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    Summary
    EudraCT Number:2012-001749-42
    Sponsor's Protocol Code Number:484/12
    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:2012-05-28
    Trial 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 number2012-001749-42
    A.3Full title of the trial
    Effects of treatment and withdrawal with inhaled beclomethasone/formoterol on lung inflammation in COPD.
    Effetti della terapia e della sospensione della terapia con beclometasone/formoterolo inalatorio sull’infiammazione polmonare nella broncopneumopatia cronica ostruttiva.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effects of treatment and withdrawal with inhaled beclomethasone/formoterol on lung inflammation in COPD.
    Effetti della terapia e della sospensione della terapia con beclometasone/formoterolo inalatorio sull’infiammazione polmonare nella broncopneumopatia cronica ostruttiva.
    A.3.2Name or abbreviated title of the trial where available
    Study 3
    Studio 3
    A.4.1Sponsor's protocol code number484/12
    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 SponsorPOLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportChiesi farmaceutici
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPoliclinico Gemelli
    B.5.2Functional name of contact pointUnita' operativa di farmacologia
    B.5.3 Address:
    B.5.3.1Street AddressL.go A. Gemelli 8
    B.5.3.2Town/ cityRoma
    B.5.3.3Post code00168
    B.5.3.4CountryItaly
    B.5.4Telephone number0630156092
    B.5.5Fax number0630156292
    B.5.6E-mailpmontuschi@rm.unicatt.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 FOSTER*INAL 120D 100/6MCG
    D.2.1.1.2Name of the Marketing Authorisation holderCHIESI FARMACEUTICI SpA
    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.3.4Pharmaceutical form Pressurised inhalation
    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 INNBECLOMETASONE DIPROPIONATE
    D.3.9.1CAS number 5534-09-8
    D.3.9.4EV Substance CodeSUB00681MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFORMOTEROL FUMARATE
    D.3.9.1CAS number 43229-80-7
    D.3.9.4EV Substance CodeSUB02257MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number6
    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
    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)
    Broncopneumopatia cronica ostruttiva (BPCO)
    E.1.1.1Medical condition in easily understood language
    COPD
    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 10029977
    E.1.2Term Obstructive chronic bronchitis
    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
    To identify breathprints of volatile organic compounds (VOC) which are associated with interruption of inhaled steroid therapy and, possibly, loss of COPD control (deterioration in symptoms and lung function, exacerbations).
    Identificare i profili respiratori di composti organici volatili che sono associati alla sospensione della terapia con beclometasone inalatorio e, possibilmente, con la perdita del controllo della BPCO (peggioramento della sintomatologia e della funzionalità respiratoria, riacutizzazioni).
    E.2.2Secondary objectives of the trial
    To investigate the effects of treatment with a combination of inhaled beclomethasone dipropionate and formoterol (Foster) on breath VOC profiles in patients with stable COPD; to investigate the effects of treatment and interruption of inhaled beclomethasone dipropionate/formoterol (Foster) on lung inflammation and oxidative stress in patients with stable COPD as reflected by neutrophil, macrophage, eosinophil and lymphocyte cell counts in sputum, profiles of metabolites in EBC measured by NMR spectroscopy, concentrations of PGE2 and 8-isoprostane in EBC, concentrations of LTB4, PGE2, 8-isoprostane, and cytokines (IL-8, TNF-, IL-1) in sputum supernatants, urinary concentrations of 8-isoprostane, and concentrations of fraction of exhaled nitric oxide (FENO
    Studiare gli effetti della terapia con una associazione di beclometasone e formoterolo inalatori (Foster) sui profili respiratori di composti organici volatili in pazienti con BPCO stabile; studiare gli effetti della terapia e della sospensione della terapia con beclometasone dipropionato/formoterolo inalatori (Foster) sull’infiammazione polmonare e sullo stress ossidativo in pazienti con BPCO stabile misurati mediante conte di neutrofili,macrofagi,eosinofili e linfociti nell’espettorato,profili di metaboliti nel condensato del respiro misurati mediante spettroscopia in NMR,concentrazioni di PGE2 and 8-isoprostano nel condensato del respiro,concentrazioni di LTB4,PGE2,8-isoprostano e citochine (IL-8,TNF-,IL-1) nel sovranatante dell’espettorato,concentrazioni urinarie di 8-isoprostano e concentrazioni di monossido di azoto nell’aria espirata
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Patient is male or female, at least 40 years of age and no more than 85 years.
    - Patient has mild, moderate or severe COPD (stage I-III) according to the GOLD guidelines with a FEV1/FVC < 70% and FEV1 > 30% of the predicted value. Diagnosis of COPD will be based on GOLD guideline criteria (16).
    - Reversibility to short-acting beta-agonists (SABA) (400 g equivalent of salbutamol) of less than 200 ml or less than 12% predicted value FEV1.
    - Patients will be on a constant dose of ICS/LABA (ICS: 1000 g/day of fluticasone or equivalent) for at least 8 weeks before study enrolment.
    - No acute exacerbations in the previous 3 months.
    - No history of systemic disease or other pulmonary disease.
    - No treatment with systemic glucocorticoids in the previous 4 weeks.
    - No history of asthma or atopic disease.
    - Current treatment for COPD can include SABA alone as needed or long-acting antimuscarinic drugs on regular basis.
    - Apart from COPD, subjects are in good psycho-physical conditions based on history, physical examimantion and laboratory tests, and are able to complete the study.
    - Ability to perform reproducible spirometry.
    - Patient is a nonsmoker and has stopped smoking for at least one year.
    - Ability of patient to provide informed consent, as evidenced by signing a copy of the consent form approved by the institutional review board of the subject’s respective study institution.
    1. Pazienti di sesso maschile e femminile, di età compresa tra 40 e 85 anni.
    2. Pazienti con BPCO di grado lieve, moderato o grave sulla base delle linee guida GOLD (16) con FEV1/FVC &lt; 70% e FEV1 &gt; 30% del valore teorico. Diagnosi di BPCO basata sui criteri delle linee guida GOLD (16).
    3. Reversibilità a beta-agonisti a breve durata di azione (SABA) (400 g di salbutamolo o equivalenti) inferiore a 200 ml FEV1 o inferiore al 12% del valore teorico di FEV1.
    4. Pazienti in terapia con una dose costante di glucocorticoide inalatorio/beta-agonista a lunga durata di azione (glucocorticoide inalatorio: 1000 g al giorno di fluticasone o equivalenti) da almeno 8 settimane prima dell’inizio dello studio.
    5. Nessuna riacutizzazione di BPCO nei 3 mesi precedenti.
    6. Assenza di malattie sistemiche o altre patologie polmonari.
    7. Nessun trattamento con glucocorticoidi sistemici nelle 4 settimane precedenti.
    8. Assenza di asma o allergia.
    9. Terapia ammessa per BPCO comprende SABA quando richiesto e somministrazione cronica di farmaci antimuscarinici inalatori a lunga durata di azione.
    10. La persona è in buone condizioni psico-fisiche, tranne che per la presenza di BPCO, sulla base di anamnesi, esame obiettivo e test di laboratorio ed è in grado di completare lo studio.
    11. Possibilità di eseguire una spirometria in modo riproducibile.
    12. Assenza di storia di fumo, compresi prodotti del tabacco non da fumo, nell’ultimo anno.
    13. Possibilità di fornire il consenso informato mediante firma del modulo di informazione per il paziente approvato dal Comitato Etico.
    E.4Principal exclusion criteria
    1. Patient is, in the opinion of the investigator, mentally or legally incapacitated preventing informed consent from being obtained, or cannot read or comprehend written material.
    2. Patient is hospitalized.
    3. Patient has undergone any major surgical procedure in the previous four weeks.
    4. Patient has participated in a clinical trial involving an investigational or marketed drug in the previous four weeks.
    5. Subjects who were current smokers in the previous year.

