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    Summary
    EudraCT Number:2015-004888-37
    Sponsor's Protocol Code Number:FFR111158
    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 number2015-004888-37
    A.3Full title of the trial
    A Pilot, Randomised, Double-blind, Placebo-controlled, Parallel-group, Multicentre Study to Evaluate the Efficacy and Safety of Once-daily Intranasal Administration of Fluticasone Furoate Nasal Spray 110 mcg for 4 Weeks in Adults and Adolescents with Irritant (Non-Allergic) Rhinitis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and safety study for Fluticasone Furoate Nasal Spray in adults and adolescents with non-allergic rhinitis.
    A.4.1Sponsor's protocol code numberFFR111158
    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 and 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
    Irritant (non-allergic) rhinitis
    E.1.1.1Medical condition in easily understood language
    Irritant (non-allergic) rhinitis
    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
    To compare the efficacy and safety of fluticasone furoate nasal spray 110 mcg (FFNS) once daily with placebo nasal spray in subjects with irritant (non-allergic) rhinitis triggered predominantly by air pollution
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Informed consent: Subject is willing and able to provide consent to participate in the study. For subjects who are under 18 years of age, an appropriately signed and dated assent must be obtained from the parents or guardian.
    - Outpatient: Subject is treatable on an outpatient basis.
    - Age: 12 years of age or older at Visit 2.
    - Gender: Male or eligible female
    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:
    • Male partner who is sterile prior to the female subject's entry into the study and is the sole sexual partner for that female subject
    • Implants of levonorgestrel
    • Injectable progestogen
    • Oral contraceptive (either combined estrogen/progestin or progestin only)
    • Any intrauterine device (IUD) with a documented failure rate of less than 1% per year, or
    • 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).
    • Double barrier method - spermicide plus a mechanical barrier (e.g., spermicide plus a male condom or a spermicide and female diaphragm).
    Female subjects should not be enrolled if they plan to become pregnant during the time of study participation. A urine pregnancy test will be performed at the screening visit (Visit 1), the randomisation visit (Visit 2) and at the final visit (Visit 6 or Early Withdrawal).
    - Clinical history: Diagnosis or evidence of air pollution triggers as the predominant irritant trigger for their rhinitis symptoms to include ALL of the following:
    • A two year clinical history of irritant (non-allergic) rhinitis triggered predominantly by air pollution exposure (written or verbal confirmation) in the opinion of the investigator and evidence of symptoms such as rhinorrhea, nasal congestion and postnasal drip relating to concentration of air particulates, air quality and levels of exposure.
    • Based on the trigger questionnaire, subjects must indicate that air pollution is the predominant trigger that makes their rhinitis symptoms worse completed at Visit 1.
    • Negative skin test (by prick method) response to seasonal allergens (including tree, grass and weed pollens) and perennial allergens (including animal dander, house dust mites, cockroach and mould) relevant to the geographical area completed at Visit 1.
    A negative response for allergen skin prick testing is defined as a wheal <3 mm than the diluent control.
    • Positive response to a histamine skin test (prick method) completed at Visit 1.
    A positive response for histamine skin prick testing is defined as a wheal ≥3 mm larger than the diluent control.
    • Normal sinus radiograph (Waters view) to rule out sinusitis (presence of mucosal thickening of ≥6 mm at the point of maximal thickening or an air fluid level or opacification). The sinus radiograph will be scheduled at Visit 1.

    - 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 or native language.

    Randomization Criteria
    - Average of the last 8, reflective, total nasal symptom score (rTNSS) assessments (4 morning [AM] assessments, 4 evening [PM] assessments) over the four 24-hour periods prior to randomisation must be greater than/equal to 4.5.
    - Average of the last 8 reflective nasal symptom assessments for congestion (4 AM assessments, 4 PM assessments) over the four 24-hour periods prior to randomisation must be greater than/equal to 2.
    - A subject must have completed 80% of assessments on the screening symptom diary card.
    E.4Principal exclusion criteria
    • historical or current evidence of clinically significant uncontrolled disease of any body system (e.g., tuberculosis, psychological disorders, eczema). • 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 3 months
    • asthma, with the exception of mild intermittent asthma [Global Initiative for Asthma (GINA), 2006]. 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 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 a sinus radiograph (Waters view) done at Visit 1
    • current or history of glaucoma and/or current cataract or ocular herpes simplex
    • physical impairment that would affect the subject's ability to participate in the study
    • clinical evidence of a Candida infection of the nose or oropharynx
    • 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 or current use of cocaine
    • history of adrenal insufficiency
    • Chickenpox or measles within 3 weeks of Visit 1.- Use of corticosteroids, defined as:
    • Intranasal corticosteroid within 4 weeks prior to Visit 1.
