Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2008-005045-34
    Sponsor's Protocol Code Number:PPCTP/001
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-10-17
    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 ConcernedUK - MHRA
    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.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study to investigate the effect and safety of up to 6 months of treatment with inhaled Promixin in the treatment of chest infections causeed by Pseudomonas in people with a lung disease called bronchiectasis
    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.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 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 supportProfile Pharma Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationProfile Pharma Ltd
    B.5.2Functional name of contact pointRob Kenyon
    B.5.3 Address:
    B.5.3.1Street AddressChichester Business Park
    B.5.3.2Town/ cityCity Fields Way, Tangmere, Chichester
    B.5.3.3Post codePO20 2FT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44 (0)870 423 1478
    B.5.5Fax number+44 (0)870 423 1471
    B.5.6E-mailrobert.kenyon@philips.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 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 AuthorisationUnited Kingdom
    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 No
    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) 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
    non-CF bronchiectasis (CF = cystic fibrosis)
    E.1.1.1Medical condition in easily understood language
    Chest infections caused by Pseudomonas in people with a lung disease called bronchiectasis
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    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 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-cystic fibrosis 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 compared to vehicle.
    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 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, myasthenia gravis and myloproliferative disease.
    3. Confirmed, recent, active ABPA (allergic bronchopulmonary aspergillosis)
    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 be HIV, Hepatitis B or C positive
    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 or other polymixins
    9. Known, on history, to have received prophylactic inhaled colistimethate sodium prior to screening
    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. Taking chronic azithromycin therapy started within 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:
    1. Use of inhaled antibiotics since screening.
    2. A ≥15% fall in FEV1 within 30 minutes of receiving the first dose of IMP.
    3. 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
    • Icreased 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
    E.5.1.1Timepoint(s) of evaluation of this end point
    This study meaaures time to exacerbation which is the primary end point
    E.5.2Secondary end point(s)
    Safety Endpoints
    1. Number of adverse events (AEs) reported.
    2. Number of patients experiencing a ≥15% reduction in FEV1 in the 30 minutes post the first dose.
    3. Number of serious AEs (SAEs) reported.
    4. Number of suspected unexpected serious adverse reactions (SUSARs) reported.
    5. Number of patients withdrawing due to AEs.
    6. Incidence of strains of P. aeruginosa resistant to Promixin.
    Efficacy Endpoints
    1. The difference in the weight in grams, of sputum expectorated in the 24 hours prior to Visits 2 and 3.
    2. The qualitative flora of sputum, the quantification of the P. aeruginosa density as determined by the CFU count and the P. aeruginosa susceptibility to colistimethate sodium.
    3. The difference in the total scores on the SGRQ to cover the inter-visit period.
    4. The data collected by the “logging system” in the I-neb, that records information on the doses taken will be collected and used to determine compliance and explore if there is a correlation between compliance and outcome.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The end of the study
    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 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.8.2.4Number 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 concerned30
    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 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
    Russian Federation
    Ukraine
    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 years3
    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 years3
    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 state77
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 77
    F.4.2.2In the whole clinical trial 144
    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 Decision2008-11-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-12-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-02-03
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Fri May 02 18:40:29 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA