AsthmaURECANCT00114881
Urban Environmental Factors and Childhood Asthma
An observational study of Asthma and Allergy, run by National Institute of Allergy and Infectious Diseases (NIAID) at 4 sites in United States.
Trial summary
Minority children who grow up in poor urban neighborhoods have the highest rates of asthma, and also experience greater morbidity from acute exacerbations of this disease. The aim of this study is to further identify environmental factors unique to the inner city that affect immune development and the expression of… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- How many people
- 560 participants
- Where
- 4 sitesUnited States
- Study dates
- 2 Feb 2005to 31 Aug 2024
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Inner city children
Who may be able to join
- Plan to give birth at the study hospital
- Have asthma, hay fever, or eczema (or infant's father has any of these diseases)
- Currently reside in a pre-selected area containing at least 20% of households below the U.S. government poverty level
- At least 34 weeks pregnant at time of delivery
- Willing to allow an umbilical cord blood specimen to be obtained from her infant
- Willing to comply with all study requirements
- Have access to a phone
- Speak English. Spanish-speaking participants enrolled at sites with Spanish-speaking staff are also eligible.
Who cannot join
- HIV infected at the time of delivery
- Plan to move out of the geographic area during the study
- Respiratory distress requiring intubation and ventilation for 4 hours or more
- Respiratory distress requiring either supplemental oxygen or continuous positive airway pressure (CPAP) for 4 days or more
- Pneumonia requiring antibiotic treatment for 1 week or more
- Significant congenital abnormality
- Received palivizumab for respiratory syncytial virus prophylaxis
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Pediatric Clinical Research Unit, Johns Hopkins University
Baltimore, Maryland, 21287
Boston Medical Center
Boston, Massachusetts, 02118
Columbia University Medical Center
New York, New York, 10032
Saint Louis Children's Hospital
St Louis, Missouri, 63110
About this study
Official title: Urban Environment and Childhood Asthma (URECA)
Minority children who grow up in poor urban neighborhoods have the highest rates of asthma, and also experience greater morbidity from acute exacerbations of this disease. The aim of this study is to further identify environmental factors unique to the inner city that affect immune development and the expression of wheezing, atopy and asthma for purposes of identifying new strategies for asthma prevention.
Read the detailed description
The purpose of this study is to determine the way environmental factors (like the components of inner-city household dust) affect immune system development and symptoms of asthma in inner city children. The study is divided into five periods, as the subjects age from birth to 17 years old. Each age bracket will explore different objectives and endpoints.
Study Objectives/Hypotheses:
- Subjects age 0 to 3 years old:
- Environmental factors in the inner city adversely influence the development of the immune system to promote cytokine dysregulation, allergy, and recurrent wheezing by age 3.
- Children who have had a viral lower respiratory infection and have developed cytokine dysregulation by age 3 are at increased risk for the development of asthma by age 6.
- Subjects age 4 to 7 years old:
- There is a unique pattern of immune development that is driven by specific urban exposures in early life, and this pattern of immune development is characterized by: 1) impairment of antiviral responses and 2) accentuation of Th2-like responses (e.g. cockroach-specific Interleukin-13(IL-13)). The clinical effects of these changes in immune development are frequent virus-induced wheezing and allergic sensitization by 3-4 years of age, and these characteristics synergistically increase the risk of asthma at age 7 years.
- Subjects age 7 to 10 years old:
- There are unique combinations of environmental exposures (cockroach allergens, indoor pollutants [Environmental Tobacco Smoke (ETS) and Nitrogen Dioxide (NO2)], lack of microbial exposure), and family characteristics (stress, genetic factors related to innate immunity) that synergistically promote asthma onset, persistence, and morbidity in urban neighborhoods. These exposures and characteristics influence immune expression and lung development during critical periods of growth, resulting in specific asthma phenotypes.
- Subjects age 10 to 16 years old: -To determine the wheezing, asthma and atopy phenotypes in minority children growing up in poor urban neighborhoods as they develop from birth through adolescence.
