- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02898129
Evaluating the Relationship Between Environmental Risk Factors in Housing Types and Chronic Respiratory Diseases in Ho Chi Minh City
The research question is "Are the different types of house in Ho Chi Minh city equally contributing to chronic respiratory diseases?".
According to this question, a cross-sectional and explorative study was set up to explore the differences in the environmental characteristics and prevalence of chronic respiratory diseases among common housing types in Ho Chi Minh city. Preliminary work was performed in 100 houses (20 houses per type, included tube houses, rental houses, rural houses, slum and apartment) from November 2013 to June 2015. It included measures by environmental devices, questionnaires and indoor activities diaries.
This study will aim to collect information about the prevalence of chronic respiratory diseases (CRDs) inside those house types to understand more about role of house types in developing CRDs.
The objective is:
- to evaluate the relationships between the type of house and lung function of inhabitants in each housing type.
- to evaluate the effects of environmental risk factors in each house type on prevalence of CRDs
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Ho Chi Minh City, Vietnam, 7000
- Pham Ngoc Thach University of medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Everybody
Exclusion Criteria:
- Not able to answer the questionnaire or give informed consent
- Have a contra-indication for lung function test (acute myocardial infarction less that 1 month ago, pain related to spirometry, dementia/confused)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Tube houses
Tube Houses.
Group of 75-100 houses, with 4 inhabitants per house.
Expected number of participants: 300-400.
Predicted number of non-smoker chronic respiratory disease of 18-24.
|
Basic lung function test performed with a micro-spirometer, without broncho dilatator
|
Experimental: Apartment
Apartments.
Group of 75-100 apartments, with 4 inhabitants per apartment.
Expected number of participants: 300-400.
Predicted number of non-smoker chronic respiratory disease of 18-24.
|
Basic lung function test performed with a micro-spirometer, without broncho dilatator
|
Experimental: Rental Houses
Rental Houses.
Group of 150-200 rental houses, with 2 inhabitants per rental house.
Expected number of participants: 300-400.
Predicted number of non-smoker chronic respiratory disease of 18-24.
|
Basic lung function test performed with a micro-spirometer, without broncho dilatator
|
Experimental: Rural houses
Rural Houses.
Group of 40-60 rural houses, with 5 inhabitant per rural house.
Expected number of participants: 200-300.
Predicted number of non-smoker chronic respiratory disease of 12-18.
|
Basic lung function test performed with a micro-spirometer, without broncho dilatator
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
FEV1/FVC
Time Frame: 5 minutes
|
Basic lung function test, without broncho dilatation (micro-spirometer).
All lung function related outcomes are performed during the same test.
FEV1: forced expiratory volume in one second.
FVC: Forced vital capacity.
|
5 minutes
|
FVC
Time Frame: 5 minutes
|
Basic lung function test, without broncho dilatation (micro-spirometer).
All lung function related outcomes are performed during the same test.FVC: Forced vital capacity.
|
5 minutes
|
VC
Time Frame: 5 minutes
|
Basic lung function test, without broncho dilatation (micro-spirometer).
All lung function related outcomes performed during the same test.
VC: Vital capacity
|
5 minutes
|
FEF 25-75%
Time Frame: 5 minutes
|
Basic lung function test, without broncho dilatation (micro-spirometer).All lung function related outcomes are performed during the same test.
FEF: Forced expiratory flow
|
5 minutes
|
Socio-demographic status
Time Frame: around 10 minutes
|
Socio-demographic data, assessed by a home made questionnaire
|
around 10 minutes
|
Health status
Time Frame: around 10 minutes
|
Health status (symptomatology) data, assessed by a home made questionnaire
|
around 10 minutes
|
Indoor air exposure time
Time Frame: around 10 minutes
|
Indoor air exposure (time spent indoor within housing types, with associated air characteristics) data, assessed by a home made questionnaire
|
around 10 minutes
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Pellegrino R, Viegi G, Brusasco V, Crapo RO, Burgos F, Casaburi R, Coates A, van der Grinten CP, Gustafsson P, Hankinson J, Jensen R, Johnson DC, MacIntyre N, McKay R, Miller MR, Navajas D, Pedersen OF, Wanger J. Interpretative strategies for lung function tests. Eur Respir J. 2005 Nov;26(5):948-68. doi: 10.1183/09031936.05.00035205. No abstract available.
