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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   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:2011-001255-36
    Sponsor's Protocol Code Number:GS-US-205-0162
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-10-18
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2011-001255-36
    A.3Full title of the trial
    Open-Label Phase 2 Trial to Evaluate the Safety and Efficacy of
    Aztreonam 75 mg Powder and Solvent for Nebuliser
    Solution/Aztreonam for Inhalation Solution (AZLI) in Pediatric
    Patients with Cystic Fibrosis (CF) and New Onset Lower Respiratory
    Tract Culture Positive for Pseudomonas aeruginosa (PA)
    Estudio abierto en fase 2 para evaluar la seguridad y la eficacia de aztreonam 75 mg en polvo y disolvente para solución para inhalación por nebulizador / aztreonam para solución para inhalación (AZLI) en pacientes pediátricos con fibrosis quística (FQ) y nueva manifestación de resultado positivo de Pseudomonas aeruginosa (PA) en cultivo de las vías respiratorias bajas
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteria
    Estudio de aztreonam lisina para inhalación en niños con fibrosis quística e infección nueva de las vías respiratorias por la bacteria Pseudomonas aeruginosa
    A.3.2Name or abbreviated title of the trial where available
    ALPINE (Aztreonam Lysine for Pseudomonas Infection Eradication)
    Estudio de aztreonam lisina para la erradicación de la infección por Pseudomonas (ALPINE)
    A.4.1Sponsor's protocol code numberGS-US-205-0162
    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 Limited
    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+441223897496
    B.5.5Fax number+441223897284
    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 polvo y disolvente para solución para inhalación por nebulizador
    D.2.1.1.2Name of the Marketing Authorisation holderGilead Sciences International
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.1Product nameAztreonam for Inhalation Solution
    D.3.2Product code AZLI
    D.3.4Pharmaceutical form Powder and solvent 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 codeAZLI
    D.3.9.3Other descriptive nameN/A
    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 new onset lower respiratory tract culture positive for P.aeruginosa.
    Fibrosis quística y nueva infección /colonización de las vías respiratorias bajas por P.aeruginosa recién detectada
    E.1.1.1Medical condition in easily understood language
    cystic fibrosis and a newly acquired lung infection with a bacterium (germ) called Pseudomonas aeruginosa
    Fibrosis quística y nueva infección pulmonar por la bacteria llamada Pseudomona 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 14.0
    E.1.2Level LLT
    E.1.2Classification code 10068288
    E.1.2Term Cystic fibrosis pulmonary exacerbation
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level PT
    E.1.2Classification code 10070608
    E.1.2Term Infective pulmonary exacerbation of cystic fibrosis
    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 and efficacy of a 28-day course of AZLI in patients with initial PA pulmonary colonization/infection at Day 28 (end of treatment) and Days 56, 112, and 196 (1, 3, and 6 months after the end of treatment, respectively).
    Evaluar la seguridad y la eficacia de un ciclo de 28 días de AZLI en pacientes con infección/colonización pulmonar inicial por PA el día 28 (fin del tratamiento) y los días 56, 112 y 196 (1, 3 y 6 meses después del fin del tratamiento respectivamente).
    E.2.2Secondary objectives of the trial
    Below the age of 6 years pharmacokinetic data will be assessed.
    Los datos farmacocinéticos se evaluarán hasta los 6 años de edad.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ? Aged 3 months to less than 18 years.
    ? 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 new onset of positive lower respiratory tract culture for PA within 30 days of study entry (screening visit) defined as either first lifetime documented PA-positive culture, or PA recovered after at least a 2-year history of PA-negative respiratory cultures (at least 2 cultures per year)
    ? FEV1 ? 80% predicted (for patients ? 6 years of age).
    ? 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.
    ? Edad: 3 meses a menos de 18 años
    ? Diagnóstico de fibrosis quística establecido de acuerdo con los criterios de la Conferencia de Consenso sobre la Fibrosis Quística de 1997: concentración de cloruro en sudor ? 60 mEq/L, evaluada mediante prueba cuantitativa de iontoforesis con pilocarpina; o bien un genotipo con 2 mutaciones identificables que concuerden con la fibrosis quística; o bien una diferencia potencial transepitelial (DPT) nasal anómala, y 1 o más características clínicas que concuerden con la fibrosis quística.
    ? Nueva manifestación documentada de un cultivo positivo del aparato respiratorio inferior para la PA en los 30 días previos a la incorporación al estudio (visita de selección) definido como un primer cultivo positivo para la PA o bien la reaparición de la PA tras al menos 2 años con cultivos respiratorios negativos para PA (al menos 2 cultivos al año)
    ? VEF1 ? 80 % del valor predicho (para pacientes ? 6 años de edad).
