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    Summary
    EudraCT Number:2015-004891-31
    Sponsor's Protocol Code Number:FFR110537
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2016-08-03
    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 number2015-004891-31
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter, Two-Year Study to Evaluate the Ocular Safety of Once-Daily, Fluticasone Furoate Nasal Spray 110mcg in Adults and Adolescents 12 Years of Age and Older with Perennial Allergic Rhinitis.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety evaluation of Once-Daily, Fluticasone Furoate Nasal Spray in Adults and Adolescents 12 Years of Age and Older with seasonal allergies.
    A.4.1Sponsor's protocol code numberFFR110537
    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 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
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithKline Research & Development Ltd
    B.5.2Functional name of contact pointGSK Clinical Support Help Desk
    B.5.3 Address:
    B.5.3.1Street AddressIron Bridge Road, Stockley Park West
    B.5.3.2Town/ cityUxbridge, Middlesex
    B.5.3.3Post codeUB11-1BT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+4408007839733
    B.5.6E-mailGSKClinicalSupportHD@gsk.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.1.1Trade name Veramyst,Avamys,Allermist
    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.3.4Pharmaceutical form
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPNasal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFLUTICASONE FUROATE
    D.3.9.1CAS number 397864-44-7
    D.3.9.2Current sponsor codeFLUTICASONE FUROATE
    D.3.9.4EV Substance CodeSUB26593
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.05
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Rhinitis, Allergic, Perennial
    E.1.1.1Medical condition in easily understood language
    Seasonal Allergies
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    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 objective of this study was to assess ocular safety in adult and adolescent Perennial Allergic Rhinitis (PAR) subjects (12 years of age and older) after two years of continuous treatment with FFNS 110mcg QD.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Informed consent
    •Subject has provided an appropriately signed and dated informed consent. An appropriately signed and dated assent must be obtained from the parents or guardian if the subject is a child under 18 years of age.
    - Outpatient
    •Subject is treatable on an outpatient basis.
    - Age
    •12 years of age and older at Visit 2
    - Male or eligible female
    Female subjects should not be enrolled if they plan to become pregnant during the time of study participation.
    To be eligible for entry into the study, females of childbearing potential must commit to the consistent and correct use of an acceptable method of birth control, as defined by the following:
    •Abstinence
    Females of childbearing potential who are not sexually active must commit to complete abstinence from intercourse for two weeks before exposure to the study drug, throughout the clinical trial, and for a period after the trial to account for elimination of the drug (minimum of six days).
    •Oral contraceptive (either combined estrogen/progestin or progestin only)
    •Injectable progestogen
    •Implants of levonorgestrel
    •Percutaneous contraceptive patches
    •Intrauterine device (IUD) or intrauterine system (IUS) with a documented failure rate of less than 1% per year,
    •Male partner who is sterile (vasectomy with documentation of azoospermia) prior to the female subject's entry into the study and is the sole sexual partner for that female subject, or
    •Double barrier method-condom or occlusive cap (diaphragm or cervical /vault caps) plus Spermicide,
    •Estrogenic vaginal ring.
    A urine pregnancy test will be done at the screening visit to confirm females of childbearing potential are not pregnant upon entry into the study. In addition, urine pregnancy tests will be done for all females of childbearing potential at each clinic visit.
    - Diagnosis of PAR to include:
    A positive skin test (by prick method) response to appropriate perennial allergen (house dust mites, animal dander, mold, or cockroach) within last 12 months prior to Visit 1 or at Visit 1.
    A positive skin test is defined as a wheal ³3mm larger than the diluent control for prick testing.
    •Two year medical history and past treatment of PAR (written or verbal confirmation) which includes perennial, i.e., year-round, symptoms. PAR symptoms could include nasal congestion, rhinorrhea, nasal itching and sneezing.
    In vitro tests for specific IgE (such as RAST, PRIST) will not be allowed for the diagnosis of PAR.
    NOTE: Subjects who meet the above criteria and who also may have seasonal allergic rhinitis (SAR) and/or perennial non-allergic rhinitis (PNAR) are eligible for randomization.
    - Environment
    •Subject must be symptomatic to appropriate perennial allergen (animal dander, house dust mites, cockroach, mold) and willing to maintain, as much as possible, the same environment throughout the study.
    - Ability to comply with study procedures
    Subject understands and is willing, able and likely to comply with study procedures and restrictions.
    - Literate
    Subject must be able to read, comprehend, and record information in English
    E.4Principal exclusion criteria
    - Significant concomitant medical conditions, defined as but not limited to:
    •A historical or current evidence of clinically significant uncontrolled disease of any body system (e.g., tuberculosis, psychological disorders, eczema).
    •History or current diagnosis of diabetes mellitus
    •Uncontrolled hypertension (i.e., systolic blood pressure ³ 140mm Hg or diastolic blood pressure ³ 90mm Hg)
    •A severe physical obstruction of the nose (e.g., deviated septum or nasal polyp) or nasal septal perforation that could affect the deposition of double blind intranasal study drug
    •Nasal (e.g., nasal septum) or ocular injury/surgery in the last 6 months (including LASIK eye surgery)
    •Asthma, with the exception of mild intermittent asthma
    NOTE: Subjects will be allowed to use short-acting inhaled beta2 agonists ONLY on an as needed basis.
