Chronic Obstructive Respiratory Diseases Clinical Trial
Official title:
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
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.
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