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   43876   clinical trials with a EudraCT protocol, of which   7294   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 Comparison of Fluticasone Furoate Nasal Spray versus Oral Fexofenadine in the treatment of seasonal allergic rhinitis

    Summary
    EudraCT number
    		 2015-004873-34
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    18 Nov 2007

    Results information
    Results version number
    		 v1(current)
    This version publication date
    22 Jan 2017
    First version publication date
    22 Jan 2017
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    FFU109047
    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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    10 Jan 2008
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Nov 2007
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    TBD
    Protection of trial subjects
    Not applicable.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    10 Aug 2007
    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
    United States: 680
    Worldwide total number of subjects
    680
    EEA total number of subjects
    0
    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)
    82
    Adults (18-64 years)
    591
    From 65 to 84 years
    7
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Forty-two sites in the mid-western United States screened 1008 subjects for this study. Any subject assigned a subjects number but not randomised was considered a screening failure. Of the 1008 subjects, 328 subjects (33%) were screening failures.

    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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Subjects received vehicle placebo nasal spray and oral placebo capsule once daily for 2 weeks.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo Capsule
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Once daily for 2 weeks

    Investigational medicinal product name
    Placebo Nasal Spray
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal spray, suspension
    Routes of administration
    Nasal use
    Dosage and administration details
    Once daily for 2 weeks

    Arm title
    		 Fluticasone Furoate 110 mcg
    Arm description
    		 Subjects received Fluticasone Furoate nasal spray 110 microgram and oral placebo capsule administered once daily for 2 weeks.
    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
    110 microgram (mcg) once daily for 2 weeks

    Investigational medicinal product name
    Placebo Capsule
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Once daily for 2 weeks

    Arm title
    		 Fexofenadine 180 mg
    Arm description
    		 Subjects received overencapsulated fexofenadine 180mg oral tablet and vehicle placebo nasal spray once daily for 2 weeks.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Fexofenadine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    180 milligram (mg) once daily for 2 weeks

    Investigational medicinal product name
    Placebo Nasal Spray
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal spray, suspension
    Routes of administration
    Nasal use
    Dosage and administration details
    Once daily for 2 weeks

    Number of subjects in period 1
    		Placebo Fluticasone Furoate 110 mcg Fexofenadine 180 mg
    Started
    229
    224
    227
    Completed
    219
    209
    214
    Not completed
    10
    15
    13
         Randomized in error
    -
    1
    1
         Sponsor Terminated Study
    1
    -
    1
         Logpad compliance <80%
    1
    -
    -
         Non-compliance with eDiary
    4
    1
    1
         Consent withdrawn by subject
    1
    1
    2
         Subject unable to swallow capsule
    1
    -
    1
         Adverse event, non-fatal
    1
    2
    1
         Non-compliance
    -
    2
    2
         Subject in jail
    -
    1
    -
         Outside pollen area more than 48 hours
    -
    1
    -
         Declining pollen counts
    -
    1
    1
         Subject took disallowed drug
    -
    -
    1
         Protocol deviation
    1
    5
    2

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received vehicle placebo nasal spray and oral placebo capsule once daily for 2 weeks.

    Reporting group title
    Fluticasone Furoate 110 mcg
    Reporting group description
    		 Subjects received Fluticasone Furoate nasal spray 110 microgram and oral placebo capsule administered once daily for 2 weeks.

    Reporting group title
    Fexofenadine 180 mg
    Reporting group description
    		 Subjects received overencapsulated fexofenadine 180mg oral tablet and vehicle placebo nasal spray once daily for 2 weeks.

    Reporting group values
    		 Placebo Fluticasone Furoate 110 mcg Fexofenadine 180 mg Total
    Number of subjects
    		 229 224 227
    Age categorical
    Units: Subjects
    Age continuous
    Age continuous description
    Units: years
        arithmetic mean (standard deviation)
    		 34.8 ± 12.71 34 ± 13.55 34.3 ± 13.66 -
    Gender categorical
    Gender categorical description
    Units: Subjects
        Female
    		 139 152 135 426
        Male
    		 90 72 92 254
    Race/Ethnicity, Customized
    Units: Subjects
        White
    		 181 189 181 551
        African American
    		 40 29 42 111
        Other
    		 8 6 4 18

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received vehicle placebo nasal spray and oral placebo capsule once daily for 2 weeks.

