Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43855   clinical trials with a EudraCT protocol, of which   7284   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Once-Daily, Intranasal Administration of GW685698X Aqueous Nasal Spray 100mcg for 4 Weeks in Adult and Adolescent Subjects (12 years of age and older) with Vasomotor/Idiopathic Rhinitis

    Summary
    EudraCT number
    		 2004-004744-43
    Trial protocol
    		 NO   CZ   DE  
    Global end of trial date
    09 Feb 2006

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Apr 2016
    First version publication date
    22 Jul 2015
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    FFR30007
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline
    Sponsor organisation address
    980 Great West Road, Brentford, Middlesex, United Kingdom,
    Public contact
    GSK Response Center, GlaxoSmithKline, 1 866-435-7343,
    Scientific contact
    GSK Response Center, GlaxoSmithKline, 1 866-435-7343,
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    20 Apr 2006
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Feb 2006
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to compare the efficacy and safety of GW685698X 100 mcg once daily (QD) aqueous nasal spray with vehicle placebo nasal spray in adult and adolescent subjects (≥ 12 years of age) with vasomotor rhinitis (VMR)/idiopathic rhinitis (IR).
    Protection of trial subjects
    Not applicable
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    06 Jul 2005
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Czech Republic: 43
    Country: Number of subjects enrolled
    Germany: 68
    Country: Number of subjects enrolled
    Canada: 34
    Country: Number of subjects enrolled
    Romania: 28
    Country: Number of subjects enrolled
    United States: 174
    Worldwide total number of subjects
    347
    EEA total number of subjects
    139
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    11
    Adults (18-64 years)
    300
    From 65 to 84 years
    36
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Males and females >=12 years of age, diagnosed with vasomotor rhinitis (VMR) and meeting the symptom requirements entered a 7 to 14 days screening period. Following screening period, participants meeting specified symptom criteria received treatment of either fluticasone furoate or placebo in 1:1 ratio up to 4 weeks.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Participants were instructed to self administer two sprays of Placebo into each nostril once daily (QD) in the morning (AM), following pre-dose symptom assessment. Administration of the dose was performed by alternately spraying one spray to each nostril followed by a second spray to each nostril.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal spray, suspension
    Routes of administration
    Nasal use
    Dosage and administration details
    2 sprays of matching placebo once daily in the morning for 4 weeks

    Arm title
    		 Fluticasone furoate 110 µg QD
    Arm description
    		 Participants were instructed to self administer two sprays of fluticasone furoate 110 micrograms (µg) into each nostril once daily (QD) in the morning (AM), following pre-dose symptom assessment. Administration of the dose was performed by alternately spraying one spray to each nostril followed by a second spray to each nostril
    Arm type
    		 Experimental

    Investigational medicinal product name
    Fluticasone furoate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal spray, suspension
    Routes of administration
    Nasal use
    Dosage and administration details
    2 sprays of 110 µg once daily in the morning for 4 weeks

    Number of subjects in period 1
    		Placebo Fluticasone furoate 110 µg QD
    Started
    173
    174
    Completed
    168
    165
    Not completed
    5
    9
         Consent withdrawn by subject
    2
    5
         Adverse event, non-fatal
    1
    1
         'Patient took two different treatments '
    -
    1
         Lost to follow-up
    1
    2
         Protocol deviation
    1
    -

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants were instructed to self administer two sprays of Placebo into each nostril once daily (QD) in the morning (AM), following pre-dose symptom assessment. Administration of the dose was performed by alternately spraying one spray to each nostril followed by a second spray to each nostril.

    Reporting group title
    Fluticasone furoate 110 µg QD
    Reporting group description
    		 Participants were instructed to self administer two sprays of fluticasone furoate 110 micrograms (µg) into each nostril once daily (QD) in the morning (AM), following pre-dose symptom assessment. Administration of the dose was performed by alternately spraying one spray to each nostril followed by a second spray to each nostril

    Reporting group values
    		 Placebo Fluticasone furoate 110 µg QD Total
    Number of subjects
    		 173 174 347
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 44 ± 14.72 43.8 ± 15.44 -
    Gender categorical
    Units: Subjects
        Female
    		 108 124 232
        Male
    		 65 50 115
    Race
    Units: Subjects
        African American/African Heritage
    		 7 6 13
        Japanese/East Asian /South East Asian Heritage
    		 1 0 1
        White
    		 164 167 331
        American Indian or Alaska Native & White
    		 1 0 1
        Asian & White
    		 0 1 1

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants were instructed to self administer two sprays of Placebo into each nostril once daily (QD) in the morning (AM), following pre-dose symptom assessment. Administration of the dose was performed by alternately spraying one spray to each nostril followed by a second spray to each nostril.

    Reporting group title
    Fluticasone furoate 110 µg QD
    Reporting group description
    		 Participants were instructed to self administer two sprays of fluticasone furoate 110 micrograms (µg) into each nostril once daily (QD) in the morning (AM), following pre-dose symptom assessment. Administration of the dose was performed by alternately spraying one spray to each nostril followed by a second spray to each nostril

    Primary: Mean change from Baseline in daily reflective total nasal symptom scores (rTNSS)

    		 Close Top of page
    End point title
    		 Mean change from Baseline in daily reflective total nasal symptom scores (rTNSS)
    End point description
    The TNSS is the sum of the three individual symptom scores for rhinorrhoea, nasal congestion, and post-nasal drip where each symptom was scored on a scale of 0 (no symptoms) to 3 (severe symptoms). The rTNSS is a rating of the severity of symptoms over the previous 12 hours and was performed in the morning (AM rTNSS) and evening (PM rTNSS). The daily rTNSS is the average of the AM rTNSS and PM rTNSS assessments. The analysis method used for comparison of the two treatment groups was Analysis of Covariance adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.. The baseline daily rTNSS was defined as the average of the daily rTNSS over the 4 consecutive 24-hour periods prior to randomization, including the assessment on the morning of randomization.. Change from Baseline was calculated as the on-treatment value minus the Baseline. Intent-to-Treat population comprised of all participants who are randomized and received at least one dose of study drug.
    End point type
    Primary
    End point timeframe
    Baseline and up to Week 4
    End point values
    		 Placebo Fluticasone furoate 110 µg QD
    Number of subjects analysed
    172 [1]
    172 [2]
    Units: Score on a scale
        least squares mean (standard error)
    -2.11 ± 0.15
    -2.01 ± 0.15
    Notes
    [1] - Intent to Treat(ITT) population. Only participants present at the specified timepoint were analyzed.
    [2] - Intent to Treat(ITT) population. Only participants present at the specified timepoint were analyzed.
    Statistical analysis title
    		 Analysis 1
    Comparison groups
    Placebo v Fluticasone furoate 110 µg QD
    Number of subjects included in analysis
    344
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.604
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.094
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.26
         upper limit
    		 0.45

    Secondary: Mean change from Baseline in morning (AM) pre-dose instantaneous total nasal symptom scores (iTNSS)

    		 Close Top of page
    End point title
    		 Mean change from Baseline in morning (AM) pre-dose instantaneous total nasal symptom scores (iTNSS)
    End point description
    The AM pre-dose iTNSS is the sum of the three individual nasal symptom score assessments for rhinorrhoea, nasal congestion and postnasal drip performed immediately prior to taking the daily dose, where each symptom was scored on a scale of 0 to 3 for severity of symptoms. The analysis method used for comparison of the two treatment groups was Analysis of Covariance (ANCOVA) adjusting for baseline iTNSS, country, age, and gender, in addition to treatment effect. The baseline daily rTNSS was defined as the average of the daily rTNSS over the 4 consecutive 24-hour periods prior to randomization, including the assessment on the morning of randomization.. Change from Baseline was calculated as the on-treatment value minus the Baseline value.
    End point type
    Secondary
    End point timeframe
    Baseline and up to Week 4
    End point values
    		 Placebo Fluticasone furoate 110 µg QD
    Number of subjects analysed
    172 [3]
    172 [4]
    Units: Score on a scale
        least squares mean (standard error)
    -1.65 ± 0.14
    -1.59 ± 0.14
    Notes
    [3] - ITT population. Only participants available at the specified timepoint were analyzed.
    [4] - ITT population. Only participants available at the specified timepoint were analyzed.
    Statistical analysis title
    		 Analysis 2
    Comparison groups
    Placebo v Fluticasone furoate 110 µg QD
    Number of subjects included in analysis
    344
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.729
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.061
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.29
         upper limit
    		 0.41

    Secondary: Number of participants based on overall evaluation of response to therapy

