NCT03904875

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 4, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 5, 2019

Completed
9 months until next milestone

Study Start

First participant enrolled

January 1, 2020

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 12, 2022

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 12, 2023

Completed
Last Updated

September 13, 2023

Status Verified

September 1, 2023

Enrollment Period

2.2 years

First QC Date

April 4, 2019

Last Update Submit

September 12, 2023

Conditions

Keywords

pollutionChronic Obstructive Pulmonary Diseaseultrathin particles

Outcome Measures

Primary Outcomes (2)

  • 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

    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.

    every day during 12 months

Secondary Outcomes (1)

  • chemical composition ultrathin particles

    every day during 12 months

Interventions

COPD is chronic obstructive pulmonary disease. Data collected are need of hospitalisation, final diagnosis, home address, work address and air quality data.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • patients non covered by national health insurance
  • patients not able to express consent
  • minors

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens

Amiens, 80480, France

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2019

First Posted

April 5, 2019

Study Start

January 1, 2020

Primary Completion

March 12, 2022

Study Completion

September 12, 2023

Last Updated

September 13, 2023

Record last verified: 2023-09

Locations