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    Summary
    EudraCT Number:2013-004659-19
    Sponsor's Protocol Code Number:BAYQ3939/15626
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-08-05
    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 ConcernedBulgarian Drug Agency
    A.2EudraCT number2013-004659-19
    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.
    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)
    A.3.2Name or abbreviated title of the trial where available
    Respire 2
    A.4.1Sponsor's protocol code numberBAYQ3939/15626
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1150-8425
    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 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 AG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBayer AG
    B.5.2Functional name of contact pointBayer Clin. Trials Contact CTP Team
    B.5.3 Address:
    B.5.3.1Street AddressBayer Pharma AG, S102, Level 2, Room 156
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code13342
    B.5.3.4CountryGermany
    B.5.6E-mailclinical-trials-contact@bayer.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 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, hard capsule
    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
    non-CF bronchiectasis
    E.1.1.1Medical condition in easily understood language
    bronchiectasis: irreversible airway widening OR localized irreversible dilation of part of the bronchial tree
    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 19.0
    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 this 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 within 48 weeks after start of treatment ( as agreed with the US FDA [Food and Drug Administration]).
    • 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 (as agreed with EMA/ CHMP and Japan PMDA) within 48 weeks after start of treatment (wording harmonized with amendment no. 2).
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are:
    • To access the frequency of pulmonary exacerbations in subjects with non-CF BE. For this secondary exacerbation events are defined as events with systemic antibiotic use and worsening of at least one sign/ symptom;
    • To assess pathogen eradication and acquisition of new pathogenic organisms not present at baseline;
    • To assess the safety and tolerability of different long term regimens of ciprofloxacin DPI;
    • To assess the improvement of quality of life by Saint George’s Respiratory Questionnaire;
    • To assess the improvement of quality of life by Quality of Life-Bronchiectasis (QoL-B) questionnaire's respiratory symptom domain;
    • To assess changes in lung function as measured by change in 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
    PK substudy integral part of study 15626: Evaluation of concentration of swallowed ciprofloxacin in the gastrointestinal tract after inhalational treatment by determining the drug concentrations in sputum, blood and fecal matter in a subgroup of subjects who provided consent for this sub-study.

    PK related objective:
    Changes from baseline in inflammatory markers (hsCRP, Polymorphphonuclear leukocytes (PMN) count);
    Changes from baseline in sputum inflammatory markers IL-8 and MPO.

    Within the report of this study, sputum, feces, and plasma concentrations will be analyzed using descriptive statistical methods in order to provide a first insight into the pharmacokinetics of Ciprofloxacin DPI. In addition the data will be evaluated under a
    separate evaluation protocol (13823) using population pharmacokinetic methods to allow pooling with information from other clinical studies in subjects receiving the drug.
    E.3Principal inclusion criteria
    1) Age at least 18 years;
    2) Proven and documented diagnosis of non-CF idiopathic or post-infectious BE by CT scan (conventional high resolution CT is considered the standard) including 2 or more lobes and dilated airways compatible with BE at initial diagnosis
    3) Positive culture from an adequate sputum sample for Pseudomonas aeruginosa, Haemophilus influenzae, Moraxella catarrhalis, Staphylococcus aureus, Streptococcus pneumoniae, Stenotrophomonas maltophilia or Burkholderia cepacia obtained at screening and with history ≥2 documented exacerbations in the past 12 months.
    4) Stable pulmonary status as indicated by FEV1 (percent of predicted) >=30% and <90% (post-bronchodilator, if used as standard of treatment);
    5) Stable regimen of standard treatment with:
    o 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
    o Macrolides if used as chronic treatment for BE for at least 6 months prior to screening.
    6) Sputum production on the majority of days;
    7) Ability to follow the inhaler device instructions;
    8) Ability to complete questionnaires;
    9) Written informed consent;
    10) Negative urine pregnancy test result for women of childbearing potential before first dose of study drug;
    11) 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.
