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    The EU Clinical Trials Register currently displays   41232   clinical trials with a EudraCT protocol, of which   6757   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 in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
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    Summary
    EudraCT Number:2013-003774-27
    Sponsor's Protocol Code Number:BC-180-12
    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:2013-11-27
    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 number2013-003774-27
    A.3Full title of the trial
    An open label, randomised, two-way crossover scintigraphic study to investigate lung deposition of radiolabelled OligoG delivered as a dry powder and as a nebulised solution in cystic fibrosis patients
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to investigate lung deposition of radiolabelled OligoG(v1.0)
    A.3.2Name or abbreviated title of the trial where available
    A study to investigate lung deposition of radiolabelled OligoG (v1.0)
    A.4.1Sponsor's protocol code numberBC-180-12
    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 supportTechnology Strategy Board
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBio-Images Research Ltd
    B.5.2Functional name of contact pointLee Ann Hodges
    B.5.3 Address:
    B.5.3.1Street AddressBio-Imaging Centre, Basement Medical Block
    B.5.3.2Town/ cityWithin Glasgow Royal Infirmary
    B.5.3.3Post codeG4 0SF
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01415528791
    B.5.5Fax number01415525572
    B.5.6E-mailleeann.hodges@bio-images.co.uk
    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 nameRadiolabelled OligoG CF-5/20 Dry Powder for Inhalation (DPI)
    D.3.4Pharmaceutical form Inhalation powder
    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 CF-5/20
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number96
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 nameRadiolabelled OligoG CF-5/20 6% Solution for Nebulisation
    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 CF-5/20
    D.3.9.4EV Substance CodeAS2
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number90
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Cystic fibrosis (CF) is an autosomal, recessive inheritable disease caused by a homozygote defect at the long arm of Chromosome 7. This mutation causes absence or defect of the cystic fibrosis transmembrane conductance regulator, an ion channel transporting chloride and bicarbonate ions across the cell membrane in exocrine glands. Decreased chloride transport leads to dehydration of the mucus layer, and decreased bicarbonate to increased mucus adhesion. Mucus stagnation results.
    E.1.1.1Medical condition in easily understood language
    Cystic fibrosis is a genetic condition in which the lungs and digestive system become clogged with thick sticky mucus.
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the lung deposition of OligoG when administered to cystic fibrosis patients either as a nebulised solution or as a dry powder for inhalation.
    E.2.2Secondary objectives of the trial
    To determine the radiolabel distribution pattern of the two formulations in the diseased lung, including calculating the ratio of radiolabel in the central airways compared to the peripheral region (C/P index)

    To characterise the extra-pulmonary deposition (i.e. oropharyngeal and stomach) of radiolabel including retention in the nebuliser or dry powder inhaler reservoir and deposition on the exhalation filter (if appropriate).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Aged at least 18 years at screening.

    2. Understands and is willing, able and likely to comply with all study procedures and restrictions.

    3. Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent (signed and dated) obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject.)

    4. Male or female with a confirmed diagnosis of cystic fibrosis defined by:
    i. Clinical features consistent with the diagnosis of cystic fibrosis (Rosenstein et al., 1998); AND
    ii. Sweat chloride ≥ 60 mmol/L by pilocarpine iontophoresis; OR
    iii. Genotypic confirmation of 2 CF-causing mutations

    5. Positive microbiological finding of Pseudomonas aeruginosa (mucoid or nonmucoid) in expectorated sputum (and/or swab) documented within the last 24 months prior to screening. Negative finding is acceptable provided the proportion of patients with positive findings is at least 80% as possible.

    6. At screening, FEV1 must be between 35 and 80% of the predicted normal value following adjustment for age, gender and height according to the Knudson equation (Knudson et al., 1983)

    7. Be clinically stable in the opinion of the referring physician at the CF unit.

    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:
    i. Oral, injected or implanted hormonal methods or contraception; OR
    ii. Placement of an intrauterine device (IUD) or intrauterine system (IUS); OR
    iii. Barrier methods of contraception: condom or occlusive cap with spermicidal foam/gel/film/cream/suppository
    E.4Principal exclusion criteria
    1. On-going acute illness. Patients must not have needed an outpatient visit, hospitalisation or required any change in therapy for other pulmonary disease between screening and AV1.

    2. History of, or planned organ transplantation.

    3. Requirement for continuous (24 hour/day) oxygen supplementation.

    4. Concomitant administration of inhaled mannitol or hypertonic saline within 48 hours of Period 1, Day 1.

    5. Clinically significant abnormal findings on haematology or clinical chemistry. In addition, any value ≥ 3 x the upper limit of normal will exclude the patient from participating in the study.

    6. Patients unable to perform pulmonary function tests according to ATS criteria.

    7. Pregnant or breast-feeding women. A negative pregnancy test must be demonstrated in females of child-bearing potential at screening.

    8. Patients who have participated in any interventional clinical trial within the 28 days prior to AV1.

    9. Patients with documented or suspected, clinically significant, alcohol or drug abuse. The determination of clinical significance will be made by the study physician.

    10. Known allergies or intolerances to alginates.

    11. Any active malignant disease (with the exception of basal cell carcinoma; BCC).

    12. Any serious or active medical or psychiatric illness, which in the opinion of the investigator, would interfere with patient treatment, assessment or compliance with the protocol.

    13. Haemoptysis more than 60 mL at any time within 30 days before study drug administration.

    14. Patients for whom participation in this study will exceed the limits of total radiation exposure allowed in any 12 month period (5 mSv), or will exceed 10 mSv over any three year period.

    15. Male patients who are intending to father a child in the 3 months following the study or are unwilling to abstain from sexual intercourse with pregnant or lactating women. Female patients who are intending to become pregnant in the 3 months following the study.

    16. Patients who have any non-removable metal objects such as metal plates, screws etc in their head, neck, chest or abdominal area.

    17. As a result of a physical examination or screening investigations, the physician responsible considers the patient unfit for the study.
    E.5 End points
    E.5.1Primary end point(s)
    To qualitatively determine the deposition of radiolabelled OligoG in the lung.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Scintigraphic imaging will be performed at one timepoint only: immediately after dosing.
    E.5.2Secondary end point(s)
    To determine the radiolabel distribution pattern of the two formulations in the diseased lung, including calculating the ratio of radiolabel in the central airways compared to the peripheral region (C/P index).

    To characterise the extra-pulmonary deposition (i.e. oropharyngeal and stomach) of radiolabel including retention in the nebuliser or dry powder inhaler reservoir and deposition on the exhalation filter (if appropriate).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Scintigraphic imaging will be performed at one timepoint only: immediately after dosing.
    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 No
    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 Yes
    E.6.13.1Other scope of the trial description
    Scintigraphic respiratory study
    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
    Respiratory investigation study
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) Yes
    E.8.2.2Placebo No
    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 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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days23
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days23
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 12
    F.1.3Elderly (>=65 years) No
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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.4.2 For a multinational trial
    F.4.2.1In the EEA 12
    F.4.2.2In the whole clinical trial 12
    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)
    Not applicable.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Greater Glasgow Health Board
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-01-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-12-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-09-10
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