Environmental Pollutants and Their Effects on Respiratory Allergy

Allergic Rhinitis Clinical Trial

Official title:

Association Between Environmental Pollutants and Their Effects on Respiratory

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04902989
• Other study ID #: AL2100004
• Status: Recruiting
• Start date: March 10, 2021
• Est. completion date: August 10, 2022

Study information

• Verified date: May 2021
• Source: Medicina
• Contact: Cindy E. de Lira-Quezada, MD
• Phone: +52 8110690275
• Email: ce.dlira[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 93
• Est. completion date: August 10, 2022
• Est. primary completion date: August 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Allergic Asthma
• Allergic Rhinitis
• Pollution; Exposure
• Rhinitis
• Rhinitis, Allergic

Intervention

Other:
• pollutants and pollen
Pollutants (ozone, SO3, NO3, PM2.5, diesel exhaust particles)

Locations

Country	Name	City	State
Mexico	Regional Center of Allergy and Clinical Immunology, Hospital Universitario "Dr. José Eleuterio González"	Monterrey	Nuevo Leon

Sponsors (2)

Lead Sponsor	Collaborator
Cindy Elizabeth de Lira-Quezada	Medicina

Country where clinical trial is conducted

Mexico, 

References & Publications (10)

Cecchi L, D'Amato G, Annesi-Maesano I. External exposome and allergic respiratory and skin diseases. J Allergy Clin Immunol. 2018 Mar;141(3):846-857. doi: 10.1016/j.jaci.2018.01.016. Review. — View Citation

D'Amato G, Bergmann KC, Cecchi L, Annesi-Maesano I, Sanduzzi A, Liccardi G, Vitale C, Stanziola A, D'Amato M. Climate change and air pollution: Effects on pollen allergy and other allergic respiratory diseases. Allergo J Int. 2014;23(1):17-23. Epub 2014 Feb 19. Review. — View Citation

D'Amato G, Holgate ST, Pawankar R, Ledford DK, Cecchi L, Al-Ahmad M, Al-Enezi F, Al-Muhsen S, Ansotegui I, Baena-Cagnani CE, Baker DJ, Bayram H, Bergmann KC, Boulet LP, Buters JT, D'Amato M, Dorsano S, Douwes J, Finlay SE, Garrasi D, Gómez M, Haahtela T, Halwani R, Hassani Y, Mahboub B, Marks G, Michelozzi P, Montagni M, Nunes C, Oh JJ, Popov TA, Portnoy J, Ridolo E, Rosário N, Rottem M, Sánchez-Borges M, Sibanda E, Sienra-Monge JJ, Vitale C, Annesi-Maesano I. Meteorological conditions, climate change, new emerging factors, and asthma and related allergic disorders. A statement of the World Allergy Organization. World Allergy Organ J. 2015 Jul 14;8(1):25. doi: 10.1186/s40413-015-0073-0. eCollection 2015. — View Citation

Krishnan S, Panacherry S. Asthma, Environment and Pollution: Where the Rubber Hits the Road. Indian J Pediatr. 2018 Oct;85(10):893-898. doi: 10.1007/s12098-018-2691-3. Epub 2018 May 30. Review. — View Citation

Lai CK, Beasley R, Crane J, Foliaki S, Shah J, Weiland S; International Study of Asthma and Allergies in Childhood Phase Three Study Group. Global variation in the prevalence and severity of asthma symptoms: phase three of the International Study of Asthma and Allergies in Childhood (ISAAC). Thorax. 2009 Jun;64(6):476-83. doi: 10.1136/thx.2008.106609. Epub 2009 Feb 22. — View Citation

Landrigan PJ, Fuller R, Acosta NJR, Adeyi O, Arnold R, Basu NN, Baldé AB, Bertollini R, Bose-O'Reilly S, Boufford JI, Breysse PN, Chiles T, Mahidol C, Coll-Seck AM, Cropper ML, Fobil J, Fuster V, Greenstone M, Haines A, Hanrahan D, Hunter D, Khare M, Krupnick A, Lanphear B, Lohani B, Martin K, Mathiasen KV, McTeer MA, Murray CJL, Ndahimananjara JD, Perera F, Potocnik J, Preker AS, Ramesh J, Rockström J, Salinas C, Samson LD, Sandilya K, Sly PD, Smith KR, Steiner A, Stewart RB, Suk WA, van Schayck OCP, Yadama GN, Yumkella K, Zhong M. The Lancet Commission on pollution and health. Lancet. 2018 Feb 3;391(10119):462-512. doi: 10.1016/S0140-6736(17)32345-0. Epub 2017 Oct 19. Review. Erratum in: Lancet. 2018 Feb 3;391(10119):430. — View Citation

Li N, Georas S, Alexis N, Fritz P, Xia T, Williams MA, Horner E, Nel A. A work group report on ultrafine particles (American Academy of Allergy, Asthma & Immunology): Why ambient ultrafine and engineered nanoparticles should receive special attention for possible adverse health outcomes in human subjects. J Allergy Clin Immunol. 2016 Aug;138(2):386-96. doi: 10.1016/j.jaci.2016.02.023. Epub 2016 Apr 6. Review. — View Citation

Murrison LB, Brandt EB, Myers JB, Hershey GKK. Environmental exposures and mechanisms in allergy and asthma development. J Clin Invest. 2019 Apr 1;129(4):1504-1515. doi: 10.1172/JCI124612. Epub 2019 Feb 11. Review. — View Citation

Nathan RA, Sorkness CA, Kosinski M, Schatz M, Li JT, Marcus P, Murray JJ, Pendergraft TB. Development of the asthma control test: a survey for assessing asthma control. J Allergy Clin Immunol. 2004 Jan;113(1):59-65. — View Citation

Traina G, Barbalace A, Betti F, Bolzacchini E, Bonini M, Contini D, Felice G, Foti T, Mantecca P. What impact of air pollution in pediatric respiratory allergic diseases. Pediatr Allergy Immunol. 2020 Nov;31 Suppl 26:26-28. doi: 10.1111/pai.13362. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Association of respiratory symptoms with exposure to pollutants and pollen	To determine the relationship between exposure to environmental pollutants and the prevalence and exacerbation of respiratory allergy.	1 year
Secondary	Avenues with highest diesel exhaust particles and traffic related particles	Locate the avenues with the highest flow and vehicular load releasing diesel removal particles (DEP) and traffic-related air pollutants (TRAP).	1 year
Secondary	Location of the main industries that emit pollutants	Location of the main industries that emit pollutants of particulate matter (PM), nitrogen dioxide (NO2), sulfur dioxide (SO2), carbon monoxide (CO) and ozone (O3).	1 year
Secondary	Distance of greater exposure to pollutants	To assess the relationship between the distance to PM, traffic-related air pollutants (TRAP) and diesel exhaust particles (DEP) with the prevalence of respiratory allergy symptoms with home and work address.	1 year
Secondary	Time of pollutant exposure and association with respiratory symptoms	Evaluate the relationship between the time of exposure to PM, NO2, SO2, O3, traffic-related air pollutants (TRAP) and diesel exhaust particles (DEP) with the prevalence of respiratory allergy symptoms.	1 year