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The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
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    The EU Clinical Trials Register currently displays   41449   clinical trials with a EudraCT protocol, of which   6808   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    EudraCT Number:2012-001541-40
    Sponsor's Protocol Code Number:Pro12/15
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2012-07-03
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedNetherlands - Competent Authority
    A.2EudraCT number2012-001541-40
    A.3Full title of the trial
    Effect of Carbon Dioxide Enriched Ambient Air on Pharmacokinetics and Deposition In Bronchiectasis Patients Using Tobramycin Inhalation: A proof of concept study.
    Het effect van koolstofdioxide verrijkte omgevingslucht op de farmacokinetiek en depositie van tobramycine inhalatie in patiënten met bronchiëctasieën.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The effect of carbon dioxide on inhaled antibiotics in bronchiectasis patients.
    Onderzoek naar het effect van antibiotica verneveling met koolstofdioxide bij patiënten met bronchiëctasieën.
    A.4.1Sponsor's protocol code numberPro12/15
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorVu University Medical Center
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportTeva Pharma NL
    B.4.1Name of organisation providing supportVu University Medical Center (department of pulmonary diseases)
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationVU University Medical Center
    B.5.2Functional name of contact pointInformation on clinical trial
    B.5.3 Address:
    B.5.3.1Street AddressDe boelelaan, PO box 7057
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1007 MB
    B.5.4Telephone number+31204444549
    B.5.5Fax number+31204445122
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D. name TOBI 300 mg/5 ml verneveloplossing
    D. of the Marketing Authorisation holderNovartis Pharma BV
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/09/613
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Inhalation solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTOBRAMYCIN
    D.3.9.1CAS number 32986-56-4
    D.3.9.4EV Substance CodeSUB11134MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Yes
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    E.1.1.1Medical condition in easily understood language
    Chronic lung damage
    Chronische longschade
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10006446
    E.1.2Term Bronchiectasis NOS
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the effect of CO2 enriched ambient air on deposition of inhaled tobramycin in bronchiectasis patients.

    Evalueren van het effect van CO2 verrijkte omgevingslucht op de depositie van tobramycine inhalatie in patiënten met bronchiëctasieën.
    E.2.2Secondary objectives of the trial
    To asses (with planar imaging) whether SPECT/CT scan are feasible in assessing pulmonary deposition of inhaled tobramycin.

    To compare pulmonary deposition of tobramycin with the Pari LC Plus ® nebulizer and the Aero Eclipse II ® nebulizer
    Evalueren van de mogelijkheid tot bepalen van de pulmonale depositie van tobramycine inhalatie met SPECT/CT scans

    Vergelijken van de pulmonale depositie van tobramycine inhalatie met de Pari LC Plus ® vernevelaar en de Aero Eclipse II ® vernevelaar.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Antibiotic inhalation treatment
    Behandeling met inhalatie antibioticum
    E.4Principal exclusion criteria
    o Age <21 years.
    o Chronic respiratory insufficiency defined according to the GOLD criteria (PaO2 < 60 mmHg or PaCO2 > 50 mmHg, WHO Global Initiative for Chronic Obstructive Lung Disease 2006)
    o Renal insufficiency defined as renal creatinine clearance of < 30 ml/minute.
    o Neuromuscular diseases.
    o Impaired hearing
    o Pregnant or breastfeeding.
    o Bronchiectasis exacerbation during last 4 weeks.
    o History of panic attacks
    o leeftijd <21 jaar.
    o Chronische respiratoire insufficientie (volgens GOLD richtlijnen (PaO2 < 60 mmHg or PaCO2 > 50 mmHg, WHO Global Initiative for Chronic Obstructive Lung Disease 2006)
    o Nierinsufficiëntie gedefinieerd als kreatinine klaring van < 30 ml/minuut
    o Neuromusculaire ziekte.
    o Gehoorverlies
    o Zwangerschap en borstvoeding.
    o Exacerbation gedurende afgelopen 4 weken.
    o Paniekaanvallen in de voorgeschiedenis
    E.5 End points
    E.5.1Primary end point(s)
    o Mean clearance rate (and range) of 99mTc-DTPA
    o Total and peripheral deposition of inhaled tobramycin (with and without carbon dioxide and with two different nebulizers)
    o Pharmacokinetics: C max (peak concentration), AUC (0-8 hours), T max (time to reach maximum concentration), T1/2 (half life).
    o Gem. klarings rate (en range) van 99mTc-DTPA
    o Totale en perifere depositie van tobramycine inhalatie (met en zonder koolstofdioxide en twee verschillende vernevelaars)
    o Farmacokinetiek: C max (piek concentratie), AUC (0-8 uur), T max (tijd tot max concentratie), T1/2 (halfwaardetijd).
    E.5.1.1Timepoint(s) of evaluation of this end point
    End of the study
    Eind van de studie
    E.5.2Secondary end point(s)
    o Peak expiratory flow
    o Respiratory parameters
    o Borg score (subjective sensation of dyspnoea)
    o Peak expiratory flow
    o Respiratoire parameters
    o Borg score (subjectieve sensatie van dyspnoe)
    E.5.2.1Timepoint(s) of evaluation of this end point
    End of study
    Eind van de studie
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E. trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind Yes
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E. description
    IMP met en onder CO2 verrijkte omgevingslucht (1); 2 verschillende vernevelaars andere dosis (2)
    IMP with and without CO2 enriched ambient air (1); 2 different nebulizers with different dose (2)
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Last visit of last subject of the trial.
    Laatste studiebezoek van de laatste proefpersoon in het onderzoek.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 11
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 3
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others Yes
    F. of other specific vulnerable populations
    Patients with chronic incurable disease (bronchiectasis) according to ICH GCP definition
    Patiënten met een chronische aandoening (bronchiectasieën), volgende de ICH GCP definitie
    F.4 Planned number of subjects to be included
    F.4.1In the member state14
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Expected normal treatment of bronchiectasis
    Normale behandeling bij bronchiëctasieën
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-07-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-08-20
    P. End of Trial
    P.End of Trial StatusOngoing
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