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临床试验/NCT02517983
NCT02517983已完成不适用

Phenotyping the Chronic Respiratory Diseases (CRD) in Ho Chi Minh City, Vietnam

Brugmann University Hospital1 个研究点 分布在 1 个国家目标入组 610 人开始时间: 2015年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
610
试验地点
1
主要终点
Relative prevalence of the different chronic respiratory diseases phenotype

研究概览

简要总结

World Health Organization (WHO) considers chronic respiratory disease (CRD) as one of its four priorities. These diseases include asthma and rhinitis, chronic obstructive pulmonary diseases (COPD), occupational lung diseases, sleep apnoea syndromes, pulmonary hypertension, bronchiectasis and interstitial lung diseases. They constitute a serious public health problem in all countries throughout the world, in particular in low and middle income countries and in deprived populations. Hundreds of millions of people of all ages, in all countries of the world, are affected by chronic respiratory diseases. More than 50% of them live in low and middle income countries. Over 90% of deaths and the complete inability, due to CRDs occur in countries with low or middle incomes.

The main causes of CRD are: tobacco smoke, occupational factors, indoor air pollution and outdoor air pollution, allergens, sequelae of respiratory infections such as tuberculosis.

More than 30% of the population of Ho Chi Minh City (HCMC) could develop a CRD. In fact, 15% of children and 7% of adults could become asthma and 6% of the population could become COPD due to smoking. Children exposed to fumes from biomass burning, early in their life, seem to have a higher risk to develop COPD. The high level of air pollution in HCMC could aggravate asthma / COPD. Populations combining the rural risk (exposure to smoke from biomass) and the urban risk (smoking, pollution) may develop COPD much earlier (before age 40). Among the 9 million people in HCMC, 50% of the population is rural origin. Within this population, parasites could play a protective role against the risk of allergic asthma and consequently, the better control of helminthiasis among urban population, may result in allergic diseases such as asthma and anaphylaxis. Finally, the sequelae of tuberculosis (incidence is 200/100000) could participate to the morbidity of COPD / CRD.

Study granted by the ARES-CUD ("Comission universitaire au développement")

研究设计

研究类型
Observational
时间视角
Cross Sectional

入排标准

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

入选标准

  • Age: ≥ 18 years old
  • Gender: Female and Male
  • Signed informed consent
  • Out-patients at the Pham Ngoc Thach Hospital
  • One or several symptoms suggesting chronic respiratory disease (cough, chest tightness, wheezing, dyspnoea, sputum), lasting 3 months or more.
  • Lung function defect (FEV1/FVC < 0,7 or FEV1 < 80% PV with FEV1/FVC > 0,7 or FEV1> 80% PV and FEV1/FVC > 0,7 with a decrease of DLCO (< 80% PV).
  • FEV1: Forced Expiratory Volume in 1 Second FVC : Forced Vital Capacity PV: predicted value DLCO: Diffusing Capacity of the Lung for Carbon Monoxide
  • Patients are able to stop anti-histamine 5 days before evaluation.
  • Patients are able to stop bronchodilator treatment before performing lung function test according to standard practice (immediate release theophylline: 24 hours, long acting β2-agonist: 12 hours, short acting β2-agonist: 6 hours and short acting anticholinergic: 8 hours).

排除标准

  • The patients do not agree to participate in the study.
  • Presence of one or more chronic diseases: HIV, active tuberculosis, hypertension, heart failure, diabetes, low BMI (<18.5) or mental health disorders.
  • Treatment with B-blockers, drugs of vascular/heart disease

结局指标

主要结局

Relative prevalence of the different chronic respiratory diseases phenotype

时间窗: 4 months after start of study

This will be measured by the percentage of each chronic respiratory diseases phenotype, according to the lung function test.

次要结局

  • Biomarkers assessment for risk factors of chronic respiratory diseases(4 months after start of study)
  • role of environmental risk factors in developing chronic respiratory diseases(4 months after start of study)
  • Induced sputum analysis to assess the relationship between phenotype and endotype among a sub-group of chronic respiratory diseases(4 months after start of study)
  • role of occupational risk factors in developing chronic respiratory diseases(4 months after start of study)
  • role of clinical risk factors in developing chronic respiratory diseases(4 months after start of study)
  • Allergen skin reactivity test to assess the role of atopic in developing chronic respiratory diseases(4 months after start of study)

研究者

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

Olivier Michel

Head of clinic

Brugmann University Hospital

研究点 (1)

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