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    Summary
    EudraCT Number:2014-005010-31
    Sponsor's Protocol Code Number:INS-212
    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:2015-04-14
    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 number2014-005010-31
    A.3Full title of the trial
    A Randomized, Open Label, Multicenter Study of Liposomal Amikacin for Inhalation (LAI) in Adult Patients with Nontuberculous Mycobacterial (NTM) Lung Infections caused by Mycobacterium avium complex (MAC) that are refractory to treatment
    Estudio aleatorizado, abierto y multicéntrico de la amicacina liposomal para inhalación (LAI) en pacientes adultos con infecciones pulmonares por micobacterias no tuberculosas (MNT) causadas por el complejo Mycobacterium avium (CMA) que son resistentes al tratamiento
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Randomized, Open Label, Multicenter Study of Liposomal Amikacin for Inhalation in Adult Patients who have Nontuberculous Mycobacterial Lung Infections caused by Mycobacterium avium complex that are refractory to treatment
    Estudio aleatorizado, abierto y multicéntrico de la amicacina liposomal para inhalación en pacientes adultos que tienen con infecciones pulmonares de micobacterias no tuberculosas causadas por el complejo Mycobacterium avium que son resistentes al tratamiento
    A.4.1Sponsor's protocol code numberINS-212
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02344004
    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 SponsorInsmed 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 supportInsmed Incorporated
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPrime Vigilance Ltd
    B.5.2Functional name of contact pointClinical Trial Inf and PV Call Cent
    B.5.3 Address:
    B.5.3.1Street Address26-28 Frederick Sanger Road, The Surrey Research Park
    B.5.3.2Town/ cityGuildford
    B.5.3.3Post codeGU2 7YD
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number0038514628523
    B.5.6E-mailIgor.Copot@primevigilance.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 No
    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/3/14/1259
    D.3 Description of the IMP
    D.3.1Product nameLiposomal Amikacin for Inhalation (LAI)
    D.3.4Pharmaceutical form Nebuliser suspension
    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 INNAMIKACIN SULFATE
    D.3.9.1CAS number 39831-55-5
    D.3.9.3Other descriptive nameAmikacin Sulfate
    D.3.9.4EV Substance CodeSUB00444MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number70
    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
    Nontuberculous Mycobacterial (NTM) Lung Infections caused by Mycobacterium avium complex (MAC) that are refractory to treatment
    Infecciones pulmonares por micobacterias no tuberculosas (MNT) causadas por el complejo Mucobacterium avium (CMA) que son resistentes al tratamiento
    E.1.1.1Medical condition in easily understood language
    Nontuberculous Mycobacterial (NTM) Lung Infections caused by Mycobacterium avium complex (MAC) that are refractory to treatment
    Infecciones pulmonares por micobacterias no tuberculosas (MNT) causadas por el complejo Mucobacterium avium (CMA) que son resistentes al tratamiento
    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 17.1
    E.1.2Level PT
    E.1.2Classification code 10058806
    E.1.2Term Mycobacterium avium complex infection
    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 the efficacy of LAI (590 mg) administered once daily (QD), when added to a multi-drug regimen, for achieving culture conversion (3 consecutive negative sputum cultures) by Month 6 compared to a multi-drug regimen alone
    Evaluar la eficacia de la LAI (590 mg) administrada una vez al día (1 v/d) y añadida a una politerapia para lograr la conversión de los cultivos (3 cultivos de esputo negativos consecutivos) para el mes 6 en comparación con la politerapia sola
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy of LAI (590 mg) administered QD when added to a multi-drug regimen
    1. on the six-minute walk test (6MWT) at Month 6 compared to a multi-drug regimen alone
    2. for time to culture conversion compared to a multi-drug regimen alone
    3. for achieving sustainability (consecutive negative sputum cultures [with no more than 2 consecutive broth positive cultures] for 12 months on treatment) compared to a multi-drug regimen alone
    4. on the durability of treatment success 3 months after the end of total treatment course (negative sputum culture after 3 months off-treatment)
    5. on the 6MWT at End of Therapy (EOT) compared to a multi-drug regimen alone
