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临床试验/NCT04232579
NCT04232579Unknown不适用

Diagnosis of Asthma, COPD and ACO in Vietnamese Context, Proposal of a Therapeutic Strategy Compatible With the Guidelines and Development of Predictive Biomarkers of the Response to Treatment

Olivier Michel2 个研究点 分布在 2 个国家目标入组 600 人开始时间: 2020年1月6日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
600
试验地点
2
主要终点
COPD Assessment Test

研究概览

简要总结

According to World Health Organization (WHO), non-communicable diseases account for 70% of global mortality. Chronic Respiratory Disease (CRD) affects more than one billion people and is the third leading cause of annual death of five million people after cardiovascular disease and cancer. Asthma and chronic obstructive pulmonary disease (COPD) are the two most common diseases of CRD and are part of obstructive airway disease (OAD).

Asthma and COPD are distinguished by the clinical manifestations and therapeutic strategy according to Global Initiative for Asthma (GINA) and Global Initiative for Chronic Obstructive Lung Disease (GOLD). However, in Vietnam, most patients with OAD are treated with an inhaled corticosteroid (ICS) combined with a long-lasting bronchodilator because the specific diagnosis is not always possible.

In addition, a significant proportion of patients have clinical features of both asthma and COPD that is defined as the asthma COPD overlap (ACO). The definition of ACO remains controversial because it is not a distinct disease in which their specific treatment is still under debate that ICS is being generally proposed.

It is understood that most OAD in Vietnam is treated with ICS. However, it is now accepted that in COPD (or COPD-like ACO) patients receiving this treatment may promote respiratory infections and even tuberculosis in endemic countries including Vietnam.

Few data on the relative prevalence of asthma, COPD, and ACO are available in Vietnam. A recent study in Vietnam proposed defining asthma, COPD and ACO based on symptoms, ventilatory obstruction and bronchodilator (BD) reversibility, cumulative smoking, and age. Mites sensitization and exposure to biomass fume were then evaluated in patients having ACO. By doing so, COPD patients are smoking (≥ 10 pack-years) and have irreversible bronchial obstruction. Asthmatics are those with completely reversible bronchial obstruction OR non-smoking patients (<10 pack-years) and partially reversible obstructive. The other OAD patients were classified as having "ACO". Based on these definitions, the prevalence of COPD, asthma and ACO was 40%, 18% and 42%, respectively. Then ACO was defined as "from COPD, or ACO-COPD" in case of biomass exposure and negative mite skin tests, the others being ACO "from asthma or ACO-asthma".

Currently, several biomarkers have been evaluated in the differential diagnosis and prognosis of OAD. The concentration of immunoglobulin E (IgE), the number of eosinophils in blood and sputum, nitric oxide (NO) in exhaled air, and recently periostin have been associated with asthma. On the other hand, biomarkers of systemic inflammation (C-reactive protein (CRP), fibrinogen, TNFα, IL-6 and IL-8) have also been investigated in COPD. Few data are available on the ACO biomarkers.

In this study, the investigators will define the different phenotypes of chronic OAD (asthma, ACO-asthma, ACO-COPD and COPD) taking into account the reversibility of bronchial obstruction, cumulative smoking, biomass fume exposure and immediate sensitization to mites. Blood biomarkers and exhaled NO will be measured and analyzed in each phenotype.

The treatment of COPD, asthma, ACO-COPD, and ACO-asthma based on the GINA and GOLD recommendations will be compared to the current practice in Vietnam: use of ICS with or without long-acting beta-agonists (LABA).

Specific biomarkers will also be evaluated as predictors of treatment response.

研究设计

研究类型
Observational
观察模型
Cohort
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
  • Signed informed consent
  • Out-patients at Nguyen Tri Phuong Hospital
  • One or several symptoms suggesting chronic respiratory disease (cough, chest tightness, wheezing, dyspnea or sputum), lasting 3 months or more.
  • Lung function abnormality (Forced Expiratory Volume in 1 Second /Forced Vital Capacity < Lower Limit of Normal)
  • 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

  • Presence of one or more chronic diseases: HIV infection, active tuberculosis, heart failure, cancers, auto-immune diseases, systemic diseases, low BMI (<18.5) or mental health disorders.
  • Treatment with non-selective beta-blockers
  • Severe exacerbation during the last month
  • Corticosteroid-dependent patients
  • Pregnant women

结局指标

主要结局

COPD Assessment Test

时间窗: 26 months after start of study

Questionnaire that contains eight questions covering domains relating to the impact of COPD symptoms. Scores of 0-10, 11-20, 21-30, 31-40 represent mild, moderate, severe or very severe clinical impact.

Relative prevalence of the different chronic obstructive respiratory disease phenotypes.

时间窗: 12 months after the start of the study

The relative prevalence will be measured by the percentage of each phenotype of chronic respiratory diseases, according to lung function test, cumulative smoking, mite sensitization on prick tests and biomass fume exposure.

Asthma Control Test

时间窗: 26 months after start of study

Questionnaire: 5 questions scored according to a 5 point Likert Scale. Total inferior to 15: uncontrolled asthma. Between 15 and 19: partially controled asthma. From 20 to 25: controled asthma.

Asthma Quality of Life Questionnaire

时间窗: 26 months after start of study

A disease-specific health-related quality of life instrument that taps both physical and emotional impact of disease. The scoring follows a 7-point Likert scale (7 = not impaired at all - 1 = severely impaired).

Number of exacerbations

时间窗: 26 months after start of study

Number of exacerbations

Spirometry results

时间窗: 26 months after start of study

Spirometry is the most common of the pulmonary function tests. Spirometry generates pneumotachographs, which are charts that plot the volume and flow of air coming in and out of the lungs from one inhalation and one exhalation.

次要结局

  • White blood cells count (WBC)(26 months after the start of the study)
  • C-reactive protein (CRP)(26 months after the start of the study)
  • Erythrocyte sedimentation rate (ESR)(26 months after the start of the study)
  • IgE concentration(26 months after the start of the study)
  • α1-antitrypsin (A1A) concentration(26 months after the start of the study)
  • Fractional exhaled nitric oxide (FENO)(26 months after the start of the study)

研究者

发起方
Olivier Michel
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Olivier Michel

Head of Immuno-allergology department

Brugmann University Hospital

研究点 (2)

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