- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03059459
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
Conditions
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
Additional Relevant MeSH Terms
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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