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    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2007-006562-15
    Sponsor's Protocol Code Number:FFU111439
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-02-12
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2007-006562-15
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Once-Daily Intranasal Administration of Fluticasone Furoate Nasal Spray 110mcg in Adult and Adolescent Subjects 12 years of Age and Older with Perennial Allergic Rhinitis (PAR)
    A.4.1Sponsor's protocol code numberFFU111439
    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 Yes
    D.2.1.1.1Trade name AVAMYS 27.5 micrograms/spray (Nasal spray suspension)
    D.2.1.1.2Name of the Marketing Authorisation holderGLAXO group Ltd
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameAVAMYS 27.5 micrograms/spray (nasal spray suspension)
    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.3.8INN - Proposed INNFluticasone furoate
    D.3.9.1CAS number 397864-44-7
    D.3.9.2Current sponsor codeFFU111439
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number27.5
    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 No
    D.3.11.8Extractive medicinal product No
    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 Information not present in EudraCT
    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
    Perennial Allergic Rhinitis (PAR) in adults and children of 12 years and older.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10034382
    E.1.2Term Perennial allergic rhinitis
    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 is to compare the efficacy and safety of FFNS 110mcg QD with vehicle placebo nasal spray in subjects with PAR, 12 years of age and older.
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects eligible for enrollment in the study must meet all of the following criteria:
    1. 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.
    2. Outpatient
    • Subject is treatable on an outpatient basis.
    3. Age
    • >= 12 years at Visit 2
    • >= 18 years at Visit 1 for Russia and Germany
    4. Male or eligible female
    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 for all females of childbearing potential at Visits 1, 2, 5, and Visit 6/Early Withdrawal to determine if the subject is pregnant.
    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 azospermia) prior to the female subject’s entry into the study and is the sole sexual partner for that female subject,
    • Double barrier method–condom or occlusive cap (diaphragm or cervical /vault caps) plus spermicide,
    • Estrogenic vaginal ring
    5. 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 >=3mm 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 would include nasal congestion, rhinorrhea, nasal itching and sneezing, eye itching/burning, eye tearing/watering, and eye redness.
    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 for PAR and who also have a history of allergy to a seasonal pollen that will be present in their geographic area during study participation are NOT eligible for randomization.
    6. Environment
    • Subject must be symptomatic to appropriate perennial allergen (animal dander, house dust mites, cockroach, mold) and willing to maintain same environment throughout the study.
    7. Ability to comply with study procedures
    • Subject understands and is willing, able and likely to comply with study procedures and restrictions.
    8. Literate
    • Subject must be able to read, comprehend, and record information in English or native language.
    E.4Principal exclusion criteria
    1. 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). 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.
    • 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 [NAEPP, 2007; GINA, 2006], or very mild asthma (Canada) [Lemiére, 2004].
    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
    • 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
    2. Use of corticosteroids, defined as:
    • Intranasal corticosteroid within 4 weeks prior to Visit 1 (please view protocol for further information).
    3. 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 please view protocol.
    • Long-acting antihistamines within 10 days prior to Visit 1, please view protocol.
    • 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 (e.g., Sudafed)
    • Long-acting beta-agonists within 3 days prior to Visit 1 (e.g., SEREVENT™, Foradil), please view protocol for further information.
    • Subjects are not permitted to use any artificial tears, eyewashes/nasal irrigation solutions, homeopathic preparations, lubricants, sympathomimetic or vasoconstrictor preparations during the screening and treatment periods. No exclusion period prior to screening (Visit 1) is required for these treatments.
    4. Use of other medications that may affect allergic rhinitis or its symptoms: please view protocol.
    5. Use of immunosuppressive medications eight weeks prior to screening and during the study
    6. Immunotherapy: Immunotherapy patients may be enrolled in the study as long as the immunotherapy was not initiated within 30 days of Visit 1 and 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.
    7. Use of any medications that significantly alter the pharmacokinetics of fluticasone furoate, including ritonavir and ketoconazole
    8. Allergy/Intolerance
    • Known hypersensitivity to corticosteroids, or any excipients in the product
    9. Use of contact lenses
    10. Use of Nasal Continuous Positive Airway Pressure (C-PAP) device (mask or pillow)
    11. Clinical trial/experimental medication experience
    • Participation in a clinical trial within 12 months prior to Visit 1
    • Participation in a previous or current FFNS (GW685698X) clinical study
    12. Positive pregnancy test or female who is breastfeeding
    • Has a positive or inconclusive pregnancy test at Visit 1 or Visit 2
    13. 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.
    14. Current tobacco use: Please view protocol.
    15. Chickenpox or measles
    • A subject is not eligible if he/she currently has chickenpox or measles, or has been exposed to chickenpox or measles during the last three weeks and is non-immune. Please view protocol for further information.
    16. Findings of a clinically significant, abnormal electrocardiogram (ECG)
    17. 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 (rTNSS)
    The TNSS is equal to the sum of the four individual nasal symptom scores for rhinorrhea, nasal congestion, nasal itching and sneezing.
    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 Yes
    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 Yes
    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 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.8.3 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months2
    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.1.1.1In 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.1.2Adults (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 Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 No
    F.4 Planned number of subjects to be included
    F.4.1In the member state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 144
    F.4.2.2In the whole clinical trial 288
    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)
    There is no extension study associated wiht this protocol. No post-study treatment will be provided.
    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 Decision2008-04-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-04-02
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-06-30
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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