Evaluating of tobramycin in lung after controlled inhalation of a radioactive solution containing tobramycin in patients with Cystic Fibrosis.

Completed

• Conditions: Cystic Fibrosis, deposition study, Tc-DTPA, SPECT-CT, Inhalation flow manoeuvre, aerosol, radioactivity, Pulmonary drug delivery, nebulizer, 3D imaging, Ineb, CF, longdepositie, tobramycine

• Registration Number: NL-OMON20058
• Lead Sponsor: Haga Teaching Hospital and Central Hospital Pharmacy, The Hague.

Brief Summary

aube, B.L., Jashnani, R., Dalby, R.N. et al. Targeting aerosol deposition in patients with cystic fibrosis. Effects of alterations in particle size and inspiratory flow rate. Chest 2000; 118:1069-1076.<br> Le Brun, P.P.H., Vinks, A.A.T.M.M., et al.. “Can tobramycin inhalation be improved with a jet nebulizer?” Ther Drug Mon.1999; 21:618-24.<br> Foster, W.M., Stetkiewicz, P.T., Freed, A.N.J. Retention of soluble 99mTc-DTPA in the human lung: 24-h postdeposition. Appl. Physiol.1997; 82:1378-1382.<br> Eberl, S., Chan, H.K., Daviskas, E., SPECT imaging for radioaerosol deposition and clearance studies. J. Aerosol Med. 2006; 19:8-20.<br> Touw, D.J., Graaf, A.I. de, Goede, P.N.F.C. de. Evaluation of a fluorescence polarographic immunoassay with increased sensitivity for measurement of low concentrations of tobramycin in serum. Ther Drug Mon 1996; 18:189-193.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

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

Inclusion Criteria

1. Clinical diagnosis of CF and a positive sweat test or two CF related mutations;

2. Adult patients aged 18 years and older;

Exclusion Criteria

1. Pregnancy or lactation, women of childbearing potential must maintain effective contraception during the treatment period;

2. Acute exacerbation of pulmonary infection;

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Total lung deposition.

Secondary Outcome Measures

Name	Time	Method
1. Location of deposition, defined as Penetration Index (PI);<br /><br>2. Pharmacoketics: e.g.: systemic bioavailability of tobramycin after inhalation.