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The European Union Clinical Trials Register allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   41018   clinical trials with a EudraCT protocol, of which   6709   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
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    Summary
    EudraCT Number:2008-008192-34
    Sponsor's Protocol Code Number:ERD-01-08/EP
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-07-12
    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 ConcernedBulgarian Drug Agency
    A.2EudraCT number2008-008192-34
    A.3Full title of the trial
    THE EFFICACY AND SAFETY OF ERDOSTEINE IN THE LONG-TERM THERAPY OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD). A 12-month, randomised, double-blind, placebo-controlled, parallel group, multicenter study
    Ефикасност и безопасност на ERDOSTEINE при продължителна терапия на хронична обструктивна белодробна болест (ХОББ). 12-месечно рандомизирано двойно-сляпо плацебо-контролирано многоцентрово проучване с паралелни групи
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The evaluation of efficacy and safety of erdosteine, a mucolytic anti-oxidant drug, in Chronic Bronchitis with Airway Obstruction
    Оценка на ефикасността и безопасността на ердостеин, муколитично антоксидантно лекарство при хроничен бронхит с обструкция на дихателните пътища
    A.3.2Name or abbreviated title of the trial where available
    Study RESTORE
    A.4.1Sponsor's protocol code numberERD-01-08/EP
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01032304
    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 SponsorEdmond Pharma S.r.l.
    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 supportEDMOND PHARMA S.r.l.
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEdmond Pharma S.r.l.
    B.5.2Functional name of contact pointMedical Department
    B.5.3 Address:
    B.5.3.1Street AddressVia dei Giovi 131
    B.5.3.2Town/ cityPaderno Dugnano
    B.5.3.3Post code20037
    B.5.3.4CountryItaly
    B.5.4Telephone number+39029100111
    B.5.5Fax number+3902910011352
    B.5.6E-mailmedical.department@edmondpharma.it
    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 Erdotin
    D.2.1.1.2Name of the Marketing Authorisation holderRottapharm S.p.A.
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameErdosteine
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNERDOSTEINE
    D.3.9.1CAS number 84611-23-4
    D.3.9.4EV Substance CodeSUB06595MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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 placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chronic Obstructive Pulmonary Disease
    Хронична обструктивна белодробна болест
    E.1.1.1Medical condition in easily understood language
    Chronic bronchitis associated to airway obstruction
    Хроничен бронхит, свързан с обструкция на дихателните пътища
    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 10009033
    E.1.2Term Chronic obstructive pulmonary disease
    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 the study is to evaluate the efficacy of erdosteine, compared to placebo, in reducing the number of acute exacerbations over a 12-month treatment period in patients with moderate-to-severe COPD.
    Главната цел на проучването е да се оцени ефикасността на ердостеин в сравнение с плацебо, при намаляване на броя на острите пристъпи през 12-месечен период на лечение при пациенти с умерена до тежка ХОББ
    E.2.2Secondary objectives of the trial
    Secondary objectives of the study will be to investigate the effects of erdosteine on chronic respiratory symptoms and quality of life, pulmonary function and exercise performance, and disease-related costs. Moreover, the safety and tolerability of the drug during lomg-term treatment administration will be assessed.
    Вторичната цел на проучването ще бъде да се изследват ефектите на ердостеин върху хроничните белодробни симптоми и качеството на живот, белодробната функция и изпълняването на упражнения и свързаните със заболяването разходи. Освен това ще се оцени безопасността и поносимостта на медикамента при дългосрочно приложение.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Outpatients of both sexes, aged between 40 and 80 years. Diagnosis of COPD (Stage II and III according to GOLD 2007) as follows: post-bronchodilator FEV1/FVC < 70% and FEV1 between 30%-70% predicted (and at least 0.7 L absolute value). Current or past cigarette smokers with an history of smoking of at least 10 pack-years. On a stable therapeutic regimen for COPD for at least 8 weeks prior to inclusion. Having experienced at least 2 acute exacerbations of COPD requiring medical intervention within 2-12 months prior to inclusion. Presence of chronic COPD symptoms (cough, sputum production, dyspnoea), and a mean cough and sputum score (derived from BCSS) of at least 1.5 for each symptom during run-in. Written informed consent to participate.
    Извънболнични пациенти от двата пола, между 40 и 80 години. Диагноза ХОББ (стадий II и III според GOLD 2007) както следва: Съотношение на ФЕО1/ФВК след бронходилататор < 70% и ФЕО1 между 30% и 70% от предвидения (и поне 0,7 L абсолютна стойност). Настоящи или минали пушачи с анамнеза за тютюнопушене от поне 10 пакетогодини. На постоянно лечение за ХОББ поне от 8 седмици преди включване. Поне 2 претърпени обостряния на ХОББ, изискващи медицинска намеса в рамките на 2-12 месеца преди включване. Наличие на хронични симптоми на ХОББ (кашлица, храчки, задух) и среден резултат за кашлица и храчки (извлечен от BCSS) от поне 1,5 за всеки симптом по време на периода на въвеждане. Подписано писмено информирано съгласие за участие
    E.4Principal exclusion criteria
    Female subjects: pregnant, lactating mother or lack of efficient contraception in a subject with child-bearing potential. Acute exacerbation of COPD within 8 weeks prior to inclusion. Treatment with antibiotics and/or systemic steroids and/or hospitalisations within 8 weeks prior to inclusion. COPD stage IV. Current or past diagnosis of asthma. Clinically significant or unstable concurrent disease, including significant pulmonary disease (e.g. tuberculosis, bronchiectasis, cystic fibrosis, lung cancer). Significant renal impairment as indicated by creatinine clearance < 25 ml/ min. Active peptic ulcer. Subjects with liver cirrhosis as well as patients with cystathionine-synthetase deficiency due to the possible interference of erdosteine metabolites with methionine metabolism. Long term oxygen therapy. Known or suspected hypersensitivity to erdosteine. Participation in another clinical trial with an investigational drug within 60 days prior to inclusion.
    Жени: бременни, кърмещи майки или липса на ефективна контрацепция при участник в детеродна възраст. Остър пристъп на ХОББ в рамките на 8 седмици преди включване. Лечение с антибиотици и/или системни стероиди и/или хоспитализация в рамките на 8 седмици преди включване. ХОББ стадий IV. Настояща или минала диагноза за астма. Клинично значимо или нестабилно съпътстващо заболяване, вкл. сериозно белодробно заболяване (напр. туберкулоза, бронхиектазии, кистична фиброза, рак на белите дробове). Значително бъбречно увреждане, доказано от креатининов клирънс < 25 ml/ min. Активна пептична язва. Участници с чернодробна цироза, както и пациенти с дефицит на цистатионин-синтетаза поради възможно взаимодействие на метаболитите на ердостеин с метиониновия метаболизъм. Дългосрочно кислородно лечение. Установена или подозирана свъхчувствителност към ердостеин. Участие в друго клинично проучване с изпитвано лекарство в рамките на 60 дни преди включване.
    E.5 End points
    E.5.1Primary end point(s)
    Number of acute exacerbations of COPD experienced by the patients in the two treatment groups during the 12-month treatment period. Acute COPD exacerbations are defined as a symptomatic worsening requiring treatment with antibiotics, systemic corticosteroids, or both. Exacerbations will be reviewed by the Steering Committee before statistical analysis.
    Брой на острите пристъпи на ХОББ, настъпили в двете групи на лечение по време на 12-месечния период на лечение. Обострянията на ХОББ са дефинирани като влошаване на симптоматиката, изискващо лечение с антибиотици, системни кортикостероиди или и двете. Обострянията ще бъдат разглеждани от наблюдаващия комитет преди извършване на статистическия анализ.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Occurrence of exacerbations will be verified at each clinic visit, i.e. after 1 - 3 - 6 - 9 and 12 months of treatment.
    Появата на обостряния ще се верифицира на всяка визита, т.е. след 1-3-6-9 и 12 месеца на лечение
    E.5.2Secondary end point(s)
    Efficacy: chronic respiratory symptoms, health-related quality of life, pulmonary function parameters and exercise performance at 6MWT. Safety: Adverse Event monitoring, measurement of vistal signs, ECG parameters and routine laboratory testing.
    Ефикасност: хроничните дихателни симптоми, свързаното със здравето качество на живот, параметрите на белодробната функция и представянето при упражненията при 6-минутния тест с ходене. Безопасност: проследяване на нежеланите събития,измерване на жизнените показатели, ЕКГ параметрите и стандартни лабораторни изследвания.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Respiratory symptoms, pulmonary function, vital signs and AEs: at each clinic visit. QoL, 6MWT, ECG and routine lab tests: before and after 12-month treatment.
    Дихателни симптоми, белодробна функция, жизнени показатели и нежелани събития: на всяка визита. Въпросник за качеството на живот, 6-минутен тест с ходене, ЕКГ и стандартни лабораторни изследвания: преди и след 12 месечното лечение.
    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 No
    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.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 Yes
    E.8.1.7.1Other trial design description
    стратифицирана рандомизация
    Stratified randomisation
    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 trial2
    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 EEA40
    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
    The clinical part of the study will be completed when the last subject has undergone the last visit. The trial will be considered completed when data entry is terminated and database locked up.
    Клиничната част на проучването ще бъде завършена, когато последният пациент е провел последното си посещение. Проучването ще се счита за завършено, когато е приключено вписването на данни и е осъществено заключване на базата данни.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months6
    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.1.1.1In 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: 220
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 342
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 542
    F.4.2.2In the whole clinical trial 542
    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)
    The patients will continue their regular COPD treatment. This study is designated to assess the therapeutic efficacy of erdosteine as long-term therapy of COPD. If positive benefits are demonstrated, a modification of the indication for the marketing licence of the drug will be considered.
    Пациентите ще продължат да бъдат на тяхното обичайно лечение за ХОББ. Това проучване цели да оцени терапевтичната ефикасност на ердостеин като дългосрочна терапия при ХОББ. Ако бъдат демонстрирани ползи, ще се обсъди промяна на показанията в разрешението за употреба на лекарството.
    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 Decision2012-08-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-08-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-02-03
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