Food and Drug Administration

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.

Who can apply

• 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)
• Nonprofits with 501(c)(3) status (other than higher education)
• Nonprofits without 501(c)(3) status (other than higher education)
• Private institutions of higher education
• For-profit organizations other than small businesses
• Small businesses
• Others

Contact

Shashi Malhotra <br/>Grants Management Specialist <br/>Phone 2404027592
shashi.malhotra@fda.hhs.gov