Effect of Atmospheric Pollution on Obstructive Lung Diseases

Sponsor
National Council of Scientific and Technical Research, Argentina (Other)
Overall Status
Unknown status
CT.gov ID
NCT03059459
Collaborator
(none)
117
36

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    117 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Effect of Atmospheric Pollution Due to Particulate Matter on Obstructive Lung Diseases in San Nicolas, Buenos Aires Province, Argentina
    Actual Study Start Date :
    Dec 4, 2015
    Anticipated Primary Completion Date :
    Dec 4, 2018
    Anticipated Study Completion Date :
    Dec 4, 2018

    Outcome Measures

    Primary Outcome Measures

    1. Asthma or COPD hospitalizations or emergency department visits [12 months]

      Asthma or COPD hospitalizations or emergency department visits measured by hospital records

    Secondary Outcome Measures

    1. Quality of life associated with obstructive lung diseases [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).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • National Council of Scientific and Technical Research, Argentina

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Pablo Orellano, Dr.PH, Researcher, National Council of Scientific and Technical Research, Argentina
    ClinicalTrials.gov Identifier:
    NCT03059459
    Other Study ID Numbers:
    • 2919/1191/15
    First Posted:
    Feb 23, 2017
    Last Update Posted:
    Jan 25, 2018
    Last Verified:
    Jan 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Pablo Orellano, Dr.PH, Researcher, National Council of Scientific and Technical Research, Argentina
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 25, 2018