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   43870   clinical trials with a EudraCT protocol, of which   7289   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 double blind, placebo controlled randomized study of nasal steroid spray treatment on the quality of life and objective sleep parameters in children with sleep disorder breathing.

    Summary
    EudraCT number
    		 2013-004620-10
    Trial protocol
    		 SE  
    Global end of trial date
    18 Oct 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 Dec 2021
    First version publication date
    13 Dec 2021
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    719-13
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Västra Götalandsregionen, Sahlgrenska Universitetssjukhus
    Sponsor organisation address
    Gröna stråket 9, Gothenburg, Sweden, 41320
    Public contact
    Johan Hellgren, Västra Götalandsregionen, Sahlgrenska Universitetssjukhus, 0046 313429147, johan.hellgren@gu.se
    Scientific contact
    Johan Hellgren, Västra Götalandsregionen, Sahlgrenska Universitetssjukhus, 0046 313429147, johan.hellgren@gu.se
    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
    18 Oct 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Jun 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Oct 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of the study is to evaluate the effect of nasal budesonide spray compared to placebo on health related quality of life in children with sleep disorder breathing (SDB) as well as symptoms of SDB such as snoring, apneas and nasal obstruction and the adenoid size. The aim was also to compare AHI in children in the two treatment groups, so all children underwent at-home respiratory polygraphy before and after 6 weeks treatment.
    Protection of trial subjects
    The study was designed and conducted in accordance with the Helsinki statement. The guardians of each child and the child, when appropriate, received both written and oral informations and gave their informed consent to participate in the study. It was approved by the Regional Ethical Board, Gothenburg (Dnr 719-13), and the Swedish Medical Products Agency (Dnr 5.1-2014-84538)
    Background therapy
    		 None
    Evidence for comparator
    		 Previous research showis that nasal steroid treatment reduces the size of the adenoids, alleviates symptoms (snoring, apneas, and nasal obstruction), and improves polysomnography (PSG) results. To our knowledge, there is no previous randomized, placebo-controlled study of the effect of intranasal steroid treatment on the HRQoL of children with SDB. The placebo spray consisted of a solution identical to the budesonide spray, except for the active substance.
    Actual start date of recruitment
    15 Jan 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Sweden: 60
    Worldwide total number of subjects
    60
    EEA total number of subjects
    60
    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)
    60
    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
    		 Children aged 4-10 that were referred to us for snoring and suspected sleep apnea during the 18 month trial period were screened and asked to participate in the trial if they fulfilled the inclusion criteria and none of the exclusion criteria.

    Pre-assignment
    Screening details
    		 134 patients were screened, 27 did not meet the inclusion criteria, 43 declined participation and 4 were excluded for other reasons.

    Pre-assignment period milestones
    Number of subjects started
    		 60
    Number of subjects completed
    		 60

    Period 1
    Period 1 title
    Overall Trial (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
    Blinding implementation details
    The study drugs were manufactured by APL (Apotek Produktion & Laboratorier AB, Gothenburg, Sweden) and were delivered in identical coded glass bottles in identical sealed containers, placebo was also delivered in identical packaging. Investigators and Monitor were blinded as to which child received wich treatment until after the trial period. The sleep physician was blinded to the treatment group allocation and the order of registration.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Budesonide treament group
    Arm description
    		 30 children allocated to treatment with budesonide nasal spray (64 μg/mL; Rhinocort Aqua) twice daily for 6 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Budesonide nasal spray
    Investigational medicinal product code
    Other name
    Rhinocort Aqua
    Pharmaceutical forms
    Nasal spray
    Routes of administration
    Nasal use
    Dosage and administration details
    Budesonide nasal spray (64 μg/mL) 1 spray in each nostril twice daily

    Arm title
    		 Placebo
    Arm description
    		 Placebo nasal spray treatment twice daily for 6 weeks
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo nasal spray
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal spray
    Routes of administration
    Nasal use
    Dosage and administration details
    Placebo nasal spray, one spray in each nostril twice daily for 6 weeks

    Number of subjects in period 1
    		Budesonide treament group Placebo
    Started
    30
    30
    Completed
    30
    25
    Not completed
    0
    5
         Consent withdrawn by subject
    -
    3
         Lost to follow-up
    -
    1
         Protocol deviation
    -
    1

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Budesonide treament group
    Reporting group description
    		 30 children allocated to treatment with budesonide nasal spray (64 μg/mL; Rhinocort Aqua) twice daily for 6 weeks.

