Chronic Obstructive Respiratory DiseasesNCT04232579
Development of Predictive Biomarkers for the Diagnosis and Treatment of Asthma and COPD in Vietnam.
An observational study of Chronic Obstructive Respiratory Diseases, run by Olivier Michel at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Respiratory Diseases
- What is being tested?
- Therapeutic strategy
- How many people
- 600 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 6 Jan 2020to Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The out-patient population with chronic obstructive respiratory disease consulted at Nguyen Tri Phuong Hospital, Ho Chi Minh city, Vietnam.
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Belgium1 site, 1 recruiting
- Recruiting
CHU Brugmann
Brussels, 1020
Olivier Michel, MD, Olivier.MICHEL@chu-brugmann.be
Olivier Michel, MD
Vietnam1 site, 1 recruiting
- Recruiting
Nguyen Tri Phuong Hospital
Ho Chi Minh City, 70000
Thuy Chau Nguyen, MD, thuychaudr@gmail.com
Thuy Chau Nguyen, MD
About this study
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.
Read more
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.
- Conditions
- Chronic Obstructive Respiratory Diseases
- Being tested
- Therapeutic strategy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic strategyOther
Therapeutic strategy compatible with the guidelines and development of predictive biomarkers of the response to treatment.
| Study group | Role | What they receive |
|---|---|---|
| Chronic obstructive respiratory disease | The out-patient population with chronic obstructive respiratory disease consulted at Nguyen Tri Phuong Hospital, Ho Chi Minh city, Vietnam. Receives: Other: Therapeutic strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months after the start of the study
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.
Measured: 26 months after start of study
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.
Measured: 26 months after start of study
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).
Measured: 26 months after start of study
Number of exacerbations
Number of exacerbations
Measured: 26 months after start of study
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.
Measured: 26 months after start of study
Secondary outcomes (12)
White blood cells count (WBC)
White blood cells count
Measured: 12 months after the start of the study
White blood cells count (WBC)
White blood cells count
Measured: 26 months after the start of the study
C-reactive protein (CRP)
C-reactive protein (CRP) level in blood
Measured: 12 months after the start of the study
C-reactive protein (CRP)
C-reactive protein (CRP) level in blood
Measured: 26 months after the start of the study
Erythrocyte sedimentation rate (ESR)
Erythrocyte sedimentation rate in blood
Measured: 12 months after the start of the study
Erythrocyte sedimentation rate (ESR)
Erythrocyte sedimentation rate in blood
Measured: 26 months after the start of the study
IgE concentration
Total IgE concentration in blood
Measured: 12 months after the start of the study
IgE concentration
Total IgE concentration in blood
Measured: 26 months after the start of the study
α1-antitrypsin (A1A) concentration
α1-antitrypsin (A1A) concentration in blood
Measured: 12 months after the start of the study
α1-antitrypsin (A1A) concentration
α1-antitrypsin (A1A) concentration in blood
Measured: 26 months after the start of the study
Fractional exhaled nitric oxide (FENO)
Fractional exhaled nitric oxide
Measured: 12 months after the start of the study
Fractional exhaled nitric oxide (FENO)
Fractional exhaled nitric oxide
Measured: 26 months after the start of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start6 Jan 2020
- Primary completionJan 2021 (estimated)
- Study completionMar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Respiratory DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Olivier Michel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Olivier Michel, Brugmann University Hospital
- Investigators
- Olivier Michel, Study director, CHU Brugmann
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04232579
- Sponsor's protocol ID
- ACORD
- Status last verified
- Mar 2020
- First submitted
- 5 Dec 2019
- Last updated
- 11 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23749841Chu 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.
PubMed 29506620Quanjer 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.
PubMed 22743675
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04232579
- Acronym / sponsor ID
- ACORD
- Conditions
- Chronic Obstructive Respiratory Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Olivier MichelUniversity, hospital or other
- Study start
- 6 Jan 2020 (actual)
- Primary completion
- Jan 2021 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 18 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic obstructive respiratory disease | – | Other: Therapeutic strategyThe out-patient population with chronic obstructive respiratory disease consulted at Nguyen Tri Phuong Hospital, Ho Chi Minh city, Vietnam. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The out-patient population with chronic obstructive respiratory disease consulted at Nguyen Tri Phuong Hospital, Ho Chi Minh city, Vietnam.
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapeutic strategyTherapeutic strategy compatible with the guidelines and development of predictive biomarkers of the response to treatment. | Other | Chronic obstructive respiratory disease |
Primary outcome
Relative prevalence of the different chronic obstructive respiratory disease phenotypes.
Time frame: 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
Time frame: 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.
COPD Assessment Test
Time frame: 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.
Asthma Quality of Life Questionnaire
Time frame: 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
Time frame: 26 months after start of study
Number of exacerbations
Spirometry results
Time frame: 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.
12 secondary outcomes
White blood cells count (WBC)
Time frame: 12 months after the start of the study
White blood cells count (WBC)
Time frame: 26 months after the start of the study
C-reactive protein (CRP)
Time frame: 12 months after the start of the study
C-reactive protein (CRP)
Time frame: 26 months after the start of the study
Erythrocyte sedimentation rate (ESR)
Time frame: 12 months after the start of the study
Erythrocyte sedimentation rate (ESR)
Time frame: 26 months after the start of the study
IgE concentration
Time frame: 12 months after the start of the study
IgE concentration
Time frame: 26 months after the start of the study
α1-antitrypsin (A1A) concentration
Time frame: 12 months after the start of the study
α1-antitrypsin (A1A) concentration
Time frame: 26 months after the start of the study
Fractional exhaled nitric oxide (FENO)
Time frame: 12 months after the start of the study
Fractional exhaled nitric oxide (FENO)
Time frame: 26 months after the start of the study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2020.
- Background: PubMed 23749841Lee 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.
- Background: PubMed 29506620Chu 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.
- Background: PubMed 22743675Quanjer 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olivier Michel study director
CHU Brugmann
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Respiratory Diseases, run by Olivier Michel at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium, Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Olivier Michel, MD (3224773664, Olivier.MICHEL@chu-brugmann.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative prevalence of the different chronic obstructive respiratory disease phenotypes. (time frame: 12 months after the start of the study). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04232579, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2020.