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    Summary
    EudraCT Number:2009-014412-35
    Sponsor's Protocol Code Number:ARD-3100-0901
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2009-10-01
    Trial 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 ConcernedUK - MHRA
    A.2EudraCT number2009-014412-35
    A.3Full title of the trial
    An International, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Once Daily Administration of Two Strengths of Ciprofloxacin for Inhalation Compared with Placebo for Inhalation in the Management of Pseudomonas aeruginosa in Patients with Non Cystic Fibrosis Bronchiectasis
    A.3.2Name or abbreviated title of the trial where available
    N/A
    A.4.1Sponsor's protocol code numberARD-3100-0901
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberNot available
    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 SponsorAradigm Corporation
    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 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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameCiprofloxacin for Inhalation
    D.3.2Product code None assigned
    D.3.4Pharmaceutical form Nebuliser solution
    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 HYDROCHLORIDE
    D.3.9.1CAS number 86483-48-9
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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) 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboNebuliser solution
    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-cystic fibrosis bronchiectasis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level LLT
    E.1.2Classification code 10006446
    E.1.2Term Bronchiectasis NOS
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine whether the microbiological efficacy of Ciprofloxacin for Inhalation (CFI) 100 mg and 150 mg are superior to placebo (Control Liposomes for Inhalation [CLI]) in the treatment of patients with non cystic fibrosis (CF) bronchiectasis by evaluating changes in P. aeruginosa log10 colony-forming units (CFU)/gram of sputum.
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study will include comparison of CFI 100 mg and 150 mg to placebo (CLI) with respect to the following:
    1. Microbiological efficacy
    2. Time to, number of, severity of, and time to resolve exacerbations
    3. Changes in spirometry
    4. Quality of life (QOL)
    5. Safety and tolerability
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Males or females at least 18 years of age who are able to walk.
    2.Have had a confirmed diagnosis of non-CF bronchiectasis per computed tomography.
    3.Confirmed history of at least one exacerbation treated with a course of antibiotics within the last 12 months.
    4.Have been off any anti-pseudomonal antibiotic for a minimum of 28 days prior to the Day 1(Visit 1).
    5.Have FEV1 of more than 25% of predicted values at the Screening Visit (Visit 0).
    6.Have positive documented P. aeruginosa in a sputum/deep-throat cough swab culture (or bronchoalveolar lavage [BAL]) within 12 months prior to the Screening Visit (Visit 0) and in the sputum/ deep-throat cough swab culture collected at the Screening Visit (Visit 0).
    7.Are clinically stable and able to do the 6-minute walk test without oxygen supplementation in the opinion of the investigator.
    8.Are willing to comply with the requirements for participation in the study.
    9.Are willing to use an acceptable method of contraception during the study.
    10.Female patients of childbearing potential must provide a negative pregnancy test at the Screening Visit and must use an acceptable method of contraception for at least 3 weeks prior to the first dose of study drug and for 30 days after the last dose of study drug. Acceptable methods of contraception for women are orally administered hormonal contraceptives, surgical intervention, intrauterine device (IUD), and sexual abstinence. If a hormonal contraceptive is utilized as the method of contraception, the same method must have been used for at least 3 months prior to Visit 1.
    To be considered “not of child bearing potential”, female patients must be at least 2 years postmenopausal, or have been irreversibly surgically sterilized by hysterectomy, oophorectomy, or bilateral tubal ligation for at least 3 months prior to the first dose of study drug.
    Male patients whose female partners are of child bearing potential (definition as above) must agree to use an acceptable method of birth control (as listed above) for the duration of study treatment and for 30 days after the last dose of study drug.
    11Patients who meet all inclusion and none of the exclusion criteria and meet the following sputum criteria at screening will be enrolled into the study:
    • Sputum P. aeruginosa density ≥6 log10 CFU/gram
    • Sputum P. aeruginosa sensitive to ciprofloxacin
    If a patient’s initial sputum sample does not meet the above criteria for density and sensitivity, the patient will be allowed a maximum of 2 additional opportunities of sputum testing for P. aeruginosa density and sensitivity to ciprofloxacin. Only the sputum sample needs to be retested if other entry criteria are sufficient for the patient to be randomized.
    E.4Principal exclusion criteria
    1.Known local or systemic hypersensitivity to fluoroquinolone or quinolone antibiotics, soybeans, or peanuts.
    2.Have an exacerbation during the Screening Phase as defined as requiring treatment with inhaled, oral, or intravenous antibiotics prior to the first dose of study drug.
    3.Have a diagnosis of cystic fibrosis.
    4.Have a diagnosis of allergic brochopulmonary aspergillosis.
    5.Have received any intravenous, oral, or inhaled anti-pseudomonal antibiotic within 28 days prior to Visit 1.
    6.Have used tizanidine within 28 days prior to Visit 1.
    7.Have used supplemental oxygen within 28 days prior to Visit 1.
    8.Have used any intravenous or intramuscular corticosteroid or have used oral corticosteroid >10 mg/day or >20 mg every other day within 28 days of Visit 1.
    9.Have had changes in either the treatment regimen or initiation of treatment with any of the following medications within 28 days prior to Visit 1:
    •Azithromycin
    •Hypertonic saline
    •Mucolytics
    •Bronchodilator medications
    •Oral corticosteroid
    10.Have had changes in physiotherapy technique or schedule within 28 days prior to Visit 1.
    11.Have a history of solid organ (e.g., lung) transplantation.
    12.Have a history of non-tuberculosis mycobacteria requiring treatment within 3 months prior to Visit 1.
    13.Have serum creatinine levels ≥ 1.5x upper limit of normal (ULN) at the Screening Visit (Visit 0).
    14.Have serum transaminase levels >3x ULN at the Screening Visit (Visit 0).
    15.Have a febrile illness within 1 week prior to Visit 1.
    16.Have had massive hemoptysis (greater than or equal to 300 mL or requiring blood transfusion) within 6 months prior to Visit 1.
    17.Have used any over-the-counter product, herbal product, diet aid, hormone supplement, etc., within 7 days prior to dosing unless approved by both the Principal Investigator and the Sponsor.
    18.Have received an investigational drug or device within 28 days prior to Visit 1.
    19.Have any serious or active medical or psychiatric illness, which in the opinion of the investigator, would interfere with patients’ treatment, assessment, or compliance with the protocol.
    20.Have a history or suspicion of unreliability, poor cooperation, or non-compliance with medical treatment.
    21.Are unable to use nebulizers.
    22.Are unable either to understand the instruction for use of the study drug or to complete the QOL questionnaire at Visit 1.
    23.Have previously been enrolled in this study.
    24.Are pregnant, plan to become pregnant during this study, are nursing mothers or are unwilling to use an acceptable method of contraception for the duration of the study.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is defined as the mean change in P. aeruginosa density in sputum (log10) CFU/gram of sputum from Baseline to Day 28. The endpoint will be summarized by treatment group and mean change differences will be assessed by statistical methods to be detailed in the statistical analysis plan (SAP). The 2 mL and 3 mL placebo treatment groups will be combined into one arm for both analyses and display purposes.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic 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 Yes
    E.7.1.3.1Other trial type description
    Phase II
    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 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.8.3 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 concerned15
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    The end of treatment visit takes place within two days of Day 28, •Patients who are prematurely withdrawn from study drug should complete the Visit Day 28 assessments.
    A final visit at Day 56 +/- 2 days will complete the patients participation in the study
    Patients who discontinue prematurely from the study (either during the On-treatment or Off-treatment Phases) should complete the assessments for Day 56.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    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 years1
    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.1.3Elderly (>=65 years) Yes
    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 state45
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 96
    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)
    Other than end-of-study follow up visit, no other treatment or extended care will be provided to study subjects
    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 Decision2009-10-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-02-23
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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