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    Summary
    EudraCT Number:2008-001156-43
    Sponsor's Protocol Code Number:205.339
    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:2009-07-28
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2008-001156-43
    A.3Full title of the trial
    A randomized, double-blind, placebo-controlled parallel group study to investigate the safety and efficacy of two doses of tiotropium bromide (2.5 micrograms and 5 micrograms) administered once daily via the Respimat device for 12 weeks in patients with cystic fibrosis
    Studio randomizzato, in doppio cieco, controllato verso placebo, a gruppi paralleli, volto a valutare la sicurezza e l`efficacia di tiotropio bromuro in due dosaggi (2,5 microgrammi e 5 microgrammi) somministrato una volta al giorno per 12 settimane mediante dispositivo Respimat, in pazienti affetti da fibrosi cistica
    A.4.1Sponsor's protocol code number205.339
    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 SponsorBOEHRINGER ING.
    B.1.3.4CountryItaly
    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 Yes
    D.2.1.1.1Trade name Spiriva Respimat 2.5 microgram, solution for inhalation
    D.2.1.1.2Name of the Marketing Authorisation holderBoehringer Ingelheim
    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 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 INNTiotropium bromide
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.3Concentration number2.5
    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.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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee 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 No
    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.IMP: 2
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameTiotropium Respimat 1.25 micrograms solution for inhalation
    D.3.2Product code NA
    D.3.4Pharmaceutical form Inhalation vapour, 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 INNTiotropium bromide
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.3Concentration number1.25
    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.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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee 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 No
    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
    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
    D.8 Placebo: 2
    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
    cystic fibrosis
    fibrosi cistica
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10011762
    E.1.2Term Cystic fibrosis
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    This study evaluates the effects of 12-week treatment with two doses of tiotropium bromide (2.5 micrograms q.d. and 5 micrograms q.d.) compared to placebo administered via the Respimat device on lung function in patients with cystic fibrosis (CF)
    Valutare l`effetto di 12 settimane di trattamento con due dosaggi (2.5 microgrammi q.d. and 5 microgrammi q.d.) di tiotropio bromuro somministrato via Respimat , rispetto al trattamento con placebo, nella funzionalita` polmonare in pazienti con fibrosi cistica (FC)
    E.2.2Secondary objectives of the trial
    A selection of the optimal dose will be based on bronchodilator efficacy, safety evaluations and pharmacokinetic evaluations.
    Una selezione del dosaggio ottimale sara' fatta basandosi sull'efficacia broncodilatatoria,sulla valutazione della sicurezza e sulla valutazione dei parametri farmacocinetici
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1)Male or female 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)Patients must be able to perform acceptable spirometric maneuvers, according to the American Thoracic Society (ATS) standards 3)Pre-bronchodilator FEV1 >=25% of predicted values*: *pediatric/adolescent (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. 4)Patients must be able to inhale medication in a reproducible manner from the Respimat inhaler and from a metered dose inhaler (MDI) 5)Patients must be clinically stable as defined by: a) no evidence of acute upper or lower respiratory tract infection within 4 weeks of screening; b) no pulmonary exacerbation requiring use of i.v./oral/inhaled antibiotics, or oral corticosteroids within 4 weeks of screening (Visit 1); c) Pre-bronchodilator FEV1 at Visit 2 must be within 15% of FEV1 at Visit 1. If pre-bronchodilator FEV1 at Visit 2 is not within 15% of FEV1 at Visit 1, Visit 2 may be re-scheduled once within 7 days. Investigator should also ascertain that the patient is symptomatically stable as per inclusion criterion 5. 6)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 7)Patients taking a chronic medication must be willing to continue this therapy for the entire duration of the study.
    1)Pazienti di sesso maschile o femminile con diagnosi documentata di FC (positivita` al test del cloruro nel sudore con valori &gt;=60 mEq/litro, mediante iontoforesi pilocarpinica) e/o genotipo con due mutazioni identificabili coerenti con FC accompagnate da una o piu` caratteristiche cliniche con il fenotipo della FC 2)I pazienti devono essere in grado di eseguire manovre spirometriche accettabili, secondo gli standard dell American Thoracic Society (ATS) 3)FEV1 pre-broncodilatatore &gt;=25% dei valori previsti*: *equazioni dei valori previsti per i pazienti pediatrici/adolescenti (fino a 18 anni di eta` compresi) tratte da: Wang X et al. Pulmonary function between 6 and 18 years of age. Pediatr Pulmonol 1993;15:75-88; *equazioni dei valori previsti per gli adulti (&gt;18 anni) tratte da: Knudson RJ et al. Changes in normal maximal expiratory flow-volume curve with growth. Am Rev Respir Dis 1983;127:725-734. 4)I pazienti devono essere in grado di inalare in maniera riproducibile il farmaco dall`inalatore Respimat e da un inalatore predosato (MDI). 5)I pazienti devono essere clinicamente stabili; un paziente e` definito clinicamente stabile in caso di: a)nessuna evidenza di infezioni acute delle vie respiratorie superiori o inferiori nelle 4 settimane precedenti lo screening; b)nessuna esacerbazione polmonare che abbia richiesto l`uso di antibiotici per via ev/orale/inalatoria o di corticosteroidi orali nelle 4 settimane precedenti lo screening (Visita 1); c) Il FEV1 pre-broncodilatatore alla Visita 2 deve essere entro il 15% del FEV1 alla Visita 1. Se il FEV1 pre-broncodilatatore alla Visita 2 non e` entro il 15% del FEV1 alla Visita 1, la Visita 2 puo` essere riprogrammata una volta entro 7 giorni. Lo sperimentatore deve verificare che il paziente sia clinicamente stabile come definito al punto 5. 6)Il paziente o il suo rappresentante legale deve essere in grado di fornire il proprio consenso informato in conformita` alle linee guida dell International Conference on Harmonization (ICH) Good Clinical Practice (GCP) e alla normativa locale. 7)I pazienti che assumono una terapia cronica devono essere disposti a continuare tale terapia per l`intera durata dello studio.
