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

Chronic Respiratory Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02517983
• Other study ID #: CHUB-CRD
• Status: Completed
• Phase: N/A
• First received: July 28, 2015
• Last updated: September 9, 2016
• Start date: August 2015
• Est. completion date: September 2016

Study information

• Verified date: September 2016
• Source: Brugmann University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Vietnam: Pham Ngoc Thach Hospital
• Study type: Observational

Clinical Trial Summary

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")

Recruitment information / eligibility

• Status: Completed
• Enrollment: 610
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 ß2-agonist: 12 hours, short acting ß2-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

Study Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Chronic Respiratory Diseases
• Respiration Disorders
• Respiratory Tract Diseases

Intervention

Other:
• epidemiology
Relative prevalence of different chronic respiratory disease phenotypes

Locations

Country	Name	City	State
Vietnam	Pham Ngoc Thach Hospital	Ho Chi Minh

Sponsors (1)

Lead Sponsor	Collaborator
Brugmann University Hospital

Country where clinical trial is conducted

Vietnam, 

References & Publications (4)

Bousquet J, Kiley J, Bateman ED, Viegi G, Cruz AA, Khaltaev N, Aït Khaled N, Baena-Cagnani CE, Barreto ML, Billo N, Canonica GW, Carlsen KH, Chavannes N, Chuchalin A, Drazen J, Fabbri LM, Gerbase MW, Humbert M, Joos G, Masjedi MR, Makino S, Rabe K, To T, Zhi L. Prioritised research agenda for prevention and control of chronic respiratory diseases. Eur Respir J. 2010 Nov;36(5):995-1001. doi: 10.1183/09031936.00012610. Epub 2010 Mar 11. — View Citation

COPD-more than just tobacco smoke. Lancet. 2009 Aug 29;374(9691):663. doi: 10.1016/S0140-6736(09)61535-X. — View Citation

Flohr C, Tuyen LN, Quinnell RJ, Lewis S, Minh TT, Campbell J, Simmons C, Telford G, Brown A, Hien TT, Farrar J, Williams H, Pritchard DI, Britton J. Reduced helminth burden increases allergen skin sensitization but not clinical allergy: a randomized, double-blind, placebo-controlled trial in Vietnam. Clin Exp Allergy. 2010 Jan;40(1):131-42. doi: 10.1111/j.1365-2222.2009.03346.x. Epub 2009 Sep 15. — View Citation

Regional COPD Working Group. COPD prevalence in 12 Asia-Pacific countries and regions: projections based on the COPD prevalence estimation model. Respirology. 2003 Jun;8(2):192-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relative prevalence of the different chronic respiratory diseases phenotype	This will be measured by the percentage of each chronic respiratory diseases phenotype, according to the lung function test.	4 months after start of study	No
Secondary	role of environmental risk factors in developing chronic respiratory diseases	This will be measured by means of a questionnaire.	4 months after start of study	No
Secondary	role of occupational risk factors in developing chronic respiratory diseases	This will be measured by means of a questionnaire.	4 months after start of study	No
Secondary	role of clinical risk factors in developing chronic respiratory diseases	This will be measured by means of a questionnaire and lung function test	4 months after start of study	No
Secondary	Allergen skin reactivity test to assess the role of atopic in developing chronic respiratory diseases		4 months after start of study	No
Secondary	Induced sputum analysis to assess the relationship between phenotype and endotype among a sub-group of chronic respiratory diseases		4 months after start of study	No
Secondary	Biomarkers assessment for risk factors of chronic respiratory diseases	Total IgE number and specific IgE number if needed depending on each phenotype of chronic respiratory disease	4 months after start of study	No