- Subjects to age 17 (Continuation of phase 4 to follow participants to age 17) To determine the wheezing, asthma and atopy phenotypes in minority children growing up in poor urban neighborhoods as they develop from birth through adolescence.
- Keywords
- Children, Urban Health, Pregnancy, Asthma
- Medical subject headings
- Asthma, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Inner-city children with asthma | Children at high risk for developing allergic diseases and asthma, on the basis of a parental history of asthma, allergic rhinitis or atopic dermatitis, and residence in the inner city |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of wheezing
Establish in inner city children the immunologic causes for the development of recurrent wheezing.
Measured: 0 to 3 years of age
Correlation of Immunologic Factors and Development of Asthma
Establish, in this cohort of inner-city children, the immunologic causes for the development of asthma at age 7
Measured: by 7 years of age
Correlation of Risk Factors to Rapidly Evolving Asthma Phenotypes
Fully define the rapidly evolving asthma phenotypes and further delineate the role of risk factors related to environmental exposure (e.g.; house dust levels found through home inspection), immune development, lung growth on the natural history of asthma and allergic diseases in urban minority children
Measured: up to 10 years of age
Incidence of Asthma
Number of participants with the incidence (development) of asthma
Measured: up to 17 years of age
Occurrence of Specific Phenotypes of Asthma
Further define asthma phenotypes based on the findings in Inner-city Asthma Consortium-19 (ICAC-19) (Asthma Phenotypes in the Inner City (APIC), ClinicalTrials.gov Identifier NCT01383941).
Measured: up to 17 years of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2005 (estimated)
- Study start2 Feb 2005
- Primary completion31 Aug 2024
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 560 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Inner-City Asthma Consortium, Rho Federal Systems Division, Inc.
- Responsible party
- Sponsor
- Investigators
- James E. Gern, MD, Study chair, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00114881
- Sponsor's protocol ID
- DAIT ICAC-07
- Other IDs
- NIAID CRMS ID#: 20126
- Acronym
- URECA
- Status last verified
- Jul 2025
- First submitted
- 17 Jun 2005
- Last updated
- 18 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lee WM, Grindle K, Pappas T, Marshall DJ, Moser MJ, Beaty EL, Shult PA, Prudent JR, Gern JE. High-throughput, sensitive, and accurate multiplex PCR-microsphere flow cytometry system for large-scale comprehensive detection of respiratory viruses. J Clin Microbiol. 2007 Aug;45(8):2626-34. doi: 10.1128/JCM.02501-06. Epub 2007 May 30.
PubMed 17537928Lee WM, Kiesner C, Pappas T, Lee I, Grindle K, Jartti T, Jakiela B, Lemanske RF Jr, Shult PA, Gern JE. A diverse group of previously unrecognized human rhinoviruses are common causes of respiratory illnesses in infants. PLoS One. 2007 Oct 3;2(10):e966. doi: 10.1371/journal.pone.0000966.
PubMed 17912345Gold DR, Bloomberg GR, Cruikshank WW, Visness CM, Schwarz J, Kattan M, O'Connor GT, Wood RA, Burger MS, Wright RJ, Witter F, Lee-Parritz A, Sperling R, Sadovsky Y, Togias A, Gern JE. Parental characteristics, somatic fetal growth, and season of birth influence innate and adaptive cord blood cytokine responses. J Allergy Clin Immunol. 2009 Nov;124(5):1078-87. doi: 10.1016/j.jaci.2009.08.021.
PubMed 19895995Zook PM, Jordan C, Adams B, Visness CM, Walter M, Pollenz K, Logan J, Tesson E, Smartt E, Chen A, D'Agostino J, Gern JE. Retention strategies and predictors of attrition in an urban pediatric asthma study. Clin Trials. 2010 Aug;7(4):400-10. doi: 10.1177/1740774510373798. Epub 2010 Jun 22.