    		 Close Top of page
    End point title
    		 Number of participants based on overall evaluation of response to therapy
    End point description
    Participants evaluated effectiveness of study medication for relieving non-allergic rhinitis symptoms over the entire treatment period. The overall evaluation of response to therapy was based on a 7-point categorical scale where the participants rate their perception of the change or lack of change in their VMR symptoms at the end of the study. The 7 categories were: significantly improved, moderately improved, mildly improved, no change, mildly worse, moderately worse, and significantly worse.
    End point type
    Secondary
    End point timeframe
    Week 4 (Day 29) or Early Withdrawal
    End point values
    		 Placebo Fluticasone furoate 110 µg QD
    Number of subjects analysed
    172 [5]
    171 [6]
    Units: Participants
        Significantly Improved
    20
    28
        Moderately Improved
    39
    41
        Mildly Improved
    42
    43
        No Change
    63
    50
        Mildly Worse
    3
    4
        Moderately Worse
    2
    3
        Significantly Worse
    3
    2
    Notes
    [5] - ITT Population. Only participants available at the specified time point were analyzed.
    [6] - ITT Population. Only participants available at the specified time point were analyzed.
    Statistical analysis title
    		 Analysis 1
    Comparison groups
    Placebo v Fluticasone furoate 110 µg QD
    Number of subjects included in analysis
    343
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.064 [7]
    Method
    		 Regression, Logistic
    Confidence interval
    Notes
    [7] - Overall evaluation of response to therapy was analyzed using logistic regression adjusting for age, gender, investigator, and treatment.

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from on or after the randomization date (Up to Day 34).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    8.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants were instructed to self administer two sprays of Placebo into each nostril QD in the AM, following pre-dose symptom assessment. Administration of the dose was performed by alternately spraying one spray to each nostril followed by a second spray to each nostril.

    Reporting group title
    Fluticasone furoate 110 µg QD
    Reporting group description
    		 Participants were instructed to self administer two sprays of fluticasone furoate 110 µg into each nostril QD in the AM, following pre-dose symptom assessment. Administration of the dose was performed by alternately spraying one spray to each nostril followed by a second spray to each nostril

    Serious adverse events
    		 Placebo Fluticasone furoate 110 µg QD
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 173 (0.00%)
    1 / 174 (0.57%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Renal and urinary disorders
    Nephrotic syndrome
         subjects affected / exposed
    0 / 173 (0.00%)
    1 / 174 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 Placebo Fluticasone furoate 110 µg QD
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    38 / 173 (21.97%)
    42 / 174 (24.14%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    16 / 173 (9.25%)
    14 / 174 (8.05%)
         occurrences all number
    24
    19
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 173 (0.00%)
    4 / 174 (2.30%)
         occurrences all number
    0
    5
    Respiratory, thoracic and mediastinal disorders
    Epistaxis
         subjects affected / exposed
    5 / 173 (2.89%)
    12 / 174 (6.90%)
         occurrences all number
    11
    12
    Pharyngolaryngeal pain
         subjects affected / exposed
    5 / 173 (2.89%)
    4 / 174 (2.30%)
         occurrences all number
    6
    4
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    4 / 173 (2.31%)
    1 / 174 (0.57%)
         occurrences all number
    6
    1
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    10 / 173 (5.78%)
    11 / 174 (6.32%)
         occurrences all number
    12
    14
    Upper respiratory tract infection
         subjects affected / exposed
    4 / 173 (2.31%)
    1 / 174 (0.57%)
         occurrences all number
    4
    1

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    03 Feb 2005
    This amendment is country specific and applies to Canada, Norway, Germany and Czech Republic. The primary purpose of this amendment is to clarify Section 5.2.1. Inclusion Criteria, #3, Age. The age of subjects for the above mentioned countries will be ≥ 18 years at Visit 2.
    13 Jun 2005
    1) delete the term ‘idiopathic rhinitis’ from the protocol 2) delete the phrase that VMR symptoms are worsened by respiratory irritants and amend the: 3) Trademarks not owned by GlaxoSmithKline table 4) Document number of the GW685698X Investigator’s Brochure 5) Introduction/Background 6) Rationale 7) Inclusion Criteria 8) Randomization Criteria 9) Exclusion Criteria 10) The organization of Section 6 11) Screening Period (Visit 1) section 12) ECG Procedure 13) Nasal Cytology section 14) Prohibited Medications 15) Medical Devices section 16) References 17) Time and Events Table 18) Vasomotor Rhinitis Questionnaire A Vasomotor Rhinitis Trigger Questionnaire has been added (Appendix 7). In addition, other minor protocol text clarifications were made.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, Contact us.
    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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Tue Apr 23 13:16:18 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA