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Allergic RhinitisNCT04902989

Environmental Pollutants and Their Effects on Respiratory Allergy

An observational study of Allergic Rhinitis and Allergic Asthma, run by Cindy Elizabeth de Lira-Quezada at 1 site in Mexico.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 6 years and older
What is being tested?
pollutants and pollen
How many people
93 participants
Where
1 siteMexico
Study dates
10 Mar 2021to 10 Aug 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 6 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Cindy E. de Lira-Quezada, MD contact

+52 8110690275

ce.dlira@gmail.com

Mexico1 site, 1 recruiting

  • Regional Center of Allergy and Clinical Immunology, Hospital Universitario "Dr. José Eleuterio González"

    Monterrey, Nuevo León, 64460

    Cindy de Lira-Quezada, MD, +52811 0690275, ce.dlira@gmail.com

    Recruiting

Other trials in Mexico

About this study

Official title: Association Between Environmental Pollutants and Their Effects on Respiratory

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.

Being tested
pollutants and pollen
Keywords
pollutants, allergy, symptoms
Medical subject headings
Rhinitis, Allergic, Hypersensitivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • pollutants and pollenOther

    Pollutants (ozone, SO3, NO3, PM2.5, diesel exhaust particles)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 1 year

Secondary outcomes (4)

  1. 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).

    Measured: 1 year

  2. 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).

    Measured: 1 year

  3. 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.

    Measured: 1 year

  4. 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.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 May 2021
  2. Study start10 Mar 2021
  3. Primary completion10 Aug 2021 (estimated)
  4. Study completion10 Aug 2022 (estimated)

Resources

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
93 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04902989
Sponsor's protocol ID
AL2100004
Status last verified
May 2021
First submitted
21 May 2021
Last updated
26 May 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 29519451

  • 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.

    PubMed 19237391

  • 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.

    PubMed 33236436

  • 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. doi: 10.1007/s40629-014-0003-7. Epub 2014 Feb 19.

    PubMed 26120514

  • Landrigan PJ, Fuller R, Acosta NJR, Adeyi O, Arnold R, Basu NN, Balde 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, Rockstrom 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. No abstract available.

    PubMed 29056410

  • 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, Gomez 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, Rosario N, Rottem M, Sanchez-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.

    PubMed 26207160

  • 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.

    PubMed 27130856

  • 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.

    PubMed 29845404

  • 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.

    PubMed 30741719

  • 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. doi: 10.1016/j.jaci.2003.09.008.

    PubMed 14713908

Questions about this trial

What is this clinical trial studying?

An observational study of Allergic Rhinitis and Allergic Asthma, run by Cindy Elizabeth de Lira-Quezada at 1 site in Mexico.

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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 26 May 2021. 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 Mexico. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Cindy E. de Lira-Quezada, MD (+52 8110690275, ce.dlira@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Association of respiratory symptoms with exposure to pollutants and pollen (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04902989, which also lists 10 linked publications.

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 26 May 2021.

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