RFA-AI-19-074: Childhood Asthma in Urban Settings -Clinical Research Network – Leadership Center (UM1 Clinical Trial Required)
Slots: 1. Applicants may submit to both the CAUSE-CRC (RFA-AI-19-073) and the CAUSE-LC (RFA-AI-19-074) funding opportunities. However, different clinical projects must be proposed in each of the two applications.
Internal Deadline: Contact the Office of Research if interested.
LOI: May 19, 2020
External Deadline: July 6, 2020
Award Information: Type: Cooperative Agreement
Estimated Number of Awards: 1
Anticipated Amount: $7 million
Submission Process: PIs must submit their application as a Limited Submission through the Office of Research Application Portal: https://app.wizehive.com/webform/USCgrants
Materials to submit:
- Single Page Proposal Summary (0.5” margins; single-spaced; font type: Arial, Helvetica, or Georgia typeface; font size: 11 pt). Page limit includes references and illustrations. Pages that exceed the 1-page limit will be excluded from review.
- CV – (5 pages maximum)
Who May Serve as PI: Standard NIH eligibility requirements.
The CAUSE-LC will provide the overall scientific strategy and organizational structure to the CAUSE Clinical Research Network and will interact closely with the CAUSE Clinical Research Centers (CAUSE -CRCs) to support the conduct of multi-site clinical studies and trials with the ultimate goal of developing effective interventions or asthma prevention approaches applicable to children residing in low-income urban settings.
The CAUSE Clinical Research Network will conduct observational studies and clinical trials to further improve our understanding of asthma and to develop effective interventions and asthma prevention approaches tailored to children of low-income families living in urban communities.
Research supported by this FOA will involve a) children of families living in census tracts within US Office of Management and Budget-defined Metropolitan Statistical Areas (MSAs) where ≥10% of families have income below the poverty level and b) children of families who have publicly-funded health insurance, but live in MSA census tracts where <10% of families have income below the poverty level.
Areas of research of interest include, but are not limited to:
- Development or evaluation of aeroallergen immunotherapy modalities to mitigate and/or prevent the effects of relevant allergens on asthma
- Development and implementation of other innovative, phenotype-specific, immunomodulatory clinical trials for the treatment of asthma
- Development and implementation of clinical trials to prevent the onset or progression of asthma
- Development and implementation of microbiome-based approaches in the treatment or prevention of asthma
- Mechanisms of natural and therapy-induced immune tolerance to aeroallergens
- The role of the respiratory epithelium in asthma
- The influence of genetics and epigenetics on innate and adaptive immunity in asthma
- Pathogenesis and mechanisms of non-atopic asthma
Other areas of interest include studies that fall under the general objective of elucidating the causes of asthma in children living in low-income, urban communities or improving immunomodulatory strategies for the prevention or treatment of asthma in those communities.
In conducting its research projects, the CAUSE Clinical Research Network is encouraged to incorporate unbiased, hypothesis-generating methodologies and systems biology analytic approaches.
The CAUSE Clinical Trial Network will also have the task to follow the participants of URECA to age 17 and to conduct studies utilizing URECA clinical and environmental data and URECA biosamples.
Areas of interest involving the URECA cohort include but are not limited to:
- Natural history of asthma in adolescence and identification of factors that contribute to asthma progression or amelioration/resolution focusing on specific asthma phenotypes, the presence of other allergic conditions, and on aeroallergen-specific and overall immune responses, endocrine function/metabolism/obesity, environmental exposures, and psychosocial factors
- Rate and risk factors for new asthma development in adolescence focusing on the same factors
- Natural history of allergic sensitization in adolescence and identification of factors that contribute to the development of new or the loss of existing IgE-mediated sensitivities
Applications proposing any of the following topics will be deemed non-responsive and will not be reviewed:
- Animal research
- Research on HIV/AIDS
- Clinical studies or clinical trials performed at a foreign site
Budgetary Requirements: Application budgets are limited to $4.3 million direct costs and need to reflect the actual needs of the proposed projects. This includes funding for 1) the CAUSE-LC functions, 2) the CAUSE network-wide clinical projects including protocol-specific funds for the CAUSE-CRCs and for the mechanistic studies incorporated in these projects, 3) the final 3 (possibly 4) years of the URECA birth cohort.
Visit our Institutionally Limited Submission webpage for updates and other announcements.