    6. To evaluate patient-reported symptoms of NTM and change from baseline (Day 1) in quality of life scores on the St. George?s Respiratory Questionnaire (SGRQ) at Month 6

    For exploratory, safety and pharmacokinetic objectives please refer to protocol synopsis on page 5 and 6
    Evaluar la eficacia de la LAI (590 mg) administrada 1 v/d y añadida a una politerapia
    1.en la prueba de la marcha de seis minutos (PM6M) en el mes 6 en comparación con la politerapia sola
    2.en el tiempo hasta la conversión de los cultivos en comparación con la politerapia sola
    3.para lograr la sostenibilidad (cultivos de esputo negativos consecutivos [con no más de 2 cultivos positivos consecutivos en caldo] para 12 meses con tratamiento) en comparación con politerapia sola
    4.en la durabilidad del éxito del tratamiento 3 meses después del fin del ciclo de tratamiento total (cultivo en esputo negativo después de 3 meses sin tratamiento)
    5.en la PM6M en el fin del tratamiento (FdT) en comparación con la politerapia sola
    6.Evaluar los síntomas de MNT referidos por el paciente y el cambio respecto al inicio (día 1) en las puntuaciones en la calidad de vida en el Cuestionario respiratorio de St. George (SGRQ) en el mes 6
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. be male or female, 18 years or older
    2. be continually positive for MAC on sputum culture while adhering to a multi-drug treatment regimen for a minimum duration of 6 months which is either ongoing or was stopped no more than 12 months before screening
    3. be diagnosed with MAC NTM lung infection with evidence of nodular bronchiectasis and/or fibrocavitary disease by chest CT
    4. have a MAC lung infection documented by at least 2 positive cultures (MAC or mixed infection with MAC as the dominant species) with at least one obtained within 6 months prior to and/or including screening.. Cultures may be obtained from sputum or bronchoscopy.
    5. have a MAC-positive sputum at screening
    6. be willing to adhere to multi-drug treatment regimen during the course of the study
    7. be able to produce at least 3 mL of sputum or be willing to undergo an induction that produces at least 3 mL of sputum for mycobacteriology
    8. female of childbearing potential agrees to practice an acceptable method of birth control (e.g., abstinence, hormonal or barrier methods, partner sterilization, or IUD)
    9. provide written informed consent before performing any study related procedure
    10. be willing to have serum specimens stored
    11. be able to comply with study medication use, study visits, and study procedures as determined by the investigator
    1.Ser varón o mujer mayor de 18 años
    2.Obtener resultados siempre positivos en los cultivos de CMA en esputo mientras recibe una politerapia de una duración mínima de 6 meses que está en curso o finalizó no más de 12 meses antes de la selección
    3.Estar diagnosticado de infección pulmonar por MNT CMA con signos de bronquiectasia nodular o enfermedad fibrocavitaria según la TAC de tórax
    4.Tener una infección pulmonar por CMA demostrada por al menos 2 cultivos positivos (CMA o infección mixta con CMA como especie dominante), de los que al menos uno se obtuvo en los 6 meses previos a la selección o durante la misma. Los cultivos pueden obtenerse del esputo o la broncoscopia.
    5.Tener un cultivo de esputo positivo para CMA en la selección
    6.Estar dispuesto a cumplir una politerapia durante el transcurso del estudio
    7.Poder producir al menos 3 ml de esputo o estar dispuesto a someterse a una inducción que produzca al menos 3 ml de esputo para micobacteriología
    8.Si es mujer en edad fértil, acceder a utilizar un método anticonceptivo aceptable (p. ej., abstinencia, métodos hormonales o de barrera, esterilización de la pareja o DIU)
    9.Dar su consentimiento informado por escrito antes de la realización de los procedimientos del estudio
    10.Estar dispuesto al almacenamiento de muestras de suero
    11.Ser capaz de cumplir el uso del fármaco en estudio, las visitas y los procedimientos del estudio que determine el investigador
    E.4Principal exclusion criteria
    1. patients with cystic fibrosis
    2. patients whose MAC NTM infection is resistant to amikacin (as identified by mutation on RNA sequencing)
    3. patients who are not able to perform the 6MWT
    4. positive pregnancy test or lactation at screening. All women of child bearing potential will be tested. Women not of childbearing potential are defined as postmenopausal (i.e., amenorrheic for at least 1 year), or surgically or naturally sterile.
