Interaction Between Air Pollution, Pollens and Allergic Rhinitis

NCT05007327 | Completed

• 1 other identifier: KM00111
• Study Type: observational
• Target: 1,215
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Allergic Rhinitis Due to Pollen; Allergic Rhinitis With Asthma

Keywords

Air pollution; Pollen; Allergic rhinitis

Outcome Measures

Primary Outcomes (1)

• 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.

  Through the whole 1-year data collection period, an average participation of 30 days per participant is expected.

Interventions

Exposure to pollen and air pollution OTHER

For all subjects of the cohort, we will follow exposure to pollen and air pollution.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Volunteers living or spending significant time in the study area

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• MASK-air SAS: lead

Study Sites (1)

Https://Clin.Edop.Fr/Etude-Mistral

Montpellier, 34184, France

Location

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal; Rhinitis, Allergic

Interventions

Air Pollution

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Environmental Pollution; Public Health; Environment and Public Health

Study Officials

• Denis Charpin, Prof

  Association pour la Prévention de la Pollution Atmosphérique

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2021
• First Posted: August 16, 2021
• Study Start: June 22, 2021
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: October 19, 2023

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)