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    The EU Clinical Trials Register currently displays   37700   clinical trials with a EudraCT protocol, of which   6177   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2005-001771-35
    Sponsor's Protocol Code Number:FFR104503
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-12-15
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2005-001771-35
    A.3Full title of the trial
    Randomized, Open Label, Active Controlled (Mometasone Furoate Aqueous Nasal Spray [Nasonex®] 200mcg QD), Parallel Group, Multi-Centre, 52-Week Study to Assess the Long Term Safety of GW685698X Aqueous Nasal Spray 100mcg QD via nasal Biopsy in Subjects ≥18 Years of Age with Perennial Allergic Rhinitis (PAR).
    A.4.1Sponsor's protocol code numberFFR104503
    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
    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.3.10 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.IMP: 2
    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 Information not present in EudraCT
    D.2.1.1.1Trade name Nasonex®
    D.2.1.1.2Name of the Marketing Authorisation holderSchering-Plough Corporation
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 nameNasonex®
    D.3.2Product code mometasone furoate aqueous nasal spray
    D.3.4Pharmaceutical form Nasal spray*
    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.3.10 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) 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 Information not present in EudraCT
    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
    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 this study is to determine effects to the nasal mucosa of PAR subjects after one year of continuous treatment with GW685698X aqueous nasal spray 100mcg QD compared to a mometasone furoate aqueous nasal spray (Nasonex®) 200mcg QD reference control group as determined by blinded morphological and immunocytochemical analyses of nasal biopsy specimens. A separate healthy (nonallergic) control group of approximately 25 subjects will not receive any treatment, but will undergo a nasal biopsy at baseline and after 12 months to assess biopsy sampling technique artifact and monitor the influence of environmental factors over 12 months. ICST assessments of mucociliary clearance will also be conducted in subjects at one selected investigational site to determine the effects, if any, of treatment on ciliary function.
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    Healthy (non-allergic) Control Inclusion Criteria
    A healthy (non-allergic) control subject will be eligible for inclusion in this study if all of the following criteria apply:
    1. Subject has provided an appropriately signed and dated informed consent.
    2. Subject is at least 18 years of age at Visit 1, either gender, and any ethnic group.
    3. Subject is willing, able and likely to attend study visits and comply with study procedures.
    4. Subject is able to read, comprehend, and record information in the native language of the country where the study is being conducted.

    PAR Subject Inclusion Criteria
    A PAR subject will be eligible for inclusion in this study only if all of the following criteria apply:
    1. Subject has provided an appropriately signed and dated informed consent.
    2. Subject must be at least 18 years of age at Visit 1, either gender, and any ethnic group.
    3. Female subjects of child-bearing potential must commit to 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 or progestin only)
    • Double barrier method – spermacide plus a mechanical barrier (e.g., spermacide plus a male condom or a spermacide and female diaphragm).
    • 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 and are not on one of the above acceptable methods of contraception 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).
    • Female subjects should not be enrolled if they plan to become pregnant during the time of study participation.
    • A serum pregnancy test will be done at the screening visit to confirm female subjects are not pregnant upon entry into the study.
    4. Subject must have a diagnosis and history of perennial allergic rhinitis (PAR) as follows:
    • Two year clinical history and treatment of PAR (written or verbal confirmation from the treating physician)
    • and,
    • Documented, positive skin test to an appropriate perennial allergen (animal dander, house dust mites, cockroaches and/or mold) or documented, positive in vitro test results for a specific IgE (such as RAST, PRIST) within the past 12 months prior to Visit 1 will be allowed. A positive skin test during Visit 1 will also be allowed. A positive skin test is defined as a wheal ≥3mm larger than the diluent control for prick testing.
    • Note: Subjects who meet the above criteria and who may also have seasonal allergic rhinitis (SAR) are eligible for randomization.
    5. Subject is treatable on an outpatient basis.
    6. Subject understands and is willing, able and likely to comply with study procedures and restrictions.
    7. Subject is able to read, comprehend, and record information in the native language of the country where the study is being conducted.
    E.4Principal exclusion criteria
    PAR Subject Exclusion Criteria
    A PAR subject will not be eligible for inclusion in this study if the subject:
    1. has a significant concomitant medical condition, defined as in the protocol:
    2. Use of corticosteroids, defined as:
    • Intranasal corticosteroid within four weeks prior to Visit 1.
    • Inhaled, oral, intramuscular, intravenous, ocular, and/or dermatological
    corticosteroid (with the exception of hydrocortisone cream/ointment, 1% or less)
    within eight weeks prior to Visit 1.
    3. currently uses or has a recent history (within the past 6 months) of using smoking
    products including cigarettes, cigars, and pipe or chewing tobacco.
    4. is hypersensitive to indigo carmine or saccharine if subject is at select site participating in the ICST assessment
    5. has positive or inconclusive pregnancy test or female who is breastfeeding
    6. is a participating investigator, sub-investigator, study co-ordinator, or employee of a participating investigator, or is an immediate family member of the aforementioned.

    PAR Subject Exclusion Criteria
    A PAR subject will not be eligible for inclusion in this study if the subject:
    1. has a significant concomitant medical condition, defined as in the protocol
    • 2. Use of corticosteroids, defined as:
    • Intranasal corticosteroid within four weeks prior to Visit 1.
    • Inhaled, oral, intramuscular, intravenous, ocular, and/or dermatological
    corticosteroid (with the exception of hydrocortisone cream/ointment, 1% or less)
    within eight weeks prior to Visit 1.
    3. Use of other allergy medications within the timeframe indicated relative to Visit 1
    • Intranasal cromolyn within 14 days prior to Visit 1
    acting prescription and OTC antihistamines, including ocular preparations
    and antihistamines contained in insomnia and 'nighttime' pain formulations
    taken for insomnia, within 3 days prior to Visit 1
    • Long-acting antihistamines: loratadine, desloratadine, fexofenadine, cetirizine
    within 10 days prior to Visit 1
    • Long-acting antihistamine: astemizole within 12 weeks prior to Visit 1
    • Intranasal antihistamines (e.g. azelastine) within 2 weeks prior to Visit 1
    • Oral or intranasal decongestants within 3 days of Visit 1
    • Intranasal, oral or inhaled anticholinergics within 3 days prior to Visit 1
    • Oral antileukotrienes within 3 days of Visit 1
    • Subcutaneous omalizumab within 5 months of Visit 1
    4. Use of other medications or treatments that may affect the signs and symptoms of
    allergic rhinitis
    • The anticipated need for the use of other intranasally administered medications
    or treatments (e.g., calcitonin-salmon, nasal irrigation solutions) as they will not
    be allowed after Visit 1.
    • 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)
    5. Immunotherapy
    • Immunotherapy patients may be enrolled in the study as long as the immunotherapy was not initiated within 30 days of Visit 1, the dose has remained fixed over the 30 days prior to Visit 1, and no significant changes are made in the dose, concentration or dilution for the duration of the study.
    6. Use of immunosuppressive medications 8 weeks prior to Visit 1 and during the study
    7. Use of any medications that significantly inhibit the cytochrome P450 subfamily enzyme CYP3A4, including ritonavir and ketoconazole
    8. Allergy/Intolerance
    • Known hypersensitivity to corticosteroids or any excipients in the nasal spray
    products
    • Known hypersensitivity to indigo carmine or saccharine if subject is at select
    site participating in the ICST assessment
    9. Clinical trial/experimental medication experience
    • Has recent exposure to any investigational study drug within 30 days of Visit 1
    • Any previous or concurrent participation in a study with GSK investigational
    study drug GW685698X.
    10. Positive or inconclusive pregnancy test or female who is breastfeeding
    • Has a positive or inconclusive pregnancy test at any visit
    11. 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.
    12. Current tobacco use
    • Subject currently uses or has a recent history (within the past 6 months) of using
    smoking products including cigarettes, cigars, and pipe or chewing tobacco.
    13. Findings of a clinically significant, abnormal ECG
    14. Findings of a clinically significant, abnormal clinical laboratory test
    E.5 End points
    E.5.1Primary end point(s)
    Quantitative and qualitative differences in the morphology and cytology of the nasal
    mucosa before and after treatment will be based on the following parameters:
    • epithelial thickness based on the ratio of cross sectional area to basement membranelength
    • percentage of intact ciliated epithelium
    • abundance of goblet cells
    • extent of inflammatory cell infiltration (eosinophils, basophils, dendritic cells) in the epithelial tissue and sub-epithelial tissue
    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 Information not present in EudraCT
    E.6.11Pharmacogenomic Yes
    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) 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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    control group of healthy volunteers (non-allergic) receiving no treatment.
    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.8.5The trial involves multiple Member States Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    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 years1
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months4
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    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) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Information not present in EudraCT
    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 2005-12-15. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 155
    F.4.2.2In the whole clinical trial 155
    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 Decision2005-10-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-09-05
    P. End of Trial
    P.End of Trial StatusCompleted
    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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