    Pulmonary
    5. Patient has, in addition to COPD, any active, acute or chronic pulmonary disorder documented by history or physical examination.
    6. Patient has history of asthma and/or reversibility to short-acting beta-agonists (SABA) (400 g equivalent of salbutamol)  200 ml or  12% predicted value FEV1.
    7. Patient has ever been intubated for COPD, has required acute COPD therapy treated in an emergency room/urgent care facility/office setting within one month or has been hospitalized for COPD in the previous three months or required 2 or more hospitalizations for COPD in the past year.
    8. Patient had an upper respiratory tract infection (URI) in the previous three weeks.

    General Medical
    4. Patient is hypersensitive to inhaled -agonists or their components.
    5. Patient has a clinically significant, active disease of the gastrointestinal, cardiovascular, hepatic, neurological, renal, genitourinary, or haematological systems, or has uncontrolled hypertension (>160/95), or an immunodeficiency, or an autoimmune disorder.
    6. Patient has a history of any illness that could be immediately life threatening (ventricular arrhythmia, neoplasia, incompletely cured or treated in the last three months, 'brittle' diabetes mellitus), or would pose restriction on participation in the study.
    Medications
    2. Patient has taken the following medications:
    5) Oral, intravenous, intramuscular, intra-articular corticosteroids in the previous 4 weeks with the exception of nasal or inhaled corticosteroids administered on a continuous basis.
    6) Antibiotics for 7 consecutive days in the previous 4 weeks.
    7) IV gammaglobulin or immunosuppressants in the previous 4 weeks.
    8) Beta-receptor-blocking agents (including ocular preparations) in individuals known to be sensitive to these compounds in the previous two weeks.

    Procedural
    3. Patient is unable to perform acceptable, reproducible spirometry, and peak flow measurements.
    4. Patient is unable or unwilling to comply with the study procedures.
    Generali
    1. Persone che non sono in grado di fornire il consenso informato.
    2. Pazienti ricoverati in ospedale.
    3. Pazienti che abbiano subito un intervento chirurgico nelle 4 settimane precedenti la visita 1.
    4. Pazienti che abbiano partecipato ad uno studio clinico farmacologico nelle 4 settimane precedenti.
    5. Soggetti fumatori nell’ultimo anno precedente l’inizio dello studio.

    Polmonari
    1. Presenza di patologie polmonari acute o croniche, oltre a BPCO, evidenziate dall’anamnesi o esame obiettivo.
    2. Pazienti con storia di asma e/o reversibilità a beta-agonisti a breve durata di azione (SABA) (400 g di salbutamolo o equivalenti) superiore a 200 ml FEV1 o superiore al 12% del valore teorico di FEV1.
    3. Pazienti che siano stati intubati per BPCO, abbiano richiesto terapia immediata per BPCO in pronto soccorso o in ambulatorio nel mese precedente l’inizio dello studio (visita 1) o siano stati ricoverati per asma nei tre mesi precedenti la visita 1 o siano stati ricoverati per BPCO due o più volte nell’anno precedente.
    4. Infezioni delle vie respiratorie superiori nelle tre settimane precedenti la visita 1.



    Generali medici

    1. Pazienti con ipersensibilità a beta-agonisti inalatori o eccipienti presenti nella formulazione farmaceutica.
    2. Patologie gastrointestinali, cardiovascolari, epatiche, neurologiche, renali, genitourinarie, ematologiche o ipertensione non controllata (&gt;160/95) o sindromi da immunodeficienza o malattie autoimmunitarie.
    3. Pazienti con storia di malattie per cui sia richiesta terapia con un farmaco la cui somministrazione non è consentita nel presente studio, malattie che possano costituire un pericolo immediato (aritmia ventricolare, neoplasia, incompletamente curata o trattata nei 3 mesi precedenti, diabete mellito non controllato).

    Farmaci
    1. Pazienti che abbiano preso i seguenti farmaci:
    1) glucocorticoidi per os, endovena, intramuscolo, intra-articolari nelle 4 settimane precedenti l’inizio dello studio con l’eccezione degli steroidi intranasali o inalatori somministrati cronicamente.
    2) antibiotici per &gt; 7 giorni consecutivi nelle 4 settimane precedenti l’inizio dello studio.
    3) gammaglobuline per via endovenosa o farmaci immunosoppressori nel mese precedente l’inizio dello studio.
    4) terapia con farmaci beta-bloccanti (comprese preparazioni oftalmiche) nelle 2 settimane precedenti l’inizio dello studio in pazienti con ipersensibilità a questi farmaci