    ? Clínicamente estable y sin evidencias de síntomas respiratorios significativos o, si se obtiene para una evaluación clínica, ausencia de hallazgos radiológicos durante la selección que requiriesen la administración de antibióticos i.v. contra Pseudomonas, suplementación con oxígeno u hospitalización.
    E.4Principal exclusion criteria
    ? Use of IV or inhaled antipseudomonal antibiotics within 2 years of study entry (screening visit).
    ? Use of oral antipseudomonal antibiotics within 30 days of study entry (screening visit).
    ? History of hypersensitivity/adverse reaction to aztreonam, or beta-agonists.
    ? Use of any investigational drug, or device within 28 days of study entry (screening visit).
    ? Presence of a condition or abnormality that would compromise the patient?s safety or the quality of study data, in the opinion of the investigator.
    ? Uso de antibióticos i.v. contra Pseudomonas o inhalados durante los 2 años anteriores a la entrada en el estudio (visita de selección).
    ? Uso de antibióticos contra Pseudomonas orales durante los 30 días anteriores a la entrada en el estudio (visita de selección).
    ? Historia de hipersensibilidad / reacción adversa al aztreonam o a los agonistas beta.
    ? Uso de cualquier fármaco o dispositivo en investigación durante los 28 días anteriores a la entrada en el estudio (visita de selección).
    ? Presencia de un trastorno o anomalía que, en opinión del investigador, ponga en peligro la seguridad del paciente o la calidad de los datos del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    The primary objective of this study is to evaluate the proportion of patients with PA-negative cultures at all time points during a 6-month monitoring period (through Day 196) after cessation of active treatment; microbiological cultures will be obtained at Baseline, Day 28 (end of treatment), Day 56 (1 month after
    completing AZLI), Day 112 (3 months after completing AZLI), and Day 196 (6 months after completing AZLI). PA-specific antibody titers will be obtained at Baseline, Day 28, and Day 196. Safety endpoints will include adverse events, airway reactivity (study drug-induced bronchspasm), vital signs, blood biochemistry
    and hematology.
    El objetivo principal de este estudio es evaluar la proporción de pacientes con cultivos negativos para PA en todos los momentos temporales durante un periodo de monitorización de 6 meses (hasta el día 196) tras el cese del tratamiento activo. Se realizarán cultivos microbiológicos al inicio, el día 28 (fin del tratamiento), el día 56 (1 mes después de finalizar AZLI), el día 112 (3 meses después de finalizar AZLI) y el día 196 (6 meses después de finalizar AZLI).Se obtendrán las titulaciones de anticuerpos específicos contra PA al inicio, el día 28 y el día 196.Los criterios de valoración de seguridad incluirán los acontecimientos adversos, la reactividad de las vías respiratorias (incluidos broncoespasmos inducidos por el fármaco del estudio), las constantes vitales, la bioquímica sanguínea y la hematología.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Microbiological cultures will be obtained at Baseline (Day 1), Day 28 (end of treatment), Day 56 (1 month after completing AZLI), Day 112 (3 months after completing AZLI), and Day 196 (6 months after completing AZLI). PA-specific antibody titers will be obtained at Baseline, Day 28, and Day 196. Airway reactivity (study drug-induced bronchospasm) will be assessed at Baseline and Day 28. Blood biochemistry and hematology will be assessed at Screening, Baseline, Day 28 and Day 196. Adverse events and vital signs will be assessed at Screening, Baseline, Day 28, Day 56, Day 112 and Day 196.
    Se realizarán cultivos microbiológicos al inicio, el día 28 (fin del tratamiento), el día 56 (1 mes después de finalizar AZLI), el día 112 (3 meses después de finalizar AZLI) y el día 196 (6 meses después de finalizar AZLI).Se obtendrán las titulaciones de anticuerpos específicos contra PA al inicio, el día 28 y el día 196.Se evaluará la reactividad de las vías respiratorias (broncoespasmo inducido por el fármaco del estudio) al inicio en el día 28. Se valorará la bioquímica se´rica y la hematologái en al visita de selección, en la visita basal, el día 28 y el dái 196. Los efectos adversos y constantes vitales se evaluarán en la visita de selección, en la visita basal, el día 28, el día 56, el día 112 y el día 196.
    E.5.2Secondary end point(s)
    In patients ? 6 years of age:
    ? Change from baseline in FEV1 % predicted at Days 28, 56, 112, and 196;
    ? Change from baseline in CFQ-R Respiratory Symptoms Score (RSS) at Days 28, 56, 112, and 196.
