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    Summary
    EudraCT Number:2009-010668-40
    Sponsor's Protocol Code Number:1237.5
    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:2011-12-22
    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 number2009-010668-40
    A.3Full title of the trial
    A randomised, double-blind, parallel group study to assess the efficacy and safety of 52 weeks of once daily treatment of orally inhaled tiotropium + olodaterol fixed dose combination (2.5 micrograms / 5 micrograms; 5 micrograms / 5 micrograms) (delivered by the Respimat Inhaler) compared with the individual components (2.5 micrograms and 5 micrograms tiotropium, 5 micrograms olodaterol) (delivered by the Respimat Inhaler) in patients with Chronic Obstructive Pulmonary Disease (COPD)
    Studio randomizzato, in doppio cieco, a gruppi paralleli, volto a valutare l'efficacia e la sicurezza di 52 settimane di trattamento inalatorio per via orale, una volta al giorno, con l'associazione fissa di tiotropio + olodaterolo (2,5 microgrammi/5 microgrammi; 5 microgrammi/5 microgrammi) somministrata mediante l'inalatore Respimat in confronto ai due componenti individuali (2,5 microgrammi e 5 microgrammi per tiotropio, 5 microgrammi per olodaterolo) somministrati mediante l`™inalatore Respimat, in pazienti con broncopneumopatia cronica ostruttiva (BPCO).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to assess the efficacy and safety of tiotropium+olodaterol fixed dose combination in patients with COPD
    Studio per valutare l'efficacia e la sicurezza di tiotropio + olodaterolo in associazione a dose fissa in pazienti con BPCO
    A.3.2Name or abbreviated title of the trial where available
    TOnado 1
    TOnado 1
    A.4.1Sponsor's protocol code number1237.5
    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 supportBoehringer Ingelheim Italia S.p.A.
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBoehringer Ingelheim Pharma GmbH & Co. KG
    B.5.2Functional name of contact pointQRPE PSC CT Information Disclosure
    B.5.3 Address:
    B.5.3.1Street AddressBinger Strasse 173
    B.5.3.2Town/ cityIngelheim am Rhein
    B.5.3.3Post code55216
    B.5.3.4CountryGermany
    B.5.4Telephone number+1-800-243-0127
    B.5.5Fax number+1-800-821-7119
    B.5.6E-mailclintriage.rdg@boehringer-ingelheim.com
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameTiotropium 1.25microgram/Olodaterol 2.5microgram
    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
    D.3.9.4EV Substance CodeSUB25691
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.25
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNolodaterol
    D.3.9.2Current sponsor codeBI 1744 CL
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    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 Yes
    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 2.5microgram/Olodaterol 2.5microgram
    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
    D.3.9.4EV Substance CodeSUB25691
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNolodaterol
    D.3.9.2Current sponsor codeBI 1744 CL
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    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 Yes
    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: 3
    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 Spiriva Respimat 2.5 microgram
    D.2.1.1.2Name of the Marketing Authorisation holderBoehringer Ingelheim Pharma GmbH & Co. KG
    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
    D.3.9.4EV Substance CodeSUB25691
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    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 Yes
    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: 4
    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 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 1.25 microgram
    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
    D.3.9.4EV Substance CodeSUB25691
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    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 Yes
    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: 5
    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 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 nameolodaterol 2.5 microgram
    D.3.2Product code BI 1744
    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 INNolodaterol
    D.3.9.2Current sponsor codeBI 1744
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    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 Yes
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with Chronic Obstructive Pulmonary Disease (COPD)
    pazienti con broncopneumopatia cronica ostruttiva (BPCO)
    E.1.1.1Medical condition in easily understood language
    Patients with Chronic Obstructive Pulmonary Disease (COPD)
    Pazienti con BPCO
    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 LLT
    E.1.2Classification code 10010952
    E.1.2Term COPD
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to assess the efficacy and safety of 52 weeks once daily treatment with orally inhaled tiotropium + olodaterol fixed dose combination ((2.5 micrograms / 5 micrograms; 5 micrograms/ 5 micrograms) (delivered by the Respimat Inhaler) compared with the individual components (2.5 and 5 micrograms tiotropium, 5 micrograms olodaterol) (delivered by the Respimat Inhaler) in patients with Chronic Obstructive Pulmonary Disease (COPD).
    l'obiettivo primario di questo studio e' valutare l’efficacia e la sicurezza di 52 settimane di trattamento inalatorio per via orale una volta al giorno con l'associazione fissa di tiotropio + olodaterolo, (2,5 microgrammi/5 microgrammi; 5 microgrammi/5 microgrammi) somministrata mediante l'Inalatore Respimat in confronto ai due componenti individuali (2,5 microgrammi e 5 microgrammi per tiotropio, 5 microgrammi per olodaterolo) somministrati mediante l'Inalatore Respimat in pazienti con broncopneumopatia cronica ostruttiva (BPCO).
    E.2.2Secondary objectives of the trial
    -
    -
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. All patients must sign an informed consent consistent with ICH-GCP guidelines prior to participation in the trial, which includes medication washout and restrictions. 2. All patients must have a diagnosis of COPD and must meet the following spirometric criteria: Patients must have relatively stable airway obstruction with a post-bronchodilator FEV1< 80% of predicted normal (ECSC; GOLD II - IV and a post-bronchodilator FEV1/FVC <70% at Visit 1. 3. Male or female patients, 40 years of age or older. 4. Patients must be current or ex-smokers with a smoking history of more than 10 pack years. 5. Patients must be able to -perform technically acceptable pulmonary function tests , -perform technically acceptable PEF measurements, -maintain records (Patient Daily e-Diary) during the study period , -perform all other assessments (e.g. complete self administed questionnaires), as required in the protocol. 6.Patients must be able to inhale medication in a competent manner from the RESPIMAT inhaler and from a metered dose inhaler (MDI).
    1.Firma di un modulo di consenso informato in accordo alle linee guida ICH-GCP, prima di avviare la partecipazione allo studio (comprensiva di washout dai trattamenti abituali e delle eventuali restrizioni farmacologiche). 2.Diagnosi di BPCO e criteri spirometrici seguenti: -broncoostruzione relativamente stabile con Volume Espiratorio Forzato in un secondo (FEV1) dopo broncodilatatore &lt; 80% del valore di normalità previsto (criteri ECSC e GOLD II-IV) e &lt; 70% della capacita' vitale forzata, misurato alla Visita 1. 3.Pazienti maschi o femmine di età &gt;= 40 anni. 4.Fumatori o ex-fumatori con anamnesi di &gt;= 10 pacchetti-anni, calcolati come segue: numero di sigarette al giorno/20 x numero di anni. Pazienti che non abbiano mai fumato devono essere esclusi. 5.Capacita' di effettuare test di funzionalita' polmonare e registrazione di picco di flusso con una tecnica di qualita' accettabile; capacita' di mantenere le registrazioni (diario elettronico del paziente) nel corso dello studio e di compilare gli altri questionari, come richiesto da protocollo. 6.Capacita' di inalare i farmaci dello studio in maniera competente dall’inalatore Respimat e da un inalatore dosato (MDI).
