Effect of Atmospheric Pollution on Obstructive Lung Diseases

Lung Diseases, Obstructive Clinical Trial

Official title:

Effect of Atmospheric Pollution Due to Particulate Matter on Obstructive Lung Diseases in San Nicolas, Buenos Aires Province, Argentina

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03059459
• Other study ID #: 2919/1191/15
• Status: Active, not recruiting
• Phase: N/A
• First received: February 15, 2017
• Last updated: January 23, 2018
• Start date: December 4, 2015
• Est. completion date: December 4, 2018

Study information

• Verified date: January 2018
• Source: National Council of Scientific and Technical Research, Argentina
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Several studies have demonstrated the association between atmospheric pollution and chronic respiratory diseases. The magnitude of this association and its dependence of local factors are still unknown in Argentina, particularly for obstructive lung diseases like asthma and chronic obstructive pulmonary disease (COPD). The objective of this study is to assess the effect of atmospheric pollution due to particulate matter (PM) on asthma and COPD exacerbations in adults. A prospective cohort study will be carried out in patients attending the pulmonary service of a public hospital located in San Nicolas, Buenos Aires province, Argentina. Patients will be followed for 12 months after recruitment. The outcome variables will be the frequency of hospitalizations or emergency department consults for asthma or COPD exacerbations and related conditions, and the impact of COPD on a person's life as measured by the COPD assessment test (CAT) questionnaire. The exposure will be the pollution level in the particular address, measuring PM10 concentrations with portable equipment. Other variables as air temperature, humidity, and individual patient risk factors will be considered as potential confounders or effect modifiers. The associations will be estimated through regression models, i.e. logistic and Poisson regressions and recurrent event survival analysis. The results of this study should provide elements to estimate the risk of chronic respiratory diseases associated with atmospheric pollution, and to evaluate strategies for risk assessment in the local community.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 117
• Est. completion date: December 4, 2018
• Est. primary completion date: December 4, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with asthma or COPD attending the pulmonary service.

Exclusion Criteria:

• Patients who refuse to participate in this study or to sign the informed consent document.

Related Conditions & MeSH terms

• Lung Diseases
• Lung Diseases, Obstructive

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Council of Scientific and Technical Research, Argentina

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Asthma or COPD hospitalizations or emergency department visits	Asthma or COPD hospitalizations or emergency department visits measured by hospital records	12 months
Secondary	Quality of life associated with obstructive lung diseases	The quality of life associated with obstructive lung diseases will be measured with a short patient-completed questionnaire, the COPD Assessment Test (CAT).	12 months