    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 or six half-lives (whichever is greater) 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) 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 females of child bearing potential) 6) Female patients of child bearing potential who are not using a medically approved form of contraception. The ICH Document M3, defines highly effective forms of birth control as: implants, injectables, combined oral contraceptives, some intrauterine contraceptive devices (IUDs), sexual abstinence, or a vasectomized partner. And, as such, this definition will constitute medically approved forms of birth control for this study 7) Patients who have started a new chronic medication for CF within 4 weeks of screening. Patients who are on a cycling TOBI regimen must have completed at least 2 cycles of every other month TOBI administration prior to the screening visit. The last TOBI cycle should have been performed 2 weeks before study entry (Visit 2). The last TOBI cycle during treatment with the investigational drug should have been performed two weeks before the last treatment visit (Visit 6). As there are other cycles used with TOBI, the clinical monitor should be consulted before the patient is enrolled 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 significant hematological, 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
    1)Pazienti con ipersensibilita` nota al farmaco dello studio o ai suoi componenti o con allergia nota al farmaco, che sia ritenuta rilevante per la sperimentazione a giudizio dello Sperimentatore. In questo contesto, rilevanza si riferisce a qualunque aumento del rischio di reazione di ipersensibilita` al farmaco della sperimentazione 2)Pazienti che abbiano partecipato a un altro studio con un farmaco sperimentale nel mese o nelle sei emivite (a seconda di quale sia maggiore) precedenti la visita di screening 3)Pazienti che attualmente partecipano ad un`altra sperimentazione. Sono consentiti gli studi osservazionali. Si dovrebbe ottenere il permesso dello sponsor dell`altro studio 4)Pazienti con abuso noto e rilevante di sostanze, compreso abuso di alcool o di farmaci. L`intento di questo criterio e` di escludere i pazienti ritenuti a rischio di mancato rispetto o di abuso delle direttive relative alla somministrazione del farmaco della sperimentazione 5)Pazienti di sesso femminile in gravidanza o in allattamento, comprese le donne che, allo screening, risultino positive al test sierico di gravidanza (saranno eseguiti test di gravidanza per tutte le donne in eta` fertile) 6)Pazienti di sesso femminile in eta` fertile che non utilizzino un metodo contraccettivo approvato dal punto di vista medico. Il Documento M3 dell ICH, definisce come metodi contraccettivi altamente efficaci: impianti, contraccettivi iniettabili, contraccettivi orali combinati, alcuni dispositivi contraccettivi intrauterini (IUD), astinenza sessuale oppure partner vasectomizzato. I metodi contraccettivi approvati dal punto di vista medico per questo studio saranno costituiti da quelli che rientrano in tale definizione. 7)Pazienti che abbiano iniziato ad assumere una nuova terapia cronica per la FC nelle 4 settimane precedenti lo screening. I pazienti che assumono un regime TOBI ciclico devono avere completato almeno 2 cicli di somministrazione di TOBI ogni due mesi prima della visita di screening. L`ultimo ciclo di TOBI dovrebbe essere stato eseguito 2 settimane prima dell`ingresso nello studio (Visita 2). L`ultimo ciclo di TOBI durante il trattamento con il farmaco sperimentale dovrebbe essere stato eseguito due settimane prima dell`ultima visita di trattamento (Visita 6). Poiche` con TOBI vengono utilizzati altri cicli, prima di arruolare il paziente si dovrebbe consultare il clinical monitor 8)Malattia clinicamente significativa o patologia diversa dalla FC o dalle patologie correlate alla FC che, a parere dello Sperimentatore, comprometterebbe la sicurezza del paziente o la qualita` dei dati. Cio` comprende malattie ematologiche, epatiche, renali, cardiovascolari e neurologiche. I pazienti affetti da diabete possono partecipare se la loro malattia risulta ben controllata prima dello screening. Questo criterio offre allo sperimentatore l`opportunita` di escludere i pazienti in base al giudizio clinico, anche se vengono soddisfatti gli altri criteri di idoneita`.
    E.5 End points
    E.5.1Primary end point(s)
    The co-primary endpoints for this trial are: Change from baseline in pct. predicted forced expiratory volume in one second (FEV1) area under the curve (AUC)0-4h at the end of Week 12 (Visit 6) Change from baseline in pct. predicted trough FEV1 at the end of Week 12 (Visit 6)
    Gli endpoint co-primari per questa sperimentazione sono: Variazione percentuale rispetto al basale dell`area sotto la curva (AUC)0-4h del previsto volume espiratorio forzato in un secondo (FEV1) previsto al termine della Settimana 12 (Visita 6) Variazione percentuale rispetto al basale del FEV1 minimo previsto al termine della Settimana 12 (Visita 6)
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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.8.2.4Number of treatment arms in the trial3
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA50
    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 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 years0
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months20
    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.1.1Number of subjects for this age range: 0
    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) Yes
    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.3.3.6.1Details of subjects incapable of giving consent
    bambini ti eta' inferiore a 18 anni
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 340
    F.4.2.2In the whole clinical trial 600
    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 Decision2009-07-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-07-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-04-02
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