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    The EU Clinical Trials Register currently displays   38451   clinical trials with a EudraCT protocol, of which   6312   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2014-002125-35
    Sponsor's Protocol Code Number:SMR-2591
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-07-21
    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 ConcernedGermany - BfArM
    A.2EudraCT number2014-002125-35
    A.3Full title of the trial
    A randomized double-blind, placebo-controlled cross-over study of inhaled alginate oligosaccharide (OligoG) for 28 days in subjects with Cystic Fibrosis using aztreonam due to chronic colonization with Burkholderia spp.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase IIb study of OligoG in subjects with cystic fibrosis colonized with Burkholderia spp.
    A.3.2Name or abbreviated title of the trial where available
    A phase IIb study of OligoG in subjects with cystic fibrosis colonized with Burkholderia spp.
    A.4.1Sponsor's protocol code numberSMR-2591
    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 supportEurostars
    B.4.2CountryEuropean Union
    B.4.1Name of organisation providing supportAlgipharma AS
    B.4.2CountryNorway
    B.4.1Name of organisation providing supportSmerud Medical Research
    B.4.2CountryNorway
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSMERUD Medical Research
    B.5.2Functional name of contact pointCRO
    B.5.3 Address:
    B.5.3.1Street AddressDrammensveien 41
    B.5.3.2Town/ cityOslo
    B.5.3.3Post codeN-0271
    B.5.3.4CountryNorway
    B.5.4Telephone number+4962117028490
    B.5.5Fax number+496211710284928
    B.5.6E-mailhans.mueller@smerud.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 CF-5/20
    D.3.4Pharmaceutical form Inhalation powder, hard capsule
    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 INNOligomer of Sodium Alginate
    D.3.9.2Current sponsor codeOligoG
    D.3.9.3Other descriptive nameOLIGOG CF-5/20
    D.3.9.4EV Substance CodeSUB130807
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number35
    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 placeboInhalation powder, hard capsule
    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] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To explore the efficacy of OligoG in reducing the microbial burden of Burkholderia spp. as measured in expectorated sputum samples.
    E.2.2Secondary objectives of the trial
    To explore the effect of inhaled OligoG on various efficacy variables such as lung function, Quality-of-Life, rheology and other microbiological outcome measures.
    To evaluate the safety, tolerability and patient compliance with treatment.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female with a confirmed diagnosis of cystic fibrosis defined by:
    a. Clinical features consistent with the diagnosis of CF (Rosenstein BJ and Cutting GR 1998); and sweat chloride ≥60 mmol/L by pilocarpine iontophoresis;
    or
    b. Genotypic confirmation of CFTR mutation
    2. Aged 18 years or older
    3. Expected ability and willingness to provide sputum samples for microbiological evaluation throughout the study either spontaneously or induced by means of using inhaled hypertonic saline.
    4. Chronic colonization with Burkholderia spp. defined as at least two positive microbiological cultures in expectorated sputum within the last 12 months prior to Visit 1.
    5. Use of inhaled aztreonam three times daily in a 4 weeks on/off cycle treatment regimen or a continuous intake regimen for at least 4 weeks before screening Visit. For on/off cycles, the Screening Visit (Day -28 to Day -7) should take place in the “off” phase. Randomization Visit (Day 0) should take place the first day “on” to harmonize the aztreonam inhalation period with the IMP intake period.
    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. In case lab values exceed 3x the upper limit, the subject will be excluded, as per exclusion criterion 10, below.
    7. FEV1 must, at Screening (Visit 1), be greater than 25% of the predicted normal value following adjustment for age, gender, and height according to the Global Lung Initiative (Quanjer PH et al 2012).
    8. 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:
    oral, injected or implanted hormonal methods of contraception; or
    placement of an intrauterine device (IUD) or intrauterine system (IUS);
    or
    barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository
    9. Provision of written informed consent.
    E.4Principal exclusion criteria
    1. Changes in underlying therapy (e.g., chest physiotherapy, bronchodilators, NSAIDs, pancreatic enzyme preparations, nutritional supplements and DNase within the 14 days prior to Day 0 (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 112 (Visit 8).
    2. Changes in physiotherapy technique or schedule within 14 days prior to Day 0 (Visit 2).
    3. Concomitant use of inhaled mannitol or hypertonic saline within 7 days prior to Day 0 (Visit 2); see also section 5.6.
    4. Concomitant use of inhaled antibiotics other than aztreonam.
    5. Pulmonary exacerbation within 28 days of Screening (Visit 1).
    6. Lactose intolerance/milk allergy. A skin test for milk allergy will be performed for lactose intolerance unknowns at screening. Subjects who have previously received inhaled formulations containing lactose without any allergic or tolerance issues are allowed to proceed without a skin test. For subjects demonstrating a positive skin prick test for milk allergy but have no problems eating milk and lactose products, the decision to exclude will be at the investigator’s discretion.
    7. 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 0 (Visit 2).
    8. History of, or planned organ transplantation.
    9. Active allergic bronchopulmonary aspergillosis (ABPA) in the last 12 months prior to Screening (Visit 1), defined as having received pharmacological treatment for ABPA.
    10. Clinically significant abnormal findings or any value ≥ 3 x the upper limit of normal on haematology or biochemistry
    11. Subjects unable to perform pulmonary function tests according to the ATS/ERS criteria.
    12. Pregnant or breast-feeding women. A negative urine pregnancy test must be demonstrated in females of child-bearing potential at Screening (Visit 1).
    13. Subjects who have participated in any clinical trial within the 28 days (or shorter than 5 half-lives of the investigational drug) prior to Screening (Visit 1).
    14. Subjects with documented or suspected clinically significant, alcohol or drug abuse as per Investigator’s discretion.
    15. Current malignant disease (with the exception of basal cell carcinoma; BCC).
    16. Any serious or active illness incl. psychiatric diseases, which in the opinion of the Investigator, would interfere with subject treatment, assessment, or compliance with the protocol.
    17. Subjects not willing/able to follow the study instructions.
    18. Resistance to aztreonam.
    19. Intolerance to aztreonam or any of its excipients.
    E.5 End points
    E.5.1Primary end point(s)
    Change in density of Burkholderia spp. in expectorated sputum from baseline to the end of treatment (and any other visit), as measured by culture independent techniques.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline and day 28 of each treatment period
    E.5.2Secondary end point(s)
    Change in sputum rheology from baseline to the end of treatment (and any other visit).
    Change in lung function tests from baseline to the end of treatment (and any other visit).
    Change in Quality of Life by CFQ-R from baseline to the end of treatment (and any other visit).
    Changes in MIC of aztreonam for other bacteria isolated by culture methods from sputum samples.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline and day 28 of each treatment period
    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) 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 Yes
    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 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 concerned2
    E.8.5The trial involves multiple Member States No
    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 No
    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
    Last visit of last subject (LVLS)
    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 months0
    E.8.9.1In the Member State concerned 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: 12
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 12
    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 state12
    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)
    None
    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 Decision2014-12-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-12-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-05-10
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