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    Summary
    EudraCT Number:2020-004420-42
    Sponsor's Protocol Code Number:COPSACazt
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-11-26
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2020-004420-42
    A.3Full title of the trial
    Azithromycin for treatment of hospitalized children with asthmatic symptoms - A double-blind, randomized, controlled study
    Azithromycin til behandling af hospitaliserede børn med astmatiske symptomer - Et dobbeltblindet randomiseret, kontrolleret studie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Antibiotic treatment for hospitalized children with asthmatic symptoms
    Antibiotika til behandling af hospitaliserede børn med astmatiske symptomer
    A.4.1Sponsor's protocol code numberCOPSACazt
    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 SponsorHerlev and Gentofte Hospital, Copenhagen Prospective Studies on Asthma in Childhood (COPSAC)
    B.1.3.4CountryDenmark
    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 Lundbeck Foundation
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportThe Ministry of Health
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportDanish Council for Strategic Research
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportThe Capital Region Research Foundation
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHerlev and Gentofte Hospital, Copenhagen Prospective Studies on Asthma in Childhood (COPSAC)
    B.5.2Functional name of contact pointCOSPAC
    B.5.3 Address:
    B.5.3.1Street AddressLedreborg Alle 34
    B.5.3.2Town/ cityGentofte
    B.5.3.3Post codeDK-2820
    B.5.3.4CountryDenmark
    B.5.4Telephone number4538677360
    B.5.6E-mailstokholm@copsac.com
    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 Azithromycin
    D.2.1.1.2Name of the Marketing Authorisation holderSTADA Nordic ApS
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 powder in single-dose container
    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 INNAzithromycin
    D.3.9.1CAS number 121470-24-4
    D.3.9.2Current sponsor codeJ 01 FA 10
    D.3.9.3Other descriptive nameAZITHROMYCIN MONOHYDRATE
    D.3.9.4EV Substance CodeSUB87696
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 Yes
    D.3.11.13.1Other medicinal product typeAntibiotic
    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 suspension
    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
    Childhood Asthma
    Børneastma
    E.1.1.1Medical condition in easily understood language
    Childhood Asthma
    Børneastma
    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 21.1
    E.1.2Level PT
    E.1.2Classification code 10081274
    E.1.2Term Childhood asthma
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10049868
    E.1.2Term Asthma exacerbation prophylaxis
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate the effect of a three-day azithromycin treatment versus placebo treatment in children aged 1-5 years who are hospitalized due to asthma-like symptoms.
    The primary purpose during hospitalization is to replicate the results of our previous study, where it was shown that azithromycin treatment significantly shortened the duration of the asthmatic episode. In this study, we will instead include hospitalized children who provide a more diverse group than the COPSAC2010 cohort.
    At undersøge effekten af en tre dages azithromycin behandling versus placebo behandling til børn i aldersgruppen 1-5 år, som er indlagt grundet med astmalignende symptomer.
    Det primære formål er under hospitalisering at replikere vores tidligere studies resultater, hvor det blev det påvist, at azithromycin behandling markant forkortede den astmatiske episodes varighed. I dette studie vil vi i stedet inkludere indlagte børn, der giver en mere divers gruppe end COPSAC2010 kohorten.
    E.2.2Secondary objectives of the trial
    The secondary purpose of the study is to focus on examining the individual response to treatment. The expectation is thus that in the future the study will be able to contribute to personal treatment based on the child's respiratory microbiome and / or immunological profile so that only the children who will benefit from the azithromycin treatment will receive it. It is also expected that the study will contribute to an increased understanding of the influence of bacteria on asthma-like episodes in preschool children, and thus will lead to an evidence-based better treatment of these.
    Studiet sekundære formål er at sætte fokus på at undersøge det individuelle respons på behandlingen. Forventningen er således, at studiet fremadrettet vil kunne bidrage til personlig behandling ud fra barnets luftvejsmikrobiom og/eller immunologiske profil således, at det kun er de børn, som vil have gavn af azithromycin behandlingen, som vil modtage den. Forventningen er også, at studiet vil bidrage til øget forståelse af bakteriers indflydelse på astmalignende episoder hos førskolebørn, og dermed vil føre til en evidensbaseret bedre behandling af disse.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ● Previous episode (s) with asthma-like symptoms and/have medical treatment with SABA as monotherapy or SABA in combination with ICS and possibly LTRA.
    ● The parent/guardian(s) agrees to admit the child and is willing to follow the procedure of the trial.
    ● The child is between 12-71 months old.
    ● Fluent Danish skills with parents / guardians.
    ● Tidligere episode(r) med astmalignende symptomer og/har medicinsk i behandling med SABA som monoterapi eller SABA i kombination med ICS og evt. LTRA.
    ● Forældre/værge(r) indvilger i at lade barnet indgå og er villige til at følge forsøgets procedurer.
    ● Barnet er mellem 12-71 mdr. gammel.
    ● Flydende danskkundskaber hos forældre/værge(r).
    E.4Principal exclusion criteria
    ● Known allergy to macrolide antibiotics.
    ● Known impaired liver function.
    ● Known renal impairment.
    ● Known with neurological or psychiatric diseases.
    ● Known with congenital or documented acquired QT interval.
    ● Known with clinically relevant bradycardia, cardiac arrhythmia or severe heart failure.
    ● Clinical signs of pneumonia (Objective findings, including severe tachypnoea: respiratory rate (RF)> 50 and / or Fever: temperature> 39 ° C and / or C-reactive protein (CRP)> 50).
    ● Use of other medications, with possible Azithromycin interactions:
    ○ Azithromycin may increase the effect of cecal alkaloids with risk of ergotism. The combination is contraindicated.
    ○ The absorption of azithromycin is inhibited by simultaneous administration of antacids.
    ○ Azithromycin is antagonistic in vitro to the bactericidal effect of penicillins and cephalosporins.
    ○ Azithromycin can increase the concentration of:
    ■ ciclosporin
    ■ colchicine
    ■ digoxin
    ■ pimozide
    ■ tacrolimus
    ○ Caution when administering drugs that prolong the QT interval, e.g. amiodarone and other class IA and III antiarrhythmics and when treating with warfarin.
    ○ Azithromycin may increase the incidence of side effects during treatment with rifabutin.
    ● Kendt allergi over for makrolid antibiotika.
    ● Kendt nedsat leverfunktion.
    ● Kendt nedsat nyrefunktion.
    ● Kendt med neurologiske eller psykiatriske sygdomme.
    ● Kendt med kongenit eller dokumenteret erhvervet forlænget QT-interval.
    ● Kendt med klinisk relevant bradykardi, hjertearytmi eller alvorlig hjerteinsufficiens.
    ● Kliniske tegn på pneumoni (Objektive fund, herunder svær takypnø: respirationsfrekvens (RF) > 50 og/eller Feber: temperatur > 39°C og/eller C-reactive protein (CRP) > 50).
    ● Brug af anden medicin, med mulige Azithromyzin interaktioner:
    ○ Azithromycin kan muligvis øge virkningen af sekalealkaloider med risiko for ergotisme. Kombinationen er kontraindiceret.
    ○ Absorptionen af azithromycin hæmmes ved samtidig indgift af antacida.
    ○ Azithromycin virker in vitro antagonistisk på den baktericide effekt af penicilliner og cefalosporiner.
    ○ Azithromycin kan øge koncentrationen af:
    ■ ciclosporin
    ■ colchicin
    ■ digoxin
    ■ pimozid
    ■ tacrolimus
    ○ Forsigtighed ved administration af lægemidler, der forlænger QT-intervallet, fx amiodaron og andre klasse IA og III antiarytmika samt ved behandling med warfarin.
    ○ Azithromycin kan øge forekomsten af bivirkninger under behandling med rifabutin.
    E.5 End points
    E.5.1Primary end point(s)
    Duration (in days) of the asthma-like episode from the start of randomization.
    Varighed (i dage) af den astmalignende episode fra start af randomisering.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Daily follow-up 30 days after initial dose of azithromycin. It is permitted to reply retrospectively for up to 7 days.
    30 dages opfølgning efter første dose antibiotika. Der tillades, at der svares retrospektivt op til 7 dage bagud i tiden.
    E.5.2Secondary end point(s)
    ● Change in symptom score from day 1 after randomization to completion of each randomized asthmatic episode aged 1-5 years assessed using a previously validated symptom scoring model based on a diary.
    ● Effect modification in relation to the child's respiratory microbiota and immunological profile.
    ● The length of hospitalization.
    ● Need for SABA during the asthma-like episode.
    ● Need for oral corticosteroids (OCS) during the asthma-like episode.
    ● Stratification of the above analyzes on the basis of the presence or absence of bacteria in the airways.
    ● Percentage of days away from daycare offers and / or work for parents / guardians.
    ● Assessment of the health economic gain based on treatment costs and lost earnings for parent / guardian (s).
    ● Ændring i symptomscore fra dag 1 efter randomisering til afslutning af hver randomiseret astmatisk episode i alderen 1-5 år vurderet vha. en tidligere valideret symptomscoringsmodel baseret på en dagbog.
    ● Effektmodikation ift. barnets luftvejsmikrobiota og immunologiske profil.
    ● Længden på hospitalsindlæggelse.
    ● Behov for SABA under den astmalignende episode.
    ● Behov for orale kortikosteroider (OCS) under den astmalignende episode.
    ● Stratificering af ovennævnte analyser på baggrund af tilstedeværelse eller fravær af bakterier i luftvejene.
    ● Procentdel af dage væk fra dagpasningstilbud og/eller arbejde for forældre/værge(r).
    ● Vurdering af den sundhedsøkonomiske gevinst baseret på behandlingsomkostninger og tabt arbejdsfortjeneste for forældre/værge(r).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Daily follow-up 30 days after initial dose of azithromycin. Follow-up again after one year
    30 dages opfølgning efter første dose antibiotika. Opfølgening igen efter et år.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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) 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 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 trial1
    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 concerned3
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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: 320
    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: 20
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 300
    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 No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Parent(s) and/or guardian(s) will be required to sign a consent form on behalf of their child.
    Forældre(r) og/eller værge(r) skal underskrive en samtykkeerklæring på vegne af deres barn.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state320
    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
    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 Decision2022-01-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-06-21
    P. End of Trial
    P.End of Trial StatusOngoing
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