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo nasal spray treatment twice daily for 6 weeks

    Reporting group values
    		 Budesonide treament group Placebo Total
    Number of subjects
    		 30 30 60
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 30 30 60
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 0 0 0
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (inter-quartile range (Q1-Q3))
    		 5.2 (4.7 to 5.8) 5.2 (4.7 to 5.7) -
    Gender categorical
    Units: Subjects
        Female
    		 16 11 27
        Male
    		 14 19 33

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Budesonide treament group
    Reporting group description
    		 30 children allocated to treatment with budesonide nasal spray (64 μg/mL; Rhinocort Aqua) twice daily for 6 weeks.

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo nasal spray treatment twice daily for 6 weeks

    Primary: OSA-18 total score

    		 Close Top of page
    End point title
    		 OSA-18 total score
    End point description
    Quality of life was assessed with the Swedish version of the OSA-18, a validated 18-item questionnaire with proven test-retest reliability, construct validity, and internal consistency. It contains questions across 5 domains (sleep disturbance, physical symptoms, emotional distress, daytime function, caregivers’ concerns). Each item is scored in relation to its frequency from “never” to “all the time” on a scale of 1 to 7 with a maximum score of 126. A total score <60 suggests a small impact on HRQoL; 60 to 80, a moderate impact; and >80, a large impact.10 The OSA-18 also includes a direct global rating of the child’s general HRQoL based on a 10-point visual analog scale (VAS; 0 = poorest, 10 = best).
    End point type
    Primary
    End point timeframe
    OSA-18 total score difference before and after 6 weeks treatment.
    End point values
    		 Budesonide treament group Placebo
    Number of subjects analysed
    30
    25
    Units: Points
    arithmetic mean (confidence interval 95%)
        Baseline
    65.2 (58.8 to 71.7)
    54.8 (50.1 to 59.5)
        Mean Difference After Treatment
    -19.5 (-24.6 to -14.4)
    -7.5 (-12.5 to -2.5)
    Statistical analysis title
    		 OSA-18 Total Score Analysis
    Comparison groups
    Placebo v Budesonide treament group
    Number of subjects included in analysis
    55
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0014
    Method
    		 Fisher Permutation Test
    Confidence interval

    Secondary: OSA-18 subgroup Sleep Disturbance

    		 Close Top of page
    End point title
    		 OSA-18 subgroup Sleep Disturbance
    End point description
    Questions regarding snoring, apnea, choking sounds and restless sleep. Possible points 4-28.
    End point type
    Secondary
    End point timeframe
    Before and after 6 weeks treatment
    End point values
    		 Budesonide treament group Placebo
    Number of subjects analysed
    30
    25
    Units: Points
    arithmetic mean (confidence interval 95%)
        Baseline
    16.7 (14.7 to 18.6)
    15.0 (13.2 to 16.8)
        Mean Difference After Treatment
    -6.5 (-8.4 to -4.6)
    -2.0 (-4.0 to 0.0)
    Statistical analysis title
    		 OSA-18 Sleep Disturbance Analysis
    Comparison groups
    Budesonide treament group v Placebo
    Number of subjects included in analysis
    55
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.002
    Method
    		 Fisher Permutation Test
    Confidence interval

