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    The EU Clinical Trials Register currently displays   41232   clinical trials with a EudraCT protocol, of which   6757   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2013-005348-28
    Sponsor's Protocol Code Number:ARD-3150-1201
    National Competent Authority:Latvia - SAM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-05-08
    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 ConcernedLatvia - SAM
    A.2EudraCT number2013-005348-28
    A.3Full title of the trial
    A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections with Pseudomonas aeruginosa in Subjects with Non-Cystic Fibrosis Bronchiectasis, including 28 Day Open-Label Extension and Pharmacokinetic Substudy (ORBIT-3)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® (ARD-3150, Dual Release Ciprofloxacin for Inhalation) in subjects who have a lung infection that includes the bacteria Pseudomonas aeruginosa due to non-cystic fibrosis bronchiectasis. This study includes a 28-day open-label extension (all patients will receive study drug for the last 28 days of the study).
    A.3.2Name or abbreviated title of the trial where available
    Pulmaquin® with Non-Cystic Fibrosis Bronchiectasis (ORBIT 3)
    A.4.1Sponsor's protocol code numberARD-3150-1201
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01515007
    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 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 supportAradigm Corporation
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAradigm Corporation
    B.5.2Functional name of contact pointChief Medical Officer
    B.5.3 Address:
    B.5.3.1Street Address3929 Point Eden Way
    B.5.3.2Town/ cityHayward, California
    B.5.3.3Post codeCA 94545
    B.5.3.4CountryUnited States
    B.5.4Telephone number0015102658838
    B.5.5Fax number0015102658878
    B.5.6E-mailfroehlichj@aradigm.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 namePulmaquin®
    D.3.2Product code ARD-3150
    D.3.4Pharmaceutical form Nebuliser solution
    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 Hydrochloride
    D.3.9.1CAS number 86483-48-9
    D.3.9.2Current sponsor codeCiprofloxacin for Inhalation (CFI)
    D.3.9.3Other descriptive nameCIPROFLOXACIN HYDROCHLORIDE
    D.3.9.4EV Substance CodeAS1
    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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCiprofloxacin Hydrochloride
    D.3.9.1CAS number 86483-48-9
    D.3.9.2Current sponsor codeFree Ciprofloxacin for Inhalation (FCI)
    D.3.9.3Other descriptive nameCIPROFLOXACIN HYDROCHLORIDE
    D.3.9.4EV Substance CodeAS2
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 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
    Chronic lung infections with Pseudomonas aeruginosa in subjects with non-cystic fibrosis bronchiectasis.
    E.1.1.1Medical condition in easily understood language
    Lung infection that includes the bacteria Pseudomonas aeruginosa due to non-cystic fibrosis bronchiectasis.
    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 18.0
    E.1.2Level PT
    E.1.2Classification code 10057582
    E.1.2Term Lung infection pseudomonal
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10006446
    E.1.2Term Bronchiectasis NOS
    E.1.2System Organ Class 100000004855
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objective of this study is to evaluate the efficacy of Pulmaquin compared to placebo in the management of chronic lung infections with P. aeruginosa (a type of bacteria) in subjects with non-cystic fibrosis bronchiectasis by evaluating the time to first pulmonary exacerbation (worsening) in the Double-Blind Phase.

    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are to evaluate:
     Efficacy of Pulmaquin compared to placebo as assessed by clinical outcomes (including pulmonary exacerbations), pulmonary function, patient-reported outomes, and exercise testing in the Double-Blind Phase.
     Microbiological response in the Double-Blind Phase and the Open-Label Extension.
     Safety and tolerability of Pulmaquin compared to placebo in the Double-Blind Phase.
     Safety and tolerability of Pulmaquin in the Open-Label Extension.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    A pharmacokinetic substudy to be conducted as part of study ARD-3150-1201 (ORBIT 3) open label extension.
    Objective: to assess the PK of Pulmaquin in blood and sputum in subjects with non-CF bronchiectasis.
