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    Summary
    EudraCT Number:2016-004558-13
    Sponsor's Protocol Code Number:Z7224L02
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-03-20
    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 ConcernedFrance - ANSM
    A.2EudraCT number2016-004558-13
    A.3Full title of the trial
    A double-blind, placebo controlled, multicentre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled Promixin® (colistimethate sodium) in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A double-blind, placebo controlled, multicentre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled Promixin® (colistimethate sodium) in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa)
    A.3.2Name or abbreviated title of the trial where available
    PROMIS II
    A.4.1Sponsor's protocol code numberZ7224L02
    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 SponsorZambon S.p.A.
    B.1.3.4CountryItaly
    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 supportZambon SpA
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationChiltern International Ltd
    B.5.2Functional name of contact pointRegulatory Service
    B.5.3 Address:
    B.5.3.1Street Address171 Bath Road
    B.5.3.2Town/ citySlough, Berkshire
    B.5.3.3Post codeSL1 4AA
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+4417535120000
    B.5.5Fax number+441753511116
    B.5.6E-mailregulatory.service@chiltern.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.3.1Product nameColistimethate sodium
    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.3.8INN - Proposed INNCOLISTIMETHATE SODIUM
    D.3.9.1CAS number 8068-28-8
    D.3.9.3Other descriptive nameColistimethate Sodium
    D.3.9.4EV Substance CodeSUB06801MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000000
    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-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa
    E.1.1.1Medical condition in easily understood language
    Non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa
    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 19.1
    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 investigate if the use of inhaled Promixin® (colistimethate sodium), administered twice daily for 12 months, delays the time to the first pulmonary exacerbation compared to placebo in subjects with non–cystic fibrosis (CF) bronchiectasis chronically infected with P. aeruginosa.
    E.2.2Secondary objectives of the trial
    Not Applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects can be included in the trial if they meet all inclusion criteria listed below:
    1. Are able and willing to give informed consent following a detailed explanation of participation in the protocol and signed consent obtained;
    2. Aged 18 years or older of either genders;
    3. Diagnosed with non-CF bronchiectasis by computerised tomography (or high resolution CT) and recorded in the subject’s notes;
    4. Had at least 2 NCFB pulmonary exacerbations requiring oral antibiotics or 1 pulmonary exacerbation requiring intravenous antibiotics in the 12 months preceding the Screening Visit (Visit 1);
    5. Had 1 positive sputum culture for P. aeruginosa in the 12 months preceding the Screening Visit (but performed at least 30 days before the Screening Visit);
    6. Are clinically stable and have not required a change in pulmonary treatment for at least 30 days before the Screening Visit;
    7. Have pre-bronchodilator FEV1 ≥30% of predicted;
    8. Had a positive sputum culture for P. aeruginosa from an adequate sample taken at the Screening Visit (Visit 1).
    E.4Principal exclusion criteria
    Subjects are not eligible for the trial if they meet one or more of the exclusion criteria listed below:
    1. known bronchiectasis as a consequence of cystic fibrosis (CF) or focal endobronchial lesion or otherwise curable causes (e.g. foreign body aspiration);
    2. known history of hypogammaglobulinaemia requiring treatment with immunoglobulin, inflammatory bowel disease, primary ciliary dyskinesia, myasthenia gravis, porphyria or myeloproliferative disease, severe cardiovascular disease;
    3. a major abdominal, chest or brain surgery in the 3 months prior to Screening Visit (Visit 1) or planned inpatient major surgery during the study period;
    4. receiving treatment for allergic bronchopulmonary aspergillosis (ABPA);
    5. massive haemoptysis (greater than or equal to 300 mL or requiring blood transfusion) in the preceding 4 weeks before Screening Visit (Visit 1);
    6. predominant lung condition being chronic obstructive pulmonary disease (COPD) or asthma or interstitial lung disease in the opinion of the Investigator;
    7. History of any of the following:
    - listed for transplantation;
    - any other significant active illness likely to affect the patient’s survival within 12 months;
    - receiving long-term domiciliary oxygen therapy or non-invasive ventilation for the management of respiratory failure;
    8. current active malignancy, except for basal cell carcinoma of the skin without metastases, history of solid organ or bone marrow transplant;
    9. taking immunosuppressive medications such as azathioprine, methotrexate, ciclosporine, tacrolimus, sirolimus, mycophenolate, anti-cytokine medications, rituximab;
    10. known history of human immunodeficiency virus (HIV), hepatitis B or C;
    11. current diagnosis of Mycobacterium tuberculosis infection;
    12. positive cultures for Mycobacterium abscessus complex, or Mycobacterium avium complex, or Mycobacterium xenopi, or Mycobacterium kansasii, or Mycobacterium malmoense or Mycobacterium simiae in the year preceding the Screening Visit (Visit 1);
