Allergic Rhinitis Due to PollenMISTRALNCT05007327
Interaction Between Air Pollution, Pollens and Allergic Rhinitis
An observational study of Allergic Rhinitis Due to Pollen and Allergic Rhinitis With Asthma, run by MASK-air SAS at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Allergic Rhinitis Due to Pollen, Allergic Rhinitis With Asthma
- What is being tested?
- Exposure to pollen and air pollution
- How many people
- 1,215 participants
- Where
- 1 siteFrance
- Study dates
- 22 Jun 2021to 30 Jun 2022
- 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: Volunteers living or spending significant time in the study area
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Being tested
- Exposure to pollen and air pollution
- Keywords
- Air pollution, Pollen, Allergic rhinitis
- Medical subject headings
- Rhinitis, Allergic, Seasonal, Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure to pollen and air pollutionOther
For all subjects of the cohort, we will follow exposure to pollen and air pollution.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
Measured: Through the whole 1-year data collection period, an average participation of 30 days per participant is expected.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2021
- Study start22 Jun 2021
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic Rhinitis Due to PollenStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,215 participants (actual)
Sponsor and investigators
- Lead sponsor
- MASK-air SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Denis Charpin, Prof, Principal investigator, Association pour la Prévention de la Pollution Atmosphérique
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05007327
- Sponsor's protocol ID
- KM00111
- Acronym
- MISTRAL
- Status last verified
- Aug 2021
- First submitted
- 19 May 2021
- Last updated
- 19 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interaction Between Air Pollution, Pollens and Allergic Rhinitis in the Aix-Marseille-Provence Metropolis
- ClinicalTrials.gov ID
- NCT05007327
- Acronym / sponsor ID
- MISTRAL / KM00111
- Keywords
- Air pollution, Pollen, Allergic rhinitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,215 participants (actual)
- Lead sponsor
- MASK-air SASIndustry (pharma, biotech, devices)
- Study start
- 22 Jun 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 16 Aug 2021 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Volunteers living or spending significant time in the study area
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Exposure to pollen and air pollutionFor all subjects of the cohort, we will follow exposure to pollen and air pollution. | Other | – |
Primary outcome
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.
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 19 Oct 2023.
- Individual participant dataSharing planned: No
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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.
Denis Charpin, Prof principal investigator
Association pour la Prévention de la Pollution Atmosphérique
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 Allergic Rhinitis Due to Pollen and Allergic Rhinitis With Asthma, run by MASK-air SAS 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 6 inclusion and 4 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 19 Oct 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?
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.). 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 19 Oct 2023.