This subproject is one of many research subprojects utilizing theresources provided by a Center grant funded by NIH/NCRR. The subproject andinvestigator (PI) may have received primary funding from another NIH source,and thus could be represented in other CRISP entries. The institution listed isfor the Center, which is not necessarily the institution for the investigator.This is a phase 3 study to assess the safety and efficacy of a 28-day treatment with Aztreonam Lysinate for inhalation (AI) in people with cystic fibrosis and positive Pa sputum/throat cultures aged greater than or equal to 6 with FEV1 between 25 and 75% predicted. It is a double-blind, randomized, placebo-controlled, multi-national, multi-center study. Subjects will receive 28 days of treatment with either 75 mg AI or placebo, taken 3 times a day using the eFlow nebulizer. The study consists of 5 outpatient visits - screening, treatment day 1, 14, 28 and 2-week follow-up visit. Only a few antibiotics are approved for inhaled therapy for Pa in CF. Aztreonam is approved for IV administration and is active against Pa. AI is a different salt form from the IV formulation to lessen the pulmonary irritation/bronchoreactivity.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR000059-46
Application #
7604924
Study Section
National Center for Research Resources Initial Review Group (RIRG)
Project Start
2007-03-01
Project End
2007-09-16
Budget Start
2007-03-01
Budget End
2007-09-16
Support Year
46
Fiscal Year
2007
Total Cost
$680
Indirect Cost
Name
University of Iowa
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
062761671
City
Iowa City
State
IA
Country
United States
Zip Code
52242
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Warren, John J; Van Buren, John M; Levy, Steven M et al. (2017) Dental caries clusters among adolescents. Community Dent Oral Epidemiol 45:538-544

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