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

NCT ID: NCT02517983

Last Updated: 2016-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

610 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-08-31

Study Completion Date

2016-09-30

Brief Summary

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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")

Detailed Description

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Conditions

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Chronic Respiratory Diseases

Study Design

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Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Chronic respiratory disease

epidemiology

Intervention Type OTHER

Relative prevalence of different chronic respiratory disease phenotypes

Interventions

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epidemiology

Relative prevalence of different chronic respiratory disease phenotypes

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Brugmann University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Olivier Michel

Head of clinic

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Oliver Michel, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Brugmann

Ha Chu Thi, MD

Role: PRINCIPAL_INVESTIGATOR

Pham Ngoc Thach Hospital, Ho Chi Minh City, Vietnam

Locations

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Pham Ngoc Thach Hospital

Ho Chi Minh City, , Vietnam

Site Status

Countries

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Vietnam

References

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COPD-more than just tobacco smoke. Lancet. 2009 Aug 29;374(9691):663. doi: 10.1016/S0140-6736(09)61535-X. No abstract available.

Reference Type BACKGROUND
PMID: 19716941 (View on PubMed)

Bousquet J, Kiley J, Bateman ED, Viegi G, Cruz AA, Khaltaev N, Ait 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.

Reference Type BACKGROUND
PMID: 20223919 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19758373 (View on PubMed)

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. doi: 10.1046/j.1440-1843.2003.00460.x.

Reference Type BACKGROUND
PMID: 12753535 (View on PubMed)

Other Identifiers

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CHUB-CRD

Identifier Type: -

Identifier Source: org_study_id

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