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    The EU Clinical Trials Register currently displays   43846   clinical trials with a EudraCT protocol, of which   7282   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).

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    Summary
    EudraCT Number:2015-003551-22
    Sponsor's Protocol Code Number:55029
    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:2016-06-27
    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 number2015-003551-22
    A.3Full title of the trial
    STATIC IV: Efficacy of a loading dose of intravenous salbutamol in patients admitted to a PICU for severe acute asthma
    STATIC IV: Efficacy van een oplaaddosis intraveneus salbutamol in patiënten opgenomen op een PICU wegens status astmaticus
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to look at the usefulness of an extra dose of salbutamol (medicine that widens the airways in the lungs) through the bloodstream, in children who are admitted to an intensive care for a very severe asthma-attack.
    Een studie om te kijken of het nuttig is om een extra dosis salbutamol te geven (medicijn dat de luchtwegen wijder maakt in de longen) via het bloed, bij kinderen die op een intensive care liggen voor een heel ernstige astma-aanval.
    A.3.2Name or abbreviated title of the trial where available
    STATIC IV: STATus asthmaticus on the paediatric Intensive Care - IntraVenous salbutamol
    STATIC IV: STATus astmaticus op de kinder Intensive Care - IntraVeneus salbutamol
    A.4.1Sponsor's protocol code number55029
    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 SponsorErasmus MC - Sophia Children's Hospital
    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 supportSophia BV
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportStichting AMMODO
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportStichting Astma Bestrijding
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationErasmus MC - Sophia Children's Hospital
    B.5.2Functional name of contact pointdrs. J.M.C. van Wijngaarden
    B.5.3 Address:
    B.5.3.1Street AddressWytemaweg 80
    B.5.3.2Town/ cityRotterdam
    B.5.3.3Post code3000CA
    B.5.3.4CountryNetherlands
    B.5.4Telephone number00310107038938
    B.5.6E-mailj.vanwijngaarden@erasmusmc.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 Ventolin Infuus, oplossing voor injectie 0,5 mg/ml
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxoSmithKline 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.3.1Product nameVentolin Infuus, oplossing voor injectie 0,5 mg/ml
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous bolus use (Noncurrent)
    Intravenous 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 placeboConcentrate for solution for infusion
    D.8.4Route of administration of the placeboIntravenous bolus use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Severe acute (viral) wheeze and severe acute asthma
    Ernstige acute (virale) wheeze en status asthmaticus
    E.1.1.1Medical condition in easily understood language
    Life-threatening attacks of (viral) wheeze and life-threatening asthma attacks
    Levensbedreigende aanvallen van hijgen ("wheeze") door een luchtwegvirus, en levensbedreigende astma-aanvallen
    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 19.0
    E.1.2Level LLT
    E.1.2Classification code 10047921
    E.1.2Term Wheeze
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10041961
    E.1.2Term Status asthmaticus
    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
    To assess the efficacy of a loading dose of intravenous salbutamol in children admitted to a PICU for severe acute wheeze or severe acute asthma. Efficacy is measured by the reduction in asthma score (Qureshi) at 1 hour after administration of the loading dose, compared to placebo.
    Het bepalen van de efficacy van een oplaaddosis intraveneus salbutamol bij kinderen opgenomen op een PICU wegens ernstige (virale) wheeze of status asthmaticus. Efficacy wordt gemeten middels de afname in astma score (Qureshi) 1 uur na toediening van de loading dose, vergeleken met placebo.
    E.2.2Secondary objectives of the trial
    To assess the following pharmacodynamics parameters of a loading dose of intravenous salbutamol in children admitted to a PICU for severe acute wheeze or severe acute asthma.
    -Maximum rate and duration of infusion of IV salbutamol
    -Total (cumulative) dose of IV salbutamol
    -Length of stay on PICU
    -Need for other medication (e.g. sodium bicarbonate, theophyllin, sevoflurane)
    -Need for non-invasive/invasive mechanical ventilation (+ duration)
    -Frequency of side effects (Tachycardia, Arrhythmia, Hypotension, Hypokalaemia, Hyperglycaemia, Lactic acidosis)
    -Distribution of ADBR2 receptor polymorphisms
    Het bepalen van de volgende farmacodynamische parameters van een oplaaddosis intraveneus salbutamol bij kinderen opgenomen op een PICU wegens ernstige (virale) wheeze of status asthmaticus.
    -Maximale infusiesnelheid en totale duur van infusie IV salbutamol
    -Totale (cumulatieve) dosis IV salbutamol
    -Verblijfsduur op de PICU
    -Noodzaak tot gebruik andere medicatie (bijv. natriumbicarbonaat, theophylline, sevofluraan)
    -Noodzaak tot inzet van niet-invasieve/invasieve mechanische ventilatie (+ duur)
    -Frequentie van optreden van bijwerkingen (Tachycardie, arrhythmie, hypotensie, hypokaliëmie, hyperglycemie, lactaat acidose)
    -Distributie van ADBR2 receptor polymorphismen
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Between 2-18 years of age at moment of inclusion
    -Admitted to PICU for Severe Acute Asthma or Severe acute (viral) wheeze
    -Requiring administration of IV salbutamol
    -Tussen 2 en 18 jaar oud op moment van inclusie
    -Opgenomen op PICU wegens status astmaticus of ernstige acute (virale) wheeze
    -Noodzaak tot toediening van IV salbutamol
    E.4Principal exclusion criteria
    -Patient is outside of specified age range
    -Patient has already received a -loading dose- of IV salbutamol in the general hospital
    -Lower airway infection with consolidation on a chest X ray
    -Patient has Down’s Syndrome
    -Patient has a congenital/acquired heart defect that interferes with normal asthma treatment
    -Patient has a primary/secondary immunodeficiency
    -Patient has a pre-existing chronic pulmonary condition, known to mimic asthma: Cystic fibrosis, Bronchopulmonary dysplasia, Bronchiolitis obliterans
    -Patiënt valt buiten het gespecificeerde leeftijdsbereik
    -Patiënt heeft reeds een -oplaaddosis- IV salbutamol ontvangen in het algemene ziekenhuis
    -Lagere luchtweg infectie met consolidatie op een X-thorax
    -Patiënt heeft Down Syndroom
    -Patiënt heeft een congenital/verworven hartafwijking welke normale behandeling van astma verhindert
    -Patiënt heeft een primaire/secundaire immuundeficiëntie
    -Patiënt heeft een aangetoonde chronische longafwijking, waarvan bekend is dat deze astma "imiteert": Taaislijmziekte, Bronchopulmonaire dysplasia, Bronchiolitis obliterans
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome variable is (reduction of) asthma score (Qureshi) 1 hour after administration of loading dose in the intervention group compared to the placebo group. Based on expert opinion, we consider a reduction of 2 points to represent a clinically relevant improvement.
    De primaire uitkomstmaat is astma score (Qureshi) 1 uur na toediening van oplaaddosis in de interventiegroep, vergeleken met de placebo groep. Gebaseerd op informatie van experts zien wij een vermindering van 2 punten in deze score als een klinisch relevante verbetering.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1 hour after administration of loading dose of IV salbutamol
    1 uur na toediening van oplaaddosis IV salbutamol
    E.5.2Secondary end point(s)
    • The (reduction of) asthma score (Qureshi) 6 hours after administration of loading dose in the intervention group compared to the placebo group.
    • Cumulative dose of IV salbutamol
    • Maximum infusion rate of IV salbutamol in mcg/kg/min
    • Total duration of IV salbutamol treatment in hours
    • Occurrence/frequency of side effects (categorical) (Tachycardia, Arrhythmia, Hypotension, Hypokalaemia, Hyperglycaemia, Lactic acidosis)
    • Length of Stay on PICU in days
    • Use of co-medication + dosage + timing (e.g. sodium bicarbonate, theophylline, sevoflurane)
    • Use of prednisone + time/method of first administration
    • Use of/duration of non-invasive/invasive mechanical ventilation in days
    • Distribution of ADRB2-receptor polymorphisms (SNPs for Arginine and Glycine on chromosomes 16 and 27) compared to normal population (non-SAA)
    • De (reductie van) astma score (Qureshi) 6 uur na toediening van oplaaddosis in de interventie groep vergeleken met de placebo groep.
    • Cumulatieve dosis van IV salbutamol
    • Maximale infusiesnelheid van IV salbutamol in mck/kg/min
    • Totale duur van behandeling met IV salbutamol in uren
    • Optreden van / frequentie van bijwerkingen (Tachycardie, arrhytmie, hypotensie, hypokaliemie, hyperglycemie, lactaatacidose)
    • Verblijfsduur op PICU in dagen
    • Gebruik van co-medicatie + dosering + tijd (bijv. natriumbicarbonaat, theofylline, sevofluraan)
    • Gebruik van prednison + tijd/methode van eerste toediening
    • Inzet van / totale duur van niet-invasieve/invasieve mechanische ventilatie in dagen
    • Verdeling van ADRB2-receptor polymorfismen (SNPs voor Arginine en Glycine op chromosomen 16 en 27) vergeleken met de normale populatie (zonder SAA)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Asthma score will be measured at baseline and the following timepoints after administration of IV salbutamol loading dose: 30 minutes, 1 hour, 3 hours, 6 hours, 12 hours, 24 hours and >24 hours.

    The remaining secondary end points have no specific time points.
    De astma score wordt gemeten op baseline en de volgende tijdspunten na toediening van IV salbutamol oplaaddosis: 30 minuten, 1 uur, 3 uur, 6 uur, 12 uur, 24 uur en >24 uur.

    De overige secundaire eindpunten hebben geen specifieke tijdspunten.
    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 Yes
    E.6.7Pharmacodynamic Yes
    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) 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 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 concerned5
    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 Yes
    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 years
    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: 52
    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: 40
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 12
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2016-06-27. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Children aged 2-11 years old
    Children aged 2-17 years old who are temporarily incapable of providing consent due to the nature of the disease (e.g. reduced conciousness, sedation, etc.)
    Kinderen van 2-11 jaar
    Kinderen van 2-17 jaar oud die tijdelijk niet in staat zijn tot het geven van consent vanwege de aard van de ziekte (bijv. verminderd bewustzijn, sedatie, etc.)
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state52
    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, unless related to AEs/SAEs/SUSARs
    Geen, tenzij gerelateerd aan AEs/SAEs/SUSARs
    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 Decision2016-06-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-12-28
    P. End of Trial
    P.End of Trial StatusOngoing
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