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Completed

NCT Number: NCT02517983

Phenotyping the Chronic Respiratory Diseases (CRD) in Ho Chi Minh City, Vietnam

World Health Organization (WHO) considers chronic respiratory disease (CRD) as one of its four priorities. These diseases include asthma and rhinitis, chronic obstructive pulmonary diseases (COPD), occupational lung diseases, sleep apnoea syndromes, pulmonary hypertension, bronchiectasis and interstitial lung diseases. They constitute a serious public health problem in all countries throughout the world, in particular in low and middle income countries and in deprived populations. Hundreds of millions of people of all ages, in all countries of the world, are affected by chronic respiratory diseases. More than 50% of them live in low and middle income countries. Over 90% of deaths and the complete inability, due to CRDs occur in countries with low or middle incomes.

The main causes of CRD are: tobacco smoke, occupational factors, indoor air pollution and outdoor air pollution, allergens, sequelae of respiratory infections such as tuberculosis.

More than 30% of the population of Ho Chi Minh City (HCMC) could develop a CRD. In fact, 15% of children and 7% of adults could become asthma and 6% of the population could become COPD due to smoking. Children exposed to fumes from biomass burning, early in their life, seem to have a higher risk to develop COPD. The high level of air pollution in HCMC could aggravate asthma / COPD. Populations combining the rural risk (exposure to smoke from biomass) and the urban risk (smoking, pollution) may develop COPD much earlier (before age 40). Among the 9 million people in HCMC, 50% of the population is rural origin. Within this population, parasites could play a protective role against the risk of allergic asthma and consequently, the better control of helminthiasis among urban population, may result in allergic diseases such as asthma and anaphylaxis. Finally, the sequelae of tuberculosis (incidence is 200/100000) could participate to the morbidity of COPD / CRD.

Study granted by the ARES-CUD ("Comission universitaire au développement")

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Key information

Conditions

Chronic Respiratory Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pham Ngoc Thach Hospital

Ho Chi Minh City, 70000, Vietnam

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age: ≥ 18 years old
  • Gender: Female and Male
  • Signed informed consent
  • Out-patients at the Pham Ngoc Thach Hospital
  • One or several symptoms suggesting chronic respiratory disease (cough, chest tightness, wheezing, dyspnoea, sputum), lasting 3 months or more.
  • Lung function defect (FEV1/FVC < 0,7 or FEV1 < 80% PV with FEV1/FVC > 0,7 or FEV1> 80% PV and FEV1/FVC > 0,7 with a decrease of DLCO (< 80% PV).

FEV1: Forced Expiratory Volume in 1 Second FVC : Forced Vital Capacity PV: predicted value DLCO: Diffusing Capacity of the Lung for Carbon Monoxide

  • 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).

Exclusion criteria

  • The patients do not agree to participate in the study.
  • Presence of one or more chronic diseases: HIV, active tuberculosis, hypertension, heart failure, diabetes, low BMI (<18.5) or mental health disorders.
  • Treatment with B-blockers, drugs of vascular/heart disease

Treatment and study plan

Epidemiology

Other

Relative prevalence of different chronic respiratory disease phenotypes

Primary outcomes

  1. Relative prevalence of the different chronic respiratory diseases phenotype

    Time frame: 4 months after start of study

    This will be measured by the percentage of each chronic respiratory diseases phenotype, according to the lung function test.

Secondary outcomes

  1. role of environmental risk factors in developing chronic respiratory diseases

    Time frame: 4 months after start of study

    This will be measured by means of a questionnaire.

  2. role of occupational risk factors in developing chronic respiratory diseases

    Time frame: 4 months after start of study

    This will be measured by means of a questionnaire.

  3. role of clinical risk factors in developing chronic respiratory diseases

    Time frame: 4 months after start of study

    This will be measured by means of a questionnaire and lung function test

  4. Allergen skin reactivity test to assess the role of atopic in developing chronic respiratory diseases

    Time frame: 4 months after start of study

  5. Induced sputum analysis to assess the relationship between phenotype and endotype among a sub-group of chronic respiratory diseases

    Time frame: 4 months after start of study

  6. Biomarkers assessment for risk factors of chronic respiratory diseases

    Time frame: 4 months after start of study

    Total IgE number and specific IgE number if needed depending on each phenotype of chronic respiratory disease

Sponsors and collaborators

Lead sponsor

Brugmann University Hospital

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Aug 7, 2015
Registry last updated
Sep 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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