- Lung function testing: selection of reference values and interpretative strategies. American Thoracic Society. Am Rev Respir Dis. 1991 Nov;144(5):1202-18. doi: 10.1164/ajrccm/144.5.1202. No abstract available.
- Quanjer PH, Tammeling GJ, Cotes JE, Pedersen OF, Peslin R, Yernault JC. Lung volumes and forced ventilatory flows. Report Working Party Standardization of Lung Function Tests, European Community for Steel and Coal. Official Statement of the European Respiratory Society. Eur Respir J Suppl. 1993 Mar;16:5-40. No abstract available.
- 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.
- Dherani M, Pope D, Mascarenhas M, Smith KR, Weber M, Bruce N. Indoor air pollution from unprocessed solid fuel use and pneumonia risk in children aged under five years: a systematic review and meta-analysis. Bull World Health Organ. 2008 May;86(5):390-398C. doi: 10.2471/blt.07.044529.
- Ezzati M, Kammen DM. The health impacts of exposure to indoor air pollution from solid fuels in developing countries: knowledge, gaps, and data needs. Environ Health Perspect. 2002 Nov;110(11):1057-68. doi: 10.1289/ehp.021101057.
- Bruce N, Perez-Padilla R, Albalak R. Indoor air pollution in developing countries: a major environmental and public health challenge. Bull World Health Organ. 2000;78(9):1078-92.
- Stocks J, Quanjer PH. Reference values for residual volume, functional residual capacity and total lung capacity. ATS Workshop on Lung Volume Measurements. Official Statement of The European Respiratory Society. Eur Respir J. 1995 Mar;8(3):492-506. doi: 10.1183/09031936.95.08030492. No abstract available.
- American Thoracic Society. Single-breath carbon monoxide diffusing capacity (transfer factor). Recommendations for a standard technique--1995 update. Am J Respir Crit Care Med. 1995 Dec;152(6 Pt 1):2185-98. doi: 10.1164/ajrccm.152.6.8520796. No abstract available.
- Cotes JE, Chinn DJ, Quanjer PH, Roca J, Yernault JC. Standardization of the measurement of transfer factor (diffusing capacity). Report Working Party Standardization of Lung Function Tests, European Community for Steel and Coal. Official Statement of the European Respiratory Society. Eur Respir J Suppl. 1993 Mar;16:41-52. No abstract available.
- Wang X, Dockery DW, Wypij D, Fay ME, Ferris BG Jr. Pulmonary function between 6 and 18 years of age. Pediatr Pulmonol. 1993 Feb;15(2):75-88. doi: 10.1002/ppul.1950150204.
- Quanjer PH, Stocks J, Polgar G, Wise M, Karlberg J, Borsboom G. Compilation of reference values for lung function measurements in children. Eur Respir J Suppl. 1989 Mar;4:184S-261S. No abstract available.
- COPD-more than just tobacco smoke. Lancet. 2009 Aug 29;374(9691):663. doi: 10.1016/S0140-6736(09)61535-X. No abstract available.
- 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.
- Samet JM, Spengler JD. Indoor environments and health: moving into the 21st century. Am J Public Health. 2003 Sep;93(9):1489-93. doi: 10.2105/ajph.93.9.1489.
- Bardana EJ Jr. Indoor pollution and its impact on respiratory health. Ann Allergy Asthma Immunol. 2001 Dec;87(6 Suppl 3):33-40. doi: 10.1016/s1081-1206(10)62338-1.
