科研之友
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摘要
This is a proof of concept study to determine whether inhalation of C-13-urea can be safely used to detect the presence of urease producing bacteria in the airways of patients with cystic fibrosis (CF) by detecting (CO2)-C-13 in breath. This was a prospective, 2-part, open label, single-center, single-arm, single-administration, dose-escalation investigational device exemption trial. First, the safety of 20 and 50mg inhaled C-13-urea was evaluated in 6 healthy adult participants. Then, 3 adult CF participants colonized with Pseudomonas aeruginosa were enrolled for each dose of inhaled C-13-urea. The safety of inhaled C-13-urea was assessed by spirometry and physical examination. C-13-urea was administered using a jet nebulizer, followed by serial spirometry (10min and 30min post inhalation) and collection of exhaled breath at 5, 10, and 15min post inhalation. There was no clinical significant change in any of the spirometry values compared to baseline in healthy participants and CF patients. Mean of (CO2)-C-13/(CO2)-C-12 delta over baseline (DOB) values in CF participants at 5, 10, and 15min post inhalation was as follows: 20mg dose 4 parts per thousand (2.2 parts per thousand-4.9 parts per thousand), 1 parts per thousand (1.0 parts per thousand-1.4 parts per thousand), and 1 parts per thousand (0.4 parts per thousand-1.5 parts per thousand); 50mg dose: 10 parts per thousand (6.2 parts per thousand-14.5 parts per thousand), 3 parts per thousand (2.1 parts per thousand-4.3 parts per thousand), and 1.5 parts per thousand (0.6 parts per thousand-2.3 parts per thousand). Inhaled C-13-urea for detection of urease producing bacteria was safe, and preliminary data suggest that (CO2)-C-13/(CO2)-C-12 DOB values may be higher in CF patients with P. aeruginosa at 5-10min after inhalation of C-13-urea. A future direction is to investigate use of inhaled C-13-urea in young children who have difficulty producing sputum for culturing.
- 出版日期2016-6
