with high prevalence of helminth infection will be selected with the assumption that approximately 20% to 30% of recruited patients will have helminth infections. Recruitment is estimated to take six months.
The study will be conducted at established healthcare sites with respiratory specialists who have access to bronchodilators and spirometers. Sites will also have a local laboratory capable of performing haematology testing and detection of helminth infection. Rural sites will be preferred due to the increased prevalence of helminth infections in these areas. Study investigators will invite patients from their practices to participate in the study. Patients who are diagnosed with a helminth infection during this study will be referred to a hospital or health care centre for treatment according toinstitutional practice.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 40.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male or female at least 40 years old 2.Capable of giving written informed consent 3.Have a prior diagnosis of COPD documented in the medical record
- •Have COPD diagnosis confirmed by post-bronchodilator spirometry test at enrolment
- •Have moderate-severe airflow limitation defined as a forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) less than 0.7 and FEV1 less than 80% predicted on post-bronchodilator spirometry at enrolment.
排除标准
- •Onset of COPD symptoms before 30 years of age
- •Experienced an acute exacerbation of COPD (defined as an acute worsening of symptoms that result in treatment with an antibiotic or oral steroid) within the four weeks prior to, or on the date of, enrolment
- •Have diagnosed asthma over the past 12 months or have experienced asthma symptoms with a clinical history suggestive of asthma in the past 12 months
- •Have cystic fibrosis, pulmonary fibrosis or bronchiectasis documented in the medical record
- •Have active tuberculosis or are taking medication for tuberculosis
- •Have had pulmonary resection surgery
- •Are pregnant (women of childbearing potential with positive urine pregnancy test will be excluded).
结局指标
主要结局
Primary outcome will include circulating blood eosinophil count; for each patient two
时间窗: 1 year
estimates will be derived: cells per μL, and as % total white blood cell count (WCC).
时间窗: 1 year
次要结局
- Primary outcome will include circulating blood eosinophil count; for each patient two(estimates will be derived: cells per μL, and as % total white blood cell count (WCC).)