Proof of Concept Study to Detect Urease Bacteria in Lungs Using Aerosolized 13C Urea1 Published in Pediatric Allergy, Immunology and Pulmonology Journal

The results of a proof of concept study to determine if aerosolized 13C urea could detect Pseudomonas aeruginosa, a urease producing bacteria, in the lungs of cystic fibrosis patients was recently published in the peer-reviewed journal, Pediatric Allergy, Immunology, and Pulmonology. The lead author of the article and principal investigator of the study was Hengameh H. Raissy, PharmD from the Department of Pediatrics at the University of New Mexico’s School of Medicine.

In this study 20 mg and 50 mg doses of 13C-urea were administered via a jet nebulizer to three subjects with cystic fibrosis and known to be colonized with P. aeruginosa and three healthy controls. Breath samples were collected in bags prior to nebulization and then at 5, 10 and 15 minutes post-nebulization. Both the 20 mg and 50 mg doses were well tolerated by all study subjects. Both the 20 mg and 50 mg doses showed distinct separation in the 13CO2/12CO2 delta over baseline (DOB) between the CF subjects and the controls with the 5 and 10 minute post-nebulization breath samples. The 50 mg dose had better separation than the 20 mg dose and the largest separation was seen at 5 minutes post-nebulization with CF subjects having an average DOB of 9.5‰ vs 2.1‰ for the healthy controls.

1Raissy Hengameh H., Timmins Graham, Davies Lea, Heynekamp Theresa, Harkins Michelle, Sharp Zachary D., and Kelly H. William. Pediatric Allergy, Immunology, and Pulmonology. June 2016, 29(2): 68-73.