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    The EU Clinical Trials Register currently displays   41235   clinical trials with a EudraCT protocol, of which   6758   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:2011-001362-18
    Sponsor's Protocol Code Number:GS-US-205-0160
    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:2012-02-22
    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 number2011-001362-18
    A.3Full title of the trial
    Open-Label Phase 3 Trial to Evaluate the Safety of Aztreonam 75 mg Powder and Solvent for Nebuliser Solution/Aztreonam for Inhalation Solution (AZLI) in Children with Cystic Fibrosis (CF) and Chronic Pseudomonas aeruginosa (PA) in the Lower Airways.
    Studio in aperto di fase 3 finalizzato alla valutazione della sicurezza di aztreonam 75 mg polvere e solvente per soluzione per nebulizzatore/aztreonam per soluzione per inalazione (AZLI) in soggetti in eta' pediatrica affetti da fibrosi cistica (FC) e infezione cronica da pseudomonas aeruginosa (PA) alle vie aeree inferiori.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of the Safety of Aztreonam for Inhalation in Children with Cystic Fibrosis and Chronic Infection of the Airways by Pseudomonas aeruginosa bacteria.
    Studio per valutare la sicurezza di aztreonam per inalazione in bambini con fibrosi cistica ed infezione cronica delle vie aeree da batterio Pseudomonas aeruginosa.
    A.3.2Name or abbreviated title of the trial where available
    PALS (Pediatric Aztreonam Lysine Safety)
    PALS (Pediatric Aztreonam Lysine Safety)
    A.4.1Sponsor's protocol code numberGS-US-205-0160
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01404234
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/117/2011
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGILEAD SCIENCES INC.
    B.1.3.4CountryUnited States
    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 supportGilead Sciences Inc,
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGilead Sciences International Ltd
    B.5.2Functional name of contact pointClinical Trials Information
    B.5.3 Address:
    B.5.3.1Street AddressFlowers Building, Granta Park
    B.5.3.2Town/ cityAbington, Cambridge
    B.5.3.3Post codeCB21 6GT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44 1223 897496
    B.5.5Fax number+44 1223 897284
    B.5.6E-mailclinical.trials@gilead.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 Yes
    D.2.1.1.1Trade name CAYSTON aztreonam 75 mg powder and solvent for nebuliser solution
    D.2.1.1.2Name of the Marketing Authorisation holderGilead Sciences International Ltd
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/04/204
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Powder for nebuliser 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 INNAZTREONAM
    D.3.9.1CAS number 78110-38-0
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeSUB05664MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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
    Cystic fibrosis and chronic infection of lower respiratory tract with Pseudomonas aeruginosa.
    Fibrosi cistica ed infezione cronica delle basse vie respiratorie dovuta a Pseudomonas aeruginosa.
    E.1.1.1Medical condition in easily understood language
    Cystic fibrosis and chronic lung infection with a bacterium (germ) called Pseudomonas aeruginosa.
    Fibrosi cistica ed infezione cronica polmonare causata da un batterio (germe) chiamato Pseudomonas aeruginosa.
    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 SOC
    E.1.2Classification code 10021881
    E.1.2Term Infections and infestations
    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 PT
    E.1.2Classification code 10056971
    E.1.2Term Infective exacerbation of chronic obstructive airways disease
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate safety of treatment with AZLI 75 mg 3 times daily (TID) for 3 courses of therapy (28 days on/28 days off) in female and male children less than 13 years of age with CF and chronic PA infection/colonization.
    Valutare la sicurezza del trattamento con AZLI 75 mg 3 volte al giorno (TID) per 3 cicli di terapia (28 giorni di trattamento/28 giorni senza trattamento) in soggetti in età pediatrica di sesso femminile e maschile di età inferiore a 13 anni affetti da FC ed infezione/colonizzazione cronica da PA.
    E.2.2Secondary objectives of the trial
    na
    na
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Aged 12 years or less. - Diagnosis of CF as determined by the 1997 CF Consensus Conference criteria: sweat chloride level ≥ 60 mEq/L by quantitative pilocarpine iontophoresis; or a genotype with 2 identifiable mutations consistent with CF; or an abnormal nasal transepithelial potential difference (NPD), and 1 or more clinical features consistent with CF. -Documented positive lower respiratory tract culture for PA at the screening visit plus 2 documented positive lower respiratory tract cultures for PA within 12 months prior to study entry (start of treatment). -Clinically stable with no evidence of significant respiratory symptoms or, if obtained for clinical evaluation, no chest radiograph findings at screening that would require administration of IV antipseudomonal antibiotics, oxygen supplementation, or hospitalization.
    -Età inferiore o pari a 12 anni. -Diagnosi di FC come stabilito in base ai criteri della Consensus Conference sulla fibrosi cistica del 1997: livello di cloruro nel sudore ≥ 60 mEq/L per ionoforesi pilocarpinica quantitativa; oppure un genotipo con due mutazioni identificabili in linea con la diagnosi di FC; oppure un'anomala differenza di potenziali transepiteliali della mucosa nasale (NPD) e 1 o più fattori clinici in linea con la diagnosi di FC. -Coltura positiva documentata del tratto respiratorio inferiore per la PA alla visita di screening oltre a 2 colture positive documentate del tratto respiratorio inferiore per la PA nei dodici mesi antecedenti all'ingresso nello studio (inizio del trattamento). -Stabilità clinica senza prova di sintomi respiratori significativi oppure, se effettuata ai fini della valutazione clinica, assenza di esiti alla radiografia toracica in sede di screening che richiederebbero la somministrazione di antibiotici anti-Pseudomonas e.v., supplementazione di ossigeno o ricovero ospedaliero.