PubMed 20571137Kakumanu S, Jaffee K, Visness CM, Dresen A, Burger M, Witter FR, O'Connor GT, Cruikshank WW, Shreffler WG, Bacharier LB, Gern JE. The influence of atopy and asthma on immune responses in inner-city adults. Immun Inflamm Dis. 2016 Feb 26;4(1):80-90. doi: 10.1002/iid3.96. eCollection 2016 Mar.
PubMed 27042305Gruenberg DA, Wright RJ, Visness CM, Jaffee KF, Bloomberg GR, Cruikshank WW, Kattan M, Sandel MT, Wood RA, Gern JE. Relation between stress and cytokine responses in inner-city mothers. Ann Allergy Asthma Immunol. 2015 Nov;115(5):439-445.e3. doi: 10.1016/j.anai.2015.07.021. Epub 2015 Sep 26.
PubMed 26409873McGowan EC, Bloomberg GR, Gergen PJ, Visness CM, Jaffee KF, Sandel M, O'Connor G, Kattan M, Gern J, Wood RA. Influence of early-life exposures on food sensitization and food allergy in an inner-city birth cohort. J Allergy Clin Immunol. 2015 Jan;135(1):171-8. doi: 10.1016/j.jaci.2014.06.033. Epub 2014 Aug 13.
PubMed 25129677Lynch SV, Wood RA, Boushey H, Bacharier LB, Bloomberg GR, Kattan M, O'Connor GT, Sandel MT, Calatroni A, Matsui E, Johnson CC, Lynn H, Visness CM, Jaffee KF, Gergen PJ, Gold DR, Wright RJ, Fujimura K, Rauch M, Busse WW, Gern JE. Effects of early-life exposure to allergens and bacteria on recurrent wheeze and atopy in urban children. J Allergy Clin Immunol. 2014 Sep;134(3):593-601.e12. doi: 10.1016/j.jaci.2014.04.018. Epub 2014 Jun 4.
PubMed 24908147Gern JE, Pappas T, Visness CM, Jaffee KF, Lemanske RF, Togias A, Bloomberg GR, Cruikshank WW, Lamm C, Tuzova M, Wood RA, Lee WM. Comparison of the etiology of viral respiratory illnesses in inner-city and suburban infants. J Infect Dis. 2012 Nov;206(9):1342-9. doi: 10.1093/infdis/jis504. Epub 2012 Sep 25.
PubMed 23014674Heymann PW, Platts-Mills TA. Deciphering the importance of host and environmental factors that influence the genesis of asthma during childhood. J Infect Dis. 2012 Nov;206(9):1331-3. doi: 10.1093/infdis/jis507. Epub 2012 Sep 25. No abstract available.
PubMed 23014673McLoughlin RM, Calatroni A, Visness CM, Wallace PK, Cruikshank WW, Tuzova M, Ly NP, Ruiz-Perez B, Kattan M, Bloomberg GR, Lederman H, Gern JE, Gold DR. Longitudinal relationship of early life immunomodulatory T cell phenotype and function to development of allergic sensitization in an urban cohort. Clin Exp Allergy. 2012 Mar;42(3):392-404. doi: 10.1111/j.1365-2222.2011.03882.x. Epub 2011 Nov 9.
PubMed 22092655Sumino K, Tucker J, Shahab M, Jaffee KF, Visness CM, Gern JE, Bloomberg GR, Holtzman MJ. Antiviral IFN-gamma responses of monocytes at birth predict respiratory tract illness in the first year of life. J Allergy Clin Immunol. 2012 May;129(5):1267-1273.e1. doi: 10.1016/j.jaci.2012.02.033. Epub 2012 Mar 27.
PubMed 22460071Chi A, Wildfire J, McLoughlin R, Wood RA, Bloomberg GR, Kattan M, Gergen P, Gold DR, Witter F, Chen T, Holick M, Visness C, Gern J, O'Connor GT. Umbilical cord plasma 25-hydroxyvitamin D concentration and immune function at birth: the Urban Environment and Childhood Asthma study. Clin Exp Allergy. 2011 Jun;41(6):842-50. doi: 10.1111/j.1365-2222.2011.03712.x. Epub 2011 Apr 11.