    Secondary: OSA-18 subgroup Physical suffering

    		 Close Top of page
    End point title
    		 OSA-18 subgroup Physical suffering
    End point description
    Qestions regarding mouth breathing, respiratory obstruction, nasal discharge or dysphagia. Possible points 4-28
    End point type
    Secondary
    End point timeframe
    Before and after 6 weeks treatment
    End point values
    		 Budesonide treament group Placebo
    Number of subjects analysed
    30
    25
    Units: Points
    arithmetic mean (confidence interval 95%)
        Baseline
    14.7 (13.0 to 16.4)
    11.9 (10.3 to 13.5)
        Mean difference after treatment
    -3.9 (-5.6 to -2.3)
    -2.0 (-4.1 to 0.1)
    Statistical analysis title
    		 Physical symptoms Analysis
    Comparison groups
    Budesonide treament group v Placebo
    Number of subjects included in analysis
    55
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.17
    Method
    		 Fishers permutation test
    Confidence interval

    Secondary: OSA-18 subgroup Emotional distress

    		 Close Top of page
    End point title
    		 OSA-18 subgroup Emotional distress
    End point description
    Questions about moodswings, behavior and disciplin problems. Possible points 3-21.
    End point type
    Secondary
    End point timeframe
    Before and after 6 weeks treatment
    End point values
    		 Budesonide treament group Placebo
    Number of subjects analysed
    30
    25
    Units: Score
    arithmetic mean (confidence interval 95%)
        Baseline Emotional Distress
    10.3 (8.4 to 12.2)
    8.8 (7.1 to 10.4)
        Difference after treatment - Emotional distress
    -2.0 (-3.7 to -0.4)
    -1.0 (-2.8 to 0.9)
    Statistical analysis title
    		 Physical symptoms analysis
    Comparison groups
    Budesonide treament group v Placebo
    Number of subjects included in analysis
    55
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.44
    Method
    		 Fishers permutation test
    Confidence interval

    Secondary: OSA-18 subgroup Daytime function

    		 Close Top of page
    End point title
    		 OSA-18 subgroup Daytime function
    End point description
    Questions about daytime sleepiness, concentration problems and problems getting out of bed in the morning. Possible points 3-21.
    End point type
    Secondary
    End point timeframe
    Before and after 6 weeks treatment
    End point values
    		 Budesonide treament group Placebo
    Number of subjects analysed
    30
    25
    Units: score
    arithmetic mean (confidence interval 95%)
        Baseline
    10.3 (8.4 to 12.2)
    8.7 (7.5 to 10.0)
        Mean difference after treatment
    -2.2 (-3.6 to -0.8)
    -1.8 (-2.8 to -0.6)
    Statistical analysis title
    		 Daytime function analysis
    Comparison groups
    Budesonide treament group v Placebo
    Number of subjects included in analysis
    55
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.71
    Method
    		 Fishers permutation test
    Confidence interval

    Secondary: OSA-18 subgroup Caregivers' concerns

    		 Close Top of page
    End point title
    		 OSA-18 subgroup Caregivers' concerns
    End point description
    Questions about caregivers concerns and frustration regarding the child's health problems. Possible points 4-28.
    End point type
    Secondary
    End point timeframe
    Before and after 6 weeks treatment
    End point values
    		 Budesonide treament group Placebo
    Number of subjects analysed
    30
    25
    Units: Score
    arithmetic mean (confidence interval 95%)
        Baseline
    13.3 (11.2 to 15.3)
    10.4 (8.7 to 12.1)
        Mean difference after treatment
    -4.8 (-6.7 to -2.9)
    -0.8 (-2.8 to 1.3)
    Statistical analysis title
    		 Caregivers' concerns analysis
    Comparison groups
    Placebo v Budesonide treament group
    Number of subjects included in analysis
    55
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0057
    Method
    		 Fishers permutation test
    Confidence interval

