CRO serves as the Statistical and Clinical Coordinating Center for NIH-sponsored study
Chapel Hill, NC ? October 5, 2016 ? Rho, a full-service contract research organization (CRO) focused on bringing new products to market through a full range of product development services, is part of a newly published observational study that identifies major factors associated with asthma severity in children from inner-city communities. The results shed light on the complexities of asthma in children and are expected to help prioritize efforts to manage difficult cases. The study, with results published in 3 complimentary manuscripts in the Journal of Allergy and Clinical Immunology, was funded by the National Institute of Allergy and Infectious Diseases (NIAID) with additional support from the National Center for Advancing Translational Sciences, both parts of the National Institutes of Health (NIH).
The novel study of 717 children between the ages of 6 and 17 found that poor lung function, sensitivity to certain inhaled allergens and exposure to second-hand smoke are important factors associated with asthma severity. Researchers collected data on the children’s symptoms and response to asthma therapy, their environment and other known risk factors bimonthly for one year, while providing the study participants with high quality, guidelines-based asthma care.
“Asthma severity in inner-city children is disproportionately high, presenting a difficult public health burden in these populations,” said Cynthia Visness, Ph.D., MPH, senior research scientist, Rho. “The data models from this study help researchers understand how different factors contribute to the severity of a child’s asthma, and this understanding can help doctors and healthcare providers manage these severe cases more effectively.”
The researchers gathered information on the children’s symptoms and response to guidelines-based asthma therapy, their environment, and other known risk factors bimonthly for one year. They observed that difficult-to-control cases of asthma were marked by persistently poor lung function and symptom exacerbations in the spring and fall, despite the use of high-dose medications. Difficult-to-control asthma was identified based on asthma control surveys and physical assessments.
By modeling the collected data, researchers examined how a variety of factors contribute to the severity of a child’s asthma. Sensitivity to a large number of inhaled allergens was linked to the presence of allergy-driven inflammation, which, in turn, is associated with poor lung function that results in severe asthma. Researchers also found that symptoms of rhinitis (inflammation in the nasal passages) and second-hand smoke exposure were both associated strongly with asthma severity. The researchers’ model will help clarify how various risk factors directly and indirectly affect asthma severity and may help prioritize efforts to manage difficult cases.
Using a computer algorithm, the researchers identified five clusters of children distinguished by their asthma characteristics. Notably, one cluster with severe asthma experienced few allergy problems and, therefore, the investigators say, requires further study to understand the cause of the severity of their disease. The researchers plan to continue working with this inner-city population to investigate appropriate interventions tailored to specific groups of children.
As part of Rho’s federal market work, the company serves as the Statistical and Clinical Coordinating Center for the NIAID Inner-City Asthma Consortium, supporting approximately 10 clinical research sites and 3 basic science sites in evaluating the efficacy of therapeutic agents for the treatment of asthma in inner-city children and to understand the underlying causes of the disease. Rho provides support for statistical analysis, safety monitoring, data management, clinical monitoring, as well as supporting study protocol and manuscript development.
For this study, Rho assisted with protocol development and handled all data management, training, clinical monitoring and distribution and accountability for study medication. Visness served as the lead scientist and Stephanie Wellford, senior project manager, Rho, served as the project manager. Rho employees Rebecca Krouse, senior biostatistician, and Denise Babineau, Ph.D., senior research scientist, also supported the study, analyzing data and producing tables and figures for the study’s manuscripts in a short period of time. Visness, Babineau, and Krouse were co-authors on all three publications.
ARTICLES:
Pongracic JA et al. Distinguishing Characteristics of Difficult-to-Control Asthma in Inner-City Children and Adolescents. Journal of Allergy and Clinical Immunology DOI: 10.2016/j.jaci.2016.06.059 (2016).
Liu AH et al. Pathways through which Asthma Risk Factors Contribute to Asthma Severity in Inner-City Children. Journal of Allergy and Clinical Immunology DOI: 10.2016/j.jaci.2016.06.060 (2016).
Zoratti EM et al. Asthma Phenotypes in Inner-City Children. Journal of Allergy and Clinical Immunology DOI: 10.XXXX/j.jaci.2016.06.061 (2016).
This work was funded in part by NIAID under award numbers HHSN272200900052C and HHSN272201000052I. GSK provided asthma and rhinitis medications. Additional details are available at ClinicalTrials.gov using the identifier NCT01383941.
To learn more about Rho, please visit www.rhoworld.com.
About Rho
Rho, a privately-held, full-service contract research organization (CRO) located in Chapel Hill, NC, provides a full range of clinical research services across the entire drug development process. For more than 32 years, Rho has been a trusted partner to some of the industry’s leading pharmaceutical, biotechnology, and medical device companies as well as academic and government organizations. Our commitment to excellence, our innovative technologies, and our therapeutic expertise accelerate time to market, maximize returns on investment, and lead to an exceptional customer experience. Please follow us on Twitter.