PubMed 21481021Wood RA, Bloomberg GR, Kattan M, Conroy K, Sandel MT, Dresen A, Gergen PJ, Gold DR, Schwarz JC, Visness CM, Gern JE. Relationships among environmental exposures, cord blood cytokine responses, allergy, and wheeze at 1 year of age in an inner-city birth cohort (Urban Environment and Childhood Asthma study). J Allergy Clin Immunol. 2011 Apr;127(4):913-9.e1-6. doi: 10.1016/j.jaci.2010.12.1122. Epub 2011 Feb 18.
PubMed 21333343Gern JE. The Urban Environment and Childhood Asthma study. J Allergy Clin Immunol. 2010 Mar;125(3):545-9. doi: 10.1016/j.jaci.2010.01.037.
PubMed 20226291
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urban Environment and Childhood Asthma (URECA)
- ClinicalTrials.gov ID
- NCT00114881
- Acronym / sponsor ID
- URECA / DAIT ICAC-07
- Keywords
- Children, Urban Health, Pregnancy, Asthma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 560 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Inner-City Asthma Consortium, Rho Federal Systems Division, Inc.
- Study start
- 2 Feb 2005 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 20 Jun 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Minority children who grow up in poor urban neighborhoods have the highest rates of asthma, and also experience greater morbidity from acute exacerbations of this disease. The aim of this study is to further identify environmental factors unique to the inner city that affect immune development and the expression of wheezing, atopy and asthma for purposes of identifying new strategies for asthma prevention.
Detailed description
The purpose of this study is to determine the way environmental factors (like the components of inner-city household dust) affect immune system development and symptoms of asthma in inner city children. The study is divided into five periods, as the subjects age from birth to 17 years old. Each age bracket will explore different objectives and endpoints.
Study Objectives/Hypotheses:
- Subjects age 0 to 3 years old:
- Environmental factors in the inner city adversely influence the development of the immune system to promote cytokine dysregulation, allergy, and recurrent wheezing by age 3.
- Children who have had a viral lower respiratory infection and have developed cytokine dysregulation by age 3 are at increased risk for the development of asthma by age 6.
- Subjects age 4 to 7 years old:
- There is a unique pattern of immune development that is driven by specific urban exposures in early life, and this pattern of immune development is characterized by: 1) impairment of antiviral responses and 2) accentuation of Th2-like responses (e.g. cockroach-specific Interleukin-13(IL-13)). The clinical effects of these changes in immune development are frequent virus-induced wheezing and allergic sensitization by 3-4 years of age, and these characteristics synergistically increase the risk of asthma at age 7 years.
- Subjects age 7 to 10 years old:
- There are unique combinations of environmental exposures (cockroach allergens, indoor pollutants [Environmental Tobacco Smoke (ETS) and Nitrogen Dioxide (NO2)], lack of microbial exposure), and family characteristics (stress, genetic factors related to innate immunity) that synergistically promote asthma onset, persistence, and morbidity in urban neighborhoods. These exposures and characteristics influence immune expression and lung development during critical periods of growth, resulting in specific asthma phenotypes.
- Subjects age 10 to 16 years old: -To determine the wheezing, asthma and atopy phenotypes in minority children growing up in poor urban neighborhoods as they develop from birth through adolescence.
