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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON20058

Enrollment

Registered

2011-10-20

Start date

2010-09-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

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

Interventions

inhaltion of solution containing tobramycin and TcDTPA.

Eligibility

Inclusion criteria

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; 3. Written informed consent; 4. Routine use of nebulized tobramycin; 5. Stable disease; 6. Patients must satisfy their medical examiner about their fitness to participate in the study; 7. Patients with no clinically significant abnormal serum biochemistry and haematology; 8. Female subjects with a negative pregnancy test, determined within 14 days of the start of the study and prior to each dosing phase.

Exclusion criteria

Exclusion criteria: 1. Pregnancy or lactation, women of childbearing potential must maintain effective contraception during the treatment period; 2. Acute exacerbation of pulmonary infection; 3. An FEV1 value which differs more than 10% from baseline value measured prior to the first dosing phase; 4. Use of any treatment within three days before the start of the study that may interfere with the effect to be studied; 5. Known impaired kidney function (serum creatinin > 177 umol/L corresponding with an estimated creatinin clearance < 60 ml/min.); 6. Patients receiving loop diuretics; 7. Intravenous use of tobramycin; 8. Treatment with any unregistered drug during the month prior to the administration of the investigational aerosol; 9. Current therapy or disease which may complicate the evaluation of the study protocol.

Design outcomes

Primary

Measure	Time frame
Total lung deposition.	—

Secondary

Measure	Time frame
1. Location of deposition, defined as Penetration Index (PI); 2. Pharmacoketics: e.g.: systemic bioavailability of tobramycin after inhalation.	—

Contacts

Public ContactJoris Uges

Central Hospital Pharmacy The Hague Escamplaan 900

j.uges@ahz.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)