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    EudraCT Number:2010-019802-17
    Sponsor's Protocol Code Number:205.438
    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:2010-09-09
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedAustria - BASG
    A.2EudraCT number2010-019802-17
    A.3Full title of the trial
    A randomised, double-blind, placebo-controlled parallel-group trial to confirm the efficacy after 12 weeks and the safety of tiotropium 5 μg administered once daily via the Respimat® device in patients with cystic fibrosis.
    A.4.1Sponsor's protocol code number205.438
    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 SponsorBoehringer Ingelheim RCV GmbH & Co KG,
    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.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 Yes
    D. name Spiriva Respimat 2.5 microgram, solution for inhalation
    D. of the Marketing Authorisation holderBoehringer Ingelheim Pharma GmbH Co. KG
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    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 nameSpiriva Respimat 2.5 mcg
    D.3.2Product code Tiotropium Respimat
    D.3.4Pharmaceutical form Inhalation vapour, 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.3.9.1CAS number 411207313
    D.3.9.2Current sponsor codeBa 679 Br
    D.3.9.3Other descriptive nameTIOTROPIUM BROMIDE MONOHYDRATE
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3.124
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product Information not present in EudraCT
    D. ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D. 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboInhalation vapour*
    D.8.4Route of administration of the placeboInhalation use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Cystic Fibrosis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10011762
    E.1.2Term Cystic fibrosis
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level PT
    E.1.2Classification code 10011762
    E.1.2Term Cystic fibrosis
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Efficacy and safety of tiotropium bromide, Spiriva, in patients with cystic fibrosis administered once daily via the Respimat device.
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Patients with a documented diagnosis of CF (positive sweat chloride ≥60 mEq/liter,
    by pilocarpine iontophoresis) and/or a genotype with two identifiable mutations
    consistent with CF accompanied by one or more clinical features with the CF
    2. Male or female patients (children less than 12 years and adolescents ≥ 12 years).
    Patients below 1 year of age, if eligible, can be included in the trial only for safety
    3. Patients ≥ 5 years of age must be able to perform acceptable spirometric maneuvers,
    according to the American Thoracic Society (ATS) standards.
    4. Pre-bronchodilator FEV1 >25% of predicted values:
    • pediatric/adolescent (≥ 5 years up to 18 years of age, inclusive) predicted
    equations from: Wang X et al. Pulmonary function between 6 and 18 years of
    age. Pediatr Pulmonol 1993;15:75-88.
    • adult (>18 years) predicted equations from: Knudson RJ et al. Changes in
    normal maximal expiratory flow-volume curve with growth. Am Rev Respir
    Dis 1983;127:725-734 [R98-1298]
    5. Patients must be able to inhale medication in a reproducible manner from the
    Respimat® inhaler and from a metered dose inhaler (MDI) for children of 5 years and
    above. For children below 5 years, patients must be able to inhale medication in a
    reproducible manner from the Respimat® inhaler with spacer (the Aerochamber
    plus® holding chamber with facemask).
    6. Pre-bronchodilator FEV1 at Visit 2 must be within 15% of FEV1 at Visit 1. If prebronchodilator
    FEV1 at Visit 2 is not within 15% of FEV1 at Visit 1, Visit 2 can be
    repeated within 7 days and rescheduled once.
    7. Investigator should also ascertain that the patient is symptomatically stable as defined
    • no evidence of acute upper or lower respiratory tract infection within 2 weeks
    of screening (Visit 1).
    • no pulmonary exacerbation requiring use of i.v./oral/inhaled antibiotics, or oral
    corticosteroids within 2 weeks of screening (Visit 1).
    8. The patient or the patient’s legally acceptable representative must be able to give
    informed consent in accordance with International Conference on Harmonization
    (ICH) Good Clinical Practice (GCP) guidelines and local regulation prior to
    participation in the trial (i.e. prior to any study procedures, including any pre-study
    washout of medication and medication restrictions for pulmonary function test at
    9. Patients who are on a cycling TOBI® regimen must have completed at least 2 cycles
    every other month TOBI® administration prior to the screening visit. The last TOBI®
    cycle should have been completed 2 weeks before randomisation visit (visit 2). For
    other inhaled antibiotics (e.g., colistin, aztreonam), please contact the local clinical
    monitor (CML) for guidance.
    10. Patients who are on daily inhaled antibiotic use must be stabilized for at least 6 weeks
    prior to Visit 1 (screening).
    11. Patients having previously participated in study 205.339 can also be selected.
    E.4Principal exclusion criteria
    1. Patients with a known hypersensitivity to study drug or its components or known
    medication allergy that is deemed relevant to the trial as judged by the Investigator.
    “Relevance” in this context refers to any increased risk of hypersensitivity reaction to
    trial medication.
    2. Patients who have participated in another study with an Investigational drug within
    one month preceding the screening visit.
    3. Patients who are currently participating in another trial. Observational studies are
    allowed. Permission should be obtained from sponsor of other study.
    4. Patients with known relevant substance abuse, including alcohol or drug abuse. The
    intention of this criterion is to exclude patients who are considered to be at risk of not
    complying with or abusing the trial medication administration directives.
    5. Adolescent and adult female patients who are pregnant or lactating, including females
    who have a positive serum pregnancy test at screening (pregnancy tests will be
    performed for all adolescent and adult females of child bearing potential).
    6. Female patients of child bearing potential who are not using a medically approved
    form of contraception. The ICH (M3) defined highly effective methods of birth
    control as those, alone or in combination, that result in a low failure rate (i.e. less than
    1% per year) when used consistently and correctly. For patients using a hormonal
    contraceptive method, information regarding the product under evaluation and its
    potential effect on the contraceptive should be addressed. Barrier contraceptives (e.g.
    male condom or diaphragm) are acceptable if used in combination with spermicides
    (e.g. foam gel).Refer to ICH Topic M3 provided in the ISF..
    7. Patients who have started a new chronic medication for CF within 2 weeks before the
    screening visit (Visit 1).
    8. Clinically significant disease or medical condition other than CF or CF-related
    conditions that, in the opinion of the Investigator, would compromise the safety of the
    patient or the quality of the data. This includes but is not limited to significant
    haematological, hepatic, renal, cardiovascular, and neurologic disease. Patients with
    diabetes may participate if their disease is under good control prior to screening. This
    criterion provides an opportunity for the investigator to exclude patients based on
    clinical judgment, even if other eligibility criteria are satisfied.
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoints: FEV1 percent predicted AUC0-4H (first) and trough FEV1 percent
    predicted (second) at week 12.
    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 Yes
    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) 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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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) No
    E.8.2.2Placebo Yes
    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.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA12
    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
    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 months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days0
    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 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 Yes
    F. of subjects incapable of giving consent
    Children and adolescents < 18 years will be enrolled.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state17
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 440
    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 Decision2010-10-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-09-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-03-07
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