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    The EU Clinical Trials Register currently displays   35654   clinical trials with a EudraCT protocol, of which   5853   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2006-002214-35
    Sponsor's Protocol Code Number:BY9010/CP-038
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-06-16
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedAustria - BASG
    A.2EudraCT number2006-002214-35
    A.3Full title of the trial
    Free, not protein-bound concentrations of budesonide in subcutaneous adipose tissue, muscle tissue, and serum after oral inhalation via Turbohaler®
    A.4.1Sponsor's protocol code numberBY9010/CP-038
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorALTANA Pharma AG
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Information not present in EudraCT
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namePulmicort Turbohaler
    D.3.4Pharmaceutical form Inhalation powder
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNBudesonide
    D.3.9.1CAS number 51333-22-3
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0,4
    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) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    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
    Phase I healthy volunteer study
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    ·To assess the free unbound concentration of budesonide in Serum, Muscle tissue, and Subcutaneous adipose tissue
    E.2.2Secondary objectives of the trial
    · To assess total concentrations (bound and unbound) of budesonide in serum
    · To assess metabolites of budesonide in serum (if feasible)
    · To assess safety and tolerability
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    · Subject has been informed both verbally and in writing about the objectives of the clinical study, the methods, the anticipated benefits and potential risks and the discomfort to which he/she may be exposed, and has given written consent to participation in the study prior to study start and any study-related procedure
    · White (Caucasian origin) healthy male/female subjects, aged between 18 and 45 years (inclusive)
    · Normal body weight as evidenced by a Body Mass Index (BMI) between > or = 18 and < or = 28kg/m², and a body weight > 50 kg
    · Safe contraception in females of childbearing potential during the entire study, which means the use of effective birth-control methods such as hormonal contraceptives for at least 2 months prior to start of screening, double barrier method (condoms and diaphragms) or intra-uterine devices, which were thought to be medically acceptable forms of birth control
    E.4Principal exclusion criteria
    Safety concerns:
    · History or current evidence of allergies or idiosyncrasy to drugs or food, if considered relevant at the discretion of the investigator
    · History of allergic reactions to any active or inactive ingredient of the trial medication
    · History or current evidence of cardiovascular, pulmonary, hepatic, renal, gastrointestinal, hematological, endocrinological, metabolic, neurological, psychiatric, or other disease within the last 2 years, if considered relevant at the discretion of the investigator
    · Impairment of blood coagulation
    · History of malignancy within the past 5 years
    · Electrocardiogram (ECG) abnormalities of relevance (assessment by investigator, e.g. QTc according to Bazett: males and females > 450 ms, PQ > or = 220 ms)
    · Relevant (assessment by investigator) abnormalities in clinical chemical, hematological or any other laboratory variables
    · Chronic or clinically relevant acute infections (assessment by investigator)
    · Proneness to orthostatic dysregulation, fainting, or blackouts
    · Positive results in any of the virology tests for HIV-Ab1 or HIV-Ab2, HCV-Ab, HBsAg.
    · Drug screen positive or not performed
    · Abuse of alcohol (>2 drinks/day defined according to USDA Dietary Guidelines 2005) or drugs
    · Pregnant or lactating females
    · ß-HCG pregnancy test (female subjects) positive or not performed

    Lack of suitability for the trial:
    · Treatment with any known CYP3A4-isoenzyme inducing / inhibiting agents (barbiturates, phenothiazines, cimetidine, ketoconazole etc.) and eating Brussels sprout or broccoli and eating grapefruits or star fruits, drinking of star- or grapefruit juice within two weeks prior to the study
    · Use of any medication (incl. herbal and over-the-counter (OTC) medication) within two weeks before trial drug administration or within less than 10 times the elimination half-life of the respective drug, or anticipated concomitant medication during the treatment period (single intake of a drug may be accepted if judged by the investigators to have no clinical relevance and no relevance for the study objectives)
    · Vegetarian diet or other peculiar dietary habits which would preclude the subject’s acceptance of standardized meals
    · Surgery of the gastrointestinal tract which may interfere with drug absorption
    · Participation in drug trials within the last 30 days before start of the study (last day of intake of medication – first day of medication in the following study)
    · Smoking of more than 5 cigarettes daily
    · Anticipated donation of spermatocytes or oocytes for medically assisted reproduction techniques (ART) within 2 months after the last dose of the present trial
    · Blood donation within the last 30 days before start of the study

    Administrative reasons:
    · Lack of ability or willingness to give informed consent
    · Anticipated non-availability for study visits/procedures.
    · Anticipated lack of willingness or inability to cooperate adequately
    · Vulnerable subjects (e.g. persons kept in detention)
    · Anticipated lack of ability or willingness to apply safe contraception (female subjects)
    E.5 End points
    E.5.1Primary end point(s)
    Free unbound concentrations of budesonide as obtained by microdialysis in serum, muscle tissue and subcutaneous adipose tissue
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Information not present in EudraCT
    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.7.1.3.1Other 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 No
    E.8.1.1Randomised No
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    F.3.3Specific vulnerable populations Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2006-06-16. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 No
    F.4 Planned number of subjects to be included
    F.4.1In the member state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 8
    F.4.2.2In the whole clinical trial 8
    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 Decision2006-08-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-08-01
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2006-08-16
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