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    Summary
    EudraCT Number:2013-000582-36
    Sponsor's Protocol Code Number:BTA51-350-201
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2013-08-07
    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 number2013-000582-36
    A.3Full title of the trial
    A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Parallel-Arm Study to Investigate the Efficacy and Safety of Inhaled Laninamivir Octanoate TwinCaps® Dry Powder Inhaler in Adults with Symptomatic Influenza A or B Infection
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Parallel-Arm Study to Investigate the Efficacy and Safety of Inhaled Laninamivir Octanoate TwinCaps® Dry Powder Inhaler in Adults with Symptomatic Influenza A or B Infection
    A.4.1Sponsor's protocol code numberBTA51-350-201
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1139-1560
    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 SponsorBiota Scientific Management Pty Ltd.
    B.1.3.4CountryAustralia
    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 supportBiota Scientific Management Pty Ltd.
    B.4.2CountryAustralia
    B.4.1Name of organisation providing supportBiomedical Advanced Research and Development Authority, U.S. Department of Health and Human Services
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBiota Scientific Management Pty Ltd.
    B.5.2Functional name of contact pointClinical Operations
    B.5.3 Address:
    B.5.3.1Street Address10/585 Blackburn Rd
    B.5.3.2Town/ cityNotting Hill
    B.5.3.3Post code3168
    B.5.3.4CountryAustralia
    B.5.6E-mailinfo@biota.com.au
    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 nameLaninamivir octanoate TwinCaps® dry powder inhaler
    D.3.2Product code CS-8958
    D.3.4Pharmaceutical form Inhalation powder, pre-dispensed
    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 INNLANINAMIVIR OCTANOATE
    D.3.9.1CAS number S900005430
    D.3.9.2Current sponsor codeCS-8958
    D.3.9.3Other descriptive nameLANINAMIVIR OCTANOATE
    D.3.9.4EV Substance CodeSUB34944
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 Yes
    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
    D.8.3Pharmaceutical form of the placeboInhalation powder, pre-dispensed
    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
    Treatment of influenza caused by viruses type A and B
    E.1.1.1Medical condition in easily understood language
    The Flu
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10022002
    E.1.2Term Influenza A virus infection
    E.1.2System Organ Class 100000004862
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10022003
    E.1.2Term Influenza B virus infection
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the study is to evaluate the efficacy of two doses of inhaled laninamivir octanoate (40 and 80mg) delivered via TwinCaps® DPI in adults with symptomatic presumptive influenza A or B infection.
    E.2.2Secondary objectives of the trial
    -To evaluate the safety and tolerability of laninamivir octanoate
    -To evaluate the efficacy of laninamivir octanoate
    -To evaluate the quantitative changes in virus shedding
    -To investigate the development of resistance to laninamivir by phenotypic and genotypic analyses
    -To investigate the impact of treatment of influenza with laninamivir octanoate on quality of life
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Pharmacokinetic Sub-Study (Selected Sites Only)
    E.3Principal inclusion criteria
    1. Provide written informed consent
    2. Males or females aged 18–64 years, inclusive
    3. A female subject is eligible to enter the study if she meets following criteria:
    - not pregnant or breast feeding / lactating
    - females of non-childbearing potential (ie, women who had a hysterectomy, had both ovaries surgically removed or have current documentation of tubal ligation, or are postmenopausal which is defined as 1 year without menses)
    - females of child bearing potential must have a negative urine pregnancy test at screening
    - females of childbearing potential must agree to use adequate and highly effective methods of contraception throughout the study. Highly effective method of birth control is one of the following:
    Complete abstinence from intercourse from two weeks prior to Day 1 until 1 month after their last dose of study drug.
    Implants of levonorgestrel
    Injectable progesterone
    Intrauterine device (IUD)
    Oral contraceptives (either combined or progesterone only)
    Double barrier method: condom, cervical cap or diaphragm with spermicidal agent
    Transdermal contraceptive patch
    Male partner who is sterile prior to the female subject's entry into study and is the sole sexual partner for the female subject.
    4. Male subjects with female partners of childbearing potential must use adequate and highly effective methods of contraception such as double barrier method, from screening until 1 month after their last dose of study drug.
