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    Summary
    EudraCT Number:2010-023600-27
    Sponsor's Protocol Code Number:FpS-AS-201
    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:2011-11-25
    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 number2010-023600-27
    A.3Full title of the trial
    A 12-Week Dose-ranging Study to Evaluate the Efficacy and Safety of Fp Spiromax® (Fluticasone Propionate Inhalation Powder) Administered Twice Daily compared with Placebo in Adolescent and Adult Subjects with Persistent Asthma Uncontrolled on Non-steroidal Therapy.
    Estudio de determinación de dosis de 12 semanas de duración para evaluar la eficacia y la seguridad de Fp Spiromax® (propionato de fluticasona en polvo para inhalación) administrado dos veces al día en comparación con placebo en adolescentes y adultos con asma persistente no controlada con tratamiento no esteroideo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A 12-week study to evaluate the effectiveness and safety of Fp Spiromax® using a range of doses, given twice daily compared with a non-active drug in Adolescent and Adult subjects with persistent Asthma uncontrolled on non-steroidal therapy
    Un estudio de 12 semanas para evaluar la eficacia y la seguridad de Fp Spiromax® empleando un rango de dosis, administrado dos veces al día en comparación con un fármaco no activo en sujetos adolescentes y adultos con asma persistente y no controlada con tratamiento no esteroide
    A.4.1Sponsor's protocol code numberFpS-AS-201
    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 SponsorTeva Branded Pharmaceutical Products R&D, 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 supportTeva Branded Pharmaceutical Products R&D, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTeva Branded Pharmaceutical Products R&D, Inc.
    B.5.2Functional name of contact pointTeva Global Respiratory R&D
    B.5.3 Address:
    B.5.3.1Street Address425 Privet Road
    B.5.3.2Town/ cityHorsham,
    B.5.3.3Post codePA 19044
    B.5.3.4CountryUnited States
    B.5.4Telephone number0018884829522
    B.5.5Fax number/
    B.5.6E-mailTevaRespiratoryStudies@tevausa.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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameFluticasona Spiromax o Fp Spiromax
    D.3.4Pharmaceutical form Inhalation powder
    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 INNPropionato de fluticasona
    D.3.9.1CAS number 80474-14-2
    D.3.9.3Other descriptive namePROPIONATO DE FLUTICASONA
    D.3.9.4EV Substance CodeSUB02241MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number12.5
    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.IMP: 2
    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 nameFluticasona Spiromax o Fp Spiromax
    D.3.4Pharmaceutical form Inhalation powder
    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 INNPropionato de fluticasona
    D.3.9.1CAS number 80474-14-2
    D.3.9.3Other descriptive namePROPIONATO DE FLUTICASONA
    D.3.9.4EV Substance CodeSUB02241MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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.IMP: 3
    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 nameFluticasona Spiromax o Fp Spiromax
    D.3.4Pharmaceutical form Inhalation powder
    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 INNPropionato de fluticasona
    D.3.9.1CAS number 80474-14-2
    D.3.9.3Other descriptive namePROPIONATO DE FLUTICASONA
    D.3.9.4EV Substance CodeSUB02241MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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.IMP: 4
    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 nameFluticasona Spiromax o Fp Spiromax
    D.3.4Pharmaceutical form Inhalation powder
    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 INNFluticasona Propionato
    D.3.9.1CAS number 80474-14-2
    D.3.9.3Other descriptive nameFLUTICASONA PROPIONATO
    D.3.9.4EV Substance CodeSUB02241MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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.IMP: 5
    D.1.2 and D.1.3IMP RoleComparator
    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 Flovent Diskus
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxoSmithKline
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameFlovent Diskus
    D.3.4Pharmaceutical form Inhalation powder
    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 INNPropionato de fluticasona
    D.3.9.1CAS number 80474-14-2
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 placeboInhalation powder
    D.8.4Route of administration of the placeboInhalation use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Persistent Asthma
    Asma persistente
    E.1.1.1Medical condition in easily understood language
    Asthma
    Asma
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to evaluate the dose response, efficacy and safety of 4 different doses of fluticasone propionate (12.5, 25, 50, and 100mcg) delivered as Fluticasone Spiromax® Inhalation Powder (Fp Spiromax) when administered twice daily in subjects 12 years of age and older with persistent asthma uncontrolled on non-steroidal therapy.
