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    Summary
    EudraCT Number:2019-001924-37
    Sponsor's Protocol Code Number:D3250C00072
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-11-04
    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 ConcernedFrance - ANSM
    A.2EudraCT number2019-001924-37
    A.3Full title of the trial
    SHAMAL: A Multicentre, Randomised, Open-Label, Parallel-Group, Active-Controlled, Phase IV Study to Assess the Reduction of Daily Maintenance ICS/LABA Treatment Towards Anti-Inflammatory Reliever Treatment in Patients with Severe Eosinophilic Asthma Treated with Benralizumab
    SHAMAL : Étude de Phase IV multicentrique, randomisée, menée en ouvert, avec groupes parallèles, contrôlée versus traitement actif, évaluant la réduction du traitement d’entretien quotidien par ICS/LABA en faveur d'un traitement anti-inflammatoire de crise chez des patients présentant un asthme éosinophilique sévère traités par benralizumab
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A trial to test if the dose of daily maintenance inhaler can be safely reduced without loss of asthma control in patients taking Fasenra for severe eosinophilic asthma.
    A.3.2Name or abbreviated title of the trial where available
    SHAMAL
    A.4.1Sponsor's protocol code numberD3250C00072
    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 SponsorAstraZeneca AB
    B.1.3.4CountrySweden
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAstraZeneca AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca AB
    B.5.2Functional name of contact pointInformation Center
    B.5.3 Address:
    B.5.3.1Street AddressN/A
    B.5.3.2Town/ cityN/A
    B.5.3.3Post codeN/A
    B.5.3.4CountrySweden
    B.5.4Telephone numberN/A
    B.5.5Fax numberN/A
    B.5.6E-mailinformation.center@astrazeneca.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 No
    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 nameBenralizumab
    D.3.2Product code MEDI-563
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBenralizumab
    D.3.9.1CAS number 1044511-01-4
    D.3.9.2Current sponsor codeMEDI-563
    D.3.9.3Other descriptive nameBenralizumab
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 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 Symbicort Turbohaler
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca UK Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameSymbicort Turbohaler
    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.3.9.3Other descriptive namebudesonide/formoterol
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400/12
    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: 3
    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 Symbicort Turbohaler
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca France
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameSymbicort Turbohaler
    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.3.9.3Other descriptive namebudesonide/formoterol
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200/6
    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
    Severe eosinophilic asthma
    Asthme éosinophilique sévère
    E.1.1.1Medical condition in easily understood language
    Severe asthma with eosinophilia
    Asthme sévère avec éosinophilie
    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 LLT
    E.1.2Classification code 10068462
    E.1.2Term Eosinophilic asthma
    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 assess the potential for Fasenra® - treated patients to reduce Symbicort® maintenance treatment while maintaining asthma symptom control
    Évaluer la possibilité pour les patients traités par Fasenra® de réduire le traitement d’entretien par Symbicort® tout en maintenant le contrôle des symptômes d’asthme
    E.2.2Secondary objectives of the trial
    - To assess changes in patient-reported outcomes for Fasenra® -treated patients while stepping down Symbicort® maintenance treatment
    - To assess the potential for Fasenra® - treated patients to maintain lung function while stepping down Symbicort® maintenance treatment
    - To assess asthma exacerbation rate
    - To assess the total ICS dose exposure
    - To assess if reductions in Symbicort® maintenance achieved at the end of the reduction period are maintained until the end of the maintenance period
    - Évaluer les changements des résultats déclarés par les patients traités par Fasenra® tout en diminuant progressivement le traitement d’entretien par Symbicort®
    - Évaluer la possibilité pour les patients traités par Fasenra® de maintenir leur fonction pulmonaire tout en diminuant progressivement le traitement d’entretien par Symbicort®
    - Évaluer le taux d’exacerbation de l’asthme
    - Évaluer l’exposition totale aux ICS
    - Évaluer si les réductions du traitement d’entretien par Symbicort® obtenues à la fin de la période de réduction sont maintenues jusqu’à la fin de la période d’entretien
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Sub-study biomarkers