    E.3Principal inclusion criteria
    Subjects will be entered into this study only if they meet all of the following criteria:
    1. Are willing and able to provide written informed consent.
    2. Are males or females who are 18 year of age or older and are able to walk.
    3. Have had a confirmed diagnosis of non-CF bronchiectasis per
    computerized tomography (or high resolution computerized tomography) showing bronchial wall dilatation (internal
    bronchial lumen diameter greater than accompanying pulmonary artery or lack of tapering) with or without bronchial wall thickening.
    4. Have a documented history of at least 2 pulmonary exacerbations treated with courses of antibiotics within the last 12 months.
    5. Have forced expiratory volume in 1 second (FEV1) ≥ 25% of predicted values at the Screening Visit (Visit 0).
    6.Have positive documented P. aeruginosa in a sputum/deep-throat swab culture (or bronchoalveolar lavage [BAL] or bronchoscopic specimen) prior to the Screening Visit (Visit 0). Subjects without documented P. aeruginosa prior to Screening who meet all other eligibility criteria must have at least two sputum samples or deep-throat swabs collected 3-4 or more weeks apart from each other during the 42- day Screening Phase. Two of the samples collected must test positive for
    P. aeruginosa. These two positive tests must be from samples taken a minimum of 3-4 or more weeks apart.
    7.Have positive P. aeruginosa in the sputum/deep-throat swab culture collected at the Screening Visit (Visit 0) and at least one P. aeruginosa isolate non-resistant to ciprofloxacin. If the sputum sample is negative for P. aeruginosa, or only shows resistant P. aeruginosa isolates, the sputum/swab culture can be repeated multiple times during Screening to document the presence of P. aeruginosa. In subjects without documented P. aeruginosa prior to Screening who meet all other eligibility criteria and who had two or more sputum cultures or deep- throat swab cultures obtained 3-4 or more weeks apart from each other during Screening, at least one P. aeruginosa isolate taken after 3-4 or more weeks must be non-resistant to ciprofloxacin for the subject to be considered eligible for randomization. The qualifying sputum culture results must be available within the 42-day Screening Phase.
    8. Are clinically stable and capable of performing the 6mwt without supplemental oxygen.
    9. Are willing and able to comply with the requirements for
    participation in the study.
    10. Female subjects of childbearing potential must have a negative
    pregnancy test at the Screening Visit and must use an acceptable
    method of contraception for at least 3 months prior to the first dose of
    study drug and for 28 days after the last dose of study drug. Acceptable
    methods of contraception for women are orally administered or
    injectable hormonal contraceptives, surgical intervention, and intrauterine device (IUD). To be considered "not of
    childbearing potential", female subjects must be postmenopausal for at
    least 1 year as confirmed by an elevated follicle-stimulating hormone
    (FSH) level (≥ 30 mIU/mL) at Screening and 1 year of amenorrhea, 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 subjects whose female partners are of
    childbearing potential (definition as above) must agree to use an
    acceptable method of birth control for the duration of study treatment
    and for 28 days after the last dose of study drug.
    E.4Principal exclusion criteria
    Subjects will be randomized into this study only if they meet none of the following criteria:
    1. Have a pulmonary exacerbation during the Screening Phase (between signing the ICF and randomization), defined as requiring acute treatment with
    inhaled, oral, or intravenous antibiotics prior to the first dose of study
    drug.
    2. Have a clinical diagnosis of CF.
    3. Have primary diagnosis of Chronic Obstructive Pulmonary Disease
    (COPD) related to smoking history of greater than 10 pack years.
    4. Have a current diagnosis of active allergic bronchopulmonary
    aspergillosis.
    5. Have received any intravenous, oral, or inhaled anti-pseudomonal
    antibiotic (except chronic macrolides erythromycin, clarithromycin or azithromycin with
    a stable dose) within 28 days prior to Visit 1.
    6. Have an allergy to ciprofloxacin, gemifloxacin, levofloxacin,
    moxifloxacin, or norfloxacin.
