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    The EU Clinical Trials Register currently displays   44364   clinical trials with a EudraCT protocol, of which   7388   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:2021-006050-31
    Sponsor's Protocol Code Number:OY102021
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2021-12-23
    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 ConcernedFinland - Fimea
    A.2EudraCT number2021-006050-31
    A.3Full title of the trial
    Vieritestauksen perusteella suunnattu kortisonihoito pienten lasten uloshengitysvaikeudessa
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Rinovirus ja kortisoni -tutkimus
    A.3.2Name or abbreviated title of the trial where available
    RhinoPOC RCT
    A.4.1Sponsor's protocol code numberOY102021
    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 SponsorOulun yliopisto
    B.1.3.4CountryFinland
    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 supportOulun yliopisto
    B.4.2CountryFinland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOulun yliopisto
    B.5.2Functional name of contact pointLasten ja nuorten klinikka
    B.5.3 Address:
    B.5.3.1Street AddressPL 23
    B.5.3.2Town/ cityOYS
    B.5.3.3Post code90029
    B.5.3.4CountryFinland
    B.5.4Telephone number+35883152011
    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 Prednisolone Sodium Phosphate Oraaliliuos
    D.2.1.1.2Name of the Marketing Authorisation holderBioComp Pharma Inc.
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 Oral solution
    D.3.4.1Specific paediatric formulation Yes
    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 SODIUM PHOSPHATE
    D.3.9.1CAS number 125-02-0
    D.3.9.4EV Substance CodeSUB04018MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboOral solution
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Rinoviruksen laukaisema akuutti uloshengitysvaikeus (obstruktiivinen bronkiitti)
    E.1.1.1Medical condition in easily understood language
    Rinoviruksen laukaisema uloshengitysvaikeus
    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
    Tutkimuksen tavoitteena on selvittää, hyötyvätkö 6 kuukauden – 2 vuoden ikäiset lapset, joilla on päivystyksen vieritestillä (ns. POC-testi) todettu rinoviruksen tai pikornaviruksen aiheuttama uloshengitysvaikeus, suun kautta annettavasta kortisonihoidosta.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Ikä ≥ 6 kk ja < 2 vuotta
    • Lääkärin arvioima akuutti uloshengitysvaikeus, joka vaatii salbutamolihoitoa päivystyksessä
    • Positiivinen hengitysteiden rino- tai pikornavirusnäyte päivystyksen vieritestauslaitteella
    E.4Principal exclusion criteria
    • Välitön painelupuhalluselvytyksen tarve
    • Välitön siirto teho-osastolle
    • Keuhkokuumeeseen sopiva auskultaatiolöydös
    • Vakavan bakteeritaudin epäily
    • Jokin muu hengitystievirus ilman rino- tai pikornavirusta
    • RSV positiivinen hengitystienäytteessä
    • SARS-CoV-2 positiivinen hengitystienäytteessä
    • Mykoplasmainfektio (M. pneumoniae positiivinen hengitystienäytteessä)
    • Hinkuyskäinfektio (B. pertussis positiivinen hengitystienäytteessä)
    • Vesirokkokontakti 14 vrk sisällä
    • Aktiivinen vesirokkoinfektio
    • Epäily hengitysteiden vierasesineestä
    • Immunosuppressiivinen hoito
    • Systeeminen kortisonihoito 14 vrk sisällä
    • Kortisoniallergia
    E.5 End points
    E.5.1Primary end point(s)
    Sairaalahoidon (mukaan lukien päivystyspoliklinikka- ja osastohoito) kesto (minuutteina) = the difference (in minutes) between the time of study drug administration and the time that the patient was deemed to be fit for discharge (signoff for discharge) (min)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Sairaalasta kotiututuessa
    E.5.2Secondary end point(s)
    Akuutit muuttujat
    o Sairaalahoidon kesto (minuutteina) = the time from enrollment to the time of actual discharge from the hospital (min)
    o Teho-osastolle otto (osuus)
    o Lisähapen tarpeen kokonaiskesto 1. hoitojakson aikana minuutteina
    o PEWS (Pediatric Early Warning Signs) -pisteet ja ajankohdat 1. hoitojakson aikana (analysoidaan AUC)

    Kotiutumisen jälkeiset muuttujat
    o Uusi vinkuna 2 kk kohdalla (osuus)
    o Päivystykseen ja/tai osastolle takaisinotot kotiutumisen jälkeen
    o Yskä 14 vrk kohdalla
    o Yskän kesto 0–28 vrk aikana niin, että on ollut kolme päivää oireeton
    o Yskän kesto 0–14 vrk aikana niin, että on ollut kolme päivää oireeton
    o Salbutamolin tarve 0–14 vrk aikana (päivinä)
    o Hengenahdistuksen kesto 0–14 vrk aikana niin, että on ollut edeltävästi kolme päivää oireeton (päivinä)
    o Kuolemat 30 vrk ajalta tutkimukseen osallistumisesta (osuus)

    Pitkäaikaismuuttujat
    o Lääkärin toteama uusi vinkuna 2 ja 12 kk kohdalla (osuus)
    o Aika lääkärin toteamaan uuteen vinkunaan 12 kk aikana (päivinä)
    o Aika säännöllisen astmalääkkeen aloittamiseen 24 kk aikana (päivinä)
    o DDD: astmalääkkeiden ja antibioottien ostot 24 kk ajalta

    Lisäksi päävastemuuttujan suhteen tehdään seuraavat alaryhmäanalyysit:
    o Ensimmäinen uloshengitysvaikeus
    o Anamneesissa aiempi lääkärin toteama uloshengitysvaikeus
    o Rino- tai pikornaviruksen Ct-luku (cycle threshold)
     Matala (≤ 29)
     Keskimääräinen (30–37)
     Korkea (38–40)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Akuutit muuttujat kotiutuessa. Kotiutumisen jälkeiset muuttujat 2-4 viikkon sisällä rekrytoinnista kuten yllä eritelty. Pitkäaikaismuuttujat 12-24 kk kohdalla rekrytoinnista kuten yllä kuvattu. Päävastemuuttujien alaryhmäanalyysit päävastemuuttujien aikataulun mukaisesti.
    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 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 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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Placebo (Ora-Sweet/Ora-Plus), jota käytetään vain sokkoutuksen varmistamiseksi.
    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
    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 months0
    E.8.9.1In the Member State concerned days0
    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: 210
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 210
    F.1.1.5Children (2-11years) No
    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 Yes
    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 Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Potilaat alle 2-vuotiaita
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state210
    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)
    Tutkimuksen jälkeinen (tai muu sen aikainen) hoito ei eroa tavanomaisista hoitokäytännöistä.
    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 Decision2022-02-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-12-13
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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