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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON33572

Enrollment

Registered

2007-06-05

Start date

2007-06-01

Completion date

Unknown

Last updated

2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic Fibrosis

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Clinical diagnosis cystic fibrosis stable of disease routine use of tobramycin

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Lungdeposition: percentage of total lung deposition, aerosol penetration index and homogeneity in aerosol distribution.	—

Secondary

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

Countries

Netherlands

Outcome results