- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04902989
Environmental Pollutants and Their Effects on Respiratory Allergy
Association Between Environmental Pollutants and Their Effects on Respiratory
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiekontakt
- Navn: Cindy E. de Lira-Quezada, MD
- Telefonnummer: +52 8110690275
- E-mail: ce.dlira@gmail.com
Studiesteder
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Nuevo Leon
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Monterrey, Nuevo Leon, Mexico, 64460
- Rekruttering
- Regional Center of Allergy and Clinical Immunology, Hospital Universitario "Dr. José Eleuterio González"
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Kontakt:
- Cindy de Lira-Quezada, MD
- Telefonnummer: +52811 0690275
- E-mail: ce.dlira@gmail.com
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
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.
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Association of respiratory symptoms with exposure to pollutants and pollen
Tidsramme: 1 year
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To determine the relationship between exposure to environmental pollutants and the prevalence and exacerbation of respiratory allergy.
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1 year
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Avenues with highest diesel exhaust particles and traffic related particles
Tidsramme: 1 year
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Locate the avenues with the highest flow and vehicular load releasing diesel removal particles (DEP) and traffic-related air pollutants (TRAP).
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1 year
|
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Location of the main industries that emit pollutants
Tidsramme: 1 year
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Location of the main industries that emit pollutants of particulate matter (PM), nitrogen dioxide (NO2), sulfur dioxide (SO2), carbon monoxide (CO) and ozone (O3).
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1 year
|
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Distance of greater exposure to pollutants
Tidsramme: 1 year
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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.
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1 year
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Time of pollutant exposure and association with respiratory symptoms
Tidsramme: 1 year
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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.
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1 year
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Studieleder: Sandra N Gonzalez Diaz, MD,PhD, Head of the Allergy and Clinical Immunology Service
Publikationer og nyttige links
Generelle publikationer
- 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.
- 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.
- 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. Erratum In: Lancet. 2018 Feb 3;391(10119):430.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- AL2100004
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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Kliniske forsøg med Allergisk rhinitis
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Teva Branded Pharmaceutical Products R&D, Inc.United BioSource, LLCAfsluttetPerennial Allergic Rhinitis (PAR)Forenede Stater
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Eli Lilly and CompanyRekrutteringPerennial Allergic Rhinitis (PAR)Forenede Stater, Kina, Polen, Belgien, Tyskland, Sydkorea
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Liaquat University of Medical & Health SciencesUniversity of Urbino "Carlo Bo"AfsluttetVasomotorisk rhinitisItalien
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Inimmune CorporationRho, Inc.AfsluttetAllergisk rhinitis | Rhinitis Allergisk | Allergisk rhinitis på grund af allergenerCanada
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Polyrizon Ltd.Ikke rekrutterer endnuAllergisk rhinitis | Sæsonbestemt allergisk rhinitis (SAR)
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Shanghai Chia Tai Tianqing Pharmaceutical Technology...RekrutteringSæsonbestemt allergisk rhinitisKina
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Winclove B.V.AlyatecRekrutteringFlerårig allergisk rhinitisFrankrig
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ALK-Abelló A/SAfsluttetFlerårig allergisk rhinitis | Sæsonbestemt allergisk rhinitis
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Chengdu Kangnuoxing Biopharma,Inc.Ikke rekrutterer endnuSæsonbestemt allergisk rhinitis (SAR)Kina
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Universitaire Ziekenhuizen KU LeuvenAZ Sint-Jan AVRekrutteringFlerårig allergisk rhinitis | Sæsonbestemt allergisk rhinitis | Lokal allergisk rhinitisBelgien
Kliniske forsøg med pollutants and pollen
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Polynoma LLCAfsluttetMelanomForenede Stater, Canada
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Universidad Rey Juan CarlosAfsluttetUdholdenhedsøvelse | Løbeydelse | TræningsfysiologiSpanien
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Ann & Robert H Lurie Children's Hospital of ChicagoNorthwestern University; Florida State UniversityTrukket tilbageØget engagement i sundhedsvæsenet via rutinevaccination blandt unge sorte mænd, der har sex med mændHepatitis A | Meningitis | HPV - Anogenital Human Papilloma Virus Infection
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National Institute of Allergy and Infectious Diseases...AfsluttetHIV-infektionerForenede Stater, Peru, Schweiz, Brasilien
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National Institute of Allergy and Infectious Diseases...AIDS Clinical Trials Group; Acute Infection and Early Disease Research...AfsluttetHIV-infektionerForenede Stater, Amerikansk Samoa, Australien
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University of Southern DenmarkDanish Heart FoundationUkendtMeddelelse | Hyperkolesterolæmi
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Martin PharmaceuticalsSuspenderetAkut-på-kronisk leversvigtSpanien, Frankrig, Østrig, Tyskland, Belgien
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National Institute of Allergy and Infectious Diseases...HIV Vaccine Trials NetworkAfsluttetHIV-infektionerForenede Stater
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Merck Sharp & Dohme LLCAfsluttet
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Merck Sharp & Dohme LLCAfsluttet