Chronic Respiratory DiseasesNCT02898129

Evaluating the Relationship Between Environmental Risk Factors in Housing Types and Chronic Respiratory Diseases in Ho Chi Minh City

A study testing Questionnaire and Lung function test in people with Chronic Respiratory Diseases, run by Brugmann University Hospital at 1 site in Vietnam.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 10 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Chronic Respiratory Diseases
What is being tested?: Questionnaire and Lung function test
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,500 participants
Where: 1 siteVietnam
Study dates: Sep 2016to Jul 2017
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 10 to 65 years
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

Everybody

Who cannot join

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)

Trial locations and contacts

1 site in 1 country.

Vietnam1 site

Pham Ngoc Thach University of medicine
Ho Chi Minh City, 7000

Other trials in Vietnam

About this study

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

Conditions: Chronic Respiratory Diseases
Being tested: Questionnaire, Lung function test
Keywords: chronic respiratory diseases, housing, lung function test

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

QuestionnaireOther
Lung function testDevice
Basic lung function test performed with a micro-spirometer, without broncho dilatator

Study groups in NCT02898129
Study group	Role	What they receive
Tube houses	Experimental	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. Receives: Other: Questionnaire; Device: Lung function test
Apartment	Experimental	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. Receives: Other: Questionnaire; Device: Lung function test
Rental Houses	Experimental	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. Receives: Other: Questionnaire; Device: Lung function test
Rural houses	Experimental	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. Receives: Other: Questionnaire; Device: Lung function test

What is being measured

The primary outcome is the main question the study is designed to answer.

FEV1/FVC
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.
Measured: 5 minutes
FVC
Basic lung function test, without broncho dilatation (micro-spirometer). All lung function related outcomes are performed during the same test.FVC: Forced vital capacity.
Measured: 5 minutes
VC
Basic lung function test, without broncho dilatation (micro-spirometer). All lung function related outcomes performed during the same test. VC: Vital capacity
Measured: 5 minutes
FEF 25-75%
Basic lung function test, without broncho dilatation (micro-spirometer).All lung function related outcomes are performed during the same test. FEF: Forced expiratory flow
Measured: 5 minutes
Socio-demographic status
Socio-demographic data, assessed by a home made questionnaire
Measured: around 10 minutes
Health status
Health status (symptomatology) data, assessed by a home made questionnaire
Measured: around 10 minutes
Indoor air exposure time
Indoor air exposure (time spent indoor within housing types, with associated air characteristics) data, assessed by a home made questionnaire
Measured: around 10 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2016Jul 2017

First posted13 Sep 2016 (estimated)
Study startSep 2016
Primary completionJul 2017
Study completionJul 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (35)Papers the sponsor has linked to this study.
Other trials for Chronic Respiratory DiseasesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Screening
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 1,500 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02898129
Sponsor's protocol ID: CHUB-CRD-Housing
Status last verified: Aug 2017
First submitted: 8 Sep 2016
Last updated: 4 Aug 2017
Results posted: No
Data monitoring committee: No

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.
PubMed 16264058
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.
PubMed 1952453
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.
PubMed 8499054
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.
PubMed 7789503
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.
PubMed 8520796
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.
PubMed 8499053
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.
PubMed 8474788
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.
PubMed 2659037
COPD-more than just tobacco smoke. Lancet. 2009 Aug 29;374(9691):663. doi: 10.1016/S0140-6736(09)61535-X. No abstract available.
PubMed 19716941
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.
PubMed 20223919
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.
PubMed 12948968
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.
PubMed 11770681
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.
PubMed 11019457
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.
PubMed 12417475
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.
PubMed 12244750

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Chronic Respiratory Diseases trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluating the Relationship Between Environmental Risk Factors in Housing Types and Chronic Respiratory Diseases in Ho Chi Minh City
ClinicalTrials.gov ID: NCT02898129
Acronym / sponsor ID: CHUB-CRD-Housing
Conditions: Chronic Respiratory Diseases
Keywords: chronic respiratory diseases, housing, lung function test
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,500 participants (actual)
Lead sponsor: Brugmann University HospitalUniversity, hospital or other
Study start: Sep 2016
Primary completion: Jul 2017 (actual)
Study completion: Jul 2017 (actual)
First posted: 13 Sep 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The research question is "Are the different types of house in Ho Chi Minh city equally contributing to chronic respiratory diseases?".

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 design

Primary purpose: Screening
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Tube houses	Experimental	Other: Questionnaire, Device: Lung function testTube 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.
Apartment	Experimental	Other: Questionnaire, Device: Lung function testApartments. 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.
Rental Houses	Experimental	Other: Questionnaire, Device: Lung function testRental 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.
Rural houses	Experimental	Other: Questionnaire, Device: Lung function testRural 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.

Who may qualify

Ages: 10 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (1 listed)

Everybody

Key exclusion criteria (2 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Questionnaire	Other	Apartment, Rental Houses, Rural houses, Tube houses
Lung function testBasic lung function test performed with a micro-spirometer, without broncho dilatator	Device	Apartment, Rental Houses, Rural houses, Tube houses

Primary outcome

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.
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.
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
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
Socio-demographic status
Time frame: around 10 minutes
Socio-demographic data, assessed by a home made questionnaire
Health status
Time frame: around 10 minutes
Health status (symptomatology) data, assessed by a home made questionnaire
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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2017.
Background: PubMed 16264058Pellegrino 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.
Background: PubMed 1952453Lung 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.
Background: PubMed 8499054Quanjer 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.
Background: PubMed 7789503Stocks 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.
Background: PubMed 8520796American 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.
Background: PubMed 8499053Cotes 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.
Background: PubMed 8474788Wang 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.
Background: PubMed 2659037Quanjer 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.
Background: PubMed 19716941COPD-more than just tobacco smoke. Lancet. 2009 Aug 29;374(9691):663. doi: 10.1016/S0140-6736(09)61535-X. No abstract available.
Background: PubMed 20223919Bousquet 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.
Background: PubMed 12948968Samet 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.
Background: PubMed 11770681Bardana 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.

Related trials for Chronic Respiratory Diseases

Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Evaluate Axatilimab and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease
Chronic Graft-versus-host-disease
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Questionnaire and Lung function test in people with Chronic Respiratory Diseases, run by Brugmann University Hospital at 1 site in Vietnam.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

FEV1/FVC (time frame: 5 minutes). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02898129, which also lists 35 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2017.