- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03904875
Air Pollution and COPD Exacerbation (BePoPi)
September 12, 2023 updated by: Centre Hospitalier Universitaire, Amiens
Impact of Air Pollution on Chronic Obstructive Pulmonary Disease (COPD) Exacerbation in Haut de France. BePoPi Project.
There is an excess of hospitalization rates for acute exacerbation of COPD in Picardy compared to the national data.
A first study realized in Picardy has shown a link between air quality and COPD.
Nevertheless, the particles type is unknown and according to it, impact on COPD could be different.
The investigator goal is to find a correlation between acute exacerbation of COPD consultation rate and daily ultra thin particles in Haut de France.
The investigators will correlate the particles composition with daily acute exacerbation of COPD rate.
All COPD patients with a diagnosis of acute exacerbation in emergency room in University Hospital of Amiens-Picardie and Lille, and Clinique de l'Europe between 01/01/2020 and 31/12/2020 will be included.
For each patient, home and work address will be collected.
The duration of 1 year was chosen to take into account seasonal variations.
In parallel, a daily report of the rate of ozone, particles (PM2.5 and PM10), dioxide nitrogen but also odours and pollens will be done by ATMO Haut de France.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
120
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Amiens, France, 80480
- CHU Amiens
-
-
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
Sampling Method
Non-Probability Sample
Study Population
All COPD patients with a diagnosis of acute exacerbation in emergency room in University Hospital of Amiens-Picardie and Lille, and Clinique de l'Europe between 01/01/2020 and 31/12/2020 will be included.
Home and work address and spirometric data will be collected.
Atmo Hauts-de-France will collect daily data on PM10, PM2,5, NO2 et O3 in Amiens and Lille metropoles.
Odours and pollens will be collected too by ATMO Haut de France.
Description
Inclusion Criteria:
- COPD patients with a diagnosis of acute exacerbation of COPD in the emergency room of Amiens and Lille centers
- Adults
- Patients able to express consent
- signed written informed consent form
- covered by national health insurance
Exclusion Criteria:
- patients non covered by national health insurance
- patients not able to express consent
- minors
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 |
|---|---|---|
|
daily rate of COPD exacerbation consultation in the emergency room of the 3 centers
Time Frame: every day during 12 months
|
daily rate of COPD exacerbation consultation in the emergency room of the 3 centers
|
every day during 12 months
|
|
ultrathin particles quantity in the air
Time Frame: every day during 12 months
|
ultrathin particles quantity will be determined by the air of "Haut de France" by the company ATMO Haut de France.
|
every day during 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
chemical composition ultrathin particles
Time Frame: every day during 12 months
|
chemical composition ultrathin particles will be determined by the air of "Haut de France" by the company ATMO Haut de France.
|
every day during 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Claire Andrejak, Pr, CHU Amiens
- Principal Investigator: Damien BASILLE, MD, CHU Amiens
- Principal Investigator: Vincent Jounieaux, Pr, CHU Amiens
- Principal Investigator: Nicolas Benoit, MD, Clinique de l'Europe, Amiens
- Principal Investigator: Youcef Douadi, MD, Clinique de l'Europe, Amiens
- Principal Investigator: Olivier Le Rouzic, MD, CHRU Lille
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)
January 1, 2020
Primary Completion (Actual)
March 12, 2022
Study Completion (Actual)
September 12, 2023
Study Registration Dates
First Submitted
April 4, 2019
First Submitted That Met QC Criteria
April 4, 2019
First Posted (Actual)
April 5, 2019
Study Record Updates
Last Update Posted (Actual)
September 13, 2023
Last Update Submitted That Met QC Criteria
September 12, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PI2019_843_0008
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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