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   43862   clinical trials with a EudraCT protocol, of which   7285   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 multicentre, randomised, double-blind, double dummy, parallel group study to compare the salmeterol/fluticasone propionate combination (SERETIDE™) at a dose of 50/100mcg twice daily and fluticasone propionate (FLIXOTIDE™) at a dose of 200mcg twice daily, both delivered via a dry powder inhaler (DISKUS™) for 12 weeks in asthma in children aged 4-11 years not controlled by inhaled corticosteroids alone at medium dose

    Summary
    EudraCT number
    		 2005-002949-40
    Trial protocol
    		 LT   NO   ES   SE   LV   BE   IT   DK  
    Global end of trial date
    26 Oct 2006

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

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    SAM104926
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00353873
    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
    08 Jan 2007
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Oct 2006
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of this study is to compare salmeterol/fluticasone propionate 50/100mcg bd with fluticasone propionate (FP) 200mcg bd on lung function in subjects that are not controlled when previously treated at medium daily doses of inhaled corticosteroids alone.
    Protection of trial subjects
    All subjects were randomized to active treatment. Oral corticosteroid use was permitted to treat asthma exacerbations should they have occurred during the study. The protocol advised that subjects should contact the investigator/primary physician should they experience worsening asthma during the study. No blood draws were required for this study.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    18 Nov 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
    Sweden: 6
    Country: Number of subjects enrolled
    Belgium: 13
    Country: Number of subjects enrolled
    Denmark: 24
    Country: Number of subjects enrolled
    France: 189
    Country: Number of subjects enrolled
    Italy: 33
    Country: Number of subjects enrolled
    Latvia: 38
    Country: Number of subjects enrolled
    Norway: 6
    Country: Number of subjects enrolled
    Spain: 8
    Country: Number of subjects enrolled
    Lithuania: 46
    Country: Number of subjects enrolled
    Netherlands: 34
    Country: Number of subjects enrolled
    Poland: 66
    Country: Number of subjects enrolled
    Russian Federation: 121
    Worldwide total number of subjects
    584
    EEA total number of subjects
    463
    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)
    584
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 584 participants were screened and entered into a 4-week run-in period receiving fluticasone propionate (FP) 100 microgram (µg) dry powder inhaler (DISKUS) twice daily (BD) and inhaled salbutamol (sal) as required. The number of participants randomized was 321, and 303 participants received investigational product post randomization.

    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
    		 Fluticasone Propionate 200 µg BD
    Arm description
    		 Participants received one inhalation from dry powder inhaler A (FP 100 µg) and dry powder inhaler B (FP 100 µg) twice-daily, in the morning and evening for 12 weeks. Participants were provided salbutamol 100 µg per actuation metered dose inhaler (MDI) to be used as needed throughout the study, for prevention of exercise induced asthma and symptomatic relief from asthma symptoms.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Fluticasone propionate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder, pre-dispensed
    Routes of administration
    Inhalation use
    Dosage and administration details
    200 μg twice daily

    Arm title
    		 Salmeterol/Fluticasone Propionate 50/100 µg BD
    Arm description
    		 Participants received one inhalation from dry powder inhaler A (salmeterol/fluticasone propionate [SFC] 50/100 µg) and dry powder inhaler B (placebo for FP 100 µg) twice-daily, in the morning and evening for 12 weeks. Participants were provided salbutamol 100 µg per actuation MDI to be used as needed throughout the study, for prevention of exercise induced asthma and symptomatic relief from asthma symptoms.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Salmeterol/fluticasone propionate combination
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder, pre-dispensed
    Routes of administration
    Inhalation use
    Dosage and administration details
    50/100 μg twice daily

    Number of subjects in period 1 [1]
    		Fluticasone Propionate 200 µg BD Salmeterol/Fluticasone Propionate 50/100 µg BD
    Started
    153
    150
    Completed
    147
    147
    Not completed
    6
    3
         Consent withdrawn by subject
    1
    1
         Adverse event, non-fatal
    1
    -
         Decision of Principal Investigator
    2
    -
         Exacerbation
    1
    -
         Protocol deviation
    1
    2
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: A total of 584 participants were screened and entered into a 4-week run-in period receiving fluticasone propionate (FP) 100 microgram (µg) dry powder inhaler (DISKUS) twice daily (BD) and inhaled salbutamol as required. The number of participants randomized was 321, and 303 participants received investigational product post randomization. These 303 participants are reported to be in the baseline period.