    •Rhinitis medicamentosa
    •Bacterial or viral infection (e.g., common cold) of the eyes or upper respiratory tract within two weeks of Visit 1 or during the screening period
    •Documented evidence of acute or significant chronic sinusitis, as determined by the individual investigator
    •Current or history of glaucoma and/or ocular herpes simplex
    •Current cataract and/or previous history of cataract surgery
    •Physical impairment that would affect subject's ability to participate safely and fully in the study
    •Clinical evidence of a Candida infection of the nose
    •History of psychiatric disease, intellectual deficiency, poor motivation, substance abuse (including drug and alcohol) or other conditions that will limit the validity of informed consent or that would confound the interpretation of the study results
    •History of adrenal insufficiency
    •History of Hepatitis B or C
    - Use of corticosteroids, defined as:
    •Intranasal corticosteroid within 4 weeks prior to Visit 1 (e.g., VERAMYST, FLONASE™, Nasonex, Rhinocort).
    •Inhaled, oral, intramuscular, intravenous, ocular, and/or topical corticosteroids (with the exception of topical hydrocortisone, 1% or less, or equivalent) within 8 weeks prior to Visit 1.
    - Use of other allergy medications within the timeframe indicated relative to Visit 1
    •Intranasal or ocular cromolyn within 14 days prior to Visit 1 (e.g., Nasalcrom, Crolom)
    •Short-acting prescription and non-prescription antihistamines, including ocular preparations and antihistamines contained in insomnia and "night time" pain formulations, within 3 days prior to Visit 1 (e.g., Benadryl, Chlortrimeton, Dimetane, Tavist)
    •Long-acting antihistamines within 10 days prior to Visit 1 (e.g., Allegra, Claritin, Clarinex, Zyrtec).
    •Intranasal antihistamines (e.g., Astelin) within 2 weeks prior to Visit 1
    •Oral or intranasal decongestants within 3 days prior to Visit 1 (e.g., Sudafed)
    •Long-acting beta-agonists within 3 days prior to Visit 1 (e.g., SEREVENT™, Foradil)
    •Intranasal, oral, or inhaled anticholinergics within 3 days prior to Visit 1 (e.g., Atrovent)
    •Oral antileukotrienes within 3 days of Visit 1 (e.g., Singulair)
    •Subcutaneous omalizumab (Xolair) within 5 months of Visit 1
    •Use of other medications that may affect allergic rhinitis or its symptoms
    •Chronic use of concomitant medications, such as tricyclic antidepressants, that would affect assessment of the effectiveness of the study drug
    •Use of other intranasally administered medications (e.g., Miacalcin)
    - Use of immunosuppressive medications 8 weeks prior to screening and during the study
    - Immunotherapy
    Immunotherapy patients may be enrolled in the study if the immunotherapy was not initiated within 30 days of Visit 1, if the dose has remained fixed over the 30 days prior to Visit 1, and the dose will remain fixed for the duration of the study.
    - Use of any medications that significantly alter the pharmacokinetics of fluticasone furoate (ritonavir and ketoconazole)
    - Use of chronic treatment with agents known to promote the development of cataracts (e.g., potassium-sparing diuretics and allopurinol)
    - Allergy/Intolerance
    •Known hypersensitivity to corticosteroids or any excipients
    - Clinical trial/experimental medication experience
    •Has recent exposure to an investigational study drug within 30 days of Visit 1
    •Participation in a previous or current FFNS (GW685698X) clinical study
    - Positive urine pregnancy test or female who is breastfeeding
    •Has a positive or inconclusive pregnancy test at Visit 1 or Visit 2
    - Affiliation with investigational site
    •Subject is a participating investigator, sub-investigator, study co-ordinator, or employee of a participating investigator, or is an immediate family member of the aforementioned.
    - Tobacco use
    •Smoking or smoker in past 6 months
    - Chickenpox or measles
    - Findings of a clinically significant, abnormal ECG
    - Findings of a clinically significant laboratory abnormality
    E.5 End points
    E.5.1Primary end point(s)
    • Time to first occurrence of an event for LOCS III posterior subcapsular opacity (P). An event for P was
    defined as an increase of 0.3 or greater from baseline in LOCS III grade for P, in either eye.
    • Time to first occurrence of an event for IOP. An event for IOP was defined as an increase of 7mm Hg or
    greater from baseline in IOP, in either eye, using Goldmann Applanation Tonometry.
    E.5.1.1Timepoint(s) of evaluation of this end point
    104 weeks
    E.5.2Secondary end point(s)
    • Change from baseline in LogMAR (Logarithm of the Minimum Angle of Resolution) visual acuity using Early
    Treatment Diabetic Retinopathy Study (ETDRS) charts
    • Change from baseline in LOCS III parameters [nuclear opalescence (NO), nuclear color (NC), cortical
    opacity (C), and P]
    • Change from baseline in IOP
    • Change from baseline in horizontal cup-to-disc ratio.
    E.5.2.1Timepoint(s) of evaluation of this end point
    104 weeks
    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 No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months8
    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 Yes
    F.1.1Number of subjects for this age range: 66
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 66
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 459
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 23
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2016-08-03. Yes
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Paediatrics
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 550
    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
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: United States
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