    E.4Principal exclusion criteria
    - Use of IV or inhaled antipseudomonal antibiotics within 14 days of study entry (start of treatment). - Presence of a condition or abnormality that would compromise the participant’s safety or the quality of study data, in the opinion of the investigator. - History of hypersensitivity/adverse reaction to aztreonam or beta-agonists. - Use of any investigational drug within 30 days of study entry (start of treatment).
    - Uso di antibiotici anti-pseudomonas e.v. o per inalazione nei 14 giorni antecedenti all'ingresso nello studio (inizio del trattamento). - Presenza di una condizione o anomalia che comprometterebbe la sicurezza del partecipante o la qualità dei dati relativi allo studio, a parere dello sperimentatore. - Storia di ipersensibilità/reazione avversa ad aztreonam o a beta-antagonisti. - Assunzione di un qualsiasi farmaco sperimentale nei 30 giorni antecedenti all'ingresso nello studio (inizio del trattamento).
    E.5 End points
    E.5.1Primary end point(s)
    Percentage of subjects who have discontinued the study drug due to safety or tolerability reasons by Day 168.
    Valutare la percentuale di pazienti che hanno interrotto la somministrazione del farmaco in studio per motivi legati alla sicurezza o alla tollerabilità entro il giorno 168.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Between baseline (Day 1) and Day 168.
    Dalla visita basale (giorno 1) al giorno 168.
    E.5.2Secondary end point(s)
    For subjects aged 6 years or more: - Change in FEV1 % predicted at end of each 28-day-on-treatment cycle of AZLI; - Change in CFQ-R respiratory symptoms scale (RSS) score at the end of each 28-day-on-treatment cycle of AZLI. For all subjects: - Change in PA sputum density at end of each 28-day-on-treatment cycle of AZLI; -Use of additional antipseudomonal antibiotics; -Number and duration of hospitalizations; -Number and time to PA exacerbations; -Study-drug induced bronchospasm; -Adverse event rates adjusted for study duration.
    Per i soggetti di età superiore o pari a 6 anni: -variazione della FEV1% alla fine di ogni ciclo di trattamento di 28 giorni con AZLI; -variazioni del punteggio nella scala dei sintomi respiratori del CFQ-R (respiratory symptoms scale, RSS) al termine di ogni ciclo di trattamento di 28 giorni con AZLI. Per tutti i soggetti: -variazone della densità dell'espettorato PA al termine di ogni ciclo di trattamento di 28 giorni con AZLI; -assunzione di altri antibiotici antipseudomonas; -numero e durata dei ricoveri ospedalieri; -numero e tempo tra le riacutizzazioni della PA; -broncospasmo indotto dal farmaco in studio; -tassi degli eventi avversi corretti in base alla durata dello studio.
    E.5.2.1Timepoint(s) of evaluation of this end point
    For subjects aged 6 years or more at Days 28, 84, and 140: - Change from baseline in FEV1 % predicted; - Change from baseline in CFQ-R respiratory symptoms scale (RSS) score. For all subjects at Days 28, 84 and 140: - Change from baseline in PA sputum density. For all subjects from baseline to end of treatment (Day 140): - Study-drug induced bronchospasm For all subjects from screening to end of study (Day 168): - Use of additional antipseudomonal antibiotics; - Number and duration of hospitalizations; - Number and time to PA exacerbations; - Adverse event rates adjusted for study duration.
    Per i soggetti di età superiore o pari a 6 anni ai giorni 28, 84 e 140: - variazione della FEV1% rispetto al basale; - variazioni del punteggio nella scala dei sintomi respiratori del CFQ-R (respiratory symptoms scale, RSS) rispetto al basale. Per tutti i soggetti ai giorni 28,84 e 140: - variazone della densità dell'espettorato PA rispetto al basale. Per tutti i soggetti dal basale alla fine del trattamento (giorno 140): - broncospasmo indotto dal farmaco in studio. Per tutti i soggetti dallo screening alla fine dello studio (giorno 168): -assunzione di altri antibiotici antipseudomonas; -numero e durata dei ricoveri ospedalieri; -numero e tempo tra le riacutizzazioni della PA; -tassi degli eventi avversi corretti in base alla durata dello studio.
    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 No
    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 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA21
    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
    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 months22
    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 months22
    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 Yes
    F.1.1Number of subjects for this age range: 60
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 2
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 48
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 10
    F.1.2Adults (18-64 years) No
    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 No
    F.3.3.2Women of child-bearing potential using contraception No
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Infants and young children
    Lattanti e bambini
    F.3.3.7Others Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Adolescent girls of childbearing potential using contraception.
    Ragazze adolescenti in età fertile che fanno uso di contraccettivi.
    F.4 Planned number of subjects to be included
    F.4.1In the member state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 60
    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)
    Upon completion of study participation, subjects will be referred back to the physician who referred them to the study for continuing care and treatment.
    Al termine della partecipazione allo studio i soggetti dovranno fare riferimento al medico per il proseguimento del trattamento.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Cystic Fibrosis Foundation Therapeutics (CFFT)
    G.4 Investigator Network to be involved in the Trial: 2
    G.4.1Name of Organisation European Cystic Fibrosis Society Clinical Trials Network (ECFS-CTN)
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-02-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-02-08
    P. End of Trial
    P.End of Trial StatusOngoing
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