    A subset of patients who consent to participation in the sub-study (approximately 32 patients are to be included, spread across the 2 treatment arms) will undergo bronchoscopy and nasosorption sampling at specific timepoints for exploratory biomarker research. Patients will be enrolled from 1 study site in the UK and will be stratified separately from the main study with a 3:1 ratio by treatment arm (treatment reduction arm: reference arm)

    Objective: To characterise the effects of Fasenra® on airway inflammation after reducing daily Symbicort® therapy (sub-study)
    Sous-étude

    Un sous-ensemble de patients acceptant de participer à la sous-étude (environ 32 patients doivent être inclus, répartis à travers les 2 bras de traitement) fera l’objet d’une bronchoscopie et d'un prélèvement par nasosorption à des moments spécifiques pour la recherche exploratoire sur les biomarqueurs. Les patients seront recrutés dans 1 centre d'étude au Royaume-Uni et ils seront stratifiés séparément de l’étude principale selon un rapport 3/1 par bras de traitement (bras de réduction du traitement/bras de référence).

    Objectif: Caractériser les effets de Fasenra® sur l’inflammation des voies aériennes après la réduction du traitement quotidien par Symbicort®
    E.3Principal inclusion criteria
    1 Provision of informed consent prior to any study-specific procedures
    2 Patient must be aged 18 years old or above at the time of consenting to study participation
    3 Documented current maintenance treatment with high-dose ICS/LABA
    4 ACQ-5 score <1.5 at Visit 1
    5 Treatment with Fasenra® for the indicated diagnosis of severe eosinophilic asthma and has received at least 3 consecutive doses (>8 weeks) prior to Visit 1
    6 Male or female
    7 Negative serum pregnancy test at Visit 1 for women of childbearing potential (WOCBP)
    8 WOCBP must agree to use a highly effective method of birth control (confirmed by the Investigator) from randomisation throughout the study duration and within 16 weeks after the last dose of study treatment. Highly effective forms of birth control include:
    - Combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation-oral, intravaginal, or transdermal
    - Progestogen-only hormonal contraception associated with inhibition of ovulation-oral, injectable, or implantable
    - Intrauterine device (IUD)
    - Intrauterine hormone-releasing system (IUS)
    - Bilateral tubal occlusion
    - Sexual abstinence, ie, refraining from heterosexual intercourse (the reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the patient)
    - Vasectomised sexual partner (provided that partner is the sole sexual partner of the WOCBP study patient and that the vasectomised partner has received medical assessment of the surgical success)
    Women not of childbearing potential are defined as women who are either permanently sterilized (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), or who are postmenopausal Women will be considered postmenopausal if they have been amenorrhoeic for ≥12 months prior to the planned date of randomisation without an alternative medical cause.
    The following age-specific requirements apply:
    - Women <50 years old will be considered postmenopausal if they have been amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatment and have follicle stimulating hormone (FSH) levels in the postmenopausal range. Until FSH or luteinizing hormone is documented to be within menopausal range, treat the patient as WOCBP
    - Women ≥50 years old will be considered postmenopausal if they have been amenorrhoeic for 12 months or more following cessation of all exogenous hormonal treatment
    1 Fourniture du consentement éclairé avant toute activité spécifique de l'étude
    2 Les patients doivent être âgés de 18 ans ou plus au moment de la fourniture de leur consentement pour la participation à l'étude
    3 Traitement d’entretien actuel documenté par ICS à dose élevée/LABA.
    4 Score ACQ-5 <1,5 à la Visite 1.
    5 Traitement par Fasenra® pour le diagnostic indiqué d'asthme éosinophilique sévère, avec au moins 3 doses consécutives (>8 semaines) reçues avant la Visite 1
    6 Homme ou femme
    7 Test sérique de grossesse négatif lors de la Visite 1 pour les femmes en âge de procréer.
    8 Les femmes en âge de procréer doivent accepter d’utiliser une méthode de contraception hautement efficace (confirmée par l’investigateur) à partir de la randomisation, pendant toute la durée de l'étude et pendant 16 semaines après la dernière dose de traitement à l’étude. Les formes de contraception hautement efficaces incluent :
    • Contraception hormonale combinée (contenant un estrogène et un progestatif) associée à une inhibition de l’ovulation, orale, intravaginale ou transdermique.
    • Contraception hormonale à base de progestatif uniquement, associée à une inhibition de l’ovulation, orale, injectable ou implantable.
    • Dispositif intra-utérin (DIU).
    • Système intra-utérin (SIU) libérant des hormones.
    • Ligature bilatérale des trompes.
    • Abstinence sexuelle, c’est-à-dire absence de rapports hétérosexuels (la fiabilité de l’abstinence sexuelle doit être évaluée en tenant compte de la durée de l’essai clinique et du mode de vie préféré et habituel du patient).
    • Partenaire sexuel vasectomisé (à condition que cet homme soit le seul partenaire sexuel de la participante en âge de procréer et que la réussite de sa vasectomie ait fait l’objet d’une évaluation médicale).
    Les femmes non en âge de procréer sont définies comme des femmes ayant fait l’objet d’une stérilisation définitive (hystérectomie, ovariectomie bilatérale ou salpingectomie bilatérale)
    ou qui sont ménopausées. Les femmes seront considérées comme ménopausées en cas
    d’aménorrhée ≥ 12 mois avant la date prévue de randomisation, sans autre cause médicale.
    Les exigences spécifiques de l’âge suivantes s'appliquent :
    • Les femmes âgées de moins de 50 ans seront considérées comme ménopausées en cas d’aménorrhée ≥ 12 mois après l'arrêt d'un traitement hormonal exogène et de taux de folliculostimuline (FSH) situé dans la plage compatible avec une ménopause. Jusqu'à ce qu’il soit documenté que le taux de FSH ou d’hormone lutéinisante se situe dans la plage compatible avec une ménopause, la patiente doit être traitée comme si elle était en âge de procréer.
    • Les femmes ≥50 ans seront considérées comme ménopausées en cas d’aménorrhée ≥ 12 mois après l'arrêt de tout traitement hormonal exogène.