    5. Symptomatic presumptive influenza A or B infection defined as the presence of:
    a. a fever of ≥38.0 ºC (≥100.4 ºF) at the screening visit OR a history of fever within the 24 hours prior to the screening visit and has administered antipyretic(s) in the 6 hours prior to the screening visit
    b. AND
    c. ≥1 moderate systemic symptom (headache, feeling feverish, body
    aches and pains, and fatigue)
    AND
    d. ≥1 moderate respiratory symptom (cough, sore throat and nasal
    congestion)
    6. Onset of illness no more than 40 hours prior to randomization. Onset
    of illness is defined as the time, the first of any one of the following,
    occurred:
    a. time when the subjects' temperature was measured as elevated (≥
    38.0 °C (≥100.4 ºF)
    OR
    b. time when the subject first experienced at least one respiratory
    symptom (cough, sore throat and nasal congestion)
    OR
    c. time when the subject first experienced at least one systemic
    symptom (headache, feeling feverish, body aches and pains, and
    fatigue)
    E.4Principal exclusion criteria
    1. Use of antiviral treatment for influenza (e.g. zanamivir, oseltamivir, rimantadine, or amantadine) within 14 days prior to screening
    2. Received live attenuated or trivalent inactivated influenza virus
    vaccine in the previous 3 weeks
    3. History or presence of clinically significant pulmonary disease (e.g.,
    chronic obstructive pulmonary disease, cystic fibrosis, or bronchiectasis)
    or asthma
    4. History of congestive heart failure with symptoms consistent with New York Heart Association Class III or IV functional status (See Appendix A: ) within the past 12 months
    5. Presence of an immune compromised status due to chronic illness, organ transplantation or use of daily systemic immunosuppressants
    6. Presence of clinically significant signs of acute respiratory distress during screening
    7. Current use of inhaled medications (nasal or oral) or anticipated use
    8. Current or a history of acute or chronic renal impairment requiring hemodialysis and/or a known or calculated creatinine clearance (CLCR) of <60 mL/min
    9. Presence of clinically significant abnormalities on ECG at screening which, in the investigator's clinical judgment, may affect either the subject's ability to participate in the study or the study results
    10. History or presence of any clinical condition or evidence of organ dysfunction on examination which, in the opinion of the investigator, may affect either the subject's ability to participate in the study or the study results
    11. Currently hospitalized or any planned hospitalizations within 1 month following the last dose of study drug
    12. Current clinical evidence of otitis, bronchitis, sinusitis, pneumonia or active bacterial infection at any body site, that requires treatment with oral or parenteral antibiotics
    13. Documented or reported (known) history of hepatitis B, hepatitis C, TB or HIV infection
    14. Severe infection within 30 days prior to screening which required parenteral antibiotic use or hospitalization
    15. History of or known clinically significant liver disease
    16. History of, or current evidence of, abuse (in the investigator's opinion) of alcohol or any licit or illicit drug substance within the past 12 months
    17. History of adverse reaction or known hypersensitivity to lactose or neuraminidase inhibitors
    18. Received an investigational drug within 30 days prior to screening
    19. Subjects who in the opinion of the investigator are unable to independently complete study documentation e.g. Flu-iiQ™ or selfadminister laninamivir octanoate TwinCaps® DPI
    E.5 End points
    E.5.1Primary end point(s)
    The primary end point for this study is time to alleviation of influenza symptoms (cough, sore throat, nasal congestion, headache, body aches and pains, feeling feverish and fatigue) and fever for ≥24 hours.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The time of symptom alleviation is defined as the period from start of study drug to the start of the first 24 hour period (three
    consecutive measurements) in which the influenza symptoms are scored as mild or absent and fever is absent (<38.0°C/<100.4ºF).
    E.5.2Secondary end point(s)
    - Time to return to normal body temperature, defined as: temperature
    has returned to normal (<37.2 °C /99.0 ºF) for ≥24 hours
    - Time to alleviation of systemic influenza symptoms (headache, feeling
    feverish, body aches and pains, fatigue, neck pain, interrupted sleep and
    loss of appetite)
    - Time to alleviation of respiratory influenza symptoms (cough, sore
    throat and nasal congestion)
    - Flu-iiQ symptom domain scores; systemic symptoms, respiratory
    symptoms and all flu symptoms
    - Area under the curve (AUC) of the duration and severity of the mean all
    symptom score
    - Determination of dose-response relationship in influenza infected
    subjects
    - Determination of the incidence of secondary bacterial infections and
    the use antibiotics
    - Incidence of SAEs, AEs leading treatment discontinuation, clinically significant changes in haematology, biochemistry and urinalysis
    laboratory tests
    - Use of concomitant medications
    - Changes on clinical assessments; vital signs, ECGs, physical
    examinations and spirometry
    - Quantitative changes in virus shedding based on qRT-PCR and viral
    culture
    - Determination of the emergence of resistance to laninamivir by
    phenotypic and genotypic analyses
    - Quality of Life; impact on daily activities, impact on emotions and
    impact on others
    E.5.2.1Timepoint(s) of evaluation of this end point
    Days 3, 5, 8, 15, and 29.
    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 Yes
    E.8.1.6Cross over No
    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 trial3
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA81
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Belgium
    Bulgaria
    Canada
    Colombia
    Estonia
    France
    Germany
    Hungary
    Latvia
    Mexico
    Peru
    South Africa
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    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 years
    E.8.9.1In the Member State concerned months6
    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 months0
    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: 636
    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 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 state35
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 636
    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 Decision2013-08-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-11-04
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2014-05-13
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