Effect of Atmospheric Pollution on Obstructive Lung Diseases

January 23, 2018 updated by: Pablo Orellano, Dr.PH, National Council of Scientific and Technical Research, Argentina

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

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.

Study Overview

Status

Unknown

Study Type

Observational

Enrollment (Actual)

117

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients attending the pulmonary service of a public hospital located in San Nicolas, Buenos Aires province, Argentina.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Asthma or COPD hospitalizations or emergency department visits
Time Frame: 12 months
Asthma or COPD hospitalizations or emergency department visits measured by hospital records
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life associated with obstructive lung diseases
Time Frame: 12 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Pablo Orellano, Dr.PH, National Scientific and Technical Research Council, Argentina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 4, 2015

Primary Completion (Anticipated)

December 4, 2018

Study Completion (Anticipated)

December 4, 2018

Study Registration Dates

First Submitted

February 15, 2017

First Submitted That Met QC Criteria

February 16, 2017

First Posted (Actual)

February 23, 2017

Study Record Updates

Last Update Posted (Actual)

January 25, 2018

Last Update Submitted That Met QC Criteria

January 23, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • 2919/1191/15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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