Airway ObstructionELISABETNCT02490553
Epidemiological Study on the Relationship Between Respiratory Health and Air Pollution From Industrial Sources
An observational study of Airway Obstruction and Hypertension, run by University Hospital, Lille.
Trial summary
The ELISABET STUDY is across sectional Survey on a representative sample of two urban area conduct on a representative sample. The main objective of the project is to compare the prevalence of the obstructive ventilatory disorders (OVD) in the Urban Community of Dunkirk touched by the industrial pollution in relation… Read more about this study
- Who is it for?
- Ages 40 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Airway Obstruction, Hypertension, Diabetes Mellitus
- What is being tested?
- heteroevaluation scale by a nurse or doctor
- How many people
- 3,276 participants
- Where
- No sites listed yet
- Study dates
- Jan 2011to Feb 2014
- 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 40 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The participants were selected from electoral rolls by random sampling, with stratification for gender, age and centercentre (Lille or Dunkirk). All participants were all recruited between January 2011 and November 2013. Each selected participant received a letter asking him/her to contact the coordinating team and make an appointment for data collection. In the absence of a reply, participants were contacted by telephone. Data was collected at home (occasionally during a consultation in a healthcare establishment). In all cases, a trained, registered nurse administered a detailed questionnaire and performed spirometry testing.
Who may be able to join
- had lived for at least 5 years in the same city or its surrounding urban area (either Lille or Dunkirk) in the northern of France
- Agreed to participate and signed contentment
Who cannot join
- The detainees
- People under legal protection
- Individuals unable to consent
About this study
Official title: ELISABET : Enquête LIttoral Souffle Air Biologie Environnement
The ELISABET STUDY is across sectional Survey on a representative sample of two urban area conduct on a representative sample. The main objective of the project is to compare the prevalence of the obstructive ventilatory disorders (OVD) in the Urban Community of Dunkirk touched by the industrial pollution in relation to the one recovered in the Urban Community of Lille (CUDL) less industrialized.
Read the detailed description
Airflow obstruction include Pulmonary Disease, Chronic Obstruction and asthma. Identification of Airflow obstruction is through Functional Tests Lung. In the 1950s, high pollution levels were associated with increased mortality. Despite a reduction of air pollution, it has been established that pollution peaks have short-term effects on acute respiratory episodes. The Urban Community of Dunkirk (CUD) focuses many large pollutant emitters. The long term effects of industrial pollution on TVO are unknown.
The main objective of the project is to compare the prevalence of Airflow obstruction in the Urban Community of Dunkirk affected by industrial pollution compared to that found in the Urban Community of Lille (CUDL) less industrialized. Secondary objectives are: 1) To assess the relationship between air pollution from industrial and biological markers, particularly the plasma concentrations of heavy metals 2) To assess the prevalence of TVO general population in French populations 3) Establish a baseline epidemiological and biological bank.
- Conditions
- Airway Obstruction, Hypertension, Diabetes Mellitus, Dyslipidemias, Pulmonary Disease, Chronic Obstructive
- Being tested
- heteroevaluation scale by a nurse or doctor
- Keywords
- air pollution, epidemiological survey, representative sample
- Medical subject headings
- Airway Obstruction, Hypertension, Diabetes Mellitus, Dyslipidemias, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
heteroevaluation scale by a nurse or doctorOther
| Study group | Role | What they receive |
|---|---|---|
| Dunkirk area | Representative sample of Dunkirk and the surrounding urban area (of ~200 000inhabitants).Dunkirk area is characterize by high emission of industrial air pollutant Receives: Other: heteroevaluation scale by a nurse or doctor | |
| Lille area | Representative sample of Lille and the surrounding urban area (of ~1 million inhabitants, the fourth urban area in France) Receives: Other: heteroevaluation scale by a nurse or doctor |
What is being measured
The primary outcome is the main question the study is designed to answer.
airway obstruction
Forced expiratory volume per second (FEV1) to forced vital capacity (FVC) ratio below 0.7. mesured by standardized spirometry
Spirometry testing was performed mostly at home using Micro 6000 spirometers (Medisoft; Sorinnes, Belgium), according to the 2005 ATS/ERS guidelines. The spirometers were calibrated weekly. No bronchodilators were administered. For each participant, the spirometry test was repeated (up to seven times) until three acceptable, reproducible flow-volume loops were obtained, following the same guidelines. The greatest reproducible values of FEV1 and FVC were selected for the statistical analysis (regardless of whether these two values came from separate curves or from the same curve). All spirometry data were validated by an experienced, specialist physician.