    E.4Principal exclusion criteria
    1) FEV1 <30% or >=90% predicted (post-bronchodilator);
    2) Active allergic bronchopulmonary aspergillosis (ABPA);
    3) Active and actively-treated non-tuberculosis mycobacterial (NTM) infection or tuberculosis;
    4) Diagnosis of common variable immunodeficiency (CVID);
    5) Recent significant hemoptysis (>=300 mL or requiring blood transfusion) in the preceding 4 weeks before screening (and during the screening period);
    6) Primary diagnosis of COPD;
    7) Known CF and / or documented chronic bronchial asthma;
    8) Administration of any investigational drug within 4 weeks before screening;
    9) Medical history of allergies to quinolones or fluoroquinolones;
    10) Women who are pregnant, lactating, or in whom pregnancy cannot be excluded;
    11) History of tendon disorders related to quinolone treatment;
    12) History of myasthenia gravis;
    13) Concomitant administration of tizanidine while on study drug;
    14) Systemic or inhaled antibiotic treatment for any indication within 4 weeks prior to the administration of study drug; except for chronic macrolide use (see section 6.9).
    15) Systemic corticosteroids at >10 mg/day prednisolone equivalent for >14 days within 4 weeks prior to the administration of study drug;
    16) If participating in or has participated in other investigational interventional studies within the previous 4 weeks before screening;
    17) Subjects with any other conditions (specifically those which are addressed in the warnings and precautions section of the IB) or clinically relevant laboratory findings that the investigator defines as not appropriate for enrollment of a subject into the study
    18) Previous assignment to treatment in this study (randomized in Study 15626); subject who has participated in RESPIRE 1 will not be enrolled in RESPIRE 2.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy variables of this study are the time to first pulmonary exacerbation requiring an intervention with systemic antibiotics within 48 weeks after start of treatment (for the US NDA[New Drug Application]), and frequency of exacerbations requiring an intervention with systemic antibiotics during the 48 weeks treatment phase (for EU MAA and further ex-US registrations).
    E.5.1.1Timepoint(s) of evaluation of this end point
    over 48 weeks after baseline
    E.5.2Secondary end point(s)
    - To access frequency of exacerbations over 48 weeks (US NDA) / time to first exacerbation within 48 weeks after the start of treatment (EU MAA);
    - To access frequency of pulmonary exacerbation in subjects with non-CF BE. For this secondary endpoint exacerbation events are defined as events with systemic antibiotic use and worsening of at least one sign/ symptom;
    - To access pathogen eradication and acquisition of new pathogenic organism not present at baseline;
    - To access the safety and tolerability of different long term regimes of ciprofloxacin DPI;
    - To access the improvement of quality of life by Saint George's Respiratory Questionnaire;
    - To access the improvement of quality of life by Qality of Life respiratory symptom domain Questionnaire (QoL-B);
    - To access changes in lung function as measured by changes in forced expiratory volume in 1 second (FEV 1).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Confirmatory analyses for pathogen eradication, occurrence of new pathogens and lung function, SGRQ and QoL-B will be evaluated at end of the on-treatment part of the 6th cycle for subjects in the 28 day on/off regimen, at end of the on-treatment part of the 12th cycle for subjects in the 14 day on/off regimen. Frequency of exacerbation (US/ NDA) / Time to first exacerbation (EU MAA) will be evaluated over 48 weeks.
    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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA73
    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
    Austria
    Brazil
    Bulgaria
    China
    Czech Republic
    Germany
    Hong Kong
    Korea, Republic of
    Latvia
    Lithuania
    Netherlands
    Philippines
    Poland
    Portugal
    Romania
    Russian Federation
    Serbia
    Slovakia
    South Africa
    Taiwan
    Thailand
    Turkey
    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
    last subject last visit
    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 days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months7
    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: 246
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 246
    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 state90
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 172
    F.4.2.2In the whole clinical trial 492
    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
    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 COPD Foundation
    G.4.3.4Network Country United States
    G.4 Investigator Network to be involved in the Trial: 2
    G.4.1Name of Organisation Lung Foundation Australia
    G.4.3.4Network Country Australia
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-08-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-09-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-10-19
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