| Opportunity ID: |
329988 |
| Opportunity Number: |
FOR-FD-20-028 |
| Opportunity Title: |
Impulse Oscillometry Endpoint Sensitivity to Regional Lung Function Changes using Computational Fluid Dynamics (CFD) |
| Opportunity Category: |
Discretionary |
| Opportunity Category Explanation: |
|
| Funding Instrument Type: |
Cooperative Agreement |
| Category of Funding Activity: |
Agriculture
Consumer Protection
Food and Nutrition |
| Category Explanation: |
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| 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 |
| Additional Information on Eligibility: |
|
| Agency Code: |
HHS-FDA |
| Agency Name: |
Department of Health and Human Services
Food and Drug Administration |
| Posted Date: |
Nov 23, 2020 |
| Last Updated Date: |
Nov 23, 2020 |
| Estimated Synopsis Post Date: |
|
| Fiscal Year: |
2021 |
| Award Ceiling: |
|
| Award Floor: |
|
| Estimated Total Program Funding: |
|
| Expected Number of Awards: |
|
| 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. |
| Version: |
1 |
