Clinical trial NCT04902989: Environmental Pollutants and Their Effects on Respiratory Allergy
Official title: Association Between Environmental Pollutants and Their Effects on Respiratory
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Allergic Rhinitis
Allergic Asthma
Pollution; Exposure
Keywords: pollutants
allergy
symptoms
Lead sponsor: Medicina
Sponsor class: OTHER
Collaborators: name: Medicina
First posted: 2021-05-26
Enrollment: 93
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects older than 6 years of age, who attend the Regional Center of Allergy and Clinical Immunology of the University Hospital "Dr. José Eleuterio González "with a diagnosis of respiratory allergy (allergic rhinitis and asthma) and type I immunological hypersensitivity demonstrated by skin tests performed by an allergist and who live in Monterrey or its metropolitan area.

They will be invited to participate in the protocol and if they agree to be included, they will respond to informed verbal consent or assent.

Brief summary: In Latin America and the Caribbean, more than 100 million people are exposed to higher levels of pollution than those recommended by WHO. The objective of the study is to determine the relationship between exposure to environmental pollutants and the prevalence and exacerbation of respiratory allergy. It is an observational, prospective, longitudinal and descriptive study that will include subjects older than 6 years who come to the consultation of the Regional Center for Allergy and Clinical Immunology with a diagnosis of respiratory allergy, positive skin tests and who live in Monterrey and its metropolitan area. After verbal assent, the subject's address and work area will be registered, the Rhinitis Control Assessment Test and the Asthma Control Test as well as spirometry will be made. The geolocation of industries and avenues near the address and work area of subjects will be carried out, as well as the determination of pollutants and pollens by the Integral Monitoring System (SIMA) and the Pollen Sense device. Subsequently, the correlation between exposure to pollutants and respiratory allergy will be analyzed. Dispersion models will be built considering pollutants and climatic factors (precipitation, wind speed, humidity and temperature). By carrying out this project, it will be possible to contribute to the identification of the factors that lead to the development and exacerbation of allergic respiratory diseases and subsequently propose the implementation of measures for their control and recommendations for prevention to the population.


Eligibility criteria: Inclusion Criteria:

* Subjects over 6 years of age who attend the the Regional Center of Allergy and Clinical Immunology of the University Hospital "Dr. José Eleuterio González "with a diagnosis of respiratory allergy (allergic rhinitis and asthma) and type I immunological hypersensitivity demonstrated by skin tests by an allergist; and who live in the city of Monterrey and its metropolitan area.

Exclusion Criteria:

* Subjects for whom it is not possible to perform a pulmonary function test or who have concomitant diseases such as COPD, heart disease or some other pathology that, in the opinion of the investigator, may cause confusion with respiratory symptoms. Patients with negative skin tests to aeroallergens.

Primary outcomes:
measure: Association of respiratory symptoms with exposure to pollutants and pollen
timeFrame: 1 year
Secondary outcomes:
measure: Avenues with highest diesel exhaust particles and traffic related particles
timeFrame: 1 year
measure: Location of the main industries that emit pollutants
timeFrame: 1 year
measure: Distance of greater exposure to pollutants
timeFrame: 1 year
measure: Time of pollutant exposure and association with respiratory symptoms
timeFrame: 1 year
Other outcomes:
Locations:
city: Monterrey
country: Mexico
facility: Regional Center of Allergy and Clinical Immunology, Hospital Universitario "Dr. José Eleuterio González"
state: Nuevo Leon
Study officials:
affiliation: Head of the Allergy and Clinical Immunology Service
name: Sandra N Gonzalez Diaz, MD,PhD
role: STUDY_DIRECTOR
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