Measured: during a the single visit scheduled (less than 3 hours in the morning)
Secondary outcomes (3)
hypertension
Hypertension was defined as ongoing antihypertensive treatment, an Systolic blood pressure >=140 mmHg or a Diastolic Blood pressure >=90 mmHg
Measured: during a the single visit scheduled (less than 3 hours in the morning)
dyslipidemia
Dyslipidemia was defined as ongoing cholesterol-lowering treatment or one or more abnormal fasting blood lipid values (total cholesterol 2.4 g/L, LDLcholesterol>=1.6 g/L, HDLcholesterol <0.4 g/L or blood triglycerides >=2 g/L)
Measured: during a the single visit scheduled (less than 3 hours in the morning)
diabetes mellitus
Diabetes mellitus was defined as ongoing antidiabetes treatment (oral medication or insulin) or a fasting blood glucose (FBG) level >=1.26 g/L
Measured: during a the single visit scheduled (less than 3 hours in the morning)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2015 (estimated)
- Study startJan 2011
- Primary completionNov 2013
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway ObstructionStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe 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
- Time perspective
- Cross-sectional
- Enrolment
- 3,276 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luc Dauchet, PhD MD, Principal investigator, CHRU LILLE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02490553
- Sponsor's protocol ID
- 2009_32/1003
- Other IDs
- 2010-A00065-34
- Acronym
- ELISABET
- Status last verified
- Jul 2015
- First submitted
- 25 Jun 2015
- Last updated
- 7 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ELISABET : Enquête LIttoral Souffle Air Biologie Environnement
- ClinicalTrials.gov ID
- NCT02490553
- Acronym / sponsor ID
- ELISABET / 2009_32/1003
- Conditions
- Airway Obstruction, Hypertension, Diabetes Mellitus, Dyslipidemias, Pulmonary Disease, Chronic Obstructive
- Keywords
- air pollution, epidemiological survey, representative sample
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,276 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Nov 2013 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 7 Jul 2015 (estimated)
- 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.
The ELISABET STUDY is across sectional Survey on a representative sample of two urban area conduct on a representative sample. The main objective of the project is to compare the prevalence of the obstructive ventilatory disorders (OVD) in the Urban Community of Dunkirk touched by the industrial pollution in relation to the one recovered in the Urban Community of Lille (CUDL) less industrialized.
Detailed description
Airflow obstruction include Pulmonary Disease, Chronic Obstruction and asthma. Identification of Airflow obstruction is through Functional Tests Lung. In the 1950s, high pollution levels were associated with increased mortality. Despite a reduction of air pollution, it has been established that pollution peaks have short-term effects on acute respiratory episodes. The Urban Community of Dunkirk (CUD) focuses many large pollutant emitters. The long term effects of industrial pollution on TVO are unknown.
The main objective of the project is to compare the prevalence of Airflow obstruction in the Urban Community of Dunkirk affected by industrial pollution compared to that found in the Urban Community of Lille (CUDL) less industrialized. Secondary objectives are: 1) To assess the relationship between air pollution from industrial and biological markers, particularly the plasma concentrations of heavy metals 2) To assess the prevalence of TVO general population in French populations 3) Establish a baseline epidemiological and biological bank.
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dunkirk area | – | Other: heteroevaluation scale by a nurse or doctorRepresentative sample of Dunkirk and the surrounding urban area (of ~200 000inhabitants).Dunkirk area is characterize by high emission of industrial air pollutant |
| Lille area | – | Other: heteroevaluation scale by a nurse or doctorRepresentative sample of Lille and the surrounding urban area (of ~1 million inhabitants, the fourth urban area in France) |
Who may qualify
- Ages
- 40 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The participants were selected from electoral rolls by random sampling, with stratification for gender, age and centercentre (Lille or Dunkirk). All participants were all recruited between January 2011 and November 2013. Each selected participant received a letter asking him/her to contact the coordinating team and make an appointment for data collection. In the absence of a reply, participants were contacted by telephone. Data was collected at home (occasionally during a consultation in a healthcare establishment). In all cases, a trained, registered nurse administered a detailed questionnaire and performed spirometry testing.
Key inclusion criteria (2 listed)
- had lived for at least 5 years in the same city or its surrounding urban area (either Lille or Dunkirk) in the northern of France
- Agreed to participate and signed contentment
Key exclusion criteria (3 listed)
- The detainees
- People under legal protection
- Individuals unable to consent
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 |
|---|---|---|
| heteroevaluation scale by a nurse or doctor | Other | Dunkirk area, Lille area |
Primary outcome
airway obstruction
Time frame: during a the single visit scheduled (less than 3 hours in the morning)
Forced expiratory volume per second (FEV1) to forced vital capacity (FVC) ratio below 0.7. mesured by standardized spirometry Spirometry testing was performed mostly at home using Micro 6000 spirometers (Medisoft; Sorinnes, Belgium), according to the 2005 ATS/ERS guidelines. The spirometers were calibrated weekly. No bronchodilators were administered. For each participant, the spirometry test was repeated (up to seven times) until three acceptable, reproducible flow-volume loops were obtained, following the same guidelines. The greatest reproducible values of FEV1 and FVC were selected for the statistical analysis (regardless of whether these two values came from separate curves or from the same curve). All spirometry data were validated by an experienced, specialist physician.
3 secondary outcomes
hypertension
Time frame: during a the single visit scheduled (less than 3 hours in the morning)
dyslipidemia
Time frame: during a the single visit scheduled (less than 3 hours in the morning)
diabetes mellitus
Time frame: during a the single visit scheduled (less than 3 hours in the morning)
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 7 Jul 2015.
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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.
Luc Dauchet, PhD MD principal investigator
CHRU LILLE
Questions about this trial
What is this clinical trial studying?
An observational study of Airway Obstruction and Hypertension, run by University Hospital, Lille.
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 2 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 7 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
airway obstruction (time frame: during a the single visit scheduled (less than 3 hours in the morning)). 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 7 Jul 2015.