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    Summary
    EudraCT Number:2005-005838-12
    Sponsor's Protocol Code Number:OC000459/004/05
    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:2006-01-30
    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 number2005-005838-12
    A.3Full title of the trial
    A PHASE II STUDY OF THE EFFICACY (AS ASSESSED BY BRONCHIAL ALLERGEN CHALLENGE) AND SAFETY OF OC000459 DOSED ORALLY (200mg BID WITH FOOD) IN SUBJECTS WITH ALLERGIC ASTHMA; IN A RANDOMISED, DOUBLE BLIND, TWO WAY BALANCED CROSSOVER COMPARING OC000459 WITH PLACEBO
    A.4.1Sponsor's protocol code numberOC000459/004/05
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorOxagen 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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameOC000459
    D.3.2Product code OC000459
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeOC000459
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Asthma
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10003553
    E.1.2Term Asthma
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the effect of OC000459 in comparison with placebo on fall in FEV1 during the late asthmatic response (LAR; 4-10 hours after allergen challenge) to inhaled allergen in subjects with allergic asthma.
    E.2.2Secondary objectives of the trial
    · To assess the safety (including lung function) of OC000459 in comparison with placebo in subjects with allergic asthma.
    · To assess the effect of OC000459 in comparison to placebo on the early asthmatic response (EAR; FEV1 0-2 hours after allergen challenge) to inhaled allergen
    · To assess the effect of OC000459 on sputum eosinophilia following inhaled allergen.
    · To assess the effect of OC000459 on exhaled NO pre- and post-allergen.
    · To assess the effect of OC000459 on hyper-responsiveness to methacholine post –allergen challenge.
    · To assess the effect of OC000459 on eosinophil shape change in blood and to relate these changes to plasma drug concentrations
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male subjects, or female subjects (not of childbearing potential; women who have had hysterectomies or are post menopausal by more than two years), any racial group.
    2. Aged 18-45 years inclusive.
    3. Known history of asthma (intermittent wheezing, cough, dyspnoea responsive to inhaled short acting beta agonists).
    4. FEV1 >65% of predicted on at least two occasions at screening.
    5. At the screening allergen challenge, a decrease in FEV1 of ≥20% in the early asthmatic reaction and of ≥15% in the LAR to allergen on 3 separate occasions between 4-10hrs post allergen, 2 of which must be consecutive.
    6. No steroid usage in the past 12 weeks.
    7. Able to comply with the protocol.
    8. Subjects with no clinically significant abnormal serum biochemistry, haematology and urine examination values at screening.
    9. Subjects with a negative urinary drugs of abuse and cotinine screen or carbon monoxide breath test, determined at screening.
    10. Subjects with negative HIV and Hepatitis B and C results determined at screening.
    11. Testing positive to skin prick challenge with at least one of the following allergens: house dust mite, pollen or cat hair within the previous 12 months.
    12. Subjects must have provided written informed consent to participate in the study.
    13. Non smokers for a minimum of 6 months; less than 10 pack year history.
    E.4Principal exclusion criteria
    1. A history of gastrointestinal disorder likely to influence drug absorption.
    2. Respiratory tract pathology other than allergic asthma.
    3. Lower respiratory tract infection within 4 weeks prior to an allergen challenge.
    4. Receipt of prescribed or OTC medication other than paracetamol or short acting inhaled beta agonists within 14 days of screening or of the first day of each dosing period.
    5. Receipt of short acting inhaled beta agonists within 8 hours of screening or of each study visit
    6. Intake of alcohol within 48 hours of screening or of the first day of each dosing period
    7. Intake of caffeine within 48 hours of screening or of each study visit
    8. Performing strenuous exercise within 48 hours of screening or of the first day of each dosing period
    9. Evidence of renal, hepatic, cardiovascular or metabolic dysfunction or any disorder requiring regular medication.
    10. A history of drug or alcohol abuse.
    11. Inability to give written informed consent and to comply with study procedures.
    12. Participation in a clinical trial of an unlicensed drug within the previous 12 weeks.
    13. Donation of 450 ml or more blood within the previous 12 weeks.
    14. A history of hypersensitivity and/or idiosyncrasy to any of the test compounds or excipients employed in this study.
    15. Any previous clinical trial involving the administration of OC000459.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint will be the diminution in the late asthmatic response to bronchial allergen challenge as measured by the AUC and the maximum of percentage reductions in FEV1 between 4 and 10 hours after allergen challenge.

    Secondary biological activity endpoints include the diminution of the early asthmatic response to bronchial allergen challenge measured by the AUC and the maximum of percentage reductions in FEV1 between 0 and 2 hours after allergen challenge, sputum eosinophilia after allergen challenge as measured by percentage of eosinophils and the number of cells per millilitre of sputum, the methacholine PC20 after allergen challenge and exhaled NO pre- and post-allergen.

    Safety endpoints will consist of adverse events, vital signs and clinical laboratory safety tests.
    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 Yes
    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.8.3 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 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
    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 months9
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months9
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) No
    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 Information not present in EudraCT
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 20
    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 Decision2006-02-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-03-30
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-10-26
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