NCT03059459

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
117

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2015

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 4, 2015

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 15, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 23, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 4, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 4, 2018

Completed
Last Updated

January 25, 2018

Status Verified

January 1, 2018

Enrollment Period

3 years

First QC Date

February 15, 2017

Last Update Submit

January 23, 2018

Conditions

Keywords

Lung Diseases, ObstructiveAir PollutionParticulate Matter

Outcome Measures

Primary Outcomes (1)

  • Asthma or COPD hospitalizations or emergency department visits

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

    12 months

Secondary Outcomes (1)

  • Quality of life associated with obstructive lung diseases

    12 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Patients with asthma or COPD attending the pulmonary service.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Lung Diseases, Obstructive

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Study Officials

  • Pablo Orellano, Dr.PH

    National Scientific and Technical Research Council, Argentina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

February 15, 2017

First Posted

February 23, 2017

Study Start

December 4, 2015

Primary Completion

December 4, 2018

Study Completion

December 4, 2018

Last Updated

January 25, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share