Acute Exacerbation CopdPolluBPCONCT03079661
Impact of Air Quality on Exacerbations of COPD in the Somme
An observational study of Acute Exacerbation Copd, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
All COPD patients with a diagnosis of acute exacerbation in emergency room in University Hospital of Amiens-Picardie between 01/01/2017 and 31/12/2017. The investigator will collect for each patient the home address and the work address. The duration of 1 year was chosen to take into account seasonal variations. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Exacerbation Copd
- How many people
- 179 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2017to 14 Jan 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The primary endpoint is the number of exacerbations of COPD corresponding to the variable of interest to be explained. The other variables are the explanatory variables (air quality data PM2.5, PM10, NO2, O3 as well as pollen data, seasonal variations, influenza epidemic and olfactory nuisance). The final diagnosis will also be collected.
Who may be able to join
- All COPD patients with a diagnosis of acute exacerbation of COPD in the emergency room. The definition of COPD and acute exacerbation are the official definition of the Société de Pneumologie en Langue Française.
Who cannot join
- no exclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
All COPD patients with a diagnosis of acute exacerbation in emergency room in University Hospital of Amiens-Picardie between 01/01/2017 and 31/12/2017. The investigator will collect for each patient the home address and the work address. 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 Picardie.
- Conditions
- Acute Exacerbation Copd
- Keywords
- pollution, ozone, Copd, particles
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
exacerbation rate : variable to be explicated with explicative variable : ozone, particles, dioxide nitrogen, but also pollens corresponding to each patient home address for period of exacerbation
exacerbation rate : variable to be explicated with explicative variable : ozone, particles, dioxide nitrogen, but also pollens corresponding to each patient home address for period of exacerbation
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2017
- Study start1 Jan 2017
- Primary completion14 Jan 2019
- Study completion14 Jan 2019
Why it stopped: investigator choice
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Exacerbation CopdStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- 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
- 179 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03079661
- Sponsor's protocol ID
- RNI2016-42
- Acronym
- PolluBPCO
- Status last verified
- Jul 2020
- First submitted
- 9 Mar 2017
- Last updated
- 15 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Basille D, Soriot L, Weppe F, Desmettres P, Henriques P, Benoit N, Devaux S, Diouf M, Jounieaux V, Andrejak C. Association between acute exacerbation of chronic obstructive pulmonary disease and short-term exposure to ambient air pollutants in France. Environ Health. 2024 Nov 29;23(1):107. doi: 10.1186/s12940-024-01146-3.
PubMed 39614356
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Air Quality on Exacerbations of COPD in the Somme
- ClinicalTrials.gov ID
- NCT03079661
- Acronym / sponsor ID
- PolluBPCO / RNI2016-42
- Conditions
- Acute Exacerbation Copd
- Keywords
- pollution, ozone, Copd, particles
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: investigator choice
- Enrolment
- 179 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 14 Jan 2019 (actual)
- Study completion
- 14 Jan 2019 (actual)
- First posted
- 14 Mar 2017 (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.
All COPD patients with a diagnosis of acute exacerbation in emergency room in University Hospital of Amiens-Picardie between 01/01/2017 and 31/12/2017. The investigator will collect for each patient the home address and the work address. 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 Picardie.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The primary endpoint is the number of exacerbations of COPD corresponding to the variable of interest to be explained. The other variables are the explanatory variables (air quality data PM2.5, PM10, NO2, O3 as well as pollen data, seasonal variations, influenza epidemic and olfactory nuisance). The final diagnosis will also be collected.
Key inclusion criteria (1 listed)
- All COPD patients with a diagnosis of acute exacerbation of COPD in the emergency room. The definition of COPD and acute exacerbation are the official definition of the Société de Pneumologie en Langue Française.
Key exclusion criteria (1 listed)
- no exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
exacerbation rate : variable to be explicated with explicative variable : ozone, particles, dioxide nitrogen, but also pollens corresponding to each patient home address for period of exacerbation
Time frame: 1 day
exacerbation rate : variable to be explicated with explicative variable : ozone, particles, dioxide nitrogen, but also pollens corresponding to each patient home address for period of exacerbation
Results and safety
The study was stopped early (reason given: investigator choice). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2020.
- Derived from this study: PubMed 39614356Basille D, Soriot L, Weppe F, Desmettres P, Henriques P, Benoit N, Devaux S, Diouf M, Jounieaux V, Andrejak C. Association between acute exacerbation of chronic obstructive pulmonary disease and short-term exposure to ambient air pollutants in France. Environ Health. 2024 Nov 29;23(1):107. doi: 10.1186/s12940-024-01146-3.
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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 Acute Exacerbation Copd, 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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 15 Jul 2020. 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 was stopped early (reason given: investigator choice). Results are not available in the source record.
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?
exacerbation rate : variable to be explicated with explicative variable : ozone, particles, dioxide nitrogen, but also pollens corresponding to each patient home address for period of exacerbation (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03079661, which also lists 1 linked publication.
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 15 Jul 2020.