Chapel Hill, NC ? October 5, 2016 ? Rho, a full-service contract research organization (CRO) focused on bringing new products to market through a full range of product development services, is part of a newly published observational study that identifies major factors associated with asthma severity in children from inner-city communities. The results shed light on the complexities of asthma in children and are expected to help prioritize efforts to manage difficult cases. The study, with results published in 3 complimentary manuscripts in the Journal of Allergy and Clinical Immunology, was funded by the National Institute of Allergy and Infectious Diseases (NIAID) with additional support from the National Center for Advancing Translational Sciences, both parts of the National Institutes of Health (NIH).
The novel study of 717 children between the ages of 6 and 17 found that poor lung function, sensitivity to certain inhaled allergens and exposure to second-hand smoke are important factors associated with asthma severity. Researchers collected data on the children’s symptoms and response to asthma therapy, their environment and other known risk factors bimonthly for one year, while providing the study participants with high quality, guidelines-based asthma care.
“Asthma severity in inner-city children is disproportionately high, presenting a difficult public health burden in these populations,” said Cynthia Visness, Ph.D., MPH, senior research scientist, Rho. “The data models from this study help researchers understand how different factors contribute to the severity of a child’s asthma, and this understanding can help doctors and healthcare providers manage these severe cases more effectively.”
The researchers gathered information on the children’s symptoms and response to guidelines-based asthma therapy, their environment, and other known risk factors bimonthly for one year. They observed that difficult-to-control cases of asthma were marked by persistently poor lung function and symptom exacerbations in the spring and fall, despite the use of high-dose medications. Difficult-to-control asthma was identified based on asthma control surveys and physical assessments.
By modeling the collected data, researchers examined how a variety of factors contribute to the severity of a child’s asthma. Sensitivity to a large number of inhaled allergens was linked to the presence of allergy-driven inflammation, which, in turn, is associated with poor lung function that results in severe asthma. Researchers also found that symptoms of rhinitis (inflammation in the nasal passages) and second-hand smoke exposure were both associated strongly with asthma severity. The researchers’ model will help clarify how various risk factors directly and indirectly affect asthma severity and may help prioritize efforts to manage difficult cases.
Using a computer algorithm, the researchers identified five clusters of children distinguished by their asthma characteristics. Notably, one cluster with severe asthma experienced few allergy problems and, therefore, the investigators say, requires further study to understand the cause of the severity of their disease. The researchers plan to continue working with this inner-city population to investigate appropriate interventions tailored to specific groups of children.
As part of Rho’s federal market work, the company serves as the Statistical and Clinical Coordinating Center for the NIAID Inner-City Asthma Consortium, supporting approximately 10 clinical research sites and 3 basic science sites in evaluating the efficacy of therapeutic agents for the treatment of asthma in inner-city children and to understand the underlying causes of the disease. Rho provides support for statistical analysis, safety monitoring, data management, clinical monitoring, as well as supporting study protocol and manuscript development.
For this study, Rho assisted with protocol development and handled all data management, training, clinical monitoring and distribution and accountability for study medication. Visness served as the lead scientist and Stephanie Wellford, senior project manager, Rho, served as the project manager. Rho employees Rebecca Krouse, senior biostatistician, and Denise Babineau, Ph.D., senior research scientist, also supported the study, analyzing data and producing tables and figures for the study’s manuscripts in a short period of time. Visness, Babineau, and Krouse were co-authors on all three publications.
ARTICLES:
Pongracic JA et al. Distinguishing Characteristics of Difficult-to-Control Asthma in Inner-City Children and Adolescents. Journal of Allergy and Clinical Immunology DOI: 10.2016/j.jaci.2016.06.059 (2016).
Liu AH et al. Pathways through which Asthma Risk Factors Contribute to Asthma Severity in Inner-City Children. Journal of Allergy and Clinical Immunology DOI: 10.2016/j.jaci.2016.06.060 (2016).
Zoratti EM et al. Asthma Phenotypes in Inner-City Children. Journal of Allergy and Clinical Immunology DOI: 10.XXXX/j.jaci.2016.06.061 (2016).
This work was funded in part by NIAID under award numbers HHSN272200900052C and HHSN272201000052I. GSK provided asthma and rhinitis medications. Additional details are available at ClinicalTrials.gov using the identifier NCT01383941.
To learn more about Rho, please visit www.rhoworld.com.
About Rho
Rho, a privately-held, full-service contract research organization (CRO) located in Chapel Hill, NC, provides a full range of clinical research services across the entire drug development process. For more than 32 years, Rho has been a trusted partner to some of the industry’s leading pharmaceutical, biotechnology, and medical device companies as well as academic and government organizations. Our commitment to excellence, our innovative technologies, and our therapeutic expertise accelerate time to market, maximize returns on investment, and lead to an exceptional customer experience. Please follow us on Twitter.
