Earmark - Clinical Trials Using a Piezoelectric Dry Powder Inhalation Device

Agency:		Department of Defense--Military
Bureau:		Research, Development, Test, and Evaluation
Account:		Research, development, test, and evaluation, Army (21-2040)
Certifying Official:		Deputy Comptroller Program/Budget
Contact Information:		http://WWW.DOD.GOV 703-697-5131

Clinical Trials Using a Piezoelectric Dry Powder Inhalation Device

1 recipient will receive $4,000,000. This is a continuing earmark.

Year Enacted: 2005

Description: This project will demonstrate that a new Dry Powder Inhaler (DPI) is a viable replacement for the military's Medical Aerosolized Nerve Agent Antidote (MANAA). The development plan includes Investigational New Drug submission followed by a Phase I bioavailability/ bioequivalence study in approximately 20 subjects. A gamma scintigraphy study will be conducted as a follow-on study and performed with similar devices manufactured and tested under good manufacturing practices. Device formulation will be finalized and an additional volunteer trial may be conducted to confirm the final formulation and device perform consistently. A protocol/ study will be performed to compare the new product with MANAA. The results will be reviewed with the Food and Drug Administration and will form the basis of a New Drug Application.

Beneficiary/Recipient	Amount ($K)	Program	Type	Address
University of Pittsburg	$4,000		Public Educational Institution	Pittsburgh, PA

Citation

Source: Appropriations Report Language - Conference

Reference: 108-622

Location: Line 29, Page 255

Citation Excerpt: Clinical Trials Using a Piezoelectric Dry Powder Inhalation Device

Last Modified: 16-Apr-2007