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    The EU Clinical Trials Register currently displays   44234   clinical trials with a EudraCT protocol, of which   7336   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2007-002912-24
    Sponsor's Protocol Code Number:BAY q 3939/12170
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-09-05
    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 ConcernedGermany - BfArM
    A.2EudraCT number2007-002912-24
    A.3Full title of the trial
    Study to evaluate the safety and pharmacokinetics of ciprofloxacin following inhalation of ciprofloxacin dry powder for inhalation administered to pediatric patients with cystic fibrosis aged 12-17 years
    A.4.1Sponsor's protocol code numberBAY q 3939/12170
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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
    D.3.2Product code BAY q 3939
    D.3.4Pharmaceutical form Inhalation powder, hard capsule
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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.3.9.1CAS number 85721331
    D.3.9.2Current sponsor codeBAY q 3939
    D.3.9.3Other descriptive name1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-[1-piperazinyl]-3-quinoline carboxylic acid
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    long term treatment of chronic lung infections caused by Pseudomonas aeruginosa in patients with cystic fibrosis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10011763
    E.1.2Term Cystic fibrosis lung
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary objective of the study is to investigate the safety and tolerability of inhaled ciprofloxacin given as single inhalation dose to pediatric CF patients.
    E.2.2Secondary objectives of the trial
    Secondary objective of the study is to investigate the pharmacokinetics of ciprofloxacin in plasma, urine and sputum after inhalative administration in order to show that an exposure needed for an assumed effective treatment of P. aeruginosa can be reached in the lung of pediatric CF patients.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Male or female subjects with cystic fibrosis confirmed by genetic testing and/or by sweat test;
    - Colonization with P. aeruginosa confirmed in sputum in the past 12 months;
    - 12 to 17 years of age;
    - Normal body weight: BMI between 15 and 30 kg/m2;
    - Subjects who are able to understand and follow instructions and who are able to participate in the study for the entire period;
    - Women who are willing to use a method of contraception with a failure rate < 1% during the course of the study until the follow-up examination. These methods of contraception according to the note for guidance on non-clinical safety studies for the conduct of human trials for pharmaceuticals (CPMP/ICH/286/95, modification) include consistent and correct use of hormone containing implants and injectables, combined oral contraceptives, hormone containing intrauterine devices, surgical sterilization, sexual abstinence and vasectomy or condom use by their partners.
    - Subjects and legal representatives must have given their written informed consent to participate in the study after receiving adequate previous information and prior to any study specific procedures.
    E.4Principal exclusion criteria
    - Participation in another clinical trial with antibiotic treatment during the preceding 2 weeks;
    - Subjects with relevant conspicuous findings in medical history and pre-study examination not related to the underlying disease;
    - Patients with FEV1 < 50%;
    - Subjects with Burkholderia cepacia colonization of their respiratory tract;
    - Subjects with acute pulmonary aspergillosis;
    - Subjects on a lung transplant list;
    - Subjects with acute pulmonary exacerbations;
    - Subjects with severe liver cirrhosis;
    - Massive hemoptysis in the preceding 4 weeks;
    - Donation of more than 150 mL of blood in the preceding 4 weeks;
    - Blood donation of approximately 500 mL in the preceding 3 months;
    - A history of relevant diseases of vital organs, of the central nervous system, or other organs not related to the underlying disease;
    - Subjects with a medical disorder, condition or history of such that would impair the subject's ability to participate or complete this study in the opinion of the investigator or the sponsor;
    - Febrile illness within 1 week before the start of the study;
    - Subjects with a history of severe allergies, non-allergic drug reactions, or multiple drug allergies;
    - Subjects with hypersensitivity to the investigational drug or to other quinolones and/ or to inactive constituents;
    - Regular daily consumption of more than 1 L of usual beer or the equivalent quantity of approximately 40 g of alcohol in another form;
    - Regular daily consumption of more than 1 L of xanthine-containing beverages;
    - Non-smoker;
    - Use of medication within the 5 days preceding the study which could interfere with the investigational drug;
    - Relevant deviation from the normal range in the clinical examination not related to the underlying disease;
    - Relevant deviation from the normal range in clinical chemistry, hematology, or urinalysis not related to the underlying disease;
    - Resting heart rate in the awake subject below 45 BPM;
    - Systolic blood pressure below 100 mmHg or above 145 mmHg;
    - Diastolic blood pressure above 95 mmHg;
    - Relevant pathological changes in the ECG such as a second or third-degree AV block, prolongation of the QRS complex over 120 msec or of the QT / QTc-interval over 450 msec for men and over 470 msec for women;
    - Concomitant inhalative therapy with antibiotics and/or concomitant systemic therapy with fluoroquinolones (see Section 4.5.7).
    - Woman of childbearing potential not using safe and highly effective contraception methods as described in Section 4.2.2.
    E.5 End points
    E.5.1Primary end point(s)
    not applicable
    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 No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    pediatric patients
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    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
    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 months2
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    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.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception 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 state16
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 16
    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)
    After the study treatment, the patients will continue their standard cystic fibrosis treatment
    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 Decision2007-10-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-10-30
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-07-07
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