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    Summary
    EudraCT Number:2010-023090-19
    Sponsor's Protocol Code Number:SMR 2375
    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:2011-02-11
    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 number2010-023090-19
    A.3Full title of the trial
    A double-blind, randomized, placebo-controlled, cross-over study to evaluate the safety, tolerability and preliminary efficacy of alginate oligosaccharide (OligoG) administered for 28 days in subjects with Cystic Fibrosis chronically colonised with Pseudomonas aeruginosa
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A double-blind, randomized, placebo-controlled, cross-over study to evaluate the safety, tolerability and preliminary efficacy of alginate oligosaccharide (OligoG) administered for 28 days in subjects with Cystic Fibrosis chronically colonised with Pseudomonas aeruginosa
    A.3.2Name or abbreviated title of the trial where available
    A phase II cross-over study of OligoG in subjects with cystic fibrosis
    A.4.1Sponsor's protocol code numberSMR 2375
    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 SponsorAlgiPharma AS
    B.1.3.4CountryNorway
    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 supportAlgiPharma AS
    B.4.2CountryNorway
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAlgiPharma AS
    B.5.2Functional name of contact pointRolf Myrvold
    B.5.3 Address:
    B.5.3.1Street AddressIndustriveien 33
    B.5.3.2Town/ cityN-1337 Sadvika
    B.5.3.3Post codeNot Applicable
    B.5.3.4CountryNorway
    B.5.4Telephone number+4767545770
    B.5.5Fax numberNot Applicable
    B.5.6E-mailrolf.myrvold@algipharma.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 Yes
    D.2.5.1Orphan drug designation numberEU/3/07/475
    D.3 Description of the IMP
    D.3.1Product nameOligoG (60 mg/ml)
    D.3.2Product code OligoG
    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 INNOligoG
    D.3.9.1CAS number 9005-38-3
    D.3.9.2Current sponsor codeOligoG
    D.3.9.3Other descriptive nameOligoG-CF5/20, Alginate oligosaccharide (G-block) fragment
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/V) percent weight/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6
    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 Yes
    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
    Cystic Fibrosis
    E.1.1.1Medical condition in easily understood language
    Cystic Fibrosis
    E.1.1.2Therapeutic area Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level PT
    E.1.2Classification code 10011762
    E.1.2Term Cystic fibrosis
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The principle research objective is:
    To determine the safety and local tolerability of multiple dose administration of inhaled OligoG in subjects with cystic fibrosis. Particular emphasis will be put on local, clinical tolerance, lung function and adverse events related to lung function.
    E.2.2Secondary objectives of the trial
    The secondary research objectives are:
    The effect of multiple dose administration of inhaled OligoG on various efficacy variables will also be explored, such as break up of mucus structure, lung function, respiratory symptoms, Quality-of-Life and microbiological outcome measures.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    In order to participate in the study subjects must meet all of the following inclusion criteria:

    1) Male or female with a confirmed diagnosis of cystic fibrosis defined by:
    a. Clinical features consistent with the diagnosis of CF AND
    b. Sweat chloride ≥60 mmol/L by pilocarpine iontophoresis; OR
    c. Genotypic confirmation of CFTR mutation
    2) Aged 18 years or older
    3) Ability to provide samples for microbiological evaluation throughout the study. Note: sputum samples are preferred however cough swabs may be performed on occasions where sputum cannot be collected.
    4) Positive microbiological finding of Pseudomonas aeruginosa in expectorated sputum or cough swab documented within 24 months prior to Screening (Visit 1).
    5) FEV1 must, at Screening (Visit 1), be between 35%-80% of the predicted normal value following adjustment for age, gender, and height according to the Knudson equation.
    6) At Screening (Visit 1), no clinical or laboratory findings suggestive of significant pulmonary illness, other than CF, which in the opinion of the investigator would preclude participation in the study
    7) Female subjects of child bearing potential and male subjects participating in the study who are sexually active must use acceptable contraception. Female subjects documented as being of non child-bearing potential are exempt from the contraceptive requirements. For the purpose of this study acceptable contraception is defined as:
    a. oral, injected or implanted hormonal methods of contraception; OR
    b. placement of an intrauterine device (IUD) or intrauterine system (IUS); OR
    c. barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository
    8) Provision written informed consent
    E.4Principal exclusion criteria
    In order to participate in the study subjects must not meet any of the following exclusion criteria