    7. Have a known allergy to soy products.
    8. Have used tizanidine within 28 days prior to Visit 1 and would need to
    use tizanidine during the study (because tizanidine is contraindicated
    due to a PK interaction with ciprofloxacin).
    9. Have initiated supplemental oxygen within 28 days prior to Visit 1.
    10. Have used any intravenous or intramuscular corticosteroid or have
    used oral corticosteroid > 10 mg/day or > 20 mg every other day (prednisone or prednisolone equivalents) within
    28 days of Visit 1.
    11. 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:
    a. Macrolides, e.g., azithromycin,clarithromycin or erythromycin
    b. Inhaled hypertonic saline or inhaled mannitol
    c. Mucolytics
    d. Bronchodilator medications
    e. Oral corticosteroid
    12. Have had changes in pulmonary rehabilitation, chest physiotherapy technique or frequency within 28
    days prior to Visit 1.
    13. Have a history of solid organ (e.g., lung) transplantation.
    14. Have a non-tuberculosis mycobacterial infection and are currently receiving antibiotic treatment or are anticipated to require initiation of antibiotic treatment during the study.
    15. Have active tuberculosis.
    16. Have serum creatinine levels ≥ 2.0x upper limit of normal (ULN) at
    the Screening Visit (Visit 0).
    17. Have serum transaminase levels > 3x ULN at the Screening Visit
    (Visit 0).
    18. Have a febrile illness within 1 week prior to Visit 1.
    19. Have had massive hemoptysis (greater than or equal to 300 mL or
    requiring blood transfusion) within 6 months prior to Visit 1.
    20. Have received an investigational drug or device within 42 days prior
    to Visit 1.
    21.Have a malignancy or any other serious or active medical illness with a life expectancy of less than 12 months.
    22. Have any serious or active medical or psychiatric illness, which in the
    opinion of the Investigator, would interfere with subjects' treatment,
    assessment, or compliance with the protocol.
    23. Have a history or suspicion of unreliability, poor cooperation, or noncompliance
    with medical treatment.
    24. Are unable to use nebulizers during the course of the study.
    25. Are unable either to understand the instruction for use of the study
    drug or to complete the Quality of Life Questionnaire-Bronchiectasis
    (QoL-B) at Visit 1.
    26. Have previously been randomized in this study.
    27. 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.
    28. Have any other condition that, in the opinion of the Investigator,
    would prohibit the subject from participating in the study.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint of this study is the time to first pulmonary exacerbation from baseline (Day 1) to Week 48.
    E.5.1.1Timepoint(s) of evaluation of this end point
    From baseline (Day 1) to Week 48.
    E.5.2Secondary end point(s)
    - Number of pulmonary exacerbations from baseline (Day 1) to Week 48.
    - Number of severe pulmonary exacerbations from baseline (Day 1) to
    Week 48.
    - Change in Respiratory Symptoms Domain score of Qol-B from baseline
    (Day 1) to Week 48.
    E.5.2.1Timepoint(s) of evaluation of this end point
    From baseline (Day 1) to Week 48.
    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 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) 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 trial2
    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 EEA35
    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
    Australia
    Canada
    France
    Germany
    Hungary
    Ireland
    Israel
    Italy
    Latvia
    New Zealand
    Poland
    Romania
    South Africa
    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
    The study will close when all subjects have completed the follow-up telephone call at Day 394(+- 4 days), which will take place 30 days after the subject receives the last dose of open-label study drug at Visit 15 (Day 364).
    Therefore End of Study is defined as when the last patient completes Visit 16 (Study Day 394) – or the last early withdrawal visit, whichever is later.
    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 months2
    E.8.9.1In the Member State concerned days11
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days11
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 55
    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.4.2.1In the EEA 140
    F.4.2.2In the whole clinical trial 255
    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)
    No arrangements will be made for continued provision once the research has finished. The investigator will discuss possible treatment options with each patient and the best course of treatment available for that patient will be followed in line with the provision of routine clinical care.
    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 Decision2014-07-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-05-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-10-14
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