Evaluating lung deposition and pharmacokinetics after controlled inhalation of a radiotracer containing tobramycin aerosol in patients with Cystic Fibrosis

Completed

• Conditions: 10010613; Cystic Fibrosis; 10004018

• Registration Number: NL-OMON33572
• Lead Sponsor: Apotheek Haagse Ziekenhuizen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 18

Inclusion Criteria

Clinical diagnosis cystic fibrosis
stable of disease
routine use of tobramycin

Exclusion Criteria

pregnancy and lactation
acute exacerbation of pulmonary infection
use of any treatment before the start of the study that may interfere with the study

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Lungdeposition: percentage of total lung deposition, aerosol penetration index<br /><br>and homogeneity in aerosol distribution.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Tobramycin serum levels after inhalation. Serum samples will be used to<br /><br>determine the tobramycin absorption kinetics, Cmax and Tmax will be determined.<br /><br><br /><br>The total lungdeposition will be measured not only by activity counts but also<br /><br>by analysis of a 24 hours urine collection sample.</p><br>