    1) Changes in underlying therapy (e.g., pulmonary massage therapy, bronchodilators, NSAIDs, antibiotic agents, pancreatic enzyme preparations, nutritional supplements and DNase within the 21 days prior to Day 1 (Visit 2). Subjects must be willing to remain on the same underlying stable therapy regimens for the duration of the study until the final follow-up visit at Day 111.
    2) Changes in physiotherapy technique or schedule within 14 days prior to Day 1 (Visit 2).
    3) Prohibited medications within 7 days prior to Day 1 (Visit 2).
    4) Pulmonary exacerbation within 28 days of Screening (Visit 1)
    5) Positive microbiological finding of Burkholderia sp. in expectorated sputum or cough swab documented within 12 months prior to Screening (Visit 1).
    6) On-going acute illness. Subjects must not have needed an outpatient visit, hospitalization or required any change in therapy for other pulmonary disease between Screening (Visit 1) and Day 1 (Visit 2).
    7) History of, or planned organ transplantation.
    8) Allergic bronchopulmonary aspergillosis (ABPA) in the last 12 months prior to Screening (Visit 1), defined as having received treatment for ABPA.
    9) Requirement for continuous (24 hour/day) oxygen supplementation.
    10) Concomitant administration of inhaled mannitol or hypertonic saline within 7 days prior to Day 1 (Visit 2).
    11) Initiation of cycled, inhaled tobramycin (TOBI) less than 4 months prior to Screening (Visit 1). Note: Chronic TOBI users are allowed to participate in this study, but subjects who have recently initiated chronic TOBI should have at least 2 cycles of TOBI in the preceding 4 months before being enrolled in this study. Chronic TOBI subjects should be starting an ‘off-TOBI’ period at Day 1 (Visit 2) so there will be no concomitant dosing of TOBI and assigned study medication.
    12) Clinically significant abnormal findings on haematology or clinical chemistry. In addition any value ≥ 3 x the upper limit of normal will exclude the subject from participating in the study.
    13) Subjects unable to perform pulmonary function tests according to the ATS/ERS criteria.
    14) Pregnant or breast-feeding women. A negative urine pregnancy test must be demonstrated in females of child-bearing potential at Screening (Visit 1).
    15) Subjects who have participated in any interventional clinical trial within the 28 days prior to Day 1 (Visit 2).
    16) Subjects with documented or suspected, clinically significant, alcohol or drug abuse. The determination of clinical significance will be determined by the Investigator.
    17) Known allergies or intolerance to alginates (e.g., foods and food additives based on seaweed extracts).
    18) Current malignant disease (with the exception of basal cell carcinoma; BCC).
    19) Any serious or active medical or psychiatric illness, which in the opinion of the Investigator, would interfere with subject treatment, assessment, or compliance with the protocol.
    E.5 End points
    E.5.1Primary end point(s)
    To determine the safety and local tolerability of multiple dose administration of inhaled OligoG in CF subjects. Particular emphasis will be put on local, clinical tolerance, pulmonary function and pulmonary adverse events.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary endpoint will be evaluated at visits 1, 2, 3, 4, 5, 6, 7, 8, 9
    E.5.2Secondary end point(s)
    The effect of multiple dose administration of inhaled OligoG on various efficacy variables will also be explored, such as mucolytic activity, lung function, respiratory systems, Quality-of-Life and microbiological outcome measures.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The secondary endpoint will be evaluated at visits 2, 3, 4, 5, 6, 7, 8, 9
    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 No
    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) 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 No
    E.8.1.6Cross over Yes
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA3
    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
    Completion of all trial procedures by participants in all countries.

    The screening and treatment periods for subjects participating in the study will be approximately 18 weeks (Day -14 to 111). All subjects will in addition be followed for up to 6 months following the last dose of study medication OR until the first post study CF Exacerbation whichever occurs sooner.
    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 years1
    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: 5
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 0
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 24
    F.4.2.2In the whole clinical trial 24
    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)
    The subjects will have an extra visit at the clinic when they have their first exacerbation of CF after completion of the intervention periods.
    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 Decision2011-03-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-01-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-11-05
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