African Severe Asthma Program
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,676
- 试验地点
- 4
- 主要终点
- Number of patients with Severe Asthma.
研究概览
简要总结
This study is a prospective observational multicentre cohort study of asthma patients in Eastern Africa whose objectives will be; The primary objective of this project is to identify and characterize severe asthma in Eastern Africa in order to understand its demographic, clinical, physiologic, pathologic, genomic and immunologic determinants.
Secondary objective(s) are; Compare the annual healthcare utilisation (HCU) (emergency room visits, hospitalization including admission to critical care units and unscheduled outpatient clinic or office visits), exacerbation, quality of life and mortality rates of severe and not- severe asthma patients Determine the factors associated with the asthma HCU events, quality of life, exacerbations and mortality The study will enroll 1676 patients aged between 12 and 70 years and follow up each patient for up to one year.
详细描述
This study is a prospective observational multicentre cohort study of asthma patients in Eastern Africa. whose objectives will be; The primary objective of this project is to identify and characterize severe asthma in Eastern Africa in order to understand its demographic, clinical, physiologic, pathologic, genomic and immunologic determinants.
Secondary objective(s) are; Compare the annual healthcare utilisation (HCU) (emergency room visits, hospitalization including admission to critical care units and unscheduled outpatient clinic or office visits), exacerbation, quality of life and mortality rates of severe and not- severe asthma patients Determine the factors associated with the asthma HCU events, quality of life, exacerbations and mortality.
The study will enroll 1676 patients aged between 12 and 70 years and follow up each patient for up to one year.
Measurements; The following will be done
- Asthma Diagnosis. This will be done and will be an entry point to the study. It will be done to ensure patients enrolled onto the study fulfill a clinical diagnosis of Asthma.
- Cohort Characterisation. Through use of a predeveloped clinical review form, data on demographics, symptoms, exposures to pollutants, known asthma triggers, tobacco smoking, psychosocial issues, comorbidities, asthma control, adherence to medication and inhaler technique will be collected. Asthma quality of life will also be ascertained through use of a questionnaire.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All Asthma Patients presenting at study clinics who are between 12 and 70 years and older resident within 30km of the enrolling sites.
排除标准
- •Asthma patients with contra-indications to any of the study procedures and tests.
- •In addition the following patients will be excluded:
- •Patients with a primary diagnosis of an alternative lung disease (e.g.: COPD, or bronchiectasis, pulmonary fibrosis.),
- •Patients with another significant disease likely to confound assessment of asthma (e.g: active tuberculosis),
- •Patients unable to perform study tests and procedures,
- •Patients over 70 years of age, patients who have been exposed to experimental treatments within the past three months
- •Pregnant women.
结局指标
主要结局
Number of patients with Severe Asthma.
时间窗: 3 years
The primary end point in this study is severe asthma. We shall document the proportion of the enrolled patients that have severe asthma and perform a factor analysis to identify factors independently associated with severe asthma.
次要结局
- Health Care Utilisation rates(3 years)
- Mortality rates(3 years)
- Treatment Severe Asthma(3 years)
- Exacerbations(3 years)
研究者
Bruce J Kirenga
Dr Bruce J Kirenga
Makerere University