    5. active pulmonary malignancy (primary or metastatic) or any malignancy requiring chemotherapy or radiation therapy within 1 year before screening or anticipated during the study period
    6. active allergic bronchopulmonary mycosis or any other condition requiring chronic systemic corticosteroids at a dose greater than the equivalent of 10 mg/day of prednisone within 3 months before screening
    7. active pulmonary tuberculosis requiring treatment at screening
    8. history of lung transplantation
    9. initiation of chronic therapy (e.g., high-dose ibuprofen, inhaled anti-inflammatory agents including steroids, low dose maintenance steroids, recombinant human deoxyribonuclease [rhDNase]) within 28 days before Day 1.
    10. administration of any investigational drug within 8 weeks before screening
    11. prior exposure to LAI (including clinical study).
    12. known hypersensitivity to aminoglycosides
    13. use of inhaled or systemic aminoglycosides (e.g., tobramycin, amikacin, gentamicin, or streptomycin) within 28 days before Day 1
    14. acquired and primary immunodeficiency syndromes
    15. significant (as determined by the investigator) hearing loss, vestibular dysfunction, or neuromuscular weakness where the potential risk of aminoglycoside toxicity outweighs the potential benefit
    16. aspartate aminotransferase or alanine aminotransferase ? 3 times the upper limit of normal (ULN) or total bilirubin ? 2 times the upper limit of normal (ULN) at screening
    17. absolute neutrophil count ?500/?L at screening
    18. serum creatinine >2 times ULN at screening
    19. current alcohol, medication or illicit drug abuse
    20. any condition that, in the opinion of the Investigator, interferes with ability to safely complete the study or adhere to study requirements
    21. persons who have been committed to an institution by virtue of an order issued either by the judicial or the administrative authorities
    1.Pacientes con fibrosis quística
    2.Pacientes con infección por MNT CMA resistente a la amicacina (identificados como mutación en la secuenciación del ARN)
    3.Pacientes que no pueden realizar la PM6M
    4.Prueba de embarazo positiva o lactancia en la selección. Todas las mujeres en edad fértil se someterán a la prueba. Las mujeres que no están en edad fértil son las posmenopáusicas (esto es, amenorreicas durante al menos 1 año) o estériles quirúrgicamente o de manera natural
    5.Cáncer pulmonar activo (primario o metastásico) o cáncer que requiera quimioterapia o radioterapia en el año previo a la selección o prevista durante la fase del estudio
    6.Micosis broncopulmonar alérgica activa o cualquier otra afección que requiera corticosteroides sistémicos crónicos a una dosis superior al equivalente de 10 mg/día de prednisona en los 3 meses previos a la selección
    7.Tuberculosis pulmonar activa que requiera tratamiento en la selección
    8.Trasplante pulmonar previo
    9.Inicio de tratamiento crónico (p. ej., ibuprofeno en dosis altas, antiinflamatorios inhalados como esteroides, esteroides de mantenimiento en dosis bajas,deoxyribonucleasa hmana recombinande ( rhDNasa)) en los 28 días previos al día 1
    10.Administración de un fármaco en investigación en las 8 semanas previas a la selección
    11.Exposición previa a la LAI (incluidos los estudios clínicos)
    12.Hipersensibilidad conocida a los aminoglucósidos
    13.Uso de aminoglucósidos inhalados o sistémicos (p. ej., tobramicina, amicacina, gentamicina o estreptomicina) en los 28 días previos al día 1
    14.Síndromes de inmunodeficiencia adquirida o primaria
    15.Pérdida auditiva significativa (según lo determine el investigador), disfunción vestibular o debilidad neuromuscular en que el posible riesgo de toxicidad de los aminoglucósidos supere el posible beneficio
    16.Aspartato aminotransferasa o alanina aminotransferasa ? 3 veces el límite superior de la normalidad (LSN) o bilirrubina total ? 2 veces el LSN en la selección
    17.Cifra absoluta de neutrófilos ? 500/?l en la selección
    18.Creatinina sérica > 2 veces el LSN en la selección
    19.Alcoholismo, abuso de medicamentos o drogodependencia en la actualidad
    20.Cualquier afección que, en opinión del investigador, interfiera en la capacidad de realizar el estudio con seguridad o cumplir con sus requisitos
    21.Personas internadas en una institución en virtud de una orden emitida por las autoridades judiciales o administrativas
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the proportion of subjectsachieving culture conversion (3 consecutive negative sputum cultures collected monthly without relapse or recurrence) by Month 6 in the LAI arm compared to multi-drug regimen alone.
    El criterio de valoración principal es la proporción de pacientes que logran la conversión de los cultivos (3 cultivos de esputo negativos consecutivos recogidos mensualmente sin recaída ni recidiva) para el mes 6 en el grupo de LAI más politerapia en comparación con la politerapia sola
    E.5.1.1Timepoint(s) of evaluation of this end point
    Evaluation of primary endpoint will be done at Month 8
    La valoración del principal criterio de valoración será realizada al mes 8
    E.5.2Secondary end point(s)
    SECONDARY EFFICACY ENDPOINTS
    1. Change in 6MWT distance at Month 6 in the LAI arm compared to a multi-drug regimen alone
    2. Time to culture conversion in the LAI arm compared to a multi-drug regimen alone at Month 6
    3. Proportion of subjects achieving culture conversion with sustainability at the EOT in the LAI arm compared to a multi-drug regimen alone
    4. Proportion of subjects achieving culture conversion with durability at the EOS (3 months off treatment) in the LAI arm compared to a multi-drug regimen alone in all evaluable subjects
    5. Change in 6MWT distance at EOT in the LAI arm compared to a multi-drug regimen alone
    6. The mean change from baseline (Day 1) at Month 6 in the SGRQ.

    EXPLORATORY ENDPOINTS
    1. Change in 6MWT distance at Month 8 in the LAI arm compared to a multi-drug regimen alone
    2. Change in 6MWT distance at EOS in the LAI arm compared to a multi-drug regimen alone
    3. The mean change from baseline (Day 1) at Month 6 in the SGRQ ? Part 2 (Activities of Daily Livings)
    4. The mean change from baseline (Day 1) at EOT in the EQ-5D
    5. Proportion of subjects who develop a new strain of MAC in the LAI arm compared to multi-drug regimen alone
    6. Radiological changes in CT Scan at EOT in the LAI arm compared to multi-drug regimen alone, where appropriate
    7. Mortality at EOS.
    E.5.2.1Timepoint(s) of evaluation of this end point
    From baseline till end of study
    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 Yes
    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 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) Yes
    E.8.2.2Placebo No
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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
    Australia
    Austria
    Canada
    France
    Germany
    Israel
    Italy
    Japan
    Netherlands
    New Zealand
    Poland
    Spain
    United Kingdom
    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
    Última visita del último paciente
    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 months7
    E.8.9.1In the Member State concerned days7
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months7
    E.8.9.2In all countries concerned by the trial days7
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    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: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 25
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 75
    F.4.2.2In the whole clinical trial 351
    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)
    At Month8, all non-converters will be eligible to enter a separate open-label study. All converters will continue on the same treatment regimen until they complete a total of 12 months beginning from the first negative culture.
    The investigator will discuss treatment options with each subjects.
    En el Mes 8, todos los no-convertidores serán elegibles para entrar en un estudio abierto separado. Todos los convertidores continuarán en el mismo régimen de tratamiento hasta completar un total de 12 meses a partir del primer cultivo negativo.
    El investigador analizará las opciones de tratamiento con cada uno de los sujetos.
    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 Decision2015-05-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-05-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-04-09
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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