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Fluticasone Propionate 200 µg BD
    Reporting group description
    		 Participants received one inhalation from dry powder inhaler A (FP 100 µg) and dry powder inhaler B (FP 100 µg) twice-daily, in the morning and evening for 12 weeks. Participants were provided salbutamol 100 µg per actuation metered dose inhaler (MDI) to be used as needed throughout the study, for prevention of exercise induced asthma and symptomatic relief from asthma symptoms.

    Reporting group title
    Salmeterol/Fluticasone Propionate 50/100 µg BD
    Reporting group description
    		 Participants received one inhalation from dry powder inhaler A (salmeterol/fluticasone propionate [SFC] 50/100 µg) and dry powder inhaler B (placebo for FP 100 µg) twice-daily, in the morning and evening for 12 weeks. Participants were provided salbutamol 100 µg per actuation MDI to be used as needed throughout the study, for prevention of exercise induced asthma and symptomatic relief from asthma symptoms.

    Reporting group values
    		 Fluticasone Propionate 200 µg BD Salmeterol/Fluticasone Propionate 50/100 µg BD Total
    Number of subjects
    		 153 150 303
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 8 ± 2.01 8.1 ± 2 -
    Gender categorical
    Units: Subjects
        Female
    		 55 53 108
        Male
    		 98 97 195
    Race, Customized
    Units: Subjects
        African American/African Heritage
    		 3 2 5
        White - Arabic/North African Heritage
    		 4 4 8
        White - White/Caucasian/European Heritage
    		 146 144 290

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Fluticasone Propionate 200 µg BD
    Reporting group description
    		 Participants received one inhalation from dry powder inhaler A (FP 100 µg) and dry powder inhaler B (FP 100 µg) twice-daily, in the morning and evening for 12 weeks. Participants were provided salbutamol 100 µg per actuation metered dose inhaler (MDI) to be used as needed throughout the study, for prevention of exercise induced asthma and symptomatic relief from asthma symptoms.

    Reporting group title
    Salmeterol/Fluticasone Propionate 50/100 µg BD
    Reporting group description
    		 Participants received one inhalation from dry powder inhaler A (salmeterol/fluticasone propionate [SFC] 50/100 µg) and dry powder inhaler B (placebo for FP 100 µg) twice-daily, in the morning and evening for 12 weeks. Participants were provided salbutamol 100 µg per actuation MDI to be used as needed throughout the study, for prevention of exercise induced asthma and symptomatic relief from asthma symptoms.

    Primary: Mean Change from Baseline in Morning Peak Expiratory Flow (PEF) Over 12 weeks in Intent-to-treat (ITT) population

    		 Close Top of page
    End point title
    		 Mean Change from Baseline in Morning Peak Expiratory Flow (PEF) Over 12 weeks in Intent-to-treat (ITT) population
    End point description
    PEF is the maximum flow generated during expiration, as measured with a peak flow meter and recorded in electronic diary record card (eDRC), performed with maximal force and started after a full inspiration. The mean morning PEF measurement was constructed by calculating a simple mean for each participant over the interval Weeks 1 to 12. All PEF measurements were converted to the Wright/McKerow peak flow meter scale for the purposes of analyses. The change from baseline is then calculated by subtracting the baseline PEF values from the individual on-treatment values. Baseline was calculated as the mean of the values recorded on the seven days preceding randomization. The analysis was done using analysis of covariance (ANCOVA) adjusted for baseline PEF, country amalgamation, age, sex and treatment. ITT Population: all participants randomized to treatment who received at least one dose of randomized study medication.
    End point type
    Primary
    End point timeframe
    Baseline; Week 1 up to Week 12
    End point values
    		 Fluticasone Propionate 200 µg BD Salmeterol/Fluticasone Propionate 50/100 µg BD
    Number of subjects analysed
    152 [1]
    150 [2]
    Units: Liters/Minute (L/min)
        least squares mean (standard error)
    19.3 ± 2.12
    26.9 ± 2.13
    Notes
    [1] - ITT Population. Only participants with analyzable data at the indicated time point were assessed.
    [2] - ITT Population. Only participants with analyzable data at the indicated time point were assessed.
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Fluticasone Propionate 200 µg BD v Salmeterol/Fluticasone Propionate 50/100 µg BD
    Number of subjects included in analysis
    302
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [3]
    P-value
    		 = 0.012
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    7.6
    Confidence interval
         level
    		 95%
         sides
    1-sided
         lower limit
    		 1.7
         upper limit
    		 -
    Notes
    [3] - Non-inferiority was tested using a one-sided significance level of 2.5%. If the lower confidence interval for the difference SFC-FP falls above -12 L/min the once daily SFC treatment combination was deemed to be statistically non-inferior. In the event that the lower confidence limit (2.5% 1-sided significance) exceeded 0, and using a separate closed testing procedure, superiority could be established.

    Primary: Mean Change from Baseline in Morning PEF Over 12 weeks in Per Protocol (PP) population

    		 Close Top of page
    End point title
    		 Mean Change from Baseline in Morning PEF Over 12 weeks in Per Protocol (PP) population
    End point description
    PEF is the maximum flow generated during expiration, as measured with a peak flow meter and recorded in eDRC, performed with maximal force and started after a full inspiration. The mean morning PEF measurement was constructed by calculating a simple mean for each participant over the interval Weeks 1 to 12. All PEF measurements were converted to the Wright/McKerow peak flow meter scale for the purposes of analyses. The change from baseline is then calculated by subtracting the baseline PEF values from the individual on-treatment values. Baseline was calculated as the mean of the values recorded on the seven days preceding randomization. The analysis was done using ANCOVA adjusted for baseline PEF, country amalgamation, age, sex and treatment. PP population: all participants in the ITT Population who did not have any protocol violations which could impact treatment effect.
    End point type
    Primary
    End point timeframe
    Baseline; Week 1 up to Week 12
    End point values
    		 Fluticasone Propionate 200 µg BD Salmeterol/Fluticasone Propionate 50/100 µg BD
    Number of subjects analysed
    135 [4]
    127 [5]
    Units: Liters/Minute
        least squares mean (standard error)
    18.4 ± 2.14
    27.7 ± 2.21
    Notes
    [4] - PP Population. Only participants with analyzable data at the indicated time point were assessed.
    [5] - PP Population. Only participants with analyzable data at the indicated time point were assessed.
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Fluticasone Propionate 200 µg BD v Salmeterol/Fluticasone Propionate 50/100 µg BD
    Number of subjects included in analysis
    262
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [6]
    P-value
    		 = 0.003
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    9.3
    Confidence interval
         level
    		 95%
         sides
    1-sided
         lower limit
    		 3.2
         upper limit
    		 -
    Notes
    [6] - Non-inferiority was tested using a one-sided significance level of 2.5%. If the lower confidence interval for the difference SFC-FP falls above -12 L/min the once daily SFC treatment combination was deemed to be statistically non-inferior. In the event that the lower confidence limit (2.5% 1-sided significance) exceeded 0, and using a separate closed testing procedure, superiority could be established.

    Secondary: Number of Participants who Achieved 'Totally Controlled' Asthma

    		 Close Top of page
    End point title
    		 Number of Participants who Achieved 'Totally Controlled' Asthma
    End point description
    Totally Controlled (TC) asthma is defined as no daily symptoms, no night-time wakening due to asthma, no exacerbations, no rescue sal/albuterol use, no emergency visits, >=80% predicted morning PEF, and no treatment related adverse events enforcing a change in asthma therapy over 7 consecutive days. Number of participants/group who achieved the status of at least TC during the last 8 weeks (wks) of treatment was analysed using logistic regression, including covariates for sex, age, treatment group, country amalgamation and baseline pre-bronchodilator forced expiratory volume in one second(FEV1). Asthma control was assessed each week for the last 8 wks of treatment period. Each week was classified as ‘Totally Controlled’, ‘Well Controlled’, ‘Not Controlled’ or ‘Unevaluable’. A subject was considered to have TC asthma if they achieved 4/4, 5/5, 6/6, 6/7, 7/8 or 8/8 wks that were TC. ‘Unevaluable’ classification included subjects with less than 4 wks of data during the assessment period.
    End point type
    Secondary
    End point timeframe
    Week 5 up to Week 12
    End point values
    		 Fluticasone Propionate 200 µg BD Salmeterol/Fluticasone Propionate 50/100 µg BD
    Number of subjects analysed
    152 [7]
    150 [8]
    Units: Participants
    23
    28
    Notes
    [7] - ITT Population. Only participants with analyzable data at the indicated time point were assessed.
    [8] - ITT Population. Only participants with analyzable data at the indicated time point were assessed.
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Fluticasone Propionate 200 µg BD v Salmeterol/Fluticasone Propionate 50/100 µg BD
    Number of subjects included in analysis
    302
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.389
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.31
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.7
         upper limit
    		 2.4

    Secondary: Number of Participants who Achieved 'Well Controlled' Asthma

    		 Close Top of page
    End point title
    		 Number of Participants who Achieved 'Well Controlled' Asthma
    End point description
    Well Controlled (WC) asthma is defined as two or more of symptom score >1 only allowed on <=2 days/week, rescue salbutamol/albuterol use on <=2 days/week and up to a maximum of 4 times per week, >=80% predicted morning PEF daily assessed for 7 consecutive days and all the following criteria: no night-time awakening due to asthma, no exacerbations, no emergency visits, no treatment related adverse events enforcing a change in any asthma therapy. Number of participants/group who achieved the status of at least WC during the last 8 wks of treatment was analysed using logistic regression, including covariates for sex, age, treatment group, country amalgamation and baseline pre-bronchodilator FEV1. Each week was classified as ‘Well Controlled’, ‘Not Controlled’ or ‘Unevaluable’. A subject was considered to have WC asthma if they achieved 4/4, 5/5, 6/6, 6/7, 7/8 or 8/8 wks that were WC. ‘Unevaluable’ classification included subjects with less than 4 wks of data during the assessment period.
    End point type
    Secondary
    End point timeframe
    Week 5 up to Week 12
    End point values
    		 Fluticasone Propionate 200 µg BD Salmeterol/Fluticasone Propionate 50/100 µg BD
    Number of subjects analysed
    152 [9]
    150 [10]
    Units: Participants
    61
    65
    Notes
    [9] - ITT Population. Only participants with analyzable data at the indicated time point were assessed.
    [10] - ITT Population. Only participants with analyzable data at the indicated time point were assessed.
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Fluticasone Propionate 200 µg BD v Salmeterol/Fluticasone Propionate 50/100 µg BD
    Number of subjects included in analysis
    302
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.535
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.16
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.7
         upper limit
    		 1.9

    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 the first day of treatment until the last day of treatment (up to 12 weeks).
    Adverse event reporting additional description
    On-treatment SAEs and non-serious adverse events were reported for ITT Population, composed of all participants randomized to treatment who received at least one dose of randomized study medication.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    9.1
    Reporting groups
    Reporting group title
    Fluticasone Propionate 200 µg BD
    Reporting group description
    		 Participants received one inhalation from dry powder inhaler A (FP 100 µg) and dry powder inhaler B (FP 100 µg) twice-daily, in the morning and evening for 12 weeks. Participants were provided salbutamol 100 µg per actuation metered dose inhaler (MDI) to be used as needed throughout the study, for prevention of exercise induced asthma and symptomatic relief from asthma symptoms.

    Reporting group title
    Salmeterol/Fluticasone Propionate 50/100 µg BD
    Reporting group description
    		 Participants received one inhalation from dry powder inhaler A (salmeterol/fluticasone propionate [SFC] 50/100 µg) and dry powder inhaler B (placebo for FP 100 µg) twice-daily, in the morning and evening for 12 weeks. Participants were provided salbutamol 100 µg per actuation MDI to be used as needed throughout the study, for prevention of exercise induced asthma and symptomatic relief from asthma symptoms.

    Serious adverse events
    		 Fluticasone Propionate 200 µg BD Salmeterol/Fluticasone Propionate 50/100 µg BD
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 153 (1.96%)
    3 / 150 (2.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Concussion
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 150 (0.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastritis
         subjects affected / exposed
    1 / 153 (0.65%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    1 / 153 (0.65%)
    1 / 150 (0.67%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Laryngotracheitis
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 150 (0.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound infection
         subjects affected / exposed
    1 / 153 (0.65%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Fluticasone Propionate 200 µg BD Salmeterol/Fluticasone Propionate 50/100 µg BD
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    61 / 153 (39.87%)
    55 / 150 (36.67%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    23 / 153 (15.03%)
    27 / 150 (18.00%)
         occurrences all number
    33
    81
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    6 / 153 (3.92%)
    8 / 150 (5.33%)
         occurrences all number
    7
    15
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    10 / 153 (6.54%)
    7 / 150 (4.67%)
         occurrences all number
    13
    7
    Rhinitis allergic
         subjects affected / exposed
    10 / 153 (6.54%)
    6 / 150 (4.00%)
         occurrences all number
    12
    12
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    19 / 153 (12.42%)
    14 / 150 (9.33%)
         occurrences all number
    25
    15
    Rhinitis
         subjects affected / exposed
    10 / 153 (6.54%)
    12 / 150 (8.00%)
         occurrences all number
    15
    15

    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-Fri Apr 26 11:50:52 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA