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    Summary
    EudraCT Number:2013-002722-23
    Sponsor's Protocol Code Number:NL44755.044.13
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2013-07-09
    Trial 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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2013-002722-23
    A.3Full title of the trial
    The protective effect of a single dose inhaled steroid with different body postures against exercise induced bronchoconstriction
    Het beschermende effect van een enkele dosis inhalatiecorticosteroid met verschillende lichaamshoudingen op inspanningsastma.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The protective effect of one dose asthma medication with different body postures against exercise asthma
    Het beschermende effect van één puff asthma medicijn in verschillende lichaamshoudingen op inspanningsastma.
    A.3.2Name or abbreviated title of the trial where available
    Body Postures Study
    Lichaamshoudingen studie
    A.4.1Sponsor's protocol code numberNL44755.044.13
    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 SponsorMedisch Spectrum Twente
    B.1.3.4CountryNetherlands
    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 supportStichtin Pedriatrisch Onderzoek Enschede
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedisch Spectrum Twente
    B.5.2Functional name of contact pointInvestigator/Docter
    B.5.3 Address:
    B.5.3.1Street AddressHaaksbergerstraat 55
    B.5.3.2Town/ cityEnschede
    B.5.3.3Post code7513 ER
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031534872310
    B.5.6E-mailr.visser@mst.nl
    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 Beclomethason-diproprionaat (Qvar) autohaler dosisaerosol
    D.2.1.1.2Name of the Marketing Authorisation holderTeva Nederland BV
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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.3.4Pharmaceutical form Inhalation vapour
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Exercise Induced Bronchoconstriction
    Inspannings-geinduceerde bronchoconstrictie
    E.1.1.1Medical condition in easily understood language
    Exercise asthma
    Inspanningsastma
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    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
    Main objective of this study is to investigate if body posture influences effectiveness of a regular single dose of BDP (200µg) against EIB.
    Doel van deze studie is om te onderzoeken of lichaamshouding tijdens inhalatie van astma medicatie het klinisch effect beïnvloedt op inspanningsastma.
    E.2.2Secondary objectives of the trial
    Secondary objectives are investigation if body posture and head position during medication inhalation influences inspiratory flow obstruction as measured with spirometry during and after an ECT in asthmatic children of > 12 years old. We also want to investigate which body postures children usually have during medication inhalation at home with the aid of a questionnaire.
    Tevens is het doel om te onderzoeken of lichaamshouding en positie van het hoofd tijdens medicatie inhalatie de inspiratoire flow obstructie beïnvloed, die gemeten wordt middels spirometrie tijdens en na een inspanningsprovocatietest bij asthmatische kinderen > 12 jaar oud.
    Als laatste willen we onderzoeken met behulp van een vragenlijst welke houding(en) een kind thuis aanneemt tijdens de medicatie inhalatie.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Clinical history of asthma symptoms.
    - Age 6 through 16 years.
    - Documented EIB < 4 weeks prior to the study as measured with an ECT.
    - Ability to perform reproducible lung function tests, i.e. coefficient of the predicted value variation in 3 of 5 consecutive measurements < 5%.
    - klinische voorgeschiedenis van astma
    - leeftijd 6-16 jaar
    - gedocumenteerde EIB gemeten door middel van een inspanningstest < 4 weken voor aanvang van de studie.
    - in staat zijn tot het uitvoeren van een inspanningsprovocatietest en het producerende van te reproduceren longfunctietests; de coeffeciënt van de voorspelde waarde varieert in 3 vd 5 opeenvolgende metingen <5%.
    E.4Principal exclusion criteria
    - Exacerbation in the last 4 weeks prior to the ECT (hospital admission or use of systemic corticosteroids).
    - Use of long acting bronchodilators 24 hours before testing.
    - Use of short acting bronchodilators 8 hours before testing.
    - Use of leukotriene antagonists 24 hours before testing.
    - Use of oral/ nasal/inhaled corticosteroids < 2months prior to the study
    - Other pulmonary or cardiac disorder.