- Subjects to age 17 (Continuation of phase 4 to follow participants to age 17) To determine the wheezing, asthma and atopy phenotypes in minority children growing up in poor urban neighborhoods as they develop from birth through adolescence.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Inner-city children with asthma | – | –Children at high risk for developing allergic diseases and asthma, on the basis of a parental history of asthma, allergic rhinitis or atopic dermatitis, and residence in the inner city |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Inner city children
Key inclusion criteria (8 listed)
- Plan to give birth at the study hospital
- Have asthma, hay fever, or eczema (or infant's father has any of these diseases)
- Currently reside in a pre-selected area containing at least 20% of households below the U.S. government poverty level
- At least 34 weeks pregnant at time of delivery
- Willing to allow an umbilical cord blood specimen to be obtained from her infant
Key exclusion criteria (7 listed)
- HIV infected at the time of delivery
- Plan to move out of the geographic area during the study
- Respiratory distress requiring intubation and ventilation for 4 hours or more
- Respiratory distress requiring either supplemental oxygen or continuous positive airway pressure (CPAP) for 4 days or more
- Pneumonia requiring antibiotic treatment for 1 week or more
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Development of wheezing
Time frame: 0 to 3 years of age
Establish in inner city children the immunologic causes for the development of recurrent wheezing.
Correlation of Immunologic Factors and Development of Asthma
Time frame: by 7 years of age
Establish, in this cohort of inner-city children, the immunologic causes for the development of asthma at age 7
Correlation of Risk Factors to Rapidly Evolving Asthma Phenotypes
Time frame: up to 10 years of age
Fully define the rapidly evolving asthma phenotypes and further delineate the role of risk factors related to environmental exposure (e.g.; house dust levels found through home inspection), immune development, lung growth on the natural history of asthma and allergic diseases in urban minority children
Incidence of Asthma
Time frame: up to 17 years of age
Number of participants with the incidence (development) of asthma
Occurrence of Specific Phenotypes of Asthma
Time frame: up to 17 years of age
Further define asthma phenotypes based on the findings in Inner-city Asthma Consortium-19 (ICAC-19) (Asthma Phenotypes in the Inner City (APIC), ClinicalTrials.gov Identifier NCT01383941).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2025.
- Background: PubMed 17537928Lee WM, Grindle K, Pappas T, Marshall DJ, Moser MJ, Beaty EL, Shult PA, Prudent JR, Gern JE. High-throughput, sensitive, and accurate multiplex PCR-microsphere flow cytometry system for large-scale comprehensive detection of respiratory viruses. J Clin Microbiol. 2007 Aug;45(8):2626-34. doi: 10.1128/JCM.02501-06. Epub 2007 May 30.
- Background: PubMed 17912345Lee WM, Kiesner C, Pappas T, Lee I, Grindle K, Jartti T, Jakiela B, Lemanske RF Jr, Shult PA, Gern JE. A diverse group of previously unrecognized human rhinoviruses are common causes of respiratory illnesses in infants. PLoS One. 2007 Oct 3;2(10):e966. doi: 10.1371/journal.pone.0000966.
- Results publication: PubMed 19895995Gold DR, Bloomberg GR, Cruikshank WW, Visness CM, Schwarz J, Kattan M, O'Connor GT, Wood RA, Burger MS, Wright RJ, Witter F, Lee-Parritz A, Sperling R, Sadovsky Y, Togias A, Gern JE. Parental characteristics, somatic fetal growth, and season of birth influence innate and adaptive cord blood cytokine responses. J Allergy Clin Immunol. 2009 Nov;124(5):1078-87. doi: 10.1016/j.jaci.2009.08.021.
- Results publication: PubMed 20571137Zook PM, Jordan C, Adams B, Visness CM, Walter M, Pollenz K, Logan J, Tesson E, Smartt E, Chen A, D'Agostino J, Gern JE. Retention strategies and predictors of attrition in an urban pediatric asthma study. Clin Trials. 2010 Aug;7(4):400-10. doi: 10.1177/1740774510373798. Epub 2010 Jun 22.
- Results publication: PubMed 27042305Kakumanu S, Jaffee K, Visness CM, Dresen A, Burger M, Witter FR, O'Connor GT, Cruikshank WW, Shreffler WG, Bacharier LB, Gern JE. The influence of atopy and asthma on immune responses in inner-city adults. Immun Inflamm Dis. 2016 Feb 26;4(1):80-90. doi: 10.1002/iid3.96. eCollection 2016 Mar.