    Reporting group title
    Fluticasone Furoate 110 mcg
    Reporting group description
    		 Subjects received Fluticasone Furoate nasal spray 110 microgram and oral placebo capsule administered once daily for 2 weeks.

    Reporting group title
    Fexofenadine 180 mg
    Reporting group description
    		 Subjects received overencapsulated fexofenadine 180mg oral tablet and vehicle placebo nasal spray once daily for 2 weeks.

    Primary: Mean Change from Baseline in the Nighttime Symptom Score (NSS)

    		 Close Top of page
    End point title
    		 Mean Change from Baseline in the Nighttime Symptom Score (NSS)
    End point description
    Questions include: 1. Nasal congestion on awakening (Score: 0=none, 1=mild, 2=moderate, 3=severe); 2. Difficulty going to sleep (Score: 0=not at all, 1=little, 2=moderately, 3=very); 3. Nighttime awakenings (Score: 0=not at all, 1=once, 2=more than once, 3=felt like awake all night). The sum of the ratings for the three items comprises the NSS. The Intent-to-Treat (ITT) population included all subjects randomized to double -blind treatment. This population formed the basis for all summaries of demographic, background, efficacy, and safety data.
    End point type
    Primary
    End point timeframe
    Baseline and Weeks 1-2
    End point values
    		 Placebo Fluticasone Furoate 110 mcg Fexofenadine 180 mg
    Number of subjects analysed
    228 [1]
    224 [2]
    226 [3]
    Units: Score on a Scale
        arithmetic mean (standard error)
    -2.3 ± 0.11
    -3.1 ± 0.12
    -2.2 ± 0.12
    Notes
    [1] - ITT population
    [2] - ITT population
    [3] - ITT population
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    The primary efficacy measure, mean change from baseline over the two-week treatment period in NSS compared between fluticasone furoate and fexofenadine, was assessed at a significance level of α=0.05. If the null hypothesis of this comparison was rejected, then the secondary measures were subject to hypothesis testing. The study was powered at 90%. Mean Difference = Mean Change in Fluticasone Furoate - Mean Change in Fexofenadine.
    Comparison groups
    Fluticasone Furoate 110 mcg v Fexofenadine 180 mg
    Number of subjects included in analysis
    450
    Analysis specification
    Pre-specified
    Analysis type
    		 other [4]
    P-value
    		 < 0.001 [5]
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    -0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.2
         upper limit
    		 -0.6
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.16
    Notes
    [4] - Symptom scores were grouped in 3 families: nasal, ocular, instantaneous. Within each family, results of hypothesis tests were adjusted using Hochberg’s method.
    [5] - Symptom scores were grouped in 3 families: nasal, ocular, instantaneous. Within each family, results of hypothesis tests were adjusted using Hochberg’s method.
    Statistical analysis title
    		 Statistical analysis 2
    Statistical analysis description
    Mean Difference = Mean Change in Fluticasone Furoate - Mean Change in Placebo
    Comparison groups
    Placebo v Fluticasone Furoate 110 mcg
    Number of subjects included in analysis
    452
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    -0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.1
         upper limit
    		 -0.4
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.16
    Statistical analysis title
    		 Statistical analysis 3
    Statistical analysis description
    Mean Difference = Mean Change in Fexofenadine - Mean Change in Placebo.
    Comparison groups
    Placebo v Fexofenadine 180 mg
    Number of subjects included in analysis
    454
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.374
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.2
         upper limit
    		 0.5
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.16

    Secondary: Mean Change from Baseline in Nighttime Reflective Total Nasal Symptom Score (N-rTNSS)

    		 Close Top of page
    End point title
    		 Mean Change from Baseline in Nighttime Reflective Total Nasal Symptom Score (N-rTNSS)
    End point description
    Subjects assessed four nasal symptoms (rhinorrhea, nasal congestion, nasal itching, and sneezing). The sum of the four nasal symptoms comprised the total nasal symptom score (TNSS). Reflective rating represented symptoms over preceding 12 hours. Scores: 0=symptoms not present, 1=mild severity, 2=moderate severity, 3=severe.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 1-2
    End point values
    		 Placebo Fluticasone Furoate 110 mcg Fexofenadine 180 mg
    Number of subjects analysed
    228 [6]
    224 [7]
    226 [8]
    Units: Score on a Scale
        arithmetic mean (standard error)
    -2.9 ± 0.15
    -4.1 ± 0.17
    -2.9 ± 0.16
    Notes
    [6] - ITT population
    [7] - ITT population
    [8] - ITT population
    No statistical analyses for this end point