    Secondary: VAS Quality of life

    		 Close Top of page
    End point title
    		 VAS Quality of life
    End point description
    Quality of life VAS scale from 1-10, (VAS; 0 = poorest, 10 = best)
    End point type
    Secondary
    End point timeframe
    Before and after 6 weeks treatment
    End point values
    		 Budesonide treament group Placebo
    Number of subjects analysed
    30
    25
    Units: points
    arithmetic mean (confidence interval 95%)
        Baseline
    6.4 (5.6 to 7.2)
    7.1 (6.4 to 7.7)
        Mean difference after treatment
    1.4 (0.8 to 1.9)
    -0.6 (-1.3 to 0.1)
    Statistical analysis title
    		 VAS Quality of lifa analysis
    Comparison groups
    Budesonide treament group v Placebo
    Number of subjects included in analysis
    55
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Fishers permutation test
    Confidence interval

    Secondary: Adenoid size

    		 Close Top of page
    End point title
    		 Adenoid size
    End point description
    Grade of obstruction of the choanae by the adenoid seen with flexible fiberoptic endoscope.
    End point type
    Secondary
    End point timeframe
    Before and after 6 weeks treatment
    End point values
    		 Budesonide treament group Placebo
    Number of subjects analysed
    25
    30
    Units: percent volume/volume
    number (confidence interval 95%)
        Baseline
    75 (69 to 81)
    73 (66 to 81)
        Mean difference after treatment
    -9.8 (-16.3 to -3.4)
    -4.1 (-10.7 to 2.6)
    Statistical analysis title
    		 Adenoid size analysis
    Comparison groups
    Budesonide treament group v Placebo
    Number of subjects included in analysis
    55
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.004
    Method
    		 Fishers permutation test
    Confidence interval

    Secondary: Tonsil size

    		 Close Top of page
    End point title
    		 Tonsil size
    End point description
    Brodski score
    End point type
    Secondary
    End point timeframe
    Tonsil size at baseline and difference after treatment
    End point values
    		 Budesonide treament group Placebo
    Number of subjects analysed
    30
    25
    Units: Score
    arithmetic mean (standard deviation)
        Baseline
    2.47 ( 0.7 )
    2.93 ( 0.8 )
        Mean difference after treatment
    -0.1 ( 0.5 )
    0.1 ( 0.5 )
    Statistical analysis title
    		 Tonsil size analysis
    Comparison groups
    Placebo v Budesonide treament group
    Number of subjects included in analysis
    55
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Fishers permutation test
    Confidence interval

    Secondary: AHI

    		 Close Top of page
    End point title
    		 AHI
    End point description
    End point type
    Secondary
    End point timeframe
    AHI measured with at-home respiratory polygraphy at baseline and after treatment.
    End point values
    		 Budesonide treament group Placebo
    Number of subjects analysed
    14
    10
    Units: Score
    arithmetic mean (standard deviation)
        Baseline
    3.33 ( 4.14 )
    3.27 ( 3.92 )
        Mean difference after treatment
    -2.84 ( 4.58 )
    -1.04 ( 3.49 )
    Statistical analysis title
    		 AHI analysis
    Comparison groups
    Budesonide treament group v Placebo
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.05
    Method
    		 Fishers permutation test
    Confidence interval

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    January 2015 to October 2106
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 SNOMED CT
    Dictionary version
    2
    Reporting groups
    Reporting group title
    Budesonide treatment group
    Reporting group description
    		 Budesonide treatment group

    Reporting group title
    Placebo group
    Reporting group description
    		 Placebo group

    Serious adverse events
    		 Budesonide treatment group Placebo group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Budesonide treatment group Placebo group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 30 (10.00%)
    2 / 30 (6.67%)
    Nervous system disorders
    Headache
    Additional description: One child admitted to hospital over-night due to headeche and dizziness.
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Blood and lymphatic system disorders
    Epistaxis
    Additional description: Mild nosebleed (epistaxis) that improved in all subjects when the treatment was stopped for 2 days and then commenced again.
         subjects affected / exposed
    3 / 30 (10.00%)
    1 / 30 (3.33%)
         occurrences all number
    3
    1

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/29161199
    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-Wed May 01 07:21:11 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA