Clinical trial NCT02898129: Evaluating the Relationship Between Environmental Risk Factors in Housing Types and Chronic Respiratory Diseases in Ho Chi Minh City
Official title: Evaluating the Relationship Between Environmental Risk Factors in Housing Types and Chronic Respiratory Diseases in Ho Chi Minh City
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Respiratory Diseases
Keywords: chronic respiratory diseases
housing
lung function test
Lead sponsor: Brugmann University Hospital
Sponsor class: OTHER
First posted: 2016-09-13
Enrollment: 1500
Sex: ALL
Minimum age (years): 10
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: 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:

1. to evaluate the relationships between the type of house and lung function of inhabitants in each housing type.
2. to evaluate the effects of environmental risk factors in each house type on prevalence of CRDs


Eligibility criteria: 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)

Primary outcomes:
measure: FEV1/FVC
timeFrame: 5 minutes
measure: FVC
timeFrame: 5 minutes
measure: VC
timeFrame: 5 minutes
measure: FEF 25-75%
timeFrame: 5 minutes
measure: Socio-demographic status
timeFrame: around 10 minutes
measure: Health status
timeFrame: around 10 minutes
measure: Indoor air exposure time
timeFrame: around 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Ho Chi Minh City
country: Vietnam
facility: Pham Ngoc Thach University of medicine
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: COPD-more than just tobacco smoke. Lancet. 2009 Aug 29;374(9691):663. doi: 10.1016/S0140-6736(09)61535-X. No abstract available.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Smith KR. National burden of disease in India from indoor air pollution. Proc Natl Acad Sci U S A. 2000 Nov 21;97(24):13286-93. doi: 10.1073/pnas.97.24.13286.
citation: Briggs D. Environmental pollution and the global burden of disease. Br Med Bull. 2003;68:1-24. doi: 10.1093/bmb/ldg019.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Schwela D. Cooking smoke: a silent killer. People Planet. 1997;6(3):24-5.
citation: 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.
citation: 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.
citation: 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.
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.
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. doi: 10.1046/j.1440-1843.2003.00460.x.
citation: 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.
citation: Tan WC, Ng TP. COPD in Asia: where East meets West. Chest. 2008 Feb;133(2):517-27. doi: 10.1378/chest.07-1131.