    - exacerbatie in de 4 wk voorafgaand aan de inspanningstest (geen klinische opname of gebruik systemische corticosteroiden).
    - gebruik van long acting bronchodilatoren binnen 24 uur voor de inspanningstest
    - gebruik van short acting bronchodilatoren binnen 8 uur voor de inspanningstest
    - gebruik van leukotriene antagonist binnen 24 uur voor de inspanningstest
    - Use of oral/ nasal/inhaled corticosteroids < 2months prior to the study
    - andere pulmonale of cardiale aandoening
    E.5 End points
    E.5.1Primary end point(s)
    EIB as measured with FEV1 (or FEV0.5 if FEV1 is not repeatable) in relation to the body posture and head position during inhalation; standard or leaning forward with the head flexed backward.

    Inspanningsastma gemeten middels FEV1 (of FEV0.5 als de FEV1 niet betrouwbaar is bv door jonge leeftijd) gerelateerd aan lichaasmhouding en positie van het hoofd tijdens inhalatie: normaal of naar voren leunend met het hoofd achterover.

    E.5.1.1Timepoint(s) of evaluation of this end point
    September 2013: recruiting children
    October 2013: start exercise challenge tests
    Time = 0: first exercise challenge test to include children who demonstrate a evident FEV0.5 or FEV1 fall.
    after 1 week and 2 weeks: second and third exercise challenge test with either a placebo four hours prior to the test or beclomethason dipropionate four hours prior to the test.
    March 2014: finishing exercise challenge tests.
    September 2013: includeren kinderen.
    Oktober 2013: start inspanningstesten
    Tijdstip = 0: eerste inspanningstest om te kijken of de kinderen een longfunctiedaling vertonen. Diegenen die dalen komen nog twee keer voor een inspanningsprovocatietest na 1 en 2 weken. Eenmaal voorafgegaan door 2puffs placebo puf, de andere maal door 2 puffs beclomethasondipropionat.
    Maart 2014: beëindiging inspanningstesten.
    E.5.2Secondary end point(s)
    Secundary study parameters/outcome of the study:
    Inspiratory flow obstruction as measured with spirometry during and after an ECT in asthmatic children of > 12 years old in relation to body posture and head position during inhalation.
    Different body postures children usually have during medication inhalation at home with the aid of a questionnaire.
    Secundaire onderzoeksvariabelen/uitkomstmaten:
    Insparatoire flow obstructie gemeten middels spirometrie tijdens en na de inspanningsprovocatietest bij astmatische kinderen >12 jaar oud gerelateerd aan lichaamshouding en positie van het hoofd tijdens inhalatie.
    Verschillende lichaamshoudingen van kinderen tijdens medicatie inhalatie thuis gemeten middels een vragenlijst.
    E.5.2.1Timepoint(s) of evaluation of this end point
    September 2013: recruiting children
    October 2013: start exercise challenge tests
    Time = 0: first exercise challenge test to include children who demonstrate a evident FEV0.5 or FEV1 fall.
    after 1 week and 2 weeks: second and third exercise challenge test with either a placebo four hours prior to the test or beclomethason dipropionate four hours prior to the test.
    March 2014: finishing exercise challenge tests.
    September 2013: includeren kinderen.
    Oktober 2013: start inspanningstesten
    Tijdstip = 0: eerste inspanningstest om te kijken of de kinderen een longfunctiedaling vertonen. Diegenen die dalen komen nog twee keer voor een inspanningsprovocatietest na 1 en 2 weken. Eenmaal voorafgegaan door 2puffs placebo puf, de andere maal door 2 puffs beclomethasondipropionat.
    Maart 2014: beëindiging inspanningstesten.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 Yes
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    gangbare lichaamshouding bij inhalatie
    conventional inhalation body posture
    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
    laatste bezoek van de laatste patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months6
    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: 38
    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: 19
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 19
    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 state38
    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)
    None
    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 Decision2013-07-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-07-01
    P. End of Trial
    P.End of Trial StatusOngoing
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