Development of Predictive Biomarkers for the Diagnosis and Treatment of Asthma and COPD in Vietnam.
- Conditions
- Chronic Obstructive Respiratory Diseases
- Interventions
- Other: Therapeutic strategy
- Registration Number
- NCT04232579
- Lead Sponsor
- Olivier Michel
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 600
- 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).
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Chronic obstructive respiratory disease Therapeutic strategy The out-patient population with chronic obstructive respiratory disease consulted at Nguyen Tri Phuong Hospital, Ho Chi Minh city, Vietnam.
- Primary Outcome Measures
Name Time Method COPD Assessment Test 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. 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 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 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 26 months after start of study Number of exacerbations
Spirometry results 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.
- Secondary Outcome Measures
Name Time Method White blood cells count (WBC) 26 months after the start of the study White blood cells count
C-reactive protein (CRP) 26 months after the start of the study C-reactive protein (CRP) level in blood
Erythrocyte sedimentation rate (ESR) 26 months after the start of the study Erythrocyte sedimentation rate in blood
IgE concentration 26 months after the start of the study Total IgE concentration in blood
α1-antitrypsin (A1A) concentration 26 months after the start of the study α1-antitrypsin (A1A) concentration in blood
Fractional exhaled nitric oxide (FENO) 26 months after the start of the study Fractional exhaled nitric oxide
Trial Locations
- Locations (2)
Nguyen Tri Phuong Hospital
🇻🇳Ho Chi Minh City, Vietnam
CHU Brugmann
🇧🇪Brussel, Belgium