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van CCT (UK)


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van CCT (UK)


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


- candidate number10460
- NTR NumberNTR3109
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR20-okt-2011
- Secondary IDs07-049 METC-ZWH
- Public TitleEvaluating of tobramycin in lung after controlled inhalation of a radioactive solution containing tobramycin in patients with Cystic Fibrosis.
- Scientific TitleEvaluating lung deposition and pharmacokinetics after controlled inhalation of a radiotracer containing tobramycin aerosol in patients with Cystic Fibrosis.
- ACRONYMDEPOSITIE
- hypothesis1. 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.
- Healt Condition(s) or Problem(s) studiedCystic Fibrosis (CF), Aerosol, Lung deposition, Nebulizer, Radioactivity, Tc-DTPA
- Inclusion criteria1. 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 criteria1. 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.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2010
- planned closingdate1-dec-2012
- Target number of participants18
- Interventionsinhaltion of solution containing tobramycin and TcDTPA.
- Primary outcomeTotal lung deposition.
- Secondary outcome1. Location of deposition, defined as Penetration Index (PI);
2. Pharmacoketics: e.g.: systemic bioavailability of tobramycin after inhalation.
- Timepoints1. 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)).
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIES Joris Uges
- CONTACT for SCIENTIFIC QUERIESDr. H. Heijerman
- Sponsor/Initiator Haga Teaching Hospital, Department of Pulmonology
- Funding
(Source(s) of Monetary or Material Support)
NCFS (Nederlandse Cystic Fibrosis Stichting)
- PublicationsLaube, 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.
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.
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.
Eberl, S., Chan, H.K., Daviskas, E., SPECT imaging for radioaerosol deposition and clearance studies. J. Aerosol Med. 2006; 19:8-20.
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.
- Brief summaryIn 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.
- Main changes (audit trail)
- RECORD20-okt-2011 - 11-aug-2012


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