    Secondary: Mean Change from Baseline in Daytime Reflective Total Nasal Symptom Score (D-rTNSS)

    		 Close Top of page
    End point title
    		 Mean Change from Baseline in Daytime Reflective Total Nasal Symptom Score (D-rTNSS)
    End point description
    Subjects assessed four nasal symptoms (rhinorrhea, nasal congestion, nasal itching, and sneezing). The sum of the four nasal symptoms comprised the total nasal symptom score. Reflective rating represented symptoms over preceding 12 hours. Scores: 0=symptoms not present, 1=mild severity, 2=moderate severity, 3=severe.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 1-2
    End point values
    		 Placebo Fluticasone Furoate 110 mcg Fexofenadine 180 mg
    Number of subjects analysed
    228 [9]
    224 [10]
    226 [11]
    Units: Score on a Scale
        arithmetic mean (standard error)
    -3 ± 0.15
    -4.2 ± 0.18
    -2.9 ± 0.16
    Notes
    [9] - ITT population
    [10] - ITT population
    [11] - ITT population
    No statistical analyses for this end point

    Secondary: Mean Change from Baseline in 24 Hour Reflective Total Nasal Symptom Score (24 Hour rTNSS)

    		 Close Top of page
    End point title
    		 Mean Change from Baseline in 24 Hour Reflective Total Nasal Symptom Score (24 Hour rTNSS)
    End point description
    Subjects assessed four nasal symptoms (rhinorrhea, nasal congestion, nasal itching, and sneezing). The sum of the four nasal symptoms comprised the total nasal symptom score. Reflective rating represented symptoms over preceding 12 hours. Scores: 0=symptoms not present, 1=mild severity, 2=moderate severity, 3=severe.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 1-2
    End point values
    		 Placebo Fluticasone Furoate 110 mcg Fexofenadine 180 mg
    Number of subjects analysed
    228 [12]
    224 [13]
    226 [14]
    Units: Score on a Scale
        arithmetic mean (standard error)
    -2.8 ± 0.14
    -4.1 ± 0.18
    -2.8 ± 0.16
    Notes
    [12] - ITT population
    [13] - ITT population
    [14] - ITT population
    No statistical analyses for this end point

    Secondary: Mean Change From Baseline in Nighttime Reflective Total Ocular Symptom Score (N-rTOSS)

    		 Close Top of page
    End point title
    		 Mean Change From Baseline in Nighttime Reflective Total Ocular Symptom Score (N-rTOSS)
    End point description
    Subjects assessed three ocular symptoms (itching/ burning eyes, tearing/watering eyes, and eye redness). The sum of the 3 ocular symptoms comprised the total ocular symptom score (TOSS). Reflective rating represented symptoms over preceding 12 hours. Scores: 0=symptoms not present, 1=mild severity, 2=moderate severity, 3=severe.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 1-2
    End point values
    		 Placebo Fluticasone Furoate 110 mcg Fexofenadine 180 mg
    Number of subjects analysed
    228 [15]
    224 [16]
    226 [17]
    Units: Score on a Scale
        arithmetic mean (standard error)
    -2.3 ± 0.13
    -2.7 ± 0.14
    -2.2 ± 0.13
    Notes
    [15] - ITT population
    [16] - ITT population
    [17] - ITT population
    No statistical analyses for this end point

    Secondary: Mean Change From Baseline in Daytime Reflective Total Ocular Symptom Score (D-rTOSS)

    		 Close Top of page
    End point title
    		 Mean Change From Baseline in Daytime Reflective Total Ocular Symptom Score (D-rTOSS)
    End point description
    Subjects assessed three ocular symptoms (itching/ burning eyes, tearing/watering eyes, and eye redness). The sum of the 3 ocular symptoms comprised the total ocular symptom score. Reflective rating represented symptoms over preceding 12 hours. Scores: 0=symptoms not present, 1=mild severity, 2=moderate severity, 3=severe.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 1-2
    End point values
    		 Placebo Fluticasone Furoate 110 mcg Fexofenadine 180 mg
    Number of subjects analysed
    228 [18]
    224 [19]
    226 [20]
    Units: Score on a Scale
        arithmetic mean (standard error)
    -2.5 ± 0.13
    -2.9 ± 0.14
    -2.4 ± 0.13
    Notes
    [18] - ITT population
    [19] - ITT population
    [20] - ITT population
    No statistical analyses for this end point

    Secondary: Mean Change From Baseline in 24 Hour Reflective Total Ocular Symptoms Score (rTOSS)

    		 Close Top of page
    End point title
    		 Mean Change From Baseline in 24 Hour Reflective Total Ocular Symptoms Score (rTOSS)
    End point description
    Subjects assessed three ocular symptoms (itching/ burning eyes, tearing/watering eyes, and eye redness). The sum of the 3 ocular symptoms comprised the total ocular symptom score. Reflective rating represented symptoms over preceding 12 hours. Scores: 0=symptoms not present, 1=mild severity, 2=moderate severity, 3=severe.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 1-2
    End point values
    		 Placebo Fluticasone Furoate 110 mcg Fexofenadine 180 mg
    Number of subjects analysed
    228 [21]
    224 [22]
    226 [23]
    Units: Score on a Scale
        arithmetic mean (standard error)
    -2.3 ± 0.13
    -2.7 ± 0.14
    -2.2 ± 0.13
    Notes
    [21] - ITT population
    [22] - ITT population
    [23] - ITT population
    No statistical analyses for this end point

    Secondary: Mean Change From Baseline in Pre-Dose Instantaneous Total Nasal Symptom Score (iTNSS)

    		 Close Top of page
    End point title
    		 Mean Change From Baseline in Pre-Dose Instantaneous Total Nasal Symptom Score (iTNSS)
    End point description
    Subjects assessed four nasal symptoms (rhinorrhea, nasal congestion, nasal itching, and sneezing). The sum of the four nasal symptoms comprised the total nasal symptom score. Instantaneous rating represented symptoms at the time of the assessment. Scores: 0=symptoms not present, 1=mild severity, 2=moderate severity, 3=severe.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 1-2
    End point values
    		 Placebo Fluticasone Furoate 110 mcg Fexofenadine 180 mg
    Number of subjects analysed
    228 [24]
    224 [25]
    226 [26]
    Units: Score on a Scale
        arithmetic mean (standard error)
    -2.8 ± 0.15
    -4.1 ± 0.18
    -2.7 ± 0.17
    Notes
    [24] - ITT population
    [25] - ITT population
    [26] - ITT population
    No statistical analyses for this end point

    Secondary: Mean Change From Baseline in Pre-Dose Instantaneous Total Ocular Symptom Score (iTOSS)

    		 Close Top of page
    End point title
    		 Mean Change From Baseline in Pre-Dose Instantaneous Total Ocular Symptom Score (iTOSS)
    End point description
    Subjects assessed three ocular symptoms (itching/ burning eyes, tearing/watering eyes, and eye redness). The sum of the three ocular symptoms comprised the total ocular Symptom score. Instantaneous rating represented symptoms at the time of the assessment. Scores: 0=symptoms not present, 1=mild severity, 2=moderate severity, 3=severe.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 1-2
    End point values
    		 Placebo Fluticasone Furoate 110 mcg Fexofenadine 180 mg
    Number of subjects analysed
    228 [27]
    224 [28]
    226 [29]
    Units: Score on a Scale
        arithmetic mean (standard error)
    -2.2 ± 0.13
    -2.7 ± 0.14
    -2.2 ± 0.14
    Notes
    [27] - ITT population
    [28] - ITT population
    [29] - ITT population
    No statistical analyses for this end point

    Secondary: Mean Change from Baseline in Morning Peak Nasal Inspiratory Flow (PNIF)

    		 Close Top of page
    End point title
    		 Mean Change from Baseline in Morning Peak Nasal Inspiratory Flow (PNIF)
    End point description
    Subjects used a portable hand-held inspiratory flow meter to measure and record PNIF in the morning prior to taking the study medication. Three measurements were taken and the highest measurement was recorded in the electronic diary. A positive change signifies improved nasal air flow. Two subjects in the placebo group & three in the Fluticasone Furoate Nasal Spray (FFNS) group recorded no data during the two-week treatment period.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 1-2
    End point values
    		 Placebo Fluticasone Furoate 110 mcg Fexofenadine 180 mg
    Number of subjects analysed
    226 [30]
    221 [31]
    226 [32]
    Units: Score on a Scale
        arithmetic mean (standard error)
    4.8 ± 1.27
    13 ± 1.61
    2.2 ± 1.21
    Notes
    [30] - ITT population
    [31] - ITT population
    [32] - ITT population
    No statistical analyses for this end point

    Secondary: Mean Change From Baseline in Evening Peak Nasal Inspiratory Flow (PNIF)

    		 Close Top of page
    End point title
    		 Mean Change From Baseline in Evening Peak Nasal Inspiratory Flow (PNIF)
    End point description
    Subjects used a portable hand-held inspiratory flow meter to measure and record PNIF in the evening. Three measurements were taken and the highest measurement was recorded in the electronic diary. A positive change signifies improved nasal air flow. Two subjects in the placebo group & two in the FFNS group recorded no data during the two-week treatment period.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 1-2
    End point values
    		 Placebo Fluticasone Furoate 110 mcg Fexofenadine 180 mg
    Number of subjects analysed
    226 [33]
    222 [34]
    226 [35]
    Units: Score on a Scale
        arithmetic mean (standard error)
    2.3 ± 1.38
    9.7 ± 1.73
    0.3 ± 1.37
    Notes
    [33] - ITT population
    [34] - ITT population
    [35] - ITT population
    No statistical analyses for this end point

    Secondary: Mean Change From Baseline at Day 15 for Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ)

    		 Close Top of page
    End point title
    		 Mean Change From Baseline at Day 15 for Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ)
    End point description
    Subjects completed the 16-item Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire to assess nocturnal rhinitis-related quality of life. The NRQLQ measures the functional problems most troublesome to patients with nocturnal allergy symptoms. Each question scored from 0-6 with higher scores indicating more nocturnal impairment. Ten placebo subjects, six FFNS subjects, and four fexofenadine subjects ha d no overall NRQLQ score at endpoint, indicating either a missing score for one or more of the NRQLQ domains, a missing baseline score , or both. One additional FFNS patient had no on-treatment NRQLQ data.
    End point type
    Secondary
    End point timeframe
    Baseline, Day 15 or if Early Withdrawal Day
    End point values
    		 Placebo Fluticasone Furoate 110 mcg Fexofenadine 180 mg
    Number of subjects analysed
    218 [36]
    217 [37]
    222 [38]
    Units: Score on a Scale
        arithmetic mean (standard error)
    -1.4 ± 0.09
    -2 ± 0.1
    -1.4 ± 0.1
    Notes
    [36] - ITT population
    [37] - ITT population
    [38] - ITT population
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    All AE data from the time of subject consent until the follow-up period (approximately 22 days) were collected.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    ​10.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received vehicle placebo nasal spray and oral placebo capsule once daily for 2 weeks.

    Reporting group title
    Fexofenadine 180 mg
    Reporting group description
    		 Subjects received overencapsulated fexofenadine 180mg oral tablet and vehicle placebo nasal spray once daily for 2 weeks.

    Reporting group title
    Fluticasone Furoate 110mcg
    Reporting group description
    		 Subjects received Fluticasone Furoate nasal spray 110 microgram and oral placebo capsule once daily for 2 weeks.

    Serious adverse events
    		 Placebo Fexofenadine 180 mg Fluticasone Furoate 110mcg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 229 (0.00%)
    1 / 227 (0.44%)
    0 / 224 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    Renal and urinary disorders
    Ureteric obstruction
         subjects affected / exposed
    0 / 229 (0.00%)
    1 / 227 (0.44%)
    0 / 224 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 3%
    Non-serious adverse events
    		 Placebo Fexofenadine 180 mg Fluticasone Furoate 110mcg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 229 (2.62%)
    9 / 227 (3.96%)
    10 / 224 (4.46%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    6 / 229 (2.62%)
    9 / 227 (3.96%)
    10 / 224 (4.46%)
         occurrences all number
    7
    13
    13

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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-Sat May 11 04:32:54 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA