OpportunityTitle: Impulse Oscillometry Endpoint Sensitivity to Regional Lung Function Changes using Computational Fluid Dynamics (CFD) (U01) Clinical Trial Required
AdditionalInformationOnEligibility: Eligible Organizations  Higher Education Institutions    &#183;        Public/State Controlled Institutions of Higher Education   &#183;        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    &#183;        Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)   &#183;        Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)   For-Profit Organizations    &#183;        Small Businesses   &#183;        For-Profit Organizations (Other than Small Businesses)   Governments    &#183;        State Governments   &#183;        County Governments   &#183;        City or Township Governments   &#183;        Special District Governments   &#183;        Indian/Native American Tribal Governments (Federally Recognized)   &#183;        Indian/Native American Tribal Governments (Other than Federally Recognized)   &#183;        U.S. Territory or Possession   Other    &#183;        Independent School Districts   &#183;        Public Housing Authorities/Indian Housing Authorities   &#183;        Native American Tribal Organizations (other than Federally recognized tribal governments)   &#183;        Faith-based or Community-based Organizations   &#183;        Regional Organizations   &#183;        Non-domestic (non-U.S.) Entities (Foreign Institutions)
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&apos;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.
GrantorContactEmailDescription: shashi.malhotra@fda.hhs.gov
GrantorContactText: Shashi Malhotra &lt;br/&gt;Grants Management Specialist &lt;br/&gt;Phone 2404027592