Pollution; ExposureBePoPiNCT03904875
Air Pollution and COPD Exacerbation
An observational study of Pollution; Exposure and Chronic Obstructive Pulmonary Disease, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pollution; Exposure, Chronic Obstructive Pulmonary Disease
- What is being tested?
- collection of data about each acute exacerbation of COPD
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2020to 12 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- patients non covered by national health insurance
- patients not able to express consent
- minors
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- collection of data about each acute exacerbation of COPD
- Keywords
- pollution, Chronic Obstructive Pulmonary Disease, ultrathin particles
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
collection of data about each acute exacerbation of COPDOther
COPD is chronic obstructive pulmonary disease. Data collected are need of hospitalisation, final diagnosis, home address, work address and air quality data.
What is being measured
The primary outcome is the main question the study is designed to answer.
daily rate of COPD exacerbation consultation in the emergency room of the 3 centers
daily rate of COPD exacerbation consultation in the emergency room of the 3 centers
Measured: every day during 12 months
ultrathin particles quantity in the air
ultrathin particles quantity will be determined by the air of "Haut de France" by the company ATMO Haut de France.
Measured: every day during 12 months
Secondary outcomes (1)
chemical composition ultrathin particles
chemical composition ultrathin particles will be determined by the air of "Haut de France" by the company ATMO Haut de France.
Measured: every day during 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2019
- Study start1 Jan 2020
- Primary completion12 Mar 2022
- Study completion12 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pollution; ExposureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Collaborators
- Clinique de l'Europe, Amiens, University Hospital, Lille
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03904875
- Sponsor's protocol ID
- PI2019_843_0008
- Acronym
- BePoPi
- Status last verified
- Sep 2023
- First submitted
- 4 Apr 2019
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Air Pollution on Chronic Obstructive Pulmonary Disease (COPD) Exacerbation in Haut de France. BePoPi Project.
- ClinicalTrials.gov ID
- NCT03904875
- Acronym / sponsor ID
- BePoPi / PI2019_843_0008
- Keywords
- pollution, Chronic Obstructive Pulmonary Disease, ultrathin particles
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Collaborators
- Clinique de l'Europe, Amiens, University Hospital, Lille
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 12 Mar 2022 (actual)
- Study completion
- 12 Sep 2023 (actual)
- First posted
- 5 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- patients non covered by national health insurance
- patients not able to express consent
- minors
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| collection of data about each acute exacerbation of COPDCOPD is chronic obstructive pulmonary disease. Data collected are need of hospitalisation, final diagnosis, home address, work address and air quality data. | Other | – |
Primary outcome
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
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.
1 secondary outcome
chemical composition ultrathin particles
Time frame: every day during 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pollution; Exposure and Chronic Obstructive Pulmonary Disease, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
daily rate of COPD exacerbation consultation in the emergency room of the 3 centers (time frame: every day during 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2023.