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    The EU Clinical Trials Register currently displays   43876   clinical trials with a EudraCT protocol, of which   7294   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:2010-022001-18
    Sponsor's Protocol Code Number:RESP_301_2010
    National Competent Authority:Ireland - HPRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-08-05
    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 ConcernedIreland - HPRA
    A.2EudraCT number2010-022001-18
    A.3Full title of the trial
    A Randomised Trial of Single Dose Oral Dexamethasone versus Multi-Dose Prednisolone in the Treatment of Acute Exacerbations of Asthma in children who attend the Emergency Department
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A trial to investigate if a single dose of the oral corticosteroid, Dexamethasone is as effective in treating exacerbations of asthma in children as 3 days of treatment with another oral corticosteroid, Prednisolone
    A.4.1Sponsor's protocol code numberRESP_301_2010
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN26944158
    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 SponsorUniversity College Dublin Clinical Research Centre
    B.1.3.4CountryIreland
    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 supportThe National Children's Research Centre, Our Lady's Children's Hospital, Crumlin
    B.4.2CountryIreland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOur Lady's Children's Hospital, Crumlin
    B.5.2Functional name of contact pointDr John Cronin
    B.5.3 Address:
    B.5.3.1Street AddressOur Lady's Children's Hospital, Crumlin
    B.5.3.2Town/ cityDublin
    B.5.3.3Post codeDublin 12
    B.5.3.4CountryIreland
    B.5.4Telephone number353(0) 14096814
    B.5.6E-mailcroninjj@gmail.com
    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 Prednesol 5mg Tablets
    D.2.1.1.2Name of the Marketing Authorisation holderPhoenix Labs Ltd
    D.2.1.2Country which granted the Marketing AuthorisationIreland
    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 Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPrednisolone
    D.3.9.1CAS number 125-02-0
    D.3.9.3Other descriptive namePREDNISOLONE SODIUM PHOSPHATE
    D.3.9.4EV Substance CodeSUB04018MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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.IMP: 2
    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 Dexamethasone Tablets 2mg
    D.2.1.1.2Name of the Marketing Authorisation holderOrganon Ireland Ltd
    D.2.1.2Country which granted the Marketing AuthorisationIreland
    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 Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDexamthasone
    D.3.9.1CAS number 50-02-2
    D.3.9.3Other descriptive nameDEXAMETHASONE
    D.3.9.4EV Substance CodeSUB07017MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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
    Exacerbation of asthma in children presenting to the Emergency Department
    E.1.1.1Medical condition in easily understood language
    Worsening of asthma symptoms in children requiring their attendance at the Emergency Department
    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 13.1
    E.1.2Level LLT
    E.1.2Classification code 10003566
    E.1.2Term Asthmatic attack
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13.1
    E.1.2Level LLT
    E.1.2Classification code 10015575
    E.1.2Term Exacerbation of 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
    To test whether a single dose of oral dexamethasone (0.3mg/kg) is non-inferior to prednisolone (1mg/kg/day for 3 days) in the treatment of exacerbations of asthma in children, as measured by the Pediatric Respiratory Assessment Measure
    E.2.2Secondary objectives of the trial
    Secondary hypotheses to be tested are related to:
    •Relapse (this is defined as a return to care at an Emergency Department or other healthcare provider with worsening or unresolving acute asthma within 14 days of inclusion in this study) - we hypothesise that the dexamethasone group will experience similar or fewer episodes of relapse as the prednisolone group
    •Number of salbutamol therapies given following enrolment – we hypothesise that patients in the dexamethasone group will require a similar number or fewer salbutamol therapies during the study period.
    •Side effects (in particular vomiting) - we hypothesise that the dexamethasone group will experience similar or fewer episodes of vomiting as the prednisolone group.
    •Compliance – we will measure compliance of each study participant in the prednisolone group with regard to taking the 2nd and 3rd dose of medication.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Ages 2 – 16 years

    •Background history of asthma.
    Asthma for the purpose of this study will be defined as either: at least one previous episode of ß2-agonist-responsive wheeze in a child two years of age or over; or a prior diagnosis of asthma, made by a paediatrician, or clinician of comparable experience.

    •Presentation with an asthma exacerbation
    An exacerbation of asthma, for the purpose of this study, will be defined as acute asthma which prompts assessment at the Emergency Department, and has any, or all, of the following clinical features:
    o Dyspnoea
    o Wheeze
    o Acute cough
    o Increased work of breathing
    o Increased requirement for ß2-agonist from baseline use
    o SpO2 <95%
    E.4Principal exclusion criteria
    •Less than 2 years old or over 16 years

    •Critical or life-threatening asthma, defined as patients displaying one or more of the following clinical features:
    o Confused/drowsy
    o Maximal accessory muscle use/recession
    o Poor respiratory effort (including bradypnoea)
    o Exhaustion
    o Silent chest
    o Cyanosis
    o O2 saturation < 90% in air
    o Marked tachycardia
    o Unable to verbalise normally
    o Pneumothorax

    •Known TB exposure

    •Active varicella or herpes simplex infection

    •Documented concurrent infection with RSV

    •Fever >39.5 degrees Celcius

    •Use of oral corticosteroids in the previous 4 weeks

    •Concurrent stridor

    •Significant co-morbid disease:
    Lung, cardiac, immune, liver, endocrine, neurological or psychiatric
    E.5 End points
    E.5.1Primary end point(s)
    The Pediatric Respiratory Assessment Measure (PRAM), as the marker of asthma symptom severity will be the primary endpoint. The PRAM is a validated, responsive and reliable tool used to determine asthma severity in children aged 2 to 17 years.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The Pediatric Respiratory Assessment Measure as the primary end point will be completed on Day 4.
    E.5.2Secondary end point(s)
    o Relapse rate, which will include any visit to a healthcare provider e.g. General Practitioner, Emergency Department
    o Number of salbutamol therapies given following enrolment
    oSide effects, in particular, vomiting
    oCompliance with medication, assessed by interview and the return of medication bottles
    E.5.2.1Timepoint(s) of evaluation of this end point
    Relapse rate will be asessed at Day 4 and Day 14
    Number of salbutamol therapies will be assessed Day 4 and Day 14
    Side effects will be assessed at Day 4 and Day 14
    Compliance will be assessed at Day 4
    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) 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) 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 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 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
    The definition of the end of the trial is the last visit of the last subject undergoing the trial
    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 months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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: 232
    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.1.1.6Adolescents (12-17 years) Yes
    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 2010-08-05. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women Yes
    F.3.3.4Nursing women Yes
    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
    Minors cannot give legally binding consent. Where appropriate they will be asked to give assent, but consent will be given by a parent/legal guardian.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state232
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 232
    F.4.2.2In the whole clinical trial 232
    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)
    Once a subject has completed their participation in the study they will be treated as per standard medical practice for this patient population
    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 Decision2011-06-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-06-30
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-07-13
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