    In all patients:
    ? Proportion of patients with PA-negative cultures at Days 28, 56, 112 and 196;
    ? Use of additional (non-study) antipseudomonal antibiotics (as a marker for PA exacerbation);
    ? Change from baseline in weight, height, and body mass index (BMI) at Days 28, 56, 112, and 196;
    In patients < 6 years of age:
    ? Pharmacokinetics: 1 peak plasma sample will be obtained 1 hour after the first dose of AZLI (Day 1); 1 trough plasma sample will be obtained immediately prior to the last dose of AZLI (Day 28). Plasma aztreonam concentrations at each time point will be summarized (mean, median, standard deviation [SD], minimum, maximum, and number of samples).
    En pacientes ? 6 años de edad:
    ? Cambio respecto al nivel inicial en el % predicho del VEF1 los días 28, 56, 112 y 196
    ? Cambio respecto al nivel inicial en la puntuación en la escala de síntomas respiratorios de la CFQ-R los días 28, 56, 112 y 196
    En todos los pacientes:
    ? Proporción de pacientes con cultivos negativos para PA los días 28, 56, 112 y 196
    ? Uso de antibióticos adicionales contra Pseudomonas (no del estudio) (como marcador de la exacerbación de PA)
    ? Cambio respecto al nivel inicial en el peso, la estatura y el índice de masa corporal (IMC) los días 28, 56, 112 y 196
    En pacientes menores de 6 años de edad:
    ? Farmacocinética: Se obtendrá una muestra plasmática del valor máximo 1 hora después de la primera dosis de AZLI (día 1); asimismo, se obtendrá una muestra plasmática del valor mínimo inmediatamente antes de la última dosis de AZLI (día 28). Se resumirán las concentraciones plasmáticas de aztreonam en cada momento temporal (media, mediana, desviación estándar [DE], mínimo, máximo y número de muestras)
    E.5.2.1Timepoint(s) of evaluation of this end point
    In patients ? 6 years of age at Days 28, 56, 112, and 196:
    ? Change from baseline in FEV1 % predicted;
    ? Change from baseline in CFQ-R Respiratory Symptoms Score (RSS).
    In all patients at Days 28, 56, 112 and 196:
    ? Proportion of patients with PA-negative cultures;
    ? Change from baseline in weight, height, and body mass index (BMI).
    In all patients at Screening and Days 1, 28, 56, 112 and 196:
    ? Use of additional (non-study) antipseudomonal antibiotics (as a marker for PA exacerbation).
    In patients < 6 years of age:
    ? Pharmacokinetics: 1 peak plasma sample will be obtained 1 hour after the first dose of AZLI (Day 1); 1 trough plasma sample will be obtained immediately prior to the last dose of AZLI (Day 28).
    En pacientes ? 6 años de edad (los días 28, 56, 112 y 196):
    ? Cambio respecto al nivel inicial en el % predicho del VEF1
    ? Cambio respecto al nivel inicial en la puntuación en la escala de síntomas respiratorios de la CFQ-R.
    En todos los pacientes(los días 28, 56, 112 y 196):
    ? Proporción de pacientes con cultivos negativos para PA
    ? Uso de antibióticos adicionales contra Pseudomonas (no del estudio) (como marcador de la exacerbación de PA)
    ? Cambio respecto al nivel inicial en el peso, la estatura y el índice de masa corporal (IMC)
    En pacientes menores de 6 años de edad:
    ? Farmacocinética: concentración plasmática máxima de 1 hora después de la primera dosis de AZLI (día 1); concentraciones plasmáticas mínimas de inmediatamente antes de la última dosis de azli(día 28)
    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 Yes
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 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
    Austria
    Belgium
    France
    Germany
    Ireland
    Italy
    Netherlands
    Poland
    Spain
    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
    Date of last study visit of last study subject.
    Fecha de la última visita del ensayo del último paciente
    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 months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months8
    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: 80
    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: 20
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 30
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 30
    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
    Bebés y niños
    F.3.3.7Others Yes
    F.3.3.7.1Details of other specific vulnerable populations
    adolescent girls of childbearing potential using contraception
    Chicas adolescentes potencialmente fértiles usando métodos anticonceptivos
    F.4 Planned number of subjects to be included
    F.4.1In the member state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 80
    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 final de su participación en el ensayo, los sujetos serán remitidos de nuevo al médico qeu les recomendó el estudio para continuar con sus cuidados y tratamiento
    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 European Cystic Fibrosis Society Clinical Trials Network (ECFS-CTN)
    G.4.3.4Network Country Denmark
    G.4 Investigator Network to be involved in the Trial: 2
    G.4.1Name of Organisation Cystic Fibrosis Foundation Therapeutics (CFFT) Therapeutics Development Network (TDN)
    G.4.3.4Network Country United States
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2011-11-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-11-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-05-29
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