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    Summary
    EudraCT Number:2021-006681-21
    Sponsor's Protocol Code Number:FVGEXACT@home2021
    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:2022-07-04
    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 number2021-006681-21
    A.3Full title of the trial
    Expertise Asthma COPD Program with Digital Support
    Expertise Astma COPD Traject met Digitale Ondersteuning
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Care path consisting of a systematic assessment of asthma patients using digital home monitoring resulting in a patient-centred treatment
    Zorgpad bestaande uit een systematische beoordeling van astma patiënten met behulp van digitale thuismonitoring wat resulteert in een patiëntgerichte behandeling
    A.3.2Name or abbreviated title of the trial where available
    EXACT@home
    EXACT@home
    A.4.1Sponsor's protocol code numberFVGEXACT@home2021
    A.5.4Other Identifiers
    Name:BFS-AS-40201Number:BFS-AS-40201
    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 SponsorFranciscus Gasthuis & Vlietland
    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 supportTeva Pharmaceuticals
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportDSW Transformatiegelden
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFranciscus Gasthuis & Vlietland
    B.5.2Functional name of contact pointHospital
    B.5.3 Address:
    B.5.3.1Street AddressKleiweg 500
    B.5.3.2Town/ cityRotterdam
    B.5.3.3Post code3045PM
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031010461 6149
    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 BF Spiromax
    D.2.1.1.2Name of the Marketing Authorisation holderTeva Pharmaceuticals B.V.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameBudesonide/formoterol (BF) Digihaler Digital System (DS)
    D.3.4Pharmaceutical form Inhalation powder
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBudesonide
    D.3.9.1CAS number 51333-22-3
    D.3.9.4EV Substance CodeSUB05955MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number160
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFormoterol Fumarate Dihydrate
    D.3.9.1CAS number 183814-30-4
    D.3.9.4EV Substance CodeSUB25660
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4.5
    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 Yes
    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
    Asthma
    Astma
    E.1.1.1Medical condition in easily understood language
    Asthma: alternating airway narrowing and - inflammation
    Astma: wisselende luchtwegvernauwing en -ontsteking
    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 22.1
    E.1.2Level LLT
    E.1.2Classification code 10003555
    E.1.2Term Asthma bronchial
    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
    To investigate if the EXACT@home program reduces the number of patients treated by biologics by means of systematic identification and treatment of treatable traits using e.g. questionnaires, eHealth and multiple digital devices before considering biologics.
    Onderzoeken of het EXACT@home programma resulteert in een reductie in het aantal patienten behandeld met biologicals door middel van systematische identificatie van treatable traits met behulp van o.a. vragenlijsten, eHealth en meerdere digitale devices voordat biologicals overwogen worden.
    E.2.2Secondary objectives of the trial
    To determine whether the use of EXACT@home results in a reduced percentage of patients treated with biologicals after 11-12 months. Next to this it will be investigated if EXACT@home has an influence on quality of life, asthma control, dyspnea perception, lung function, exacerbation frequency, prednisolone use, direct healthcare consumption, self-management skills, patient satisfaction, adherence to ICS/LABA therapy and inhaler technique, physical activity, sleep and vital parameters. Next to this, breath pattern analysis will be performed with the electronic nose (eNose). Moreover, the safety of the Digital inhaler (BF-Digihaler-DS from Teva) and eNose (Spironose from Breathomix) and the course of the treatment in each patient will also be investigated.
    Nagaan of het gebruik van EXACT@home resulteert in een reductie van het percentage patienten dat behandeld wordt met een biological na 11-12 maanden. Daarnaast wordt onderzocht of EXACT@home invloed heeft op de kwaliteit van leven, astma controle, dyspneu perceptie, long functie, exacerbatie frequentie, prednisolon gebruik, directe zorgconsumptie, zelfmanagment, patient tevredenheid, therapietrouw aan ICS/LABA therapie, inhalatietechniek, fysieke activiteit, slaap en vitale parameters. Daarnaast wordt er een analyse van deeltjes in de uitgeademde lucht met de eNose verricht. Verder wordt er gekeken naar de veiligheid van de BF-Digihaler-DS (digitale inhalator) en SpiroNose (eNose) en het beloop van de behandeling in elke individuele patiënt.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Confirmed asthma diagnosis (≥12% and ≥200 ml reversibility in FEV1 or positive histamine/methacholine provocation test or FeNO >50) according to the asthma guidelines.
    - Diagnosed with severe, refractory asthma with eligibility for treatment with specific asthma biologics (omalizumab, mepolizumab, benralizumab, reslizumab, dupilumab) as determined at the regional asthma MDTM according to the asthma guidelines.
    - Age ≥ 18 years.
    - Previous prescribed asthma biologics have to be ceased ≥ 4 times the half-life of that specific biologic.
    - The patient has be relatively stable. The onset of an asthma exacerbation and/or a lower respiratory tract infection which requires a treatment with prednisolone and/or antibiotics has to be ≥ 2 weeks ago.
