Interaction Between Air Pollution, Pollens and Allergic Rhinitis (MISTRAL)

October 18, 2023 updated by: MASK-air SAS

Interaction Between Air Pollution, Pollens and Allergic Rhinitis in the Aix-Marseille-Provence Metropolis

Seasonal allergic rhinitis has multiple consequences: sleep disturbances, fatigue, depressed mood, impaired quality of life and productivity, and co-morbid conditions such as asthma, which affects one third of AR patients.

In Europe, more than 150 million people suffer from allergic rhinitis and more than 25 million suffer from asthma. About 30% have uncontrolled rhinitis during exposure to allergens. The impact of allergic diseases on work productivity is estimated to be between 30 and 50 billion € per year in the EU.

Studies show that pollution can play a role in the amplification of the response to inhaled pollen allergens by inducing morphological and functional modifications of nasal and bronchial epithelia, but also by inducing structural modifications of allergenic molecules. However, although data show that the symptoms of AR are aggravated by exposure to air pollution, this effect is not observed for all pollens.

The study area is very exposed to pollens (with a significant presence of cypress pollen) and air pollution, and presents a prevalence of asthma of 17% while the national average is about 7%.

The aim of this study is to establish, if they exist, links between pollens of various species, air pollution and symptoms of allergic rhinitis. The knowledge of these links will allow public authorities to set up prevention actions, and patients to better manage their allergic rhinitis on a daily basis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

For this study, the investigators will collect real life data from volunteer citizens via the MASK-air® mobile application, and exposure data to air pollutants and pollens from their partners. The data will be collected over one year in order to cover all pollen seasons.

A communication of the project will be deployed to the citizens in the study area. The recruitment of participants will be done via an internet page accessible to all and presenting the MISTRAL study. Interested citizens can then access the electronic consent platform.

After signing the participation agreement, they will receive a link to download the MASK-air® mobile application (freely available via the Android and Apple stores) and a personal study code, which will allow them to install the application on their smartphone.

Participants will report their symptoms on the MASK-air app on a daily basis. Entry will only take 1 minute/day. This real-life data will be correlated with air pollution and pollen exposure data.

In anticipation of the prevention actions that will be deployed by the public authorities following this study, an analysis of the expectations and needs of the citizens will be carried out among a part of the participants in the form of 4 questionnaires.

Study Type

Observational

Enrollment (Actual)

1215

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Montpellier, France, 34184
        • Https://Clin.Edop.Fr/Etude-Mistral

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

Volunteers living or spending significant time in the study area

Description

Inclusion Criteria:

  • Person 18 years of age and older,
  • Person suffering from seasonal allergic rhinitis (hay fever, pollen allergy),
  • Person with an android and/or IOS smartphone and having the possibility to connect to the internet (via phone subscription or WIFI connection),
  • Person agreeing to install the MASK-air application (medical device) on his personal smartphone,
  • Person agreeing to activate their GPS when using the MASK-air® application for the study,
  • Person having read and understood the information note and having signed their participation agreement prior to any specific study procedure.

Exclusion Criteria:

  • Person who did not sign their participation agreement,
  • Person who has difficulty understanding or reading the information note,
  • Person planning to spend a significant percentage of time outside the area of interest (e.g., due to frequent business or personal travel),
  • Person declaring to be under guardianship, curatorship or safeguard of justice.

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in uncontrolled allergic rhinitis due to exposure to pollutants, exposure to pollens, and their interaction, as defined by VAS scores measuring the global discomfort and the use of medication in the MASK-air app.
Time Frame: Through the whole 1-year data collection period, an average participation of 30 days per participant is expected.

A Visual Analogue Scale (VAS) measuring the global discomfort and the use of medication will be completed by the participants through the MASK-air mobile app.

The minimum value of this VAS is 0 and means "no symptoms". The maximum value of the VAS is 100 and means worse outcome.
Through the whole 1-year data collection period, an average participation of 30 days per participant is expected.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MASK-air SAS

Investigators

  • Principal Investigator: Denis Charpin, Prof, Association pour la Prévention de la Pollution Atmosphérique

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)

June 22, 2021

Primary Completion (Actual)

June 30, 2022

Study Completion (Actual)

June 30, 2022

Study Registration Dates

First Submitted

May 19, 2021

First Submitted That Met QC Criteria

August 10, 2021

First Posted (Actual)

August 16, 2021

Study Record Updates

Last Update Posted (Actual)

October 19, 2023

Last Update Submitted That Met QC Criteria

October 18, 2023

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KM00111

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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