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    EudraCT Number:2010-019802-17
    Sponsor's Protocol Code Number:205.438
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-08-20
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    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 micrograms administered once daily via the Respimat device in patients with cystic fibrosis.
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code number205.438
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberND
    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 ING.
    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
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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.3.4Pharmaceutical 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.3.8INN - Proposed INNTiotropium bromide
    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, solution
    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
    Patients with cystic fibrosis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10011762
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To confirm the efficacy of 5 micrograms of tiotropium compared to placebo administered via the Respimat device over 12 weeks. To assess the long term safety of tiotropium 5 micrograms Respimat over a minimum of 6 months (24 weeks).
    E.2.2Secondary objectives of the trial
    -Change from baseline in percent predicted forced vital capacity (FVC) (AUC0-4H) at 12 weeks. -Change from baseline in percent predicted trough FVC at 12 weeks. -Change from baseline in pre-bronchodilator mean forced expiratory flow between 25%-75% of FVC (FEF25-75) at 12 weeks. -Proportion of patients with at least 1 pulmonary exacerbation during the treatment period as assessed by the Respiratory and Systemic Symptoms Questionnaire (RSSQ); using the definition as given in Fuchs et al. -Change from baseline in Cystic fibrosis Questionnaire revised (CFQ-R) at 12 weeks.
    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 phenotype. 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 assessment. 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. 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 by: • 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 Visit1). 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. For TOBI cycling during the trial please refer to section 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. 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. Thiscriterion 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)
    The co-primary efficacy endpoints are: -change from baseline in percent predicted forced expiratory volume in one second (FEV1) area under the curve (AUC0-4H) at the end of week 12 (visit 5) and -change from baseline in percent predicted trough FEV1 at 12 weeks.
    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 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 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA61
    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 months3
    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 months3
    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) Yes
    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
    lattanti e bambini di eta` <= 11 anni
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state16
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 272
    F.4.2.2In the whole clinical trial 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 Decision2010-07-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-07-26
    P. End of Trial
    P.End of Trial StatusCompleted
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