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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.
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    Summary
    EudraCT Number:2011-004351-39
    Sponsor's Protocol Code Number:FARM8MXYFL
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2012-03-13
    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 number2011-004351-39
    A.3Full title of the trial
    Phase II, randomized, double arm, multi-center study evaluating the efficacy and safety of azithromycin for the long term prophylactic treatment of COPD in primary antibody deficiency patients with clinical and spirometrically confirmed COPD suffering from repeated acute exacerbations
    STUDIO MULTICENTRICO RANDOMIZZATO IN DOPPIO CIECO DI FASE II PER LA VALUTAZIONE DELL'™EFFICACIA CLINICA E DELLA SICUREZZA DELL'AZITROMICINA NELLA PROFILASSI A LUNGO TERMINE DELLE RIACUTIZZAZIONI DELLA BPCO IN PAZIENTI AFFETTI DA DIFETTI PRIMITIVI DELL'™IMMUNITA' CON BPCO CONFERMATA CLINICAMENTE E CON SPIROMETRIA
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase II, randomized, double arm, multi-center study evaluating the efficacy and safety of azithromycin for the long term prophylactic treatment of COPD in primary antibody deficiency patients with clinical and spirometrically confirmed COPD suffering from repeated acute exacerbations
    STUDIO MULTICENTRICO RANDOMIZZATO IN DOPPIO CIECO DI FASE II PER LA VALUTAZIONE DELL’EFFICACIA CLINICA E DELLA SICUREZZA DELL’AZITROMICINA NELLA PROFILASSI A LUNGO TERMINE DELLE RIACUTIZZAZIONI DELLA BPCO IN PAZIENTI AFFETTI DA DIFETTI PRIMITIVI DELL’IMMUNITA' CON BPCO CONFERMATA CLINICAMENTE E CON SPIROMETRIA
    A.4.1Sponsor's protocol code numberFARM8MXYFL
    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 SponsorAZIENDA UNIVERSITARIA POLICLINICO UMBERTO I DI ROMA
    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 supportAIFA (bandi per la ricerca indipendente)
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAzienda Policlinico Umberto I
    B.5.2Functional name of contact pointUOD Reference Centre for Immunodefi
    B.5.3 Address:
    B.5.3.1Street AddressViale dell’Universita' 37
    B.5.3.2Town/ cityRoma
    B.5.3.3Post code00185
    B.5.3.4CountryItaly
    B.5.4Telephone number06-49972007
    B.5.5Fax number06-49972007
    B.5.6E-mailisabella.quinti@uniroma1.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 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 nameAzytromicyn
    D.3.2Product code NA
    D.3.4Pharmaceutical form Film-coated tablet
    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.3.9.2Current sponsor codeFARM8MXYFL
    D.3.9.3Other descriptive nameAzithromycin
    D.3.9.4EV Substance CodeJ01FA10
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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 placeboFilm-coated tablet
    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
    primary immunodefciency patients with COPD and frequent exacerbations
    difetti primitivi dell'immunità umorale e da BPCO con frequenti riacutizzazioni ed associata asma grave
    E.1.1.1Medical condition in easily understood language
    primary immunodefciency patients with COPD and frequent exacerbations
    difetti primitivi dell'immunità umorale e da BPCO con frequenti riacutizzazioni ed associata asma grave
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10029978
    E.1.2Term Obstructive chronic bronchitis with acute exacerbation
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10013289
    E.1.2Term Disorders involving the immune mechanism
    E.1.2System Organ Class 10021428 - Immune system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10003554
    E.1.2Term Asthma aggravated
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    in the arm of patients under azythomycin prophylaxis we expect a superiority on the following end-point: - decrease annual episodes of acute COPD exacerbations defined as: - dyspnoea;- increased cough; -increased sputum volume and purulence
    Nel braccio dei pazienti in antibioticoprofilassi con azitromicina in confronto con il braccio di pazienti trattati con placebo ci aspettiamo una superiorità nel seguente obiettivo: diminuzione delle riacutizzazioni di BPCO definite come: dispnea, aumento della tosse, aumento del volume e della purulenza dell’espettorato
    E.2.2Secondary objectives of the trial
    in the arm of patients under azythomycin prophylaxis in respect to the arm of patients under placebo we expect a superiority on the following end-points: - decrease number of additional doses of antibiotics required for treatment of the exacerbations (other than the prophylactic antibiotics given as study medicine) - decrease in the number of patients not having an exacerbation during the course of the study - decrease in the recurrence time to next exacerbation - decrease of the duration of exacerbations (days of disability per exacerbation) - improvement of the Health Related Quality of Life measures - increase of FEV1 - reduction in the number of days of disability variously defined as days in bed, days off work or days where the subject is unable to undertake normal activities Safety analy sis: -calculate the number of adverse events
    Nel braccio dei pazienti in antibioticoprofilassi con azitromicina ci aspettiamo una superiorità nei seguenti obiettivi: Diminuzione delle dosi addizionali di antibiotici necessari al trattamento delle riacutizzazioni (oltre al trattamento utilizzato per l’antibiotico-profilassi) Diminuzione nel numero di pazienti che non hanno riacutizzazioni durante la durata dello studio. Diminuzione nel tempo di ricorrenza della riacutizzazione successiva Diminuzione della durata delle riacutizzazioni (giorni di disabilità per riacutizzazione) Miglioramento degli indici di qualità di vita Aumento del FEV1 Riduzione nel numero di giorni di disabilità definito come giorni di allettamento, assenza lavorativa o da scuola, giorni nei qulai il paziente non può assolvere alle normali attività quotidiane Sicurezza: del numero di eventi avversi
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •diagnosis of X-linked Agammaglobulinemia or Common Variable Immunodeficiency •male or female aged 12 to 74 years •clinical and spirometrically confirmed COPD •written informed consent.
    • diagnosi di X-linked-Agammaglobulinemia o Immunodeficienza Comune Variabile • maschio o femmina di età compresa tra 12 e 74 anni • BPCO confermata clinicamente e con spirometria • consenso informato scritto
    E.4Principal exclusion criteria
    • known allergic reaction to azithromycin • patients taking drugs that could adversely interact with macrolides • lymphoproliferative disease • Creatinine concentration >1.5 times the UNL • ASAT or ALAT concentration >2.5 times the UNL • HIV infection, acute hepatitis or clinically active chronic hepatitis • Pregnancy or breast feeding females planning to become pregnant during the course of the study • Any condition that is likely to interfere with the evaluation of the study drug or satisfactory conduct of the trial
    • reazioni allergiche all’azitromicina • pazienti che effettuano trattamenti che interferiscono con l’azitromicina o altri macrolidi • malattie linfoproliferative • Creatininemia &gt;1.5 volte il valore normale • ASAT or ALAT &gt;2.5 times il valore normale • HIV infezione, epatite acuta o cronica • Gravidanza • Ogni altra condizione che possa interferire con la possibilità di valutare i risultati dello studio
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy: Decrease annual episodes of acute COPD exacerbations defined as: - dyspnoea;- increased cough; -increased sputum volume and purulence. Safety: Adverse events (total, severe, fatal)
    Endpoint di efficacia: Diminuzione degli episodi di esacerbazione della BPCO acuta definiti come: • dispnea • aumento della tosse • aumento di volume e della purulenza dello sputo Endpoint di sicurezza: Eventi avversi (totali, severi, fatali)
    E.5.1.1Timepoint(s) of evaluation of this end point
    30 visits have been scheduled: 1 visit each month for the treatment period (24 months); 1 visit each month for the treatment period (6 months). During each visit will be performed the physical examination and will be collected informations concerning AE/SAE and the drug compliance. the patient will compile diaries and the SF36 questionnaire at visits 1, 12, 24 and 26. Sputum sample will be collected on each visit. Every 4 months will be performed the routine blood testing, urinalysis and FEV1 evaluation,
    Sono state previste 30 visite complessive: una visita mensile di controllo per tutta la durata del trattamento (24 mesi); una visita al mese dopo il trattamento per un totale di 6 visite (6 mesi). Ad ogni visita verrà effettuato l’esame obiettivo e verranno raccolte le informazioni sugli eventi/reazioni avverse e sulla compliance al trattamento. Ai pazienti verrà fornito un diario per la registrazione dei cambiamenti e verrà chiesto di rispondere ai questionari sulla qualità della vita alle visite 1, 12, 24 e 26. Ad ogni visita verrà effettuatol’esame dello sputo. Ogni 4 mesi verranno effettuati esami ematochimici, delle urine ed una spirometria.
    E.5.2Secondary end point(s)
    • Decrease number of additional doses of antibiotics required for treatment of the exacerbations (other than the prophylactic antibiotics given as study medicine) • Decrease in the number of patients not having an exacerbation during the course of the study -Decrease in the recurrence time to next exacerbation • Decrease of the duration of exacerbations (days of disability per exacerbation) • Improvement of the Health related quality of life measures • Increase of FEV1 • Reduction in the number of days of disability variously defined as days in bed, days off work or days where the subject is unable to undertake normal activities
    • Riduzione del numero di dosi aggiuntive di antibiotico richieste per il trattamento delle esacerbazioni • Riduzione nel numero di pazienti senza esacerbazioni nel corso dello studio • Riduzione della durata delle esacerbazioni • Miglioramento dello stato di salute in relazione alla qualità di vita • Aumento della FEV1 • Riduzione dei giorni di disabilità definiti come giorni a letto, giornate di lavoro perse o giorni in cui il paziente era impossibilitato a svolgere le normali attività
    E.5.2.1Timepoint(s) of evaluation of this end point
    30 visits have been scheduled: 1 visit each month for the treatment period (24 months); 1 visit each month for the treatment period (6 months). During each visit will be performed the physical examination and will be collected informations concerning AE/SAE and the drug compliance. the patient will compile diaries and the SF36 questionnaire at visits 1, 12, 24 and 26. Sputum sample will be collected on each visit. Every 4 months will be performed the routine blood testing, urinalysis and FEV1 evaluation.
    Sono state previste 30 visite complessive: una visita mensile di controllo per tutta la durata del trattamento (24 mesi); una visita al mese dopo il trattamento per un totale di 6 visite (6 mesi). Ad ogni visita verrà effettuato l’esame obiettivo e verranno raccolte le informazioni sugli eventi/reazioni avverse e sulla compliance al trattamento. Ai pazienti verrà fornito un diario per la registrazione dei cambiamenti e verrà chiesto di rispondere ai questionari sulla qualità della vita alle visite 1, 12, 24 e 26. Ad ogni visita verrà effettuatol’esame dello sputo. Ogni 4 mesi verranno effettuati esami ematochimici, delle urine ed una spirometria.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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) 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 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 concerned10
    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 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 months36
    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 Yes
    F.1.1Number of subjects for this age range: 38
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 38
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 120
    F.1.3Elderly (>=65 years) No
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2012-03-13. Yes
    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 state158
    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)
    Patients will continue to be treated at the Site.
    Il paziente continuerà ad essere seguito presso il centro.
    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 Decision2011-10-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-10-27
    P. End of Trial
    P.End of Trial StatusOngoing
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