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    Summary
    EudraCT Number:2018-001291-38
    Sponsor's Protocol Code Number:Salsa
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-06-04
    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 number2018-001291-38
    A.3Full title of the trial
    In vivo efficacy of Salbutamol Sandoz versus salbutamol Ventolin GSK in children with asthma
    in vivo effectiviteit van Salbutamol Sandoz versus Salbutamol Ventolin GSK in kinderen met astma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy of two bronchodilators in children with asthma
    Werkzaamheid van twee luchtwegverwijders in kinderen met astma
    A.3.2Name or abbreviated title of the trial where available
    Salsa
    Salsa
    A.4.1Sponsor's protocol code numberSalsa
    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 SponsorRadboud University Medical Center
    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 supportDutch Lung Foundation
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRadboud University Medical Center
    B.5.2Functional name of contact pointPeter Merkus
    B.5.3 Address:
    B.5.3.1Street AddressGeert Grooteplein-Zuid 30
    B.5.3.2Town/ cityNijmegen
    B.5.3.3Post code6525 GA
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31243614430
    B.5.5Fax number+31243616428
    B.5.6E-mailpeter.merkus@radboudumc.nl
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 Ventolin
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxo Wellcome UK Ltd trading as GlaxoSmithKline UK
    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.3.1Product nameSalbutamol
    D.3.4Pharmaceutical form Inhalation vapour, emulsion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNsalbutamol Sandoz
    D.3.9.3Other descriptive nameSALBUTAMOL MICRONIZED
    D.3.9.4EV Substance CodeSUB22974
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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
    Asthma in children
    astma bij kinderen
    E.1.1.1Medical condition in easily understood language
    Asthma in children
    astma bij kinderen
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10003553
    E.1.2Term Asthma
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The hypothesis of this study is that reference product SalbR is more effective than SalbG in improving lung function in children with asthma and diminished asthma control, and that this difference is larger in children with more airways resistance. The Null hypothesis is that there is no difference

    The primary objective of the study is to reject the Null Hypothesis
    This will be determined by the answers on the following questions:

    Research questions:
    1. Is there a difference between the increase of Forced Expiratory Volume in 1 second (FEV1) following inhalation of 100 ug SalbG versus FEV1 following 100 ug SalbR in children with reduced asthma control
    De hypothese van dit onderzoek luidt dat het referentieproduct SalbR effectiever is dan SalbG in het verbeteren van de longfunctie bij kinderen met astma, en dat dit verschil groter is naarmate de luchtwegweerstand ernstiger is. (Nul hypothese: er is geen verschil). Dit zou verklaard kunnen worden door ander eigenschappen en depositie van het aerosol.

    Primaire doel van dit onderzoek:
    Het verwerpen van de nulhypothese. Dit wordt gebaseerd op de antwoorden op de onderstaande vragen via patiëntgebonden onderzoek.

    Onderzoeksvragen zijn:
    1. Is er een verschil tussen de toename van de Forced Expiratory Volume in 1 second (FEV1) na 100 ug SalbG versus FEV1 na 100 ug SalbR bij kinderen met onvoldoende astmacontrole? (primaire vraagstelling)
    E.2.2Secondary objectives of the trial
    secondary aims of the study are:
    2. Is there a difference in the subjective feeling of children after inhalation of 100 ug SalbR versus after 100 ug SalbG, using a visual analogue scale?
    3. Is the increase of FEV1 in children with asthma after inhalation of in total 400 ug SalbR higher than after inhalation of in total 400 ug SalbG?
    4. Is there a difference in subjective feeling of the children after inhalation of 400 ug SalbR versus after 400 ug SalbG, using a visual analogue scale?
    secundaire doelen van het onderzoek zijn:
    2. Is er een verschil in het subjectieve gevoel van de kinderen na inhalatie met 100 ug SalbR en na 100 ug SalbG, gemeten met een VAS score?
    3. Is de toename van de FEV1 bij kinderen met astma na inhalatie van totaal 400 ug SalbR hoger dan na inhalatie van totaal 400 ug SalbG?
    4. Is er een verschil in het subjectieve gevoel van de kinderen na inhalatie met 400 ug SalbR en na 400 ug SalbG, gemeten met een VAS score?
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion criteria:
    - Informed consent of the parents of children up to 12 yrs of age, and informed consent from parents/caretakers of children and of the children aged 12-14 years. van ouders bij kinderen tot 12 jaar, en informed consent van ouders en assent van kinderen bij de leeftijd van 12-14 jaar
    - Children known with doctor’s diagnosed asthma, and a history, or physical examanation, or documented positive response on bronchodilators following lung function testing, indicating reversibility of airways obstruction
    - C-ACT (children astma controle test questionnaire 4-11 yrs) or ACT(12-16 yrs) <20 and/or FEV1 decline of at least 15% compared to personal's best and/or FEV1 < 80 % of predicted value and/or such symptoms that the parents or the physician would administer a bronchodilator