    13. current treatment for non-tuberculous mycobacterial (NTM) pulmonary infection or be under consideration for NTM treatment in the next 12 months;
    14. current smokers or ex-smokers less than 6 months prior to Screening Visit (Visit 1);
    15. evidence of bronchial hyperreactivity that may, in the opinion of the Investigator, indicate such subjects will not be able to tolerate colistimethate sodium;
    16. known to be intolerant to inhaled beta agonists (bronchodilators);
    17. known or suspected to be allergic or unable to tolerate colistimethate sodium or other polymixins;
    18. therapy with long term (≥ 30 days) prednisone at stable dose greater than 15 mg a day (or equivalent dose of any other corticosteroid) prior to Screening Visit 1 (Visit 1);
    19. new maintenance treatment with oral macrolides (azithromycin or erythromycin) started within 30 days of the Screening Visit (Visit 1);
    20. use of any intravenous or intramuscular or oral or inhaled antipseudomonal antibiotic (except chronic macrolides azithromycin or erythromycin with a stable dose) within 30 days prior to Screening Visit (Visit 1);
    21. pregnant or breast feeding or plan to become pregnant over the next year or of child bearing potential and unwilling to use a reliable method of contraception throughout their involvement in the trial;
    22. Significant abnormality in clinical evaluations and/or laboratory tests (physical examination, vital signs, haematology, clinical chemistry, ECG) endangering the safe participation of the patient in the study at the Screening Visit (Visit 1) and during the study;
    23. in the opinion of the Investigator not suitable for inclusion for whatever reason;
    24. participated in another clinical trial within 30 days prior to the Screening Visit (Visit 1).
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of this trial is the time (in days) from first dose of IMP until the first NCFB pulmonary exacerbation.
    E.5.1.1Timepoint(s) of evaluation of this end point
    • time to event evaluated during the entire treatment period
    E.5.2Secondary end point(s)
    Efficacy Endpoints
    The secondary efficacy endpoints of this trial are:
    • the yearly mean NCFB pulmonary exacerbation rate;
    • the number of NCFB pulmonary exacerbations requiring intravenous antibiotics or oral antibiotics;
    • the QoL as measured by the total scores of the SGRQ and QOL-B questionnaires;
    • the time to first NCFB pulmonary exacerbation (in days) and the yearly mean pulmonary exacerbation rate considering adherent subjects only (adherent subjects are defined as taking at least 80% of the prescribed therapy, according recordings by the I-neb logging system);
    • the P. aeruginosa density as determined by the mean change in log10 CFU/g sputum from baseline (Visit 2) to Day 28 of treatment (Visit 3).
    • The average number of hospitalizations for pulmonary exacerbations.
    • The number of subjects hospitalized for NCFB pulmonary exacerbations;
    • The number of days of work absence

    Safety Endpoints
    The safety endpoints of this trial are:
    • the incidence of TEAEs;
    • the number of subjects experiencing bronchospasm clinically or spirometrically determined following IMP administration during clinic visit ;
    • P. aeruginosa susceptibility to colistin at end of treatment (12 months [Visit 7]).
    • Haematology and clinical chemistry;
    • Physical examination and vital signs data;
    • 12-lead Electrocardiogram.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Efficacy Endpoints
    • yearly mean pulmonary exacerbation rate: from baseline to the End of the study
    • number of pulmonary exacerbations requiring intravenous antibiotics..: from baseline to the End of the study
    • QoL: from baseline (visit 2) to the End of the study
    Safety Endpoints
    • incidence of TEAEs: from baseline to the End of the study
    • the number of subjects experiencing bronchospasm ...: from baseline to the End of the study
    • monitoring subjects’ lung function: over the duration of the study by means of presalbutamol
    • FEV1 and FVC measurements & physical/vital signs data: from baseline to the End of the study
    • P. aeruginosa susceptibility to colistin: at End of the study
    • Haematology, clinical chemistry & 12-ECG: at screening vist and at the end of the trial
    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 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 No
    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.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA9
    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
    Canada
    France
    Poland
    United States
    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
    LVLS
    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 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 months3
    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.1.2.1Number of subjects for this age range: 132
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 132
    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 state28
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 77
    F.4.2.2In the whole clinical trial 264
    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 end of the study the patient will return to standard 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 Decision2017-05-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-04-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-03-15
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