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    Summary
    EudraCT Number:2012-000741-12
    Sponsor's Protocol Code Number:HZA112776
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2012-03-08
    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
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2012-000741-12
    A.3Full title of the trial
    A Randomized, Double blind, Placebo controlled, Two-Way Crossover 7-day study to Investigate the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Repeat Dose Inhaled GW642444 25μg in Children aged 5-11 years with Persistent Asthma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to see if it is safe to give a new asthma reliever drug (called vilanterol) to 5 to 11 year old children with asthma
    A.3.2Name or abbreviated title of the trial where available
    Not Applicable
    A.4.1Sponsor's protocol code numberHZA112776
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/119/2011
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGlaxoSmithKline Research & Development 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 supportGlaxoSmithKline Research & Development Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithKline
    B.5.2Functional name of contact pointGSK Clinical Support Helpdesk
    B.5.3 Address:
    B.5.3.1Street AddressGlaxoSmithKline, Iron Bridge Road, Stockley Park
    B.5.3.2Town/ cityUxbridge, Middlesex
    B.5.3.3Post codeUB11 1BU
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44 20 8990 4466
    B.5.5Fax number+44208990 1234
    B.5.6E-mailGSKClinicalSupportHD@gsk.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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameVilanterol/GW642444
    D.3.2Product code GW642444
    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 INNVilanterol trifenatate
    D.3.9.1CAS number 503070-58-4
    D.3.9.2Current sponsor codeGW642444M (M suffix defines triphenylacetate salt)
    D.3.9.3Other descriptive nameVilanterol trifenatate
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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
    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
    Asthma
    E.1.1.1Medical condition in easily understood language
    Asthma: A medical condition where inflammation (redness and swelling) and constriction (tightening) of the airways is present in the lungs making it difficult to breath.
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level PT
    E.1.2Classification code 10003553
    E.1.2Term Asthma
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    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 safety and tolerability following administration of GW642444 25
    μg, via a novel dry powder inhaler, once-daily for 7 days in subjects aged 5–11
    years.
    E.2.2Secondary objectives of the trial
    • To characterise the pharmacokinetics of GW642444 25 μg, following administration
    via a novel dry powder inhaler, once-daily for 7 days in subjects aged 5–11 years.
    • To determine the effects of administration of GW642444 25 μg, via a novel dry powder inhaler, once-daily for 7 days on glucose and potassium in subjects aged 5–11 years.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male and pre-menarchial female subjects aged 5–11 years on the last planned
    treatment day are eligible for this study. Pre-menarchial females are defined as
    any female who has yet to begin menses and is considered Tanner Stage 2 or
    less.
    2. Diagnosis of asthma at least 6 months prior to screening.
    3. Patients must be controlled on their existing asthma treatment at Screening as
    defined by a Childhood Asthma Control Test score of >19 and PEF >75 %
    predicted.
    4. Subjects must be taking a stable regimen of fluticasone propionate (up to ≤200
    μg twice daily; no more than 400 μg total daily dose) or an equivalent
    corticosteroid and a short acting beta-agonist inhaler on an as-needed basis for at
    least 4 weeks prior to screening.
    5. Apart from asthma, eczema and rhinitis, subjects should be healthy and suffer
    from no other significant medical conditions.
    6. Subjects must weigh at least 15 kg.
    7. Subjects must demonstrate ability to accept and effectively use the GW642444
    device using the demonstration kits provided to the site.
    8. The subject and parent or guardian are able to understand and comply with
    protocol requirements, instructions, and protocol-stated restrictions. The parent
    or guardian must have the ability to read, write and record diary information
    collected throughout the study. The parent or guardian must also have the ability
    to manage study drug administration and PEF assessments.
    9. At least one parent or guardian has signed and dated the written informed
    consent prior to admission to the study. This will be accompanied by informed
    assent from the subject.
    E.4Principal exclusion criteria
    1. Subjects currently receiving (or have received within 4 weeks of screening) any of
    the following asthma therapies: theophyllines, long-acting inhaled beta-agonists, oral
    beta-agonist.
    2. Subjects who have changed their asthma medication within 4 weeks of screening.
    3. Clinical visual evidence of oral candidiasis at screening.
    4. Any clinically relevant abnormality identified on the screening medical assessment
    5. Any medical condition or circumstance making the subject unsuitable for
    participation in the study (e.g. history of life-threatening asthma)
    6. Asthma exacerbation requiring systemic corticosteroids (oral, intramuscular,
    intravenous) or Emergency Room attendance within 3 months or asthma
    exacerbation requiring hospitalization within 6 months prior to the screening visit.
    7. Culture-documented or suspected bacterial or viral infection of the upper or lower
    respiratory tract which is not resolved within 4 weeks of the screening visit.
    8. Any adverse reaction including immediate or delayed hypersensitivity to any betaagonist
    therapy.
    9. Known or suspected sensitivity to the constituents of the novel dry powder inhaler
    (i.e., lactose or magnesium stearate), for example, history of severe milk protein
    allergy.
    10. The parent or guardian has history of psychiatric disease, intellectual deficiency,
    substance abuse, or other condition (e.g., inability to read, comprehend or write)
    which will limit the validity of consent to participate in this study.
    11. A subject will not be eligible for this study if he/she is an immediate family member
    of the participating Investigator, sub-Investigator, study coordinator, or employee of
    the participating Investigator.
    12. Children who are wards of the state or government.
    13. Evidence of clinically significant abnormality in the 12-lead ECG at Screening, as
    follows:
    i. Ventricular rate <65 bpm or >115 bpm if aged 5–7 years.
    ii. Ventricular rate <55 bpm or >110bpm if aged 8–11 years.
    iii. PR interval >160 msec if aged 5–7 years.
    iv. PR interval >170 msec if aged 8–11 years.
    v. QRS >100 msec.
    vi. Evidence of Mobitz II second degree or third degree AV block.
    vii. Evidence of ≥2 unifocal ventricular ectopic beats, couplets, bigeminy,
    trigeminy or multifocal premature ventricular complexes.
    viii. QTc(B) >450 msec or an ECG that is not suitable for QT measurements
    (e.g. poor defined termination of the T wave).
    ix. Right or left complete bundle branch block.
    x. Clinically significant conduction abnormalities (e.g., left bundle branch
    block, Wolff-Parkinson-White syndrome).
    xi. Clinically significant arrhythmias (e.g. atrial fibrillation, atrial flutter,
    ventricular tachycardia).
    xii. Non-sustained ventricular tachycardia (3 or more consecutive ventricular
    beats greater than 100 bpm).
    E.5 End points
    E.5.1Primary end point(s)
    • Adverse events.
    • Clinical laboratory assessments (hematology, chemistry and urinalysis).
    • Peak expiratory flow on Days 1, 8 and 14.
    • Systolic Blood Pressure (BP).
    • Diastolic BP.
    • Heart rate at the following times:
    • Day 1 maximum and weighted mean at 0-2 h
    • Day 14 maximum and weighted mean at 0–2 h and 0-8 h.
    Electrocardiographic (ECG) parameters: QT duration corrected for Fridericia’s
    formula (QTcF) at the following times:
    • Day 1 weighted mean and peak response at 0-2 h
    • Day 14 weighted mean and peak response at 0–2 h and 0-8 h.
    E.5.1.1Timepoint(s) of evaluation of this end point
    •Adverse events from start of investigational product until follow up contact
    •Clinical laboratory assessments at screening and on Day 14
    •Peak expiratory flow at screening and on Days 1, 8, and 14 in the clinic; Days 9-13 at home.
    •Systolic and diastolic blood pressure at screening, and Days 1, 8, and 14
    •Heart rate and ECG at screening, and Days 1, 8 and 14
    E.5.2Secondary end point(s)
    • Pharmacokinetic parameters: maximum observed plasma GW642444 maximum
    observed concentration at steady-state (Cmaxss), area under the concentration-time
    curve (AUC)(0-t), AUC(0-8) and time of maximum observed concentration at steady
    state (Tmaxs) on Day14.
    • Glucose weighted mean 0–2 h and 0–8 h and maximum (0–2 h) and maximum (0–
    8 h) on Day 14.
    • Potassium weighted mean 0–2 h and 0–8 h and minimum (0–2 h) and minimum (0–
    8 h) on Day 14.
    E.5.2.1Timepoint(s) of evaluation of this end point
    •GW642444 on Day 14
    •Glucose and potassium 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 No
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Repeat dose
    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.8.2.4Number of treatment arms in the trial2
    E.8.3 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA Yes
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    United States
    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 Subject Last visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial days6
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 26
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 26
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    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 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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Children
    F.4 Planned number of subjects to be included
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 26
    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)
    Subjects will not receive any additional treatment after completion of the study because other treatment options are available.
    G. Investigator Networks to be involved in the Trial
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: United States
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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