    E.4Principal exclusion criteria
    1.Patients with a significant disease other than COPD; a significant disease is defined as a disease which, in the opinion of the investigator, may (i) put the patient at risk because of participation in the study, (ii) influence the results of the study, or (iii) cause concern regarding the patient's ability to participate in the study. 2.Patients with a, in the opinion of the investigator, clinically relevant abnormal baseline haematology, blood chemistry, or urinalysis; all patients with an SGOT >x2 ULN, SGPT >x2 ULN, bilirubin >x2 ULN or creatinine >x2 ULN will be excluded regardless of clinical condition (a repeat laboratory evaluation will not be conducted in these patients). 3. Patients with a history of asthma. For patients with allergic rhinitis or atopy, source documentation is required to verify that the patient does not have asthma. If a patient has a total blood eosinophil count >=600/mm**3, source documentation is required to verify that the increased eosinophil count is related to a non-asthmatic condition. Patients with any of the following conditions: 4. A diagnosis of thyrotoxicosis (due to the known class side effect profile of beta2- agonists). 5. A diagnosis of paroxysmal tachycardia (>100 beats per minute) (due to the known class side effect profile of beta2-agonists). 6. A history of myocardial infarction within 1 year of screening visit (Visit 1). 7. Unstable or life-threatening cardiac arrhythmia. 8. Hospitalization for heart failure within the past year. 9. Known active tuberculosis. 10. A malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years (patients with treated basal cell carcinoma are allowed). 11. A history of life-threatening pulmonary obstruction. 12. A history of cystic fibrosis. 13. Clinically evident bronchiectasis. 14. A history of significant alcohol or drug abuse. 15. Patients who have undergone thoracotomy with pulmonary resection (patients with a history of thoracotomy for other reasons should be evaluated as per exclusion criterion No. 1). 16. Patients being treated with oral or patch beta-adrenergics. 17. Patients being treated with oral corticosteroid medication at unstable doses (i.e., less than six weeks on a stable dose) or at doses in excess of the equivalent of 10 mg of prednisone per day or 20 mg every other day. 18. Patients who regularly use daytime oxygen therapy for more than one hour per day and in the investigator's opinion will be unable to abstain from the use of oxygen therapy during clinic visits. 19. Patients who have completed a pulmonary rehabilitation program in the six weeks prior to the screening visit (Visit 1) or patients who are currently in a pulmonary rehabilitation program. 20. Patients who have taken an investigational drug within one month or six half lives (whichever is greater) prior to screening visit (Visit 1). 21. Patients with known hypersensitivity to beta-adrenergic and/or anticholinergics drugs, BAC, EDTA, or any other component of the RESPIMAT inhalation solution 22. Pregnant or nursing women. 23. Women of childbearing potential not using a highly effective method of birth control. Female patients will be considered to be of childbearing potential unless surgically sterilised by hysterectomy or bilateral tubal ligation, or post-menopausal for at least two years. 24. Patients who have previously been randomized in this study or are currently participating in another study. 25. Patients who are unable to comply with pulmonary medication restrictions prior to randomization.
    1.Malattie significative oltre alla BPCO, definite come malattie o condizioni che a giudizio dello sperimentatore possano mettere a rischio il paziente in conseguenza della sua partecipazione allo studio, o possano influenzare i risultati dello studio, o possano ingenerare perplessita' in merito alla capacita' del paziente di prendervi parte. 2.Valori ematologici, ematochimici o urinari con anomalie clinicamente significative, secondo l'opinione dello sperimentatore, al basale; tutti i pazienti con valori di SGOT, SGPT, bilirubina o creatinina &gt; x2 ULN (superiori a due volte il limite superiore di normalita', indipendentemente dalla condizione clinica). 3.Anamnesi di asma. Per i pazienti con rinite allergica o atopia si richiede di documentare che il paziente non abbia asma. Per i pazienti con conta eosinofila &gt;= 600/mm**3 si richiede di documentare che l'aumento degli eosinofili sia correlato ad una condizione differente dall'asma. 4.Diagnosi di tirotossicosi causata dall'effetto collaterale dei beta2-agonisti 5.Diagnosi di tachicardia parossistica (&gt; 100 battiti/minuto), causata dall'effetto collaterale dei beta2-agonisti. 