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    Summary
    EudraCT Number:2007-005094-54
    Sponsor's Protocol Code Number:TPI ASM8-205
    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:2007-11-26
    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 number2007-005094-54
    A.3Full title of the trial
    A MULTICENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, CROSSOVER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF 14-DAY INHALED TPI ASM8 IN SUBJECTS WITH ASTHMA
    A.4.1Sponsor's protocol code numberTPI ASM8-205
    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 SponsorTopigen Pharmaceuticals Inc.
    B.1.3.4CountryCanada
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    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.3.2Product code TPI ASM8
    D.3.4Pharmaceutical form Nebuliser solution
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeTOP 004
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/V) percent weight/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeTOP 005
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/V) percent weight/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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) 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 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
    allergic asthma and allergen-induced asthma
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10001705
    E.1.2Term Allergic asthma
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10003638
    E.1.2Term Atopic 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 determine the efficacy and safety of multiple inhaled daily doses of TPI ASM8 in steroid-naïve asthmatic adults with atopy.
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Men and women 18 to 65 years of age; non-smoking, steroid-naive, (i.e.. those who are not currently on corticosteroid or those who have not taken any oral/ inhaled/ ophthalmic or injectable corticosteroid within 60 days prior to start of the study); and generally in good health;
    • Intermittent or persistent mild to moderate allergic asthma as defined by ATS/ ERS criteria ((American Thoracic Society Lung function testing, 1991);
    • History of episodic wheeze and shortness of breath;
    • Forced expiratory volume in 1 second (FEV1) at baseline at least 70% of the predicted value;
    • Able to comprehend and follow all required study procedures;
    • Willing and able to sign an REB/IEC-approved informed consent form;
    • Subjects must not be taking any other regular anti-asthmatic medication except for the short-acting B2-agonist bronchodilator (e.g. salbutamol/albuterol) on an as needed basis;
    • Positive 5’AMP challenge at baseline (AMP-PC20 ≤ 60 mg/mL);
    • Positive skin-prick test to at least one of common aeroallergens (including cat fur and dander, house dust mite, mixed grass pollen);
    • Positive allergen-induced early (fall equal to or greater than 20% in FEV1 at 0-3 hrs following allergen challenge) and late (fall in FEV1 equal to or greater than 15% at 3-7 hrs) airway response (Dual responders).
    E.4Principal exclusion criteria
    • Significant acute or chronic medical, neurologic, cardiovascular or psychiatric illness;
    • Known coagulopathy;
    • Asthma exacerbation or respiratory infection in the preceding 6 weeks;
    • Use of oral / injectable corticosteroids within the last 60 days or currently on any anti-asthmatic drugs, immunosuppressives, nonsteroidal anti-inflammatory drugs, or anticoagulants. (Intermittent doses of short-acting β2-agonist are allowed);
    • Investigational drug use within 30 days;
    • Any clinically significant abnormality on physical examination or on screening laboratory determinations;
    • A >20% fall in FEV1 or FVC with baseline saline in the first AMP challenge during the screening period (Day –14).
    • Blood draws of 100 mL or more within 45 days prior to enrolment in the study.
    • Ongoing use of tobacco products of any kind or previous usage within the past 12 months or past history of greater than or equal to 10 pack years
    • Pregnant or lactating women; women actively seeking pregnancy or who are unwilling to use adequate contraception.
    E.5 End points
    E.5.1Primary end point(s)
    1. Safety
    • Vital signs include heart rate (preferably taken after a 10-15 min rest), respiratory rate, blood pressure, supine and standing and body temperature (oral or tympanic). Weight (kg) and height (cm) will be measured only at screening.
    • Adverse Events (AEs) & Serious Adverse Events (SAEs):
    An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation subject who receives a pharmaceutical product at any dose, whether or not there is a causal relationship with the investigational treatment. An AE could therefore be any unfavourable or unintended sign (including abnormal laboratory findings), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. This definition includes intercurrent illnesses or injuries and exacerbation of pre-existing conditions. An unexpected AE is an AE not identified in nature, severity, or frequency in the current Investigator Brochure.
    An SAE is defined as any untoward medical occurrence that 1) results in death; 2) is life threatening (i.e., the subject was, in the opinion of the investigator, at immediate risk of death from the event as it occurred); 3) requires or prolongs hospitalization; 4) results in persistent or significant disability or incapacity (i.e., the event causes a substantial disruption of a person’s ability to conduct normal life functions); 5) is a congenital anomaly or birth defect in the offspring of the treated subject; and 6) is an important and significant medical event that, based upon appropriate medical judgment, may jeopardize the subject or may require medical or surgical intervention to prevent one of the other outcomes defining SAE.
    • Concomitant medications
    • Routine laboratory (haematology and chemistry), complement (Bb split product) and urinalysis, CRP
    • Total serum IgE level and immunogenicity profile
    • Single breath lung diffusion capacity (DLCO).

    2. Allergen-induced late airway response (LAR), maximum decrease in FEV1 (%) on Day 14.
    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 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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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.8.3 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 Yes
    E.8.5.1Number of sites anticipated in the EEA6
    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 years
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months7
    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 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.4.2 For a multinational trial
    F.4.2.1In the EEA 18
    F.4.2.2In the whole clinical trial 18
    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 Decision2008-01-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-01-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-09-08
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