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    Summary
    EudraCT Number:2008-005045-34
    Sponsor's Protocol Code Number:PPCTP/001
    National Competent Authority:Ireland - HPRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-05-18
    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 ConcernedIreland - HPRA
    A.2EudraCT number2008-005045-34
    A.3Full title of the trial
    A double-blind, vehicle-controlled, multi-centre, clinical study to investigate the efficacy and safety of up to 6 months of therapy with inhaled Promixin in the treatment of patients with non-cystic fibrosis bronchiectasis infected with Pseudomonas aeruginosa susceptible to Promixin
    A.3.2Name or abbreviated title of the trial where available
    Inhaled Promixin in the treatment of non-CF bronchiectasis
    A.4.1Sponsor's protocol code numberPPCTP/001
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN49790596
    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 SponsorProfile Pharma Ltd
    B.1.3.4CountryUnited Kingdom
    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 Yes
    D.2.1.1.1Trade name Promixin 1 million International Units (IU) Powder for Nebuliser Solution
    D.2.1.1.2Name of the Marketing Authorisation holderProfile Pharma Limited
    D.2.1.2Country which granted the Marketing AuthorisationIreland
    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.3.4Pharmaceutical form Powder for 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.3.9.3Other descriptive namecolistimethate sodium
    D.3.10 Strength
    D.3.10.1Concentration unit Munit million units
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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-CF bronchiectasis (CF = cystic fibrosis)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10006445
    E.1.2Term Bronchiectasis
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate that inhaled Promixin, administered twice a day for up to 6 months, at a concentration of 1 MIU/mL via an I-neb with a 0.3 mL metering chamber, increases the time to a pulmonary exacerbation, compared to vehicle, in patients with non-CF bronchiectasis infected with P. aeruginosa susceptible to Promixin.
    E.2.2Secondary objectives of the trial
    1. To assess the safety of Promixin when administered for 6 months to patients with non-CF bronchiectasis infected with P. aeruginosa susceptible to Promixin compared to vehicle.
    2. To assess the effect of Promixin on the weight of sputum produced in 24 hours compared to vehicle.
    3. To assess the impact of Promixin on symptoms by means of the St. George’s Respiratory Questionnaire (SGRQ) compared to vehicle.
    4. To assess the effect of inhaled Promixin on the flora of sputum and to quantify the effect on P. aeruginosa density.
    5. To assess patients’ compliance with the I-neb system and to explore if there is a correlation between compliance and outcome.
    6. To assess the incidence of bronchospasm as detected by a reduced forced expiratory volume in 1 second (FEV1) following inhalation of the Promixin compared to vehicle.
    7. To assess the severity of exacerbation (requires intravenous antibiotics = severe / requires oral antibiotics = moderate).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    At Screening (Visit 1)
    1. Aged 18 years and over.
    2. Have had P. aeruginosa grown from their sputum at least twice in the 12 months preceding the screening visit.
    3. Be within 21 days of completing a course of anti-pseudomonal antibiotics for the successful treatment of an exacerbation.
    4. Able and willing to give informed consent, following a detailed explanation of participation in the protocol and signed consent obtained.
    5. Diagnosed with non-CF bronchiectasis by computerised tomography (CT) and recorded in the patient’s notes.
    At Randomisation/Baseline (Visit 2)
    6. P. aeruginosa grown from patients’ sputa taken at Visit 1 (Screening).
    E.4Principal exclusion criteria
    At Screening (Visit 1)
    1. Known on history to have cystic fibrosis (CF).
    2. Known on history to have hypogammaglobulinaemia, inflammatory bowel disease, primary ciliary dyskinesia or myloproliferative disease.
    3. Confirmed, recent, active allergic bronchopulmonary aspergillosis (ABPA).
    4. Significant immune suppression that would interfere with the interpretation of the study e.g. current active malignancy requiring treatment, post solid organ or bone marrow transplant.
    5. Known on history, to have HIV, hepatitis B or hepatitis C.
    6. Evidence of bronchoreactivity that may, in the opinion of the investigator, indicate that such patients will not be able to tolerate colistimethate sodium.
    7. Not able to tolerate inhaled beta agonists.
    8. Allergic to or unable to tolerate colistimethate sodium.
    9. Known on history, to have received prophylactic inhaled colistimethate sodium prior to screening. (Note: Previous use of other inhaled anti-pseudomonal antibiotics, such as gentamycin and/or tobramycin, does not exclude a patient from the study)
    10. Requiring therapy with steroids excepting a stable dose of 15 mg a day or less.
    11. Taking anti tumour necrosis factor alpha products.
    12. New maintenance azithromycin therapy started with in 6 months of Visit 1.
    13. Taking hypertonic saline.
    14. Pregnant or breast feeding or who plan to become pregnant over the next year or of child bearing potential and unwilling to use a reliable method of contraception (oral contraceptive pills (OCP) or barrier methods with a spermicidal preparation) throughout their involvement in the study.
    15. In the opinion of the investigator are not suitable for inclusion for whatever reason.
    16. Do not have access to a telephone for telephone contacts.

    At Randomisation/Baseline (Visit 2) patients who satisfy one or more of the following criteria will be withdrawn:
    17. Use of inhaled antibiotics since screening.
    18. A ≥15% fall in FEV1 in the 30 minutes after receiving the first dose of IMP.
    19. Haematology and biochemistry test results make the patient unsuitable for the study in the opinion of the investigator.
    E.5 End points
    E.5.1Primary end point(s)
    The time (in days), from Baseline/Visit 2 (first dose) for each individual patient, until he/she experiences an exacerbation. An exacerbation is defined as:

    • Presence of at least 3 of the following 8 signs or symptoms present for at least 24 hours:
    ♦ Increased cough
    ♦ Increased amount of sputum produced
    ♦ Increased sputum purulence
    ♦ Haemoptysis
    ♦ Increased dyspnoea
    ♦ Increased wheezing
    ♦ Fever (temperature ≥38°C)
    ♦ Malaise
    Plus:
    • It is clinically determined that the patient requires antibiotic therapy. Antibiotic therapy for exacerbations will be divided into those treated with:
    • oral antibiotics
    • intravenous antibiotics
    The start of the exacerbation will be taken as the first day that the defining symptoms occurred. The treatment of exacerbations will follow current treatment regimens used in the participating hospital.
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    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.8.3 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 EEA34
    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
    The end of the trial is defined as completion of the trial procedures defined in the protocol by all participants (e.g. last follow-up visit or questionnaire)
    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 months3
    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 months9
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 260
    F.4.2.2In the whole clinical trial 260
    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)
    For each patient at the time of completion he/she will be offered the option of continuing therapy on commercial Promixin and will be provided with an I-neb nebulizer system.
    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 Decision2010-07-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-07-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-02-02
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