- Results publication: PubMed 26409873Gruenberg DA, Wright RJ, Visness CM, Jaffee KF, Bloomberg GR, Cruikshank WW, Kattan M, Sandel MT, Wood RA, Gern JE. Relation between stress and cytokine responses in inner-city mothers. Ann Allergy Asthma Immunol. 2015 Nov;115(5):439-445.e3. doi: 10.1016/j.anai.2015.07.021. Epub 2015 Sep 26.
- Results publication: PubMed 25129677McGowan EC, Bloomberg GR, Gergen PJ, Visness CM, Jaffee KF, Sandel M, O'Connor G, Kattan M, Gern J, Wood RA. Influence of early-life exposures on food sensitization and food allergy in an inner-city birth cohort. J Allergy Clin Immunol. 2015 Jan;135(1):171-8. doi: 10.1016/j.jaci.2014.06.033. Epub 2014 Aug 13.
- Results publication: PubMed 24908147Lynch SV, Wood RA, Boushey H, Bacharier LB, Bloomberg GR, Kattan M, O'Connor GT, Sandel MT, Calatroni A, Matsui E, Johnson CC, Lynn H, Visness CM, Jaffee KF, Gergen PJ, Gold DR, Wright RJ, Fujimura K, Rauch M, Busse WW, Gern JE. Effects of early-life exposure to allergens and bacteria on recurrent wheeze and atopy in urban children. J Allergy Clin Immunol. 2014 Sep;134(3):593-601.e12. doi: 10.1016/j.jaci.2014.04.018. Epub 2014 Jun 4.
- Results publication: PubMed 23014674Gern JE, Pappas T, Visness CM, Jaffee KF, Lemanske RF, Togias A, Bloomberg GR, Cruikshank WW, Lamm C, Tuzova M, Wood RA, Lee WM. Comparison of the etiology of viral respiratory illnesses in inner-city and suburban infants. J Infect Dis. 2012 Nov;206(9):1342-9. doi: 10.1093/infdis/jis504. Epub 2012 Sep 25.
- Results publication: PubMed 23014673Heymann PW, Platts-Mills TA. Deciphering the importance of host and environmental factors that influence the genesis of asthma during childhood. J Infect Dis. 2012 Nov;206(9):1331-3. doi: 10.1093/infdis/jis507. Epub 2012 Sep 25. No abstract available.
- Results publication: PubMed 22092655McLoughlin RM, Calatroni A, Visness CM, Wallace PK, Cruikshank WW, Tuzova M, Ly NP, Ruiz-Perez B, Kattan M, Bloomberg GR, Lederman H, Gern JE, Gold DR. Longitudinal relationship of early life immunomodulatory T cell phenotype and function to development of allergic sensitization in an urban cohort. Clin Exp Allergy. 2012 Mar;42(3):392-404. doi: 10.1111/j.1365-2222.2011.03882.x. Epub 2011 Nov 9.
- Results publication: PubMed 22460071Sumino K, Tucker J, Shahab M, Jaffee KF, Visness CM, Gern JE, Bloomberg GR, Holtzman MJ. Antiviral IFN-gamma responses of monocytes at birth predict respiratory tract illness in the first year of life. J Allergy Clin Immunol. 2012 May;129(5):1267-1273.e1. doi: 10.1016/j.jaci.2012.02.033. Epub 2012 Mar 27.
- National Institute of Allergy and Infectious Diseases (NIAID)Link provided by the sponsor.
- Division of Allergy, Immunology, and Transplantation (DAIT), NIAIDLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James E. Gern, MD study chair
University of Wisconsin, Madison
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma and Allergy, run by National Institute of Allergy and Infectious Diseases (NIAID) at 4 sites in United States.
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 8 inclusion and 7 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: finished, as of the sponsor's last update on 18 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of wheezing (time frame: 0 to 3 years of age). The study lists 5 primary outcomes in all. 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 NCT00114881, which also lists 26 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 18 Jul 2025.