Impulse Oscillometry Endpoint Sensitivity to Regional Lung Function Changes using Computational Fluid Dynamics (CFD) (U01) Clinical Trial Required

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Funding Opportunity ID:331662
Opportunity Number:RFA-FD-21-020
Opportunity Title:Impulse Oscillometry Endpoint Sensitivity to Regional Lung Function Changes using Computational Fluid Dynamics (CFD) (U01) Clinical Trial Required
Opportunity Category:Discretionary
Opportunity Category Explanation:
Funding Instrument Type:Cooperative Agreement
Category of Funding Activity:Consumer Protection
Food and Nutrition
Science and Technology and other Research and Development
Category Explanation:
CFDA Number(s):93.103
Eligible Applicants:State governments
County governments
City or township governments
Special district governments
Independent school districts
Public and State controlled institutions of higher education
Native American tribal governments (Federally recognized)
Public housing authorities/Indian housing authorities
Native American tribal organizations (other than Federally recognized tribal governments)
Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
Private institutions of higher education
For profit organizations other than small businesses
Small businesses
Others (see text field entitled “Additional Information on Eligibility” for clarification)
Additional Information on Eligibility:Eligible Organizations Higher Education Institutions · Public/State Controlled Institutions of Higher Education · Private Institutions of Higher Education The following types of Higher Education Institutions are always encouraged to apply for FDA support as Public or Private Institutions of Higher Education: o Hispanic-serving Institutions o Historically Black Colleges and Universities (HBCUs) o Tribally Controlled Colleges and Universities (TCCUs) o Alaska Native and Native Hawaiian Serving Institutions o Asian American Native American Pacific Islander Serving Institutions (AANAPISIs) Nonprofits Other Than Institutions of Higher Education · Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education) · Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education) For-Profit Organizations · Small Businesses · For-Profit Organizations (Other than Small Businesses) Governments · State Governments · County Governments · City or Township Governments · Special District Governments · Indian/Native American Tribal Governments (Federally Recognized) · Indian/Native American Tribal Governments (Other than Federally Recognized) · U.S. Territory or Possession Other · Independent School Districts · Public Housing Authorities/Indian Housing Authorities · Native American Tribal Organizations (other than Federally recognized tribal governments) · Faith-based or Community-based Organizations · Regional Organizations · Non-domestic (non-U.S.) Entities (Foreign Institutions)
Agency Code:HHS-FDA
Agency Name:Department of Health and Human Services
Food and Drug Administration
Posted Date:Feb 22, 2021
Close Date:Apr 26, 2021
Last Updated Date:Feb 22, 2021
Award Ceiling:$1,000,000
Award Floor:$500,000
Estimated Total Program Funding:
Expected Number of Awards:1
Description:Impulse oscillometry (IOS) is a technique used to assess lung function that does not require patient coordination, that uses sound waves that are introduced to the subject's lung airways. Research has suggested that in some cases, one or more IOS clinical endpoints may be more sensitive to differences in lung function than the spirometric measurement forced expiratory volume after 1 second (FEV1). With respect to generic orally inhaled drug products (OIDPs), a more sensitive clinical endpoint than FEV1 may be useful for the purposes of product comparison. The objective of this study is to conduct a small in vivo study using IOS and spirometry endpoints to assess the treatment effect of an OIDP, and to concurrently develop a computational fluid dynamics (CFD) model that may be used to better understand the applicability of IOS endpoints for generic product comparison with the reference product.
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