    • Inhaled, oral, intramuscular, intravenous, ocular, and/or dermatological corticosteroid (with the exception of hydrocortisone cream/ointment, 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
    • Short-acting prescription and over the counter (OTC) antihistamines, including ocular preparations and antihistamines contained in insomnia and 'nighttime' pain formulations taken for insomnia, within 7 days prior to Visit 1
    • Long-acting antihistamines within 10 days prior to Visit 1: loratadine, desloratadine, fexofenadine, cetirizine
    • Long-acting antihistamine, astemizole, within 12 weeks prior to Visit 1
    • Intranasal antihistamines (e.g. Astelin) within 2 weeks prior to Visit 1
    • Oral or intranasal decongestants within 3 days prior to Visit 1
    • Intranasal, oral, or inhaled anticholinergics within 3 days prior to Visit 1
    • Oral antileukotrienes within 3 days prior to Visit 1
    • Subcutaneous omalizumab (Xolair) within 5 months of Visit 1
    • Use of any medications that significantly inhibit the cytochrome P450 subfamily enzyme CYP3A4, including ritonavir and ketoconazole.
    • Ocular antihistamines, artificial tears, eyewashes/nasal irrigation solutions, homeopathic preparations, lubricants, sympathomimetic or vasoconstrictor preparations during the screening or treatment periods. No exclusion period prior to screening (Visit 1) is required for these treatments.
    • Throat treatments (e.g., cough lozenges, throat sprays) during the screening and treatment periods.
    - Use of other medications that may affect irritant rhinitis or its symptoms
    • Chronic use of concomitant medications, such as tricyclic antidepressants, that would affect assessment of the effectiveness of the study drug.
    • Chronic use of long-acting beta-agonists (e.g., salmeterol).
    • Chronic use of other intranasally administered medications (e.g., calcitonin-salmon).
    • Use of face masks (e.g, general face masks that are used for protection from air pollution, and C-PAP face masks or pillows), saline nasal sprays and lavages, eye drops, and local, herbal and homeopathic treatments.
    - Chronic use of medications that could cause drug-induced rhinitis including:
    • ACE inhibitors, reserpine, guanethidine, methyldopa, hydralazine, beta-blockers, alpha-adrenoceptor antagonists (e.g., Prazosin), phentolamine, chlorpromazine, aspirin, and non-steroidal anti-inflammatory medications (NSAIDS).
    - Use of immunosuppressive medications 8 weeks prior to screening and during the study
    - Immunotherapy
    - Allergy/Intolerance
    • Known hypersensitivity to corticosteroids, - Clinical trial/experimental medication experience
    • Exposure to an investigational study drug within 30 days prior to Visit 1
    • Participation in a previous or current fluticasone furoate nasal spray (GW685698X) clinical study
    - Positive or inconclusive pregnancy test or female who is breastfeeding
    • Has a positive or inconclusive pregnancy test at Visit 1 or Visit 2
    - Tobacco use
    • Subjects who currently use or have smoking
    - Findings of a clinically significant, abnormal electrocardiogram (ECG)
    - Findings of a clinically significant laboratory abnormality
    E.5 End points
    E.5.1Primary end point(s)
    Mean change from baseline over the entire treatment period in daily reflective total nasal symptom scores (daily rTNSS)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 1-4 (on-going)
    E.5.2Secondary end point(s)
    Nasal Symptoms
    Mean change from baseline over the entire treatment period in morning (AM) pre-dose instantaneous total nasal
    symptom scores (AM predose iTNSS)
    Mean change from baseline over the entire treatment period in AM rTNSS
    Mean change from baseline over the entire treatment period in evening (PM) rTNSS
    Mean change from baseline over the entire treatment period in individual (1) daily reflective, (2) AM pre-dose
    instantaneous, (3) AM reflective, and (4) PM reflective nasal symptom scores for rhinorrhea, nasal congestion, and
    postnasal drip.
    Ocular Symptoms
    Mean change from baseline over the entire treatment period in the daily, reflective, total ocular symptom score
    (rTOSS).
    Mean change from baseline over the entire treatment period in AM, pre-dose, instantaneous, total ocular symptoms
    scores (iTOSS)
    Mean change from baseline over the entire treatment period in AM rTOSS
    Mean change from baseline over the entire treatment period in PM rTOSS
    Mean change from baseline over the entire treatment period in individual (1) daily reflective, (2) AM pre-dose
    instantaneous, (3) AM reflective, and (4) PM reflective nasal symptom scores for eyes itching/ burning, eye
    tearing/watering, eye redness
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 1-4 (on-going)
    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 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) 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 No
    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
    Thailand
    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 years0
    E.8.9.2In all countries concerned by the trial months11
    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: 3
    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: 3
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 99
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Paedatrics
    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 102
    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: Thailand
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