    Inclusiecriteria
    - Informed consent van ouders bij kinderen tot 12 jaar, en informed consent van ouders en assent van kinderen bij de leeftijd van 12-14 jaar
    - Kinderen bekend met de diagnose astma (doctor’s diagnosed asthma), waarbij bij voorkeur ooit bronchiale hyperreactiviteit of reversibiliteit is vastgelegd bij longfunctieonderzoek van FEV1 van ten minste 9% voorspelde waarde en waarbij salbutamol als rescue medicatie in het verleden anamnestisch en/of klinisch effectief is gebleken
    - Longfunctie onderzoek is aangevraagd en verricht in het kader van reguliere zorg
    - C-ACT (children astma controle test vragenlijst, 4-11 jaar)) of ACT(12-16 jaar) <20 en/of FEV1 (relatief ten opzichte van personal’s best) verlaagd met ten minste 10% en/of FEV1 < 80% voorspelde waarde en/of dusdanige dyspnoe dat ouders een luchtverwijder zouden willen geven

    E.4Principal exclusion criteria
    - Severe acute asthma for which high and frequent dosages of Salbutamol are needed
    - Inability to conduct a lung function test well
    - Inability to read or understand the Dutch Language
    - Concomitant other chronic physical or mental condition that precludes conducting a reliable lung function test.
    - Status asthmaticus waarbij continue vernevelen van salbutamol geindiceerd is
    - Niet in staat zijn technisch reproduceerbaar/betrouwbaar te blazen
    - Kind en/of ouders niet in staat instructies te begrijpen door communicatieprobleem/taalbarrière
    - Klinisch relevante comorbiditeit die de betrouwbaarheid van longfunctie kan beinvloeden (b.v. andere (cardio)pulmonale aandoening, spierziekte, e.d.)
    E.5 End points
    E.5.1Primary end point(s)
    Forced Expiratory in 1 second before and after inhalation of 100 ug salbutamol (SalbR - Ventolin- or SalbG - Salbutamol Sandoz) with a spacer.
    Primary endpoint of study:

    Differences in FEV1 follwing the first dose of 100 ug, expressed as SDS/Z-scores or in % of the predicted value [1] between SalbR and SalbG.
    Based on the literature [2] a sample size calculation was conducted. With the SD FEV1 of 8% of predicted value, a difference of 5% can be detected when 2x3 childen participate (Beta = 80% and alfa = 5%). Assuming a drop out rate of 10%, the aim of the study is to include 2x 40 children with asthma.
    Through the design of the study, we can compare the effect of dosages of 100 ug in 2 groups of 40 children, can we compare the effects of the second dose of 300 ug in 2 groups of 40 children , and can we compare the effect of 400 ug SalbR with that of 400 ug SalbG in 2 groups of 20 children.

    [1] Quanjer PH, Hall GL, Stanojevic S, Cole TJ, Stocks J; Global Lungs Initiative. Age- and height-based prediction bias in spirometry reference equations. Eur Respir J. 2012 Jul;40(1):190-7.

