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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   41039   clinical trials with a EudraCT protocol, of which   6717   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:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-05-11
    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 ConcernedBelgium - FPS Health-DGM
    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
    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.
    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 Mucodox
    D.2.1.1.2Name of the Marketing Authorisation holderMADAUS PHARMA s.a.
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 (COPD)
    E.1.1.1Medical condition in easily understood language
    Chronic bronchitis associated to airway obstruction
    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 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
    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 long-term treatment administration will be assessed
    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 0.7L absolute value). Current or past cigarette smokers with a smoking history 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 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.
    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 hospitalisation 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, cystic fibrosis, bronchiectasis, 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. Long term oxygen therapy. Known or suspected hypersensitivity to erdosteine. Participation in another clinical trial with an investigational drug in the 60 days prior to inclusion
    E.5 End points
    E.5.1Primary end point(s)
    Number of acute COPD exacerbations 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.
    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.
    E.5.2Secondary end point(s)
    Efficacy: chronic respiratory symptoms, health-related quality of life, pulmonary function parameters and exercise performance at the 6MWT. Safety: Adverse Events monitoring, measurement of vital signs, ECG parameters and routine laboratory testing.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Respiratory symptoms, pulmonary function, vital signs and AE monitoring: at each clinic visit.
    QoL, 6MWT, ECG and routine lab tests: before and after 12-month treatment
    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
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA39
    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
    Moldova, Republic of
    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
    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 years3
    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 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 420
    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
    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 Decision2011-06-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-06-29
    P. End of Trial
    P.End of Trial StatusCompleted
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