    El objetivo principal de este estudio es evaluar la respuesta a la dosis, la eficacia y la seguridad de 4 dosis diferentes de propionato de fluticasona (12,5, 25, 50 y 100 µg) administrado como Fluticasona Spiromax® Polvo para Inhalación (Fp Spiromax), dos veces al día, en sujetos de 12 años o más de edad con asma persistente no controlada con tratamiento no esteroideo.
    E.2.2Secondary objectives of the trial
    Not applicable
    No aplica
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written informed consent/assent signed and dated by the subject and/or parent /legal guardian before conducting any study related procedure.
    2. Male or female 12 years and older, as of the Screening Visit. Male or female 18 years and older, as of the Screening Visit, in countries where local regulations or the regulatory status of study medication permit enrollment of adults only.
    3. General good health, and free of any concomitant conditions or treatment that could interfere with study conduct, influence the interpretation of study observations/results, or put the subject at increased risk during the study.
    4. Asthma Diagnosis: Asthma as defined by the National Institutes of Health (NIH).
    5. Severity of Disease: A best forced expiratory volume in one second (FEV1) of 40%-85% of the predicted normal value during the Screening Visit. NHANES III predicted values will be used for subjects aged >= 12 years and adjustments to predicted values will be made for African American subjects.
    6. Reversibility of Disease: Demonstrated a >= 15% reversibility of FEV1 within 30 minutes following 2 inhalations of albuterol/salbutamol inhalation aerosol (if required, spacers are permitted for reversibility testing only) at the Screening Visit. If a subject fails to demonstrate an increase in FEV1 >= 15%, then the subject is not eligible for the study and will not be allowed to re-screen.
    7. Current Asthma Therapy: Subjects must be on a short-acting Beta2-agonist alone or a non-corticosteroid maintenance medication (with or without a short-acting Beta2-agonist) for >= 3 months preceding the Screening Visit. Subjects must not have used an inhaled corticosteroid for at least 6 weeks preceding the Screening Visit.
    Exception: Based upon the investigator's judgment that there is no inherent harm in changing the subject's current ICS therapy and the subject provides consent, subjects onlow dose ICS (100mcg Fp BID or equivalent) may be switched to a short acting Beta2-agonist alone at a Pre-screening Visit. The subject will be required to return to the clinic to complete the Screening Visit once the 2-week washout period has been completed.
    8. Short-Acting Beta2-Agonists: All subjects must be able to replace their current short-acting Beta2-agonists with albuterol/salbutamol inhalation aerosol at the Screening Visit for use as needed for the duration of the study. The use of spacer devices with the metered dose inhaler (MDI) will not be allowed during the study with exception of its use during reversibility testing at the Screening Visit. Nebulized albuterol/salbutamol will not be allowed at any time during the study. Subjects must be able to withhold all inhaled short-acting beta sympathomimetic bronchodilators for at least 6 hours prior to all study visits.
    9. If female, is currently not pregnant, breast feeding, or attempting to become pregnant, has a negative serum pregnancy test, and is of
    a) Non-childbearing potential, defined as:
    Before menarche, or
    - >= 1 year post-menopausal, or
    - Surgically sterile (tubal ligation, bilateral oophorectomy, or hysterectomy), or
    - Congenital sterility, or
    - Diagnosed as infertile and not undergoing treatment to reverse infertility
    or is of
    b) Child-bearing potential, willing to commit to using a consistent and acceptable method of birth control as defined below for the duration of the study:
    - Systemic contraception used for >=1 month prior to screening, including birth control pills, transdermal patch (Ortho Evra®), vaginal ring (NuvaRing®), levonorgesterel (Norplant®), or injectable progesterone (Depo-Provera®), or
    - Double barrier methods (condoms, cervical cap, diaphragm, and vaginal contraceptive film with spermicide), or
    - Intrauterine device (IUD)
    or is of
    c) Child-bearing potential and not sexually active, willing to commit to using a consistent and acceptable method of birth control as defined above for the duration of the study, in the event the subject becomes sexually active
    10. Capable of understanding the requirements, risks, and benefits of study participation, and, as judged by the investigator, capable of giving informed consent/assent and being compliant with all study requirements (visits, record-keeping, etc).
    1. Consentimiento/asentimiento informado por escrito firmado y fechado por el paciente y/o el padre o tutor antes de realizar cualquiera de los procedimientos relacionados con el estudio.
    2. Varones o mujeres de 12 años o más de edad en la fecha de la visita de selección. Varones o mujeres de 18 años o más de edad, en la fecha de la visita de selección, en los países en que la normativa local o la situación de registro de la medicación del estudio permitan la inclusión sólo de adultos.
    3. Buen estado general de salud y ausencia de enfermedades o tratamientos concomitantes que puedan interferir en la realización del estudio, influir en la interpretación de las observaciones/resultados del estudio o representar un riesgo para el paciente durante el estudio.
    4. Diagnóstico de asma: Asma según la definición de los National Institutes of Health (NIH).
    5. Gravedad de la enfermedad: Mejor valor del volumen espiratorio forzado en el primer segundo (FEV1) del 40%-85% del valor normal teórico en la visita de selección. Se aplicarán los valores teóricos del NHANES III en los pacientes >= 12 años y se ajustarán los valores teóricos en pacientes afroamericanos.
    6. Reversibilidad de la enfermedad: Demostrada por una reversibilidad >= 15% del FEV1 30 minutos después de 2 inhalaciones de salbutamol en aerosol (si es necesario, se permite el uso de cámaras de inhalación sólo para la prueba de reversibilidad) en la visita de selección. Si un paciente no experimenta un aumento del FEV1 >= 15%, no podrá participar en el estudio y no se le permitirá repetir la selección.
    7. Tratamiento actual para el asma: Los pacientes deben recibir tratamiento con un agonista Beta2 de acción corta, solo o junto con medicación de mantenimiento no esteroidea (con o sin un agonista Beta2 de acción corta) en >= 3 meses previos a la visita de selección. Los pacientes no podrán haber utilizado un corticosteroide inhalado como mínimo durante las 6 semanas anteriores a la visita de selección.
    Excepción: Si, según el criterio del investigador, el cambio del tratamiento actual con CI no supone ningún riesgo intrínseco para el paciente y éste otorga su consentimiento, los sujetos tratados con CI en dosis bajas (100 µg de Fp, 2 veces al día o equivalente) podrán cambiar a monoterapia con un agonistaBeta2 de acción corta en la visita de preselección. El paciente deberá acudir al centro para completar la visita de selección, una vez finalizado el período de lavado de 2 semanas.
    8. Agonistas Beta2 de acción corta: Todos los pacientes deben poder sustituir su tratamiento actual de agonistas Beta2 de acción corta por un aerosol de salbutamol en la visita de selección para su uso a demanda durante el estudio. No se permitirá el uso de cámaras de inhalación con el inhalador dosificador (ID) durante el estudio, a excepción del uso durante la prueba de reversibilidad en la visita de selección. No se permitirá el uso de salbutamol nebulizado en ningún momento del estudio. Los pacientes deberán ser capaces de abstenerse de usar todos los broncodilatadores simpaticomiméticos beta de acción corta inhalados durante un mínimo de 6 horas antes de todas las visitas del estudio.
    9. En caso de ser mujer, actualmente no está embarazada, en período de lactancia o intentando quedarse embarazada, presenta una prueba de embarazo negativa y:
    - No tiene capacidad reproductiva, definida como:
    o No ha llegado a la menarquia; o
    o Es posmenopáusica desde hace >= 1 año; o
    Ha sido sometida a esterilización quirúrgica (ligadura de trompas, ovariectomía bilateral o histerectomía); o
    o Tiene esterilidad congénita; o
    o Tiene un diagnóstico de infertilidad y no recibe tratamiento contra la infertilidad;
    o si
    - Tiene capacidad reproductiva, estará dispuesta a comprometerse a utilizar un método anticonceptivo sistemático y aceptable, según la definición siguiente, durante el estudio:
    o Anticoncepción sistémica empleada durante >=1 mes antes de la selección, como anticonceptivos orales, parche transdérmico (Ortho Evra®), anillo vaginal (NuvaRing®), levonorgestrel (Norplant®) o progesterona inyectable (Depo-Provera®); o
    o Métodos de doble barrera (preservativos, capuchón cervical, diafragma y película anticonceptiva vaginal con espermicida); o
    o Dispositivo intrauterino (DIU);
    o si tiene
    - Capacidad reproductiva y no es sexualmente activa, estará dispuesta a comprometerse a utilizar un método anticonceptivo sistemático y aceptable, según la definición anterior, durante el estudio, si vuelve a ser sexualmente activa.
    10. Capacidad para comprender los requisitos, los riesgos y las ventajas de la participación en el estudio, y, en opinión del investigador, capaz de otorgar su consentimiento/asentimiento informado y cumplir los requisitos del estudio (visitas, mantenimiento de registros, etc.).
    E.4Principal exclusion criteria
    1. History of life-threatening asthma that is defined for this protocol as an asthma episode that required intubation &/or was associated with hypercapnea, respiratory arrest or hypoxic seizures.
    2. Culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus, or middle ear that is not resolved within 2 weeks of the Screening Visit. In addition, the subject must be excluded if such infection occurs between the Screening Visit & the Randomization Visit.
    3. Any asthma exacerbation requiring oral corticosteroids within 3 months of the Screening Visit. A subject must not have had any hospitalization for asthma within 6 months prior to the Screening Visit.
    4. Presence of glaucoma, cataracts, ocular herpes simplex, or malignancy other than basal cell carcinoma.
    5. Historical or current evidence of a clinically significant disease including, but not limited to: cardiovascular (e.g congestive heart failure, known aortic aneurysm, clinically significant cardiac arrhythmia or coronary heart disease), hepatic, renal, hematological, neuropsychological, endocrine (e.g uncontrolled diabetes mellitus, uncontrolled thyroid disorder, Addison?s disease, Cushing's syndrome), gastrointestinal (e.g poorly-controlled peptic ulcer, GERD), or pulmonary (e.g chronic bronchitis, emphysema, bronchiectasis with the need for treatment, cystic fibrosis, bronchopulmonary dysplasia, chronic obstructive pulmonary disease).
    6. Have any of the following conditions that, in the judgment of the investigator, might cause participation in this study to be detrimental to the subject, including, but not limited to:
    - Current malignancy excluding basal cell carcinoma; History of malignancy is acceptable only if the subject has been in remission for one year prior to the Screening Visit.
    - Current or untreated tuberculosis; History of tuberculosis is acceptable only if a subject has received an approved prophylactic treatment regimen or an approved active treatment regimen and has had no evidence of active disease for a minimum of 2 years
    - Uncontrolled hypertension (systolic BP >= 160 or diastolic BP >100)
    - Stroke within 3 months prior to the Screening Visit
    - Immunologic compromise
    7. History of a positive test for HIV, hepatitis B or hepatitis C infection.
    8. Clinical visual evidence of oral candidiasis at the Screening Visit.
    9. History of any adverse reaction, including immediate or delayed hypersensitivity to any Beta2-agonist, sympathomimetic drug, or any intranasal, inhaled, or systemic corticosteroid therapy. Known or suspected sensitivity to the constituents of the dry powder inhalers used in the study (i.e lactose).
    10. History of severe allergy to milk protein.
    11. Use of systemic, oral or depot corticosteroids within 12 weeks prior to the Screening Visit
    - Use of topical corticosteroids (<=1% hydrocortisone cream) for dermatological disease is permitted
    - Use of intranasal corticosteroids at a stable dose for at least 4 weeks prior to the Screening Visit and throughout the study is permitted
    12. Use of immunosuppressive medications within 4 weeks prior to the Screening Visit and during the study.
    13. Immunotherapy at a stable dose for at least 90 days prior to the Screening Visit and throughout the study for the treatment of allergies is permitted.
    14. Use of potent Cytochrome P450 3A4 (CYP3A4) inhibitors (e.g ritonavir, ketoconazole, itraconazole) within 4 weeks prior to the Screening Visit.
    15. History of alcohol or drug abuse within 2 years preceding the Screening Visit.
    16. Current smoker or a smoking history of 10 pack years or more. A subject may not have used tobacco products within the past one year (e.g cigarettes, cigars, chewing tobacco, or pipe tobacco).
    17. Study participation by clinical investigator site employees and/or their immediate relatives.
    18. Study participation by more than 1 subject from the same household at the same time. However, after the study completion or discontinuation by one subject another subject from the same household may be screened.
    19. Participation in any investigational drug study within the 30 days (starting at the final follow-up visit) preceding the Screening Visit or planned participation in another investigational drug study at any time during this study.
    20. Pregnancy, nursing, or plans to become pregnant or donate gametes (ova or sperm) for in vitro fertilization during the study period or for 30 days following the subject's last study related visit (for eligible subjects only - if applicable). Eligible female subjects unwilling to employ appropriate contraceptive measures to ensure that pregnancy will not occur during the study will be excluded.
    1. Antecedentes de asma potencialmente mortal, que se define para este protocolo como un episodio de asma que requiera intubación y/o se asocie a hipercapnia, parada respiratoria o crisis hipóxicas.
    2. Infección bacteriana o viral, sospechada o demostrada por cultivo, de las vías respiratorias superiores o inferiores, de los senos paranasales o del oído medio que no se resuelva en el plazo de 2 semanas antes de la visita de selección. Además, se excluirá al paciente si la infección ocurre entre la visita de selección y la visita de aleatorización.
    3. Cualquier exacerbación del asma que requiera corticosteroides orales en los 3 meses anteriores a la visita de selección. Los pacientes no deberán haber sido hospitalizados por asma en los 6 meses previos a la visita de selección.
    4. Presencia de glaucoma, cataratas, herpes simple ocular o neoplasia maligna distinta del carcinoma basocelular.
    5. Antecedentes o signos activos de una enfermedad clínicamente importante, incluidas, entre otras, la enfermedad cardiovascular, hepática, renal, hematológica, neuropsicológica, endocrina, digestiva o pulmonar.
    6. Presencia de alguna de las siguientes condiciones que, en opinión del investigador, motive que la participación en este estudio sea perjudicial para paciente (entre otras):
    - Neoplasia maligna activa
    - Tuberculosis activa o no tratada
    - Hipertensión no controlada (PA sistólica >= 160 o PA diastólica >100)
    - Ictus en los 3 meses previos a la visita de selección
    - Inmunodepresión
    7. Antecedentes de análisis positivo para el VIH, la hepatitis B o la hepatitis C.
    8. Signos clínicos evidentes a la vista de candidiasis bucal en la visita de selección.
    9. Antecedentes de reacción adversa, incluida la hipersensibilidad inmediata o retardada, a cualquier agonista Beta2, simpaticomimético o corticoterapia intranasal, inhalada o sistémica. Certeza o sospecha de hipersensibilidad a los componentes de los inhaladores de polvo seco (Spiromax o Diskus) utilizados en el estudio (es decir, lactosa).
    10. Antecedentes de alergia grave a las proteínas de la leche.
    11. Uso de corticosteroides sistémicos, orales o de depot en las 12 semanas previas a la visita de selección
    12. Uso de inmunosupresores en las 4 semanas previas a la visita de selección y durante el estudio.
    13. Se permite la inmunoterapia en una dosis estable durante al menos 90 días antes de la visita de selección y durante todo el estudio para el tratamiento de alergias.
    14. Uso de inhibidores potentes del citocromo P450 3A4 (CYP3A4) (p. ej., ritonavir, ketoconazol, itraconazol) en las 4 semanas previas a la visita de selección.
    15. Antecedentes de alcoholismo o toxicomanía en los dos años anteriores a la visita de selección.
    16. Tabaquismo activo o antecedentes de tabaquismo de 10 paquetes-año o más. El paciente no podrá haber utilizado productos de tabaco en el año anterior (p. ej., cigarrillos, puros, tabaco de mascar o tabaco para pipa).
    17. Participación en el estudio de los empleados del centro del investigador clínico y/o sus familiares inmediatos.
    18. Participación en el estudio de más de un sujeto de un mismo domicilio al mismo tiempo. Sin embargo, después de la finalización o retirada del estudio de un sujeto, podrá seleccionarse a otro sujeto del mismo domicilio.
    19. Participación en cualquier estudio con un fármaco en investigación en los 30 días (a partir de la visita de final de seguimiento) previos a la visita de selección o participación prevista en otros estudios de investigación en cualquier momento del estudio.
    20. Embarazo, lactancia o previsión de quedarse embarazada o donar gametos (óvulos o espermatozoides) para fecundación in vitro durante el período del estudio o en los 30 días siguientes a la última visita relacionada con el estudio (para pacientes elegibles, sólo si procede). Se excluirá a las mujeres elegibles que no estén dispuestas a utilizar métodos anticonceptivos adecuados para garantizar que no se producirá un embarazo durante el estudio.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is:
    - Change from baseline in trough (AM pre-dose and pre-rescue bronchodilator) FEV1 over the 12-week Treatment Period
    El criterio principal de valoración de la eficacia es:
    - Variación con respecto al valor basal del FEV1 valle (antes de la dosis matutina y del broncodilatador de rescate) durante el período de tratamiento de 12 semanas.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Primary efficacy endpoint timeline is over the 12-week treatment period.

    The primary pharmacokinetic endpoint:
    At Treatment Visit 1, a sub-set of subjects (Pharmacokinetic [PK] cohort) from pre-selected study centers will have serial blood samples obtained immediately prior to and at scheduled times for 12 hours after administration of study medication for PK assessments.
    El criterio principal de valoración es durante el periodo de tratamiento de 12 semanas.

    El criterio principal de valoración farmacocinética:
    En la Visita 1 del tratamiento, un subconjunto de sujetos (cohorte de farmacocinética [FC] de los centros del estudio preseleccionados tendrá muestras de sangre en serie recogidas de forma inmediata antes y en los momentos programados durante 12 horas después de la administración del fármaco del estudio para las valoraciones de FC.
    E.5.2Secondary end point(s)
    The secondary efficacy endpoints include:
    - Change from baseline in weekly average of daily trough (pre-dose and pre-rescue bronchodilator) AM PEF over the 12-week Treatment Period
    - Change from baseline in weekly average of daily PM PEF over the 12-week Treatment Period
    - Change from baseline in the percentage of symptom-free 24-hour periods during the 12-week Treatment Period
    - Change from baseline in the percentage of rescue-free 24-hour periods during the 12-week Treatment Period
    Los criterios secundarios de valoración de la eficacia son:
    - Variación con respecto al valor basal del promedio semanal del PEF valle matutino diario (antes de la administración y del broncodilatador de rescate) durante el período de tratamiento de 12 semanas
    - Variación con respecto al valor basal del promedio semanal del PEF vespertino diario durante el período de tratamiento de 12 semanas.
    - Variación con respecto al valor basal del porcentaje de los períodos de 24 horas sin síntomas durante el período de tratamiento de 12 semanas
    - Variación con respecto al valor basal del porcentaje de los períodos de 24 horas sin medicación de rescate durante el período de tratamiento de 12 semanas
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Change from baseline in weekly average of daily trough (pre-dose and pre-rescue bronchodilator) AM PEF over the 12-week Treatment Period
    - Change from baseline in weekly average of daily PM PEF over the 12-week Treatment Period
    - Change from baseline in the percentage of symptom-free 24-hour periods during the 12-week Treatment Period
    - Change from baseline in the percentage of rescue-free 24-hour periods during the 12-week Treatment Period
    - Variación con respecto al valor basal del promedio semanal del PEF valle matutino diario (antes de la administración y del broncodilatador de rescate) durante el período de tratamiento de 12 semanas
    - Variación con respecto al valor basal del promedio semanal del PEF vespertino diario durante el período de tratamiento de 12 semanas.
    - Variación con respecto al valor basal del porcentaje de los períodos de 24 horas sin síntomas durante el período de tratamiento de 12 semanas
    - Variación con respecto al valor basal del porcentaje de los períodos de 24 horas sin medicación de rescate durante el período de tratamiento de 12 semanas
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Doble ciego para las dosis de Fp Spiromax vs. placebo, pero el brazo del comparador es abierto
    The study is double blind for doses of Fp Spiromax vs placebo but the comparator arm is open label.
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Flovent Diskus
    E.8.2.4Number of treatment arms in the trial6
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA29
    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
    Bulgaria
    Croatia
    Hungary
    Israel
    Poland
    Russian Federation
    Serbia
    Spain
    Ukraine
    United States
    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
    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 years0
    E.8.9.1In the Member State concerned months9
    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 months9
    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: 70
    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: 70
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 545
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 12
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Minors
    Menores
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state16
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 116
    F.4.2.2In the whole clinical trial 627
    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)
    Patient will continue on normal standard of care.
    El paciente continuará con su cuidado habitual.
    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 Decision2012-01-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-12-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-07-10
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