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    Summary
    EudraCT Number:2004-004749-17
    Sponsor's Protocol Code Number:FFR101747
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-07-10
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2004-004749-17
    A.3Full title of the trial
    A randomized, double-blind, placebo-controlled, 2-week crossover, knemometric
    assessment of the effect of once daily GW685698X Aqueous Nasal Spray 100 mcg
    on short term growth in children ages 6 - 11 years with seasonal and/or perennial
    allergic rhinitis
    A.4.1Sponsor's protocol code numberFFR101747
    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 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 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 Information not present in EudraCT
    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 nameGW685698X
    D.3.2Product code GW685698X
    D.3.4Pharmaceutical form Nasal spray, suspension
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPNasal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeGW685698
    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) 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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 placeboNasal spray, suspension
    D.8.4Route of administration of the placeboNasal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Seasonal and/or perennial allergic rhinitis
    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
    The primary objective of the study is to determine the effect on lower leg growth of
    treatment with 100 mcg of intranasal GW685698X aqueous nasal spray QD versus
    placebo nasal spray QD in children ages 6 to 11 years with seasonal allergic rhinitis
    (SAR) and/or perennial allergic rhinitis (PAR).
    E.2.2Secondary objectives of the trial
    None
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    A subject will be eligible for inclusion in this study only if all of the following criteria
    apply:

    • Pre-menarcheal female subjects who are 6 years to less than 11 years of age at
    the time of randomization
    • Male subjects who are 6 years to less than 12 years of age at the time of
    randomization
    • Tanner Stage 1
    • Documented clinical history of SAR or PAR of at least one year prior to study entry
    with (in the opinion of the investigator):
    - a current level of allergic rhinitis symptoms that warrant treatment with an
    intranasal corticosteroid and/or
    - expected symptoms during a majority of the study period
    Diagnosis must be confirmed by a positive skin test (by skin prick method) to an
    appropriate seasonal or perennial allergen within 12 months prior to Visit 1 or at
    Visit 1. A positive skin test is defined as a wheal > or equal to 3 mm larger than
    the diluent control for prick testing.
    In vitro tests for specific IgE (such as RAST, PRIST) will also be permitted as
    confirmation for a diagnosis of SAR or PAR if performed within the last 12 months
    or at Visit 1.
    • Normal current growth as reflected by baseline height within the 5th and 95th
    percentiles of normal for their age and gender as determined by stadiometry and
    Danish longitudinal standard charts
    • Subjects must be willing and able to comply with study procedures
    • Written informed consent must be provided by the parent or guardian
    E.4Principal exclusion criteria
    A subject will not be eligible for inclusion in this study if any of the following criteria
    apply:
    • History of abnormal growth or gross malnutrition
    • Findings of a clinically significant laboratory abnormality (Section 6.4.4)
    • History of any condition that may have substantially affected growth
    • Subjects with historical or current evidence of clinically significant, uncontrolled
    disease of any body system (in addition to allergic rhinitis), such as uncontrolled,
    epilepsy, active tuberculosis, attention deficit hyperactive disorder, psychological
    disorders or eczema, will not be eligible. Significant is defined as any disease that,
    in the opinion of the investigator, would put the safety of the subject at risk
    through study participation or which would confound the interpretation of the
    study results if the disease/condition exacerbated during the study
    • Any asthma other than mild, intermittent asthma controlled by short-acting, β-
    agonists [Global Initiative for Asthma (GINA) Guidelines, 2003]
    • Recent major surgery and/or trauma to the legs
    • Current or history of glaucoma and/or cataracts or ocular herpes simplex
    • History of adrenal insufficiency
    • Current or prior treatment with any medication that may have a potential for an
    ongoing effect on linear growth
    • Use of corticosteroids, defined as Any corticosteroid use by any route within 4
    weeks prior to Visit 1
    • Any nasal condition or deformity that would impair nasal breathing or deposition of
    medication (i.e., nasal polyps, marked septal deviation)
    • Physical impairment that would affect the subject’s ability to participate in the study
    • Documented evidence of acute or significant chronic sinusitis
    • Upper or lower respiratory or sinus infection during the 7 days before screening
    • Clinical evidence of a nasal or oropharyngeal Candida infection
    • Rhinitis medicamentosa
    • Severe dehydration
    • Use of any medications that significantly inhibit the cytochrome P450 subfamily
    enzyme CYP3A4, including ritonavir and ketoconazole
    • Subjects with known hypersensitivity to any excipients in the study medications
    • Previous clinical trial experience with GW685698X aqueous nasal spray
    • Exposure to clinical trial/experimental medication within 30 days of Visit 1
    • Affiliation with investigational site such that the subject is an immediate family
    member of any site personnel
    • Chickenpox or measles infections - A subject is not eligible if he/she currently has
    chickenpox or measles, or has been exposed to chickenpox or measles during the
    last 3 weeks and is non-immune.
    E.5 End points
    E.5.1Primary end point(s)
    The primary safety endpoint will be the mean growth velocity (mm/wk) in lower leg
    growth, as determined by knemometry, over a 2-week treatment period with intranasal GW685698X aqueous nasal spray versus a 2-week treatment with placebo nasal spray.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Information not present in EudraCT
    E.6.4Safety Yes
    E.6.5Efficacy Information not present in EudraCT
    E.6.6Pharmacokinetic Information not present in EudraCT
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Information not present in EudraCT
    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) Information not present in EudraCT
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) Information not present in EudraCT
    E.8 Design of the trial
    E.8.1Controlled Information not present in EudraCT
    E.8.1.1Randomised Yes
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Yes
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Yes
    E.8.2.3Other Information not present in EudraCT
    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 Information not present in EudraCT
    E.8.5The trial involves multiple Member States Information not present in EudraCT
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Information not present in EudraCT
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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 months3
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    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) Yes
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Information not present in EudraCT
    F.1.3Elderly (>=65 years) Information not present in EudraCT
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Information not present in EudraCT
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state56
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 56
    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 Decision2005-03-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-03-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2006-01-31
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