    - Bevestigde astma diagnose (>12% en >200 ml reversibiliteit in FEV1 of positieve histamine/methacholine provocatietest of FeNO >50) volgens de astmarichtlijnen.
    - Gediagnosticeerd met ernstig, refractair astma en waarvoor hij/zij in aanmerking komt voor een behandeling met specifieke astma biologicals (omalizumab, mepolizumab, benralizumab, reslizumab, dupilumab) zoals besloten tijdens het regionale astma Multidisciplinair Overleg ernstig astma (MDO) volgens de astmarichtlijnen.
    - Leeftijd ≥ 18 jaar.
    - Voorgaande astma biologicals moeten ten minste 4 keer de halfwaardetijd geleden zijn gestaakt.
    - De patiënt moet relatief stabiel zijn. Het begin van een astma exacerbatie en/of lagere luchtweginfectie waarvoor een behandeling met prednisolon en/of antibiotica noodzakelijk is moet ≥ 2 weken geleden zijn.
    E.4Principal exclusion criteria
    - Primary COPD diagnosis
    - History of cancer:
    > Current basal cell carcinoma of the skin, localized squamous cell carcinoma of the skin or in situ carcinoma of the cervix. Patients are eligible to participate in the study provided that curative therapy was completed at least 12 months prior to the start of the study.
    > Current other malignancies. Patients are eligible to participate in the study provided that curative therapy was completed at least 5 years prior to the start of the study.
    - Inability to fully understand and read the Dutch language.
    - Being unable to engage in a remote monitoring and coaching program through the use of a smartphone.
    - Being unable to engage in physical activity (e.g. physical disability).
    - Current pregnancy.
    - Current breastfeeding.
    - Primaire COPD diagnose
    - Maligniteit in de voorgeschiedenis:
    > Huidig basaal cel carcinoom van de huid, gelokaliseerd plaveiselcelcarcinoom van de huid en een carcinoma in situ van de cervix. Patiënten mogen deelnemen in de studie, indien curatieve therapie ten minste 1 jaar is afgerond voor de start van de studie.
    > Huidige overige maligniteiten. Patiënten mogen deelnemen in de studie, indien curatieve therapie ten minste 5 jaar is afgerond voor de start van de studie.
    - De Nederlandse taal niet goed kunnen beheersen.
    - Niet kunnen omgaan met een monitoring en coaching programma op afstand met behulp van een smartphone.
    - Geen fysieke activiteit kunnen verrichten.
    - Huidige zwangerschap.
    - Het geven van borstvoeding.
    E.5 End points
    E.5.1Primary end point(s)
    Reduction in number of patients treated by biologics in the treatment arm (EXACT@home) compared to the control arm (gold standard: immediate start of biologics after the indication is determined at the regional asthma MDTM).
    Reductie in het aantal patiënten behandeld met een biological in de interventiegroep (EXACT@home) vergeleken met de controle groep (gouden standaard: direct starten met biologicals nadat de indicatie is gesteld op het regionale astma MDO).
    E.5.1.1Timepoint(s) of evaluation of this end point
    After 6 months.
    Na 6 maanden.
    E.5.2Secondary end point(s)
    Percentage of patients treated with biologicals after 11-12 months of follow up, quality of life, asthma control, dyspnea perception, lung function, exacerbation frequency, prednisolone use, direct healthcare consumption, self-management skills, patient satisfaction, adherence to ICS/LABA therapy, inhaler technique, physical activity, sleep, vital parameters, breath pattern analysis with the eNose, safety of the BF-Digihaler-DS (digital inhaler) and SpiroNose (eNose) and the course of the treatment in each patient.
    Percentage patiënten dat behandeld wordt met een biological na 11-12 maanden, kwaliteit van leven, astma controle, dyspneu perceptie, long functie, exacerbatie frequentie, prednisolon gebruik, directe zorgconsumptie, zelfmanagement, patiënt tevredenheid, therapietrouw aan ICS/LABA therapie, inhalatietechniek, fysieke activiteit, slaap, vitale parameters, analyse van deeltjes in de uitgeademde lucht met de eNose, veiligheid van de BF-Digihaler-DS (digitale inhalator) en SpiroNose (eNose) en het beloop van de behandeling in elke individuele patiënt.
    E.5.2.1Timepoint(s) of evaluation of this end point
    After 6 and 11-12 months.
    Na 6 en 11-12 maanden.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    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) Yes
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    EXACT@home wordt vergeleken met de directe start van biologicals (na het regionale astma MDO)
    EXACT@home will be compared to the immediate start of biologics (after the regional asthma MDTM)
    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
    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 months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    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 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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 38
    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 2022-07-04. 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 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 state138
    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)
    The chosen treatment which is started during the study (treatment of treatable trait(s) or with a specific asthma biological) will be continued.
    De gekozen behandeling die gestart is tijdens de studie (behandeling van treatable trait(s) of met een specifieke astma biological) zal voorgezet worden.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-07-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-11-17
    P. End of Trial
    P.End of Trial StatusOngoing
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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