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    Summary
    EudraCT Number:2020-000886-17
    Sponsor's Protocol Code Number:SORETROATH
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-10-21
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2020-000886-17
    A.3Full title of the trial
    SUBGLOTTIC INSTILLATION OF FLURBIPROFENE TO PREVENT LARYNGEAL INFLAMMATION FOLLOWING ENDOTRACHEAL INTUBATION: PROSPECTIVE, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED PILOT STUDY
    INSTILLAZIONE SOTTOGLOTTICA DI FLURBIPROFENE PER PREVENIRE L’INFIAMMAZIONE LARINGEA CONSEGUENTE ALL’ INTUBAZIONE ENDOTRACHEALE: STUDIO PILOTA RANDOMIZZATO CONTROLLATO
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    SUBGLOTTIC INSTILLATION OF FLURBIPROFENE TO PREVENT LARYNGEAL INFLAMMATION FOLLOWING ENDOTRACHEAL INTUBATION: PROSPECTIVE, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED PILOT STUDY
    INSTILLAZIONE SOTTOGLOTTICA DI FLURBIPROFENE PER PREVENIRE L’INFIAMMAZIONE LARINGEA CONSEGUENTE ALL’ INTUBAZIONE ENDOTRACHEALE: STUDIO PILOTA RANDOMIZZATO CONTROLLATO
    A.3.2Name or abbreviated title of the trial where available
    SORE TROATH
    SORE TROATH
    A.4.1Sponsor's protocol code numberSORETROATH
    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 SponsorFONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE
    B.1.3.4CountryItaly
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDirezione scientifica Fondazione Policlinico A.Gemelli IRCCS
    B.5.2Functional name of contact pointDirezione Scientifica Fondazione Po
    B.5.3 Address:
    B.5.3.1Street AddressLargo Agostino Gemelli 8
    B.5.3.2Town/ cityRoma
    B.5.3.3Post code00168
    B.5.3.4CountryItaly
    B.5.4Telephone number0630155701
    B.5.5Fax number0630155701
    B.5.6E-maildirezione.scientifica@policlinicogemelli.it
    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.2.5The 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 nameFLURBIPROFENE
    D.3.2Product code [R02AX01]
    D.3.4Pharmaceutical form Mouthwash
    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 INNFLURBIPROFENE
    D.3.9.1CAS number 5104-49-4
    D.3.9.2Current sponsor codeMERCK
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number1
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 placeboMouthwash
    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
    Sore throat generally associated with cough and hoarseness after orotracheal intubation.
    Mal di gola generalmente associato a tosse e raucedine dopo intubazione orotracheale
    E.1.1.1Medical condition in easily understood language
    Sore throat generally associated with cough and hoarseness after orotracheal intubation.
    Mal di gola generalmente associato a tosse e raucedine dopo intubazione orotracheale
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.1
    E.1.2Level LLT
    E.1.2Classification code 10041367
    E.1.2Term Sore throat
    E.1.2System Organ Class 100000004855
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The purpose of the protocol is to evaluate the effectiveness of a solution of flurbiprofen through the subglottic suction port on the incidence and intensity of the POST in patients undergoing cardiac surgery in extracorporeal circulation and for this reason subjected to endotracheal intubation lasting several hours.
    Obiettivo del protocollo è valutare l’efficacia di una soluzione di flurbiprofene attraverso la porta di aspirazione subglottica sull’incidenza e sull’intensità del POST (post operative sore throat) in pazienti sottoposti ad interventi di cardiochirurgia in circolazione extracorporea e per tale motivo sottoposti ad intubazione endotracheale della durata di diverse ore.
    E.2.2Secondary objectives of the trial
    Assess the effects on the incidence and intensity of cough and hoarseness
    Valutare gli effetti sull’incidenza e sull’intensità della tosse e della raucedine.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ¿ Patients undergoing 9-12 hours orotracheal intubation for aortocoronary bypass, valve replacement
    ¿ Plastic surgery in extracorporeal circulation
    ¿ Patient aged between 50 and 75
    ¿ Patients in NYHA class I and II
    ¿ Patients who have given their written consent to the study and treatment of their clinical data for the purpose of the study
    • Pazienti sottoposti a intubazione orotracheale della durata di 9-12 ore per interventi elettivi di rivascolarizzazione miocardica o di sostituzione/plastica valvolare in circolazione extracorporea.
    • Pazienti di età compresa tra 50 e 75 anni
    • Pazienti in classe NYHA Io II
    • Pazienti che hanno dato il loro consenso per iscritto di partecipazione allo studio ed al trattamento dei loro dati clinici ai fini dello studio
    E.4Principal exclusion criteria
    Exclusion criteria
    ¿ Previous upper airway surgery
    ¿ A positive history of recent acute pathologies or chronic pathologies of the upper airways
    ¿ Nicotine addiction
    ¿ Positive history of difficult intubation including objective examination suggestive of difficult
    orotracheal intubation (Mallampati = 3)
    ¿ Orotracheal intubation with more than two attempts or with the aid of devices (spindles, Airtrag, Fibroscopy)
    ¿ Nasotracheal intubation
    ¿ Positive history of gastroesophageal reflux
    ¿ Patients participating in other experimental trials
    ¿ Patients who have not given their written consent to participate in the study and have specifically refused the use of their clinical data for the purpose of the study and have not given their consent.
    Criteri di esclusione
    • Precedente chirurgia delle vite aeree superiori
    • Anamnesi positiva per patologie acute recenti o patologie croniche delle prime vie aeree
    • Tabagismo
    • Anamnesi positiva per intubazione difficoltosa compreso esame obiettivo suggestivo di incubazione orotracheale difficoltosa (Mallampati uguale o superiore a 3)
    • Intubazione orotracheale con più di due tentativi o con ausilio di presidi (mandrini, Airtrag, Fibroscopy)
    • Intubazione naso-tracheale
    • Anamnesi positiva per reflusso gastro-esofageo
    • Pazienti che partecipano ad altri trial sperimentali
    • Pazienti che non abbiano dato il consenso per iscritto di partecipazione allo studio e che abbiano specificamente rifiutato l’utilizzo dei propri dati clinici ai fini dello studio
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint is to evaluate the effectiveness of a solution of flurbiprofen through the subglottic suction port on the incidence and intensity of the POST in patients undergoing cardiac surgery in extracorporeal circulation and for this reason subjected to endotracheal intubation lasting several hours.
    Valutare l’efficacia di una soluzione di flurbiprofene sull’incidenza e sull’intensità del POST (postoperative sore throat) in pazienti sottoposti ad interventi di cardiochirurgia in circolazione extracorporea e per tale motivo sottoposti ad intubazione endotracheale della durata di diverse ore.
    E.5.1.1Timepoint(s) of evaluation of this end point
    ¿ T0 Anesthesiologic visit and request for informed consent
    ¿ T0.25 15 minutes after endotracheal tube removal
    ¿ T3 three hours after endotracheal tube removal
    ¿ T12 twelve hours after endotracheal tube removal (1 postoperative day)
    ¿ T 36 36 hours after endotracheal tube removal (2 postoperative day)
    • T0 Visita anestesiologica e richiesta del consenso informato
    • T0.25 15 minuti dopo la rimozione del tubo endotracheale
    • T3 tre ore dopo la rimozione del tubo endotracheale
    • T12 dodici ore dopo la rimozione del tubo endotracheale (1^ giornata postoperatoria)
    • T36 trentasei ore dopo la rimozione del tubo endotracheale (2^ giornata postoperatoria)
    E.5.2Secondary end point(s)
    Assess the effects on the incidence and intensity of cough and hoarseness.
    Valutare gli effetti sull’incidenza e sull’intensità della tosse e della raucedine.
    E.5.2.1Timepoint(s) of evaluation of this end point
    ¿ T0.25 15 minutes after endotracheal tube removal
    ¿ T3 three hours after endotracheal tube removal
    ¿ T12 twelve hours after endotracheal tube removal (1 postoperative day)
    ¿ T 36 36 hours after endotracheal tube removal (2 postoperative day)
    • T0.25 15 minuti dopo la rimozione del tubo endotracheale
    • T3 tre ore dopo la rimozione del tubo endotracheale
    • T12 dodici ore dopo la rimozione del tubo endotracheale (1^ giornata postoperatoria)
    • T36 trentasei ore dopo la rimozione del tubo endotracheale (2^ giornata postoperatoria)
    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 No
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    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 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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    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 Information not present in EudraCT
    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
    LVLS
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    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) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state70
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 70
    F.4.2.2In the whole clinical trial 70
    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)
    CLINICAL PRACTICE
    NORMALE PRATICA CLINICA
    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 Decision2020-11-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-07-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-04-29
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