    Procedurali
    1. Pazienti che non sono in grado di eseguire una spirometria
    2. Il paziente non è in grado o non vuole eseguire le procedure previste dallo studio.
    E.5 End points
    E.5.1Primary end point(s)
    . Response of electronic nose after steroid-withdrawal (sensor 19) (post-withdrawal visit compared with baseline visit)
    Risposta del naso elettronico (sensore 19) dopo sospensione della terapia con glucocorticoide inalatorio (visita post-sospensione della terapia in confronto a visita baseline)
    E.5.1.1Timepoint(s) of evaluation of this end point
    4 and 8 week
    4 e 8 settimane
    E.5.2Secondary end point(s)
    Secondary end-points:
    1. Response of electronic nose after re-introduction of steroid treatment (sensor 19) (post-treatment visit compared with post-withdrawal visit)
    2. Neutrophil cell counts in sputum after steroid-withdrawal and treatment
    3. Macrophage cell counts in sputum after steroid-withdrawal and treatment
    4. Eosinophil cell counts in sputum after steroid-withdrawal and treatment
    5. Lymphocyte cell counts in sputum after steroid-withdrawal and treatment
    6. Profiles of metabolites in EBC after steroid-withdrawal and treatment
    7. LTB4 concentrations in sputum supernatants after steroid-withdrawal and treatment
    8. PGE2 concentrations in sputum after steroid-withdrawal and treatment
    9. 8-Isoprostane concentrations in sputum after steroid-withdrawal and treatment
    10. IL-8 concentrations in sputum supernatants after steroid-withdrawal and treatment
    11. TNF- concentrations in sputum supernatants after steroid-withdrawal and treatment
    12. IL-1 concentrations in sputum supernatants after steroid-withdrawal and treatment
    13. PGE2 concentrations in EBC after steroid-withdrawal and treatment
    14. 8-Isoprostane concentrations in EBC after steroid-withdrawal and treatment
    15. 8-Isoprostane concentrations in urine after steroid-withdrawal and treatment
    16. FENO concentrations after steroid-withdrawal and treatment
    17. FEV1 (forced expiratory volume in one second) after steroid-withdrawal and treatment
    18. FVC (forced vital capacity) after steroid-withdrawal and treatment
    19. FEV1/FVC after steroid-withdrawal and treatment
    20. PEF (peak expiratory flow) after steroid-withdrawal and treatment
    21. FEF25%-75% (forced expiratory flow at 25%-75% of forced vital capacity) after steroid- withdrawal and treatment
    22. St. George’s Respiratory Questionnaire (SGRQ) score after steroid-withdrawal and treatment

    Safety endpoints

    1. COPD exacerbation rate (defined as a symptomatic deterioration requiring treatment with antibiotic agents, systemic corticosteroids, hospitalization, or a combination of these)
    2. other adverse events (including oro-pharyngeal candidiasis, dysphonia, pneumonia, fractures, cataract).
    Response of electronic nose after re-introduction of steroid treatment (sensor 19) (post-treatment visit compared with post-withdrawal visit)
    2. Neutrophil cell counts in sputum after steroid-withdrawal and treatment
    3. Macrophage cell counts in sputum after steroid-withdrawal and treatment
    4. Eosinophil cell counts in sputum after steroid-withdrawal and treatment
    5. Lymphocyte cell counts in sputum after steroid-withdrawal and treatment
    6. Profiles of metabolites in EBC after steroid-withdrawal and treatment
    7. LTB4 concentrations in sputum supernatants after steroid-withdrawal and treatment
    8. PGE2 concentrations in sputum after steroid-withdrawal and treatment
    9. 8-Isoprostane concentrations in sputum after steroid-withdrawal and treatment
    10. IL-8 concentrations in sputum supernatants after steroid-withdrawal and treatment
    11. TNF- concentrations in sputum supernatants after steroid-withdrawal and treatment
    12. IL-1 concentrations in sputum supernatants after steroid-withdrawal and treatment
    13. PGE2 concentrations in EBC after steroid-withdrawal and treatment
    14. 8-Isoprostane concentrations in EBC after steroid-withdrawal and treatment
    15. 8-Isoprostane concentrations in urine after steroid-withdrawal and treatment
    16. FENO concentrations after steroid-withdrawal and treatment
    17. FEV1 (forced expiratory volume in one second) after steroid-withdrawal and treatment
    18. FVC (forced vital capacity) after steroid-withdrawal and treatment
    19. FEV1/FVC after steroid-withdrawal and treatment
    20. PEF (peak expiratory flow) after steroid-withdrawal and treatment
    21. FEF25%-75% (forced expiratory flow at 25%-75% of forced vital capacity) after steroid- withdrawal and treatment
    22. St. George’s Respiratory Questionnaire (SGRQ) score after steroid-withdrawal and treatment

    Safety endpoints

    1. COPD exacerbation rate (defined as a symptomatic deterioration requiring treatment with antibiotic agents, systemic corticosteroids, hospitalization, or a combination of these)
    2. other adverse events (including oro-pharyngeal candidiasis, dysphonia, pneumonia, fractures, cataract).
    E.5.2.1Timepoint(s) of evaluation of this end point
    4/8 week
    4/8 settimane
    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 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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.2.4Number of treatment arms in the trial1
    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.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    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 No
    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
    LVSC
    LVSC
    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 months0
    E.8.9.1In the Member State concerned 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: 4
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 9
    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 state14
    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)
    usual clinical practice
    Normale pratica clinica
    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 Decision2012-08-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-05-17
    P. End of Trial
    P.End of Trial StatusCompleted
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