- Smith KR. Indoor air pollution in developing countries: recommendations for research. Indoor Air. 2002 Sep;12(3):198-207. doi: 10.1034/j.1600-0668.2002.01137.x.
- Smith KR, Mehta S. The burden of disease from indoor air pollution in developing countries: comparison of estimates. Int J Hyg Environ Health. 2003 Aug;206(4-5):279-89. doi: 10.1078/1438-4639-00224.
- Smith KR, Samet JM, Romieu I, Bruce N. Indoor air pollution in developing countries and acute lower respiratory infections in children. Thorax. 2000 Jun;55(6):518-32. doi: 10.1136/thorax.55.6.518.
- Rojas-Bracho L, Suh HH, Koutrakis P. Relationships among personal, indoor, and outdoor fine and coarse particle concentrations for individuals with COPD. J Expo Anal Environ Epidemiol. 2000 May-Jun;10(3):294-306. doi: 10.1038/sj.jea.7500092.
- Sarnat JA, Koutrakis P, Suh HH. Assessing the relationship between personal particulate and gaseous exposures of senior citizens living in Baltimore, MD. J Air Waste Manag Assoc. 2000 Jul;50(7):1184-98. doi: 10.1080/10473289.2000.10464165.
- Jaakkola MS. Environmental tobacco smoke and health in the elderly. Eur Respir J. 2002 Jan;19(1):172-81. doi: 10.1183/09031936.02.00270702.
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- Raw GJ, Coward SK, Brown VM, Crump DR. Exposure to air pollutants in English homes. J Expo Anal Environ Epidemiol. 2004;14 Suppl 1:S85-94. doi: 10.1038/sj.jea.7500363.
- Viegi G, Simoni M, Scognamiglio A, Baldacci S, Pistelli F, Carrozzi L, Annesi-Maesano I. Indoor air pollution and airway disease. Int J Tuberc Lung Dis. 2004 Dec;8(12):1401-15.
- Levesqu B, Allaire S, Gauvin D, Koutrakis P, Gingras S, Rhainds M, Prud'Homme H, Duchesne JF. Wood-burning appliances and indoor air quality. Sci Total Environ. 2001 Dec 17;281(1-3):47-62. doi: 10.1016/s0048-9697(01)00834-8.
- Naeher LP, Smith KR, Leaderer BP, Neufeld L, Mage DT. Carbon monoxide as a tracer for assessing exposures to particulate matter in wood and gas cookstove households of highland Guatemala. Environ Sci Technol. 2001 Feb 1;35(3):575-81. doi: 10.1021/es991225g.
- Rollin HB, Mathee A, Bruce N, Levin J, von Schirnding YE. Comparison of indoor air quality in electrified and un-electrified dwellings in rural South African villages. Indoor Air. 2004 Jun;14(3):208-16. doi: 10.1111/j.1600-0668.2004.00238.x.
- Schwela D. Cooking smoke: a silent killer. People Planet. 1997;6(3):24-5.
- Wolkoff P, Schneider T, Kildeso J, Degerth R, Jaroszewski M, Schunk H. Risk in cleaning: chemical and physical exposure. Sci Total Environ. 1998 Apr 23;215(1-2):135-56. doi: 10.1016/s0048-9697(98)00110-7.
- Delfino RJ. Epidemiologic evidence for asthma and exposure to air toxics: linkages between occupational, indoor, and community air pollution research. Environ Health Perspect. 2002 Aug;110 Suppl 4(Suppl 4):573-89. doi: 10.1289/ehp.02110s4573.
- Payne-Sturges DC, Burke TA, Breysse P, Diener-West M, Buckley TJ. Personal exposure meets risk assessment: a comparison of measured and modeled exposures and risks in an urban community. Environ Health Perspect. 2004 Apr;112(5):589-98. doi: 10.1289/ehp.6496.
- 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.
- Tan WC, Ng TP. COPD in Asia: where East meets West. Chest. 2008 Feb;133(2):517-27. doi: 10.1378/chest.07-1131.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHUB-CRD-Housing
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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