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    Summary
    EudraCT Number:2013-004620-10
    Sponsor's Protocol Code Number:719-13
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-10-16
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSweden - MPA
    A.2EudraCT number2013-004620-10
    A.3Full title of the trial
    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.
    En dubbelblind, placebokontrollerad, randomiserad studie med steroid nässpray avseende livskvalité och objektiva sömnparametrar på barn med sömnrelaterade andningsstörningar.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of nasal steroid spray treatment on the quality of life and sleep parameters in children with sleep disorder breathing.
    Studie med kortisonnässpray avseende livskvalité och sömnparametrar på barn med sömnrelaterade andningsstörningar
    A.4.1Sponsor's protocol code number719-13
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorJohan Hellgren
    B.1.3.4CountrySweden
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportSahlgrenska University Hospital, Department of ENT
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJohan Hellgren
    B.5.2Functional name of contact pointJohan Hellgren
    B.5.3 Address:
    B.5.3.1Street AddressGröna Stråket 9
    B.5.3.2Town/ cityGöteborg
    B.5.3.3Post code413 45
    B.5.3.4CountrySweden
    B.5.4Telephone number0046313429147
    B.5.5Fax number004631416734
    B.5.6E-mailjohan.hellgren@gu.se
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Rhinocort Aqua
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameRhinocort Aqua
    D.3.4Pharmaceutical form Nasal spray, suspension
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPNasal use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboNasal spray, suspension
    D.8.4Route of administration of the placeboNasal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Sleep disordered breathing due to enlarged tonsils and/or adenoid
    Sömnrelaterade andningsstörningar pga förstorade halsmandlar och/eller adenoid
    E.1.1.1Medical condition in easily understood language
    Sleep disordered breathing due to enlarged tonsils and/or adenoid
    Sömnrelaterade andningsstörningar pga förstorade halsmandlar och/eller adenoid
    E.1.1.2Therapeutic area Diseases [C] - Ear, nose and throat diseases [C09]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The purpose of the study is to evaluate the effect of nasal steroid spray on health related quality of life in children with sleep disorder breathing

    Utvärdera effekten av nasal steroidspray med avseende på livskvalitet hos barn med sömnrelaterade andningsstörningar
    E.2.2Secondary objectives of the trial
    To evaluate improvement in objective sleep parameters such as Anea-hyponea-index (AHI) and oxygen desaturation index (ODI), time of snoring during sleep.

    To evaluate a standardised protocol for assessing children with suspected SDB including health related quality of life and objective sleep parameters.

    Utvärdera förbättring i objektiva sömnparametrar såsom AHI och ODI samt snarktid under sömn.

    Utvärdera ett standardprotokoll med avseende på livskavlitet och objektiva sömnparametrar hos barn med sömnrelaterade andningsstörningar
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Children 4-10 years old
    Valid address in Sweden 2015-16
    Snoring and/or apneas during at least 3 months
    Barn 4-10 år
    Valid adress i Sverige 2015-16
    Snarkningar och/eller apné under minst 3 månader
    E.4Principal exclusion criteria
    Lack of ability to read and write Swedish
    Acute respiratory infection
    Use of nasal or systemic corticosteroids or antibiotics within 4 wks prior to study
    Prior tonsil or adenoid surgery
    History of craniofacial, neuromuscular or genetic disorders
    Severe obstructive sleep apnea (OSA) requiring urgent surgery
    No interest in participating in study

    Oförmåga att läsa och skriva svenska
    Akut halsinfektion
    Användning av nasal eller systemisk kortikosteroid eller antibiotika inom 4 veckor före studiestart
    Tidigare tonsill eller adenoid kirurgi
    Tidigare kranofasial, neuromuskulär eller genetisk sjukdom
    Svår obstruktiv sömn apné (OSA) som kräver omedelbar kirurgi
    Inget intresse av att medverka i studien
    E.5 End points
    E.5.1Primary end point(s)
    Change in OSA-18 scores after treatment
    Förändring i OSA-18 index efter behandling
    E.5.1.1Timepoint(s) of evaluation of this end point
    After 6 weeks
    treatment
    Efter 6 veckors behandling
    E.5.2Secondary end point(s)
    Change in PSG results after treatment (AHI, ODI)
    Change in adenoid (photo documented measurements) and tonsil size (Brodsky score) after treatment.
    Förändring i PSG resultat efter behandling (AHI, ODI)
    Förändring i adenoid (foto dokumenterad mätning) och tonsill storlek(Brodsky score) efter behandling
    E.5.2.1Timepoint(s) of evaluation of this end point
    after 6 weeks
    treatment
    efter 6 veckors behandling
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 60
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 60
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state60
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Routine care. Surgery for patients still having symtoms after study treatment
    Rutinbehandling. Kirurgi för patienter som har kvarstående symtom efter studiebehandlingen
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-12-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-10-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-10-18
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