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    Summary
    EudraCT Number:2011-004208-39
    Sponsor's Protocol Code Number:BAYq3939/15625
    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:2012-11-26
    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 number2011-004208-39
    A.3Full title of the trial
    Randomized, double-blind, placebo-controlled, multicEnter Study comParing CIprofloxacin DPI 32.5 mg BID intermittently administered for 28 days on / 28 days off or 14 days on / 14 days off versus placebo to evaluate the time to fiRst pulmonary exacErbation and frequency of exacerbations in subjects with non-cystic fibrosis bronchiectasis.
    Estudio aleatorizado, en doble ciego, controlado con placebo y multicéntrico, de ciprofloxacino 32,5 mg en polvo seco para inhalación dos veces al día en administración intermitente, durante 28 días con otros 28 de descanso o durante 14 días con otros 14 de descanso, en comparación con placebo, en la evaluación del tiempo hasta la primera exacerbación pulmonar y la frecuencia de las exacerbaciones en sujetos con bronquiectasias no debidas a fibrosis quística.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis (non-CF BE)
    Ciprofloxacino en polvo seco para inhalación en las bronquiectasias no debidas a fibrosis quística (BE-no-FQ)
    A.3.2Name or abbreviated title of the trial where available
    RESPIRE 1
    A.4.1Sponsor's protocol code numberBAYq3939/15625
    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 SponsorBayer HealthCare AG
    B.1.3.4CountryGermany
    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 supportBayer HealthCare AG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBayer HealthCare AG
    B.5.2Functional name of contact pointClinical Trials Contact
    B.5.3 Address:
    B.5.3.1Street AddressCTP Team / Ref:"EU CTR" / Bayer Pharma AG
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code13342
    B.5.3.4CountryGermany
    B.5.6E-mailclinical-trials-contact@bayerhealthcare.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/3/07/469
    D.3 Description of the IMP
    D.3.1Product nameCiprofloxacin DPI
    D.3.2Product code BAYq3939
    D.3.4Pharmaceutical form Inhalation powder, hard capsule
    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 INNCiprofloxacin
    D.3.9.2Current sponsor codeBAYq3939
    D.3.9.3Other descriptive nameCIPROFLOXACIN
    D.3.9.4EV Substance CodeSUB07470MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number32.5
    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 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
    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
    bronchiectasis
    bronquiectasias
    E.1.1.1Medical condition in easily understood language
    bronchiectasis: localized, irreversible dilation of part of the bronchial tree
    bronquiectasia: dilatación localizada e irreversible de parte del árbol bronquial
    E.1.1.2Therapeutic area Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10006445
    E.1.2Term Bronchiectasis
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objectives of the study are:

    - To evaluate the efficacy of ciprofloxacin DPI administered BID
    intermittently for 28 days on study treatment / 28 days off study
    treatment or 14 days on study treatment / 14 days off study treatment to prolong the time to first exacerbation requiring an intervention with systemic antibiotics in subjects with non CF BE.

    - To evaluate the efficacy of ciprofloxacin dry powder for inhalation (DPI) administered 2 times a day (BID) intermittently for 28 days on study treatment / 28 days off study treatment or 14 days on study treatment / 14 days off study treatment in reducing the frequency of pulmonary exacerbation requiring an intervention with systemic antibiotics in subjects with non-CF BE within 48 weeks after start of treatment.
    Los objetivos principales del estudio son:
    - Evaluar la eficacia de ciprofloxacino PSI administrado 2/d de forma intermitente durante 28 días de tratamiento con 28 días de descanso del tratamiento de estudio o 14 días de tratamiento con 14 días de descanso del tratamiento del estudio para prolongar el tiempo hasta la primera exacerbación que precisa una intervención con antibióticos sistémicos en sujetos con BE-no-FQ.
    -Evaluar la eficacia de ciprofloxacino en polvo seco para inhalación (PSI) administrado 2 veces al día (2/d) de forma intermitente durante 28 días de tratamiento con 28 días de descanso del tratamiento de estudio o 14 días de tratamiento con 14 días de descanso del tratamiento de estudio para reducir la frecuencia de exacerbaciones pulmonares que precisan una intervención con antibióticos sistémicos en sujetos con BE-no-FQ en las 48 semanas posteriores al comienzo del tratamiento
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are:
    - To assess pathogen eradication and acquisition of new pathogenic organisms not present at baseline;
    - To assess the safety and tolerability of different long term regimen of ciprofloxacin DPI;
    - To assess the improvement of quality of life by Saint George's
    Respiratory Questionnaire (SGRQ);
    - To assess changes in lung function as measured by change in FEV1.
    Los objetivos secundarios de este estudio son:
    -Evaluar la erradicación de patógenos y la adquisición de nuevos microrganismos patógenos no presentes en el momento basal;
    -Evaluar la seguridad y tolerabilidad de diferentes pautas de administración a largo plazo de ciprofloxacino PSI;
    -Evaluar la mejora de la calidad de vida mediante el Cuestionario de Saint George sobre problemas respiratorios (SGRQ);
    -Evaluar los cambios en la función pulmonar medidos por los cambios en el FEV1.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Pharmacokinetics will be assessed on blood and sputum samples collected at baseline and at one other study visit, for a subset of subjects at selected sites. The subject will be asked to produce one to two sputum samples. Sampling should start after the administration of the study drug, with the first sample ideally approximately 2-4 h after the end of inhalation. All records identifying the patient will be kept confidential and, to the extent permitted by the applicable laws and/or regulations, will not be made publicly available. Rationale and procedures of Pharmacokinetics are described in the Pharmacokinetic Sampling Manual version 3.0 dated 13/Sep/2012
    Se evaluará la farmacocinética mediante el examen de muestras de sangre y esputo, a recoger en el basal y en otra visita del estudio, en un subgrupo de sujetos de determinados centros. Se pedirá al sujeto dos muestras de esputo. La obtención de las muestras deberá comenzar tras la administración del fármaco del estudio, siendo deseable obtener la primera muestra aproximadamente 2-4 h después del final de la inhalación. Todos los documentos en los que se identifique a los pacientes se conservarán de manera confidencial y, en la medida permitida por las leyes y/o normativas aplicables, no se harán públicamente disponibles. La justificación y los procedimientos de la Farmacocinética se describen en el Manual para la obtención de Muestras para Farmacocinética, versión 3.0 de 13 de septiembre de 2012
    E.3Principal inclusion criteria
    -Age >=18 years;
    -Proven and documented diagnosis of non-CF idiopathic or post-infectious BE by both:
    * HRCT scan including 2 or more lobes and dilated airways compatible with BE at initial diagnosis;
    and
    * Positive culture from an adequate sputum sample for Pseudomonas aeruginosa, Haemophilus influenzae, Moraxella catarrhalis, Staphylococcus aureus, Streptococcus pneumoniae, Stenotrophomonas maltophilia or Burkholderia cepacia at screening and with history >=2 documented exacerbations in the past 12 months;
    -Stable pulmonary status as indicated by FEV1 (percent of predicted) >= 30% and < 90% (post-bronchodilator, if used as standard of treatment);
    -Stable regimen of standard treatment with:
    * Bronchodilators, anticholinergics, inhaled corticosteroids, or mucolytics, if used as chronic treatment for BE, at least for the past 4 weeks prior to screening; Subjects on maintenance therapy with low-dose systemic corticosteroids should be receiving <=10 mg/day prednisolone equivalent at least for the past 4 weeks before the screening visit;
    and/or
    * Macrolides if used as chronic treatment for BE for at least 6 months prior to screening;
    -Sputum production on the majority of days;
    -Ability to follow the inhaler device instructions;
    -Ability to complete questionnaires;
    -Written informed consent;
    -Negative urine pregnancy test result for women of childbearing potential before first dose of study drug;
    -Women of childbearing potential and men must agree to use adequate contraception when sexually active. This applies from the time of signing of the informed consent form (ICF) until 3 months after the last study drug administration. Adequate methods of contraception include vasectomy, or condom use, diaphragm with spermicidal gel, coil (intrauterine device), surgical sterilization, or oral contraceptives.
    -Edad >= 18 años;
    -Diagnóstico demostrado y documentado de BE idiopática o posinfecciosa no relacionada con FQ según ambos:
    * TCAR que incluya 2 o más lóbulos y vías respiratorias dilatadas compatibles con BE en el momento del diagnóstico inicial;
    y
    * Cultivo de una muestra de esputo adecuada positivo para Pseudomonas aeruginosa, Haemophilus influenzae, Moraxella catarrhalis, Staphylococcus aureus, Streptococcus pneumoniae, Stenotrophomonas maltophilia o Burkholderia cepacia en el momento de la selección y con antecedentes de >= 2 exacerbaciones confirmadas en los últimos 12 meses.
    -Estado pulmonar estable, indicado por el FEV1 (porcentaje del valor predicho) >= 30 % y < 90 % (después del broncodilatador, si se usaba como tratamiento habitual).
    -Pauta estable del tratamiento habitual con:
    * Broncodilatadores, anticolinérgicos, corticosteroides inhalados o mucolíticos, si se usan como tratamiento crónico de la BE, al menos durante las últimas 4 semanas antes de la selección. Los sujetos en tratamiento de mantenimiento con corticosteroides sistémicos a dosis bajas deben estar recibiendo un equivalente a <= 10 mg/día de prednisolona al menos durante las últimas 4 semanas antes de la visita de selección;
    y/o
    * Macrólidos si se usan como tratamiento crónico para BE durante al menos 6 meses antes de la selección.
    -Producción de esputo la mayoría de los días;
    -Capacidad de seguir las instrucciones para el uso del dispositivo inhalador;
    -Capacidad para cumplimentar cuestionarios;
    -Consentimiento informado por escrito;
    -Resultado negativo en la prueba de embarazo en orina en mujeres potencialmente fértiles antes de la primera dosis del fármaco del estudio;
    -Las mujeres potencialmente fértiles y los varones deben estar de acuerdo en utilizar métodos anticonceptivos adecuados mientras sean sexualmente activos. Esto se aplica desde el momento de la firma del documento de consentimiento informado (DCI) hasta 3 meses después de la última administración del fármaco del estudio. Entre los métodos anticonceptivos adecuados están la vasectomía o el uso de preservativos, el diafragma con gel espermicida, la bobina (dispositivo intrauterino), la esterilización quirúrgica o los anticonceptivos orales.
    E.4Principal exclusion criteria
    -FEV1 <30% or >= 90% predicted (post-bronchodilator);
    -Active allergic bronchopulmonary aspergillosis (ABPA);
    -Active and actively-treated non-tuberculosis mycobacterial (NTM) infection or tuberculosis;
    -Diagnosis of common variable immunodeficiency (CVID);
    -Recent significant hemoptysis (>= 300 mL or requiring blood transfusion) in the preceding 4 weeks before screening (and during the screening period);
    -Primary diagnosis of COPD;
    -Known CF and / or documented chronic bronchial asthma;
    -Administration of any investigational drug within 4 weeks before screening;
    -Medical history of allergies to quinolones or fluoroquinolones;
    -Women who are pregnant, lactating, or in whom pregnancy cannot be excluded;
    -History of tendon disease and other disorders related to quinolone treatment;
    -History of myasthenia gravis;
    -Concomitant administration of tizanidine while on study drug;
    -Systemic or inhaled antibiotic treatment for any indication within 4 weeks prior to the administration of study drug; except for chronic macrolide use
    -Systemic corticosteroids at >10 mg/day prednisolone equivalent for >14 days within 4 weeks prior to the administration of study drug
    -Previous assignment to treatment in this study (randomized in Study 15625).
    -FEV1 < 30 % o >= 90 % respecto al valor predicho (post-broncodilatador);
    -Aspergilosis broncopulmonar alérgica (ABPA) activa;
    -Infección por micobacterias no tuberculosas (MNT) o tuberculosis activa y tratada activamente;
    -Diagnóstico de inmunodeficiencia variable común (IDVC);
    -Hemoptisis significativa reciente (>= 300 mL o que ha precisado transfusión de sangre) en las 4 semanas previas a la selección (y durante el período de selección);
    -Diagnóstico principal de EPOC;
    -FQ conocida y/o asma bronquial crónica documentada;
    -Administración de cualquier fármaco en investigación en las 4 semanas anteriores a la selección;
    -Antecedentes médicos de alergia a quinolonas o fluoroquinolonas;
    -Mujeres embarazadas, en periodo de lactancia o en las que no puede descartarse el embarazo;
    -Antecedentes de enfermedades tendinosas y otros trastornos relacionados con el tratamiento con quinolonas;
    -Antecedentes de miastenia gravis;
    -Administración concomitante de tizanidina mientras se recibe el fármaco del estudio;
    -Tratamiento antibiótico sistémico o inhalado para cualquierindicación en las 4 semanas previas a la administración del fármaco del estudio; excepto el uso crónico de macrólidos
    -Corticosteroides sistémicos a dosis equivalentes a > 10 mg/día de prednisolona durante > 14 días en las 4 semanas anteriores a la administración del fármaco del estudio
    -Asignación previa al tratamiento en este estudio (aleatorizado en el estudio 15625)
    E.5 End points
    E.5.1Primary end point(s)
    Time to first exacerbation
    Description: Exacerbation is defined by signs and symptoms plus intervention with systemic antibiotics
    Tiempo hasta la primera exacerbación
    Descripción: La exacerbación se define por la presencia de signos y síntomas más la intervención con antibióticos sistémicos
    E.5.1.1Timepoint(s) of evaluation of this end point
    over 48 weeks after baseline
    transcurridas 48 semanas después del basal
    E.5.2Secondary end point(s)
    - Mean number of exacerbations per patient per 48 weeks
    - Pathogens present at baseline and eradicated at 48 weeks
    - Changes of Saint George's Respiratory Questionnaire (SGRQ) score from baseline to 48 weeks
    - New pathogens at 48 weeks, not present at baseline
    - Changes of forced expiratory volume in 1 second (FEV1) from baseline to 48 weeks
    - Number of participants with adverse events as a measure of safety and tolerability
    - Número medio de exacerbaciones por paciente durante 48 semanas
    - Patógenos presentes en el basal y erradicados a las 48 semanas
    - Cambios en la puntuación del Cuestionario de Saint George sobre problemas respiratorios entre el basal y las 48 semanas
    - Nuevos patógenos a las 48 semanas, no presentes en el basal
    - Cambios en el volumen espiratorio forzado en 1 segundo (FEV1) entre el basal y las 48 semanas
    - Número de participantes con acontecimientos adversos, como medida de la seguridad y la tolerancia
    E.5.2.1Timepoint(s) of evaluation of this end point
    respectively:
    - over 48 weeks after baseline
    - baseline and 48 weeks
    - baseline and 48 weeks
    - baseline and 48 weeks
    - baseline and 48 weeks
    - over 56 weeks after screening
    Respectivamente:
    - transcurridas 48 semanas del basal
    - basal y 48 semanas
    - basal y 48 semanas
    - basal y 48 semanas
    - basal y 48 semanas
    - transcurridas 56 semanas de la selección
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy 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 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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    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 concerned14
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA41
    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
    Argentina
    Australia
    Brazil
    Denmark
    France
    Germany
    Israel
    Italy
    Japan
    New Zealand
    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
    Último sujeto última visita
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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 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: 150
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 150
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 105
    F.4.2.2In the whole clinical trial 300
    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)
    None
    Ninguno
    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 Decision2013-01-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-01-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-03-09
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