    [2] Merkus PJ, Rooda HM, van Essen-Zandvliet EE, Duiverman EJ, Quanjer PH, Kerrebijn KF. Assessment of bronchodilatation after spontaneous recovery from a histamine challenge in asthmatic children. Thorax. 1992;47:355–359
    Eenseconde waarde voor en na inhalatie van 100 ugram salbutamol met een voorzetkamer


    Op basis van literatuurgegevens [1] is een sample size berekening uitgevoerd. Met een gebruikelijke SD FEV1 van 8 % voorspelde waarde kan een verschil van FEV1 van ten minste 5% van de voorspelde waarde gedetecteerd worden indien er in totaal 2x36 kinderen geincludeerd worden (Beta 80%, alfa 5%). Rekening houdend met een uitval van 10% wordt derhalve gestreefd naar groepsgrootte van 2x40 kinderen.
    Door de design van de studie kan het effect van zowel de doseringen van 100 ug vergeleken worden in 2 groepen van 40 kinderen; kan het effect van de tweede gift van 300 ug ook vergeleken worden in 2 groepen van 40 kinderen, en kan het effect van 400 ug SalbR en SalbG vergeleken worden in 2 groepen van 20 kinderen.


    [1] Quanjer PH, Hall GL, Stanojevic S, Cole TJ, Stocks J; Global Lungs Initiative. Age- and height-based prediction bias in spirometry reference equations. Eur Respir J. 2012 Jul;40(1):190-7.

    [2] Merkus PJ, Rooda HM, van Essen-Zandvliet EE, Duiverman EJ, Quanjer PH, Kerrebijn KF. Assessment of bronchodilatation after spontaneous recovery from a histamine challenge in asthmatic children. Thorax. 1992;47:355–359
    E.5.1.1Timepoint(s) of evaluation of this end point
    T=15; 15 minutes after inhalation van 100 ug salbutamol
    T=15: 15 minuten na inhalatie van 100 ug salbutamol
    E.5.2Secondary end point(s)
    FEV1 before and after inhalation of the second dose of salbutamol (300 ug), VAS scores for dyspnea, and short questionnaire after end of study.
    This implies 3 times lung function testing instead of twice (twice being usual care)
    FEV1 voor en na inhalatie van de tweede gift Salbutamol (300 ug), VAS scoring voor benauwdheid, en korte vragenlijst aan het einde van de studie.
    Dit betekent 3 keer een longfunctie blazen in plaats van 2 keer (2 keer is gebruikelijke zorg)
    E.5.2.1Timepoint(s) of evaluation of this end point
    T=0: first VAS scoring
    T=15: 2nd VAS scoring
    T=35: FEV1 measurement 15 minuten after the 2nd dose of salbutamol,
    T=35: 3rd VAS scoring
    T=40 short questionnaire:
    1) does the first puff taste differently than the first?
    2) which one doe you prefer? (first, second, donot know)
    3) is the first more effective or is the second more effective?
    4) Does one of them taste as you have at home?
    T=0: eerste VAS score
    T=15: 2e VAS score
    T=35: FEV1 gemeten 15 minuten na de 2e toediening salbutamol, 3e VAS score
    T=40 korte vragenlijst:
    1) smaakt de eerste puff anders dan de tweede puff?
    2) welke vind je fijner? (eerste, tweede, weet niet)ene anders dan de andere? Zo ja hoe dan?
    3) is the first more effective or is the second more effective?
    4) Smaakt een van de puffs zoals die die je thuis hebt?
    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 No
    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 No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    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) Yes
    E.8.2.2Placebo No
    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 No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    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
    The end of trial will be the day that 80 participants have been included, and will be within 12 month after the start of study
    Het einde van het onderzoek zal zijn de dag dat 80 patiënten zijn geincludeerd, en zal zijn binnen 12 maanden na start van de studie.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    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: 80
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 20
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 state80
    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, patients will follow routine clinical care after trial completion
    Deze studie gaat niet gepaard met vervolg afspraken of monitoring
    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 Decision2018-06-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-08-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-12-19
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