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    Summary
    EudraCT Number:2005-003772-37
    Sponsor's Protocol Code Number:CTBM100C2302
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-07-03
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2005-003772-37
    A.3Full title of the trial
    A Randomized, Open-label, Multicenter, Phase 3 Trial to Assess the Safety of Tobramycin Inhalation Powder Compared to TOBI® in Cystic Fibrosis Subjects
    A.3.2Name or abbreviated title of the trial where available
    TIP003
    A.4.1Sponsor's protocol code numberCTBM100C2302
    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 SponsorNovartis Pharma Services AG
    B.1.3.4CountrySwitzerland
    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 No
    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/3/03/140
    D.3 Description of the IMP
    D.3.1Product nameTobramycin Inhalation Powder (TIP)
    D.3.2Product code TBM100C
    D.3.4Pharmaceutical form Inhalation powder, hard capsule
    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 INNTobramycin
    D.3.9.1CAS number 32986-56-4
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number28
    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 No
    D.3.11.8Extractive medicinal product No
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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.2.1.1.1Trade name TOBI
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Hungária Kft. Pharma részlege
    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 nameTOBI
    D.3.4Pharmaceutical form Nebuliser solution
    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 INNTobramycin
    D.3.9.1CAS number 32986-56-4
    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) 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 No
    D.3.11.8Extractive medicinal product No
    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
    Pulmonary pseudomonas aeruginosa infections in patients with cystic fibrosis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Classification code 10011762
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to evaluate the safety in cystic fibrosis (CF) subjects of a twice-daily (BID) dosing regimen of Tobramycin Inhalation Powder (TIP) delivered by the T-326 Inhaler as compared to TOBI delivered with the PARI LC PLUS™ Jet Nebulizer and DeVilbiss PulmoAide™ compressor or a suitable alternative. Suitable compressors are those that, when attached to a PARI LC PLUS nebulizer, deliver a flow rate of 4 to 6 L/min and/or back pressure of 110 to 217 kPa.
    E.2.2Secondary objectives of the trial
    The secondary objectives are: (a) to assess the efficacy of TIP as compared to TOBI, as measured by the relative change in forced expiratory volume at 1 second (FEV1 % predicted) from baseline to the end of cycle 3 dosing; and (b) to assess subject-reported treatment satisfaction by administering the Treatment Satisfaction Questionnaire for Medication (TSQM©).
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Population Pharmacokinetic Substudy, as described in section 9.5.1.5.4 of CTBM100C2302 (TIP003) protocol.
    E.3Principal inclusion criteria
    · Confirmed diagnosis of CF by the presence of one or more clinical features of CF in
    addition to:
    - a quantitative pilocarpine iontophoresis sweat chloride test of > 60 mEq/L; or
    - identification of well-characterized disease-causing mutations in each CFTR
    gene; or
    - an abnormal nasal transepithelial potential difference characteristic of CF.
    · Male and female subjects greater than or equal to 6 years of age at the time of screening.
    · FEV1 at screening must be greater than or equal to 25% and less than or equal to 75% of normal predicted values for age, sex, and height based on Knudson criteria.
    · P aeruginosa must be present in a sputum/deep-throat cough swab culture (or bronchoalveolar lavage [BAL]) within 6 months prior to screening and in the sputum/ deep-throat cough swab culture at the screening visit.
    · Able to comply with all protocol requirements.
    · Clinically stable in the opinion of the investigator.
    · Use of an effective means of contraception in females of childbearing potential. The definition of effective contraception will be based on the judgment of the investigator or a designated associate. Acceptable methods of contraception include oral, depot and injectable contraceptives, total abstinence and surgical sterilization (e.g., bilateral tubal ligation). Double barrier methods (i.e. combination of: IUD, male or female condom with spermicidal gel, diaphragm, sponge, cervical cap) are acceptable with the exception of a combination of condom and diaphragm. Emergency contraceptive treatment after intercourse, coitus interruptus, single barrier methods and periodic abstinence (e.g. calendar, ovulation, symptothermal, post ovulation methods) are not considered effective forms of contraception.
    · Provide written informed consent and assent (as appropriate) prior to the performance of any study-related procedure
    E.4Principal exclusion criteria
    · History of sputum culture or deep-throat cough swab (or BAL) culture yielding Burkholderia cepacia (B cepacia) within 2 years prior to screening and/or sputum culture yielding B cepacia at screening.
    · Hemoptysis more than 60 cc at any time within 30 days prior to study drug administration.
    · Known local or systemic hypersensitivity to aminoglycosides or inhaled antibiotics.
    · Serum creatinine 2 mg/dl or more, BUN 40 mg/dl or more, or an abnormal urinalysis defined as 2+ or greater proteinuria.
    · Females who are pregnant (positive pregnancy test), lactating, or are planning to become pregnant during the study.
    · History of hearing loss or chronic tinnitus deemed clinically significant by the investigator.
    · Use of systemic or inhaled antipseudomonal antibiotics within 28 days prior to study drug administration.
    · Use of loop diuretics within 7 days prior to study drug administration.
    · Use of any investigational treatment within 28 days prior to study drug administration.
    · Initiation of treatment with chronic macrolide therapy within 28 days prior to study drug administration (subjects may be taking chronic macrolide therapy at the time of enrollment into CTBM100C2302, but they must have initiated treatment more than 28 days prior to study drug administration).
    · Initiation of treatment with dornase alpha within 28 days prior to study drug administration (subjects may be taking dornase alpha at the time of enrollment into CTBM100C2302, but they must have initiated treatment more than 28 days prior to study drug administration).
    · Initiation of treatment with inhaled steroids (or increased dose) within 28 days prior to study drug administration (subjects may be taking inhaled steroids at the time of enrollment into CTBM100C2302, but they must have initiated treatment more than 28 days prior to study drug administration).
    · Initiation of treatment with inhaled hypertonic saline (HS) within 28 days prior to
    study drug administration (subjects may be taking inhaled HS at the time of
    enrollment into CTBM100C2302, but they must have initiated treatment more than
    28 days prior to study drug administration and be on a stable regimen). In addition,
    patients should be instructed to take their HS at least 30 minutes before their PFT.
    Patients should be consistent with the timing of taking their HS at home, or clinic
    prior to their PFT.
    E.5 End points
    E.5.1Primary end point(s)
    Criteria for evaluation:
    Safety
    · Incidence of treatment-emergent adverse events (AE).
    · Clinical laboratory test results.
    · Serum tobramycin concentrations.
    · Audiology test results (at select CF centers).
    · Acute change in FEV1% predicted values from pre-dose to 30 minutes post-dose at
    visits 2, 3, 5, 7, 8, 9, and 10.

    Efficacy
    · Relative changes of FEV1 % predicted from baseline to all scheduled posttreatment visits (weeks 2, 5, 9, 13, 17, 21, and 25).
    · Area under the curve (AUC) of relative changes of FEV1% predicted from baseline (predose day 1) to all scheduled posttreatment visits (weeks 2, 5, 9, 13, 17, 21, and 25).
    · Time from start of first inhalation of study drug to first antipseudomonal antibiotic use (IV alone, oral alone, and IV or oral).
    · Time from start of inhalation of study treatment to first hospitalization due to serious respiratory-related AEs.

    Treatment Satisfaction
    · Treatment Satisfaction Questionnaire for Medication (TSQM) at end of each treatment cycle (weeks 5, 13, and 21) and upon early termination, if applicable.

    Microbiology
    · Change in P aeruginosa density (log10 colony-forming units [CFU] per gm sputum) from baseline to weeks 5, 9, 13, 17, 21, and 25 (refer to Time and Events Table 2 1).
    · Change in P aeruginosa tobramycin minimum inhibitory concentration (MIC) susceptibility from baseline to weeks 5, 9, 13, 17, 21, and 25.

    Pharmacokinetics
    · Serum pharmacokinetics (PK) of tobramycin after administration of both formulations in up to 30 evaluable subjects per arm.

    Administration Time
    · For each treatment group, the administration time for doses administered in the clinic at visits 2, 3, 5, 7, 8, 9, and 10 (weeks 1, 2, 4, 9, 13, 17, and 21) will be recorded
    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 Yes
    E.6.5Efficacy Yes
    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 Yes
    E.6.13.1Other scope of the trial description
    treatment satisfaction
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.5The trial involves multiple Member States Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee Yes
    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
    Termination will occur on the date the subject completes the follow-up/termination visit (visit 11). If a subject does not complete visit 11, termination will occur on the date of the last subject visit.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    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) Yes
    F.1.1.6Adolescents (12-17 years) Yes
    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 No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Information not present in EudraCT
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    The subject may be too young to give consent personally. In this case a legal representative may sign on their behalf. The patient in these situations will be asked to sign an assent form if appropriate.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 125
    F.4.2.2In the whole clinical trial 500
    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 Decision2007-11-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-07-25
    P. End of Trial
    P.End of Trial StatusCompleted
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