1. Inhaltion of tobramycin containing aerosols using the INeb® in the TBM mode is less effective as inhalation of in the TIM mode; 2. The amount of deposition is correlated to the systemic Area Under the Curve of tobramycin after inhaltion of…
ID
Bron
Verkorte titel
Aandoening
Cystic Fibrosis, deposition study, Tc-DTPA, SPECT-CT, Inhalation flow manoeuvre, aerosol, radioactivity, Pulmonary drug delivery, nebulizer, 3D imaging, Ineb, CF, longdepositie, tobramycine
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Total lung deposition.
Achtergrond van het onderzoek
In de depositiestudie vernevelen 18 CF patienten met verschilende ziektestadia 2 maal met een INeb een radioactief gelabelde tobramycine oplossing. Het ene bezoek staat de Ineb in TIM en het andere in TBM modus op basis van randomisatie. Naast SPECT-CT opnamen worden bloedmonsters afgenomen gedurende 24 uur. De volgende vragen worden onderzocht: hoeveelheid en locatie van depositie na een verneveling met de Ineb, relatie tussen Farmacokinetiek en locatie van depositie, invloed van de inhalatiemanoevre op de depositie, relatie tussen depositie en ziekteactiviteit.
Doel van het onderzoek
1. Inhaltion of tobramycin containing aerosols using the INeb® in the TBM mode is less effective as inhalation of in the TIM mode;
2. The amount of deposition is correlated to the systemic Area Under the Curve of tobramycin after inhaltion of tobrmaycin.
Onderzoeksopzet
1. Total lung deposition: %deposition in lung (of activity (MBq) administered);
2. PI: Quotient of amount (MBq) central vs amount (MBq) periferic airways;
3. AUC_0-12 hr (based on serum tobramycin levels (mg/l)).
Onderzoeksproduct en/of interventie
inhaltion of solution containing tobramycin and TcDTPA.
Algemeen / deelnemers
Escamplaan 900
Joris Uges
Den Haag 2547 EX
The Netherlands
j.uges@ahz.nl
Wetenschappers
Escamplaan 900
Joris Uges
Den Haag 2547 EX
The Netherlands
j.uges@ahz.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL2962 |
| NTR-old | NTR3109 |
| Ander register | METC-ZWH : 07-049 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
Samenvatting resultaten
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.