6.Anamnesi di infarto del miocardio recente (&lt;= 1 anno dalla visita 1 di screening). 7.Aritmia instabile o tale da porre il paziente in pericolo di vita. 8.Ricovero per insufficienza cardiaca nel corso dell’ultimo anno. 9.Tubercolosi attiva nota. 10.Neoplasia che abbia richiesto resezione chirurgica, radioterapia o chemioterapia negli ultimi 5 anni (i pazienti con carcinoma basocellulare trattato sono ammessi). 11.Anamnesi di ostruzione polmonare tale da porre il paziente in pericolo di vita. 12.Anamnesi di fibrosi cistica. 13.Bronchiettasie clinicamente evidenti. 14.Anamnesi di etilismo o tossicomania significativi. 15.Anamnesi di toracotomia con resezione polmonare (i pazienti con anamnesi di toracotomia per altre ragioni devono essere valutati in rapporto al criterio di esclusione n. 1). 16.Pazienti in trattamento con agonisti dei recettori beta-adrenergici per via orale o transdermica. 17.Pazienti in trattamento con corticosteroidi per via orale a dosi instabili (meno di sei settimane alla stessa dose) o a dosi superiori all'equivalente di 10 mg di prednisone al giorno o 20 mg ogni due giorni. 18.Pazienti che usino regolarmente la terapia con ossigeno per oltre un'ora al giorno e che, a giudizio dello sperimentatore, non possano astenersi dall'ossigenoterapia durante le visite in clinica. 19.Pazienti che abbiano completato un programma di riabilitazione polmonare nelle sei settimane prima della visita di screening (V1) o pazienti che stiano seguendo un programma di riabilitazione polmonare. 20.Pazienti che abbiano assunto un farmaco sperimentale entro un mese o sei emivite (il valore maggiore fra i due) prima della visita di screening (V1). 21.Pazienti con ipersensibilita' nota ai beta2-agonisti, a benzalconio cloruro (BAC), a EDTA o a qualsiasi altro componente della soluzione per inalazione Respimat. 22.Donne in gravidanza o che allattino. 23.Donne potenzialmente fertili che non usino un metodo anticoncezionale efficace (per la definizione ved. protocollo pag 23). Saranno considerate potenzialmente fertili le donne non sterilizzate chirurgicamente, o non in menopausa da almeno 2 anni. 24.Pazienti precedentemente randomizzati in questo studio o che stiano partecipando ad un altro studio. 25.Pazienti non in grado di rispettare le restrizioni farmacologiche polmonari prima della randomizzazione.
    E.5 End points
    E.5.1Primary end point(s)
    There are three primary endpoints in this study which are assessed after 24 weeks of treatment: -FEV1 AUC0-3h response -Trough FEV1 response -SGRQ (total score).
    Gli endpoints primari di efficacia sono tre, valutati dopo 24 settimane dall’inizio del trattamento: -Area sotto la Curva (AUC) da 0 a 3 ore del FEV1. -FEV1 di valle. -Punteggio totale del SGRQ (Saint George Respiratory Questionnaire).
    E.5.1.1Timepoint(s) of evaluation of this end point
    after 24 weeks of treatment
    valutati dopo 24 settimane dall'inizio del trattamento
    E.5.2Secondary end point(s)
    TDI focal score
    TDI focal score
    E.5.2.1Timepoint(s) of evaluation of this end point
    after 24 weeks of treatment
    valutato dopo 24 settimane dall'inizio del trattamento
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    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) 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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    - Stesso farmaco ad altro dosaggio
    - same IMP used at different dosage
    E.8.2.4Number of treatment arms in the trial5
    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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA86
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Australia
    Canada
    China
    Guatemala
    India
    Japan
    Korea, Republic of
    Mexico
    Réunion
    Russian Federation
    Turkey
    United States
    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
    LVLS
    LVLS
    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 months25
    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 months25
    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 No
    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) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 2000
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1220
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state81
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1183
    F.4.2.2In the whole clinical trial 3220
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    n.a.
    n.d.
    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 Decision2011-10-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-10-06
    P. End of Trial
    P.End of Trial StatusCompleted
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