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
| NCT number | NCT04232579 |
| Other study ID # | ACORD |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | January 6, 2020 |
| Est. completion date | March 2022 |
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.
| Status | Recruiting |
| Enrollment | 600 |
| Est. completion date | March 2022 |
| Est. primary completion date | January 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - 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 ß2-agonist: 12 hours, short acting ß2-agonist: 6 hours and short acting anticholinergic: 8 hours). Exclusion Criteria: - 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 |
| Country | Name | City | State |
|---|---|---|---|
| Belgium | CHU Brugmann | Brussel | |
| Vietnam | Nguyen Tri Phuong Hospital | Ho Chi Minh City |
| Lead Sponsor | Collaborator |
|---|---|
| Olivier Michel |
Belgium, Vietnam,
Chu HT, Godin I, Phuong NT, Nguyen LH, Hiep TTM, Michel O. Allergen sensitisation among chronic respiratory diseases in urban and rural areas of the south of Viet Nam. Int J Tuberc Lung Dis. 2018 Feb 1;22(2):221-229. doi: 10.5588/ijtld.17.0069. — View Citation
Lee CH, Kim K, Hyun MK, Jang EJ, Lee NR, Yim JJ. Use of inhaled corticosteroids and the risk of tuberculosis. Thorax. 2013 Dec;68(12):1105-13. doi: 10.1136/thoraxjnl-2012-203175. Epub 2013 Jun 8. — View Citation
Quanjer PH, Stanojevic S, Cole TJ, Baur X, Hall GL, Culver BH, Enright PL, Hankinson JL, Ip MS, Zheng J, Stocks J; ERS Global Lung Function Initiative. Multi-ethnic reference values for spirometry for the 3-95-yr age range: the global lung function 2012 equations. Eur Respir J. 2012 Dec;40(6):1324-43. doi: 10.1183/09031936.00080312. Epub 2012 Jun 27. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Relative prevalence of the different chronic obstructive respiratory disease phenotypes. | 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. | 12 months after the start of the study | |
| Primary | Asthma Control Test | 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. | 26 months after start of study | |
| Primary | COPD Assessment Test | 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. | 26 months after start of study | |
| Primary | Asthma Quality of Life Questionnaire | 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). | 26 months after start of study | |
| Primary | Number of exacerbations | Number of exacerbations | 26 months after start of study | |
| Primary | Spirometry results | 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. | 26 months after start of study | |
| Secondary | White blood cells count (WBC) | White blood cells count | 12 months after the start of the study | |
| Secondary | White blood cells count (WBC) | White blood cells count | 26 months after the start of the study | |
| Secondary | C-reactive protein (CRP) | C-reactive protein (CRP) level in blood | 12 months after the start of the study | |
| Secondary | C-reactive protein (CRP) | C-reactive protein (CRP) level in blood | 26 months after the start of the study | |
| Secondary | Erythrocyte sedimentation rate (ESR) | Erythrocyte sedimentation rate in blood | 12 months after the start of the study | |
| Secondary | Erythrocyte sedimentation rate (ESR) | Erythrocyte sedimentation rate in blood | 26 months after the start of the study | |
| Secondary | IgE concentration | Total IgE concentration in blood | 12 months after the start of the study | |
| Secondary | IgE concentration | Total IgE concentration in blood | 26 months after the start of the study | |
| Secondary | a1-antitrypsin (A1A) concentration | a1-antitrypsin (A1A) concentration in blood | 12 months after the start of the study | |
| Secondary | a1-antitrypsin (A1A) concentration | a1-antitrypsin (A1A) concentration in blood | 26 months after the start of the study | |
| Secondary | Fractional exhaled nitric oxide (FENO) | Fractional exhaled nitric oxide | 12 months after the start of the study | |
| Secondary | Fractional exhaled nitric oxide (FENO) | Fractional exhaled nitric oxide | 26 months after the start of the study |