    E.4Principal exclusion criteria
    1 As judged by the Investigator, any evidence of a severe or serious treatment-related AE during Fasenra® treatment which in the Investigator’s opinion makes it undesirable for the patient to participate in the study
    2 History of exacerbation requiring systemic corticosteroids or hospitalisation during the last 3 months prior to Visit 1 or during the run-in period
    3 Clinically important pulmonary disease other than asthma (eg, active lung infection, COPD, bronchiectasis, pulmonary fibrosis, cystic fibrosis), or ever been diagnosed with pulmonary or systemic disease, other than asthma, that are associated with elevated peripheral eosinophil counts (eg, allergic bronchopulmonary aspergillosis/mycosis, Churg-Strauss syndrome, hypereosinophilic syndrome)
    4 Current smokers or former smokers with a smoking history ≥20 pack/years
    5 History of alcohol or drug abuse within 12 months prior to Visit 1
    6 A helminth parasitic infection diagnosed within 24 weeks prior to Visit 1 that has not been treated with, or has failed to respond to, standard of care therapy
    7 History of anaphylaxis to any biologic therapy
    8 Known history of allergy or reaction to any component of the study treatment formulation
    9 A history of known immunodeficiency disorder, including history of a positive human immunodeficiency virus (HIV) test
    10 Current malignancy, or history of malignancy, except for:
    - Patients who have had basal cell carcinoma, localized squamous cell carcinoma of the skin or in situ carcinoma of the cervix are eligible provided that the patient is in remission and curative therapy was completed at least 12 months prior to the date informed consent was obtained
    - Patients who have had other malignancies are eligible provided that the patient is in remission and curative therapy was completed at least 5 years prior to the date informed consent was obtained
    1 Tout signe d’EI sévère ou grave lié au traitement pendant l’administration de Fasenra® qui, de l'avis de l’investigateur, rend non souhaitable la participation du patient à l’étude
    2 Antécédents d’exacerbation nécessitant des corticoïdes systémiques ou une hospitalisation au cours des 3 derniers mois précédant la Visite 1 ou pendant la période de préinclusion.
    3 Maladie pulmonaire cliniquement importante autre que l’asthme (par exemple, infection bronchique active, BPCO, bronchiectasie, fibrose pulmonaire, fibrose kystique) ou diagnostic passé ou actuel de maladie bronchique ou systémique, autre que l'asthme, associée à des taux élevés d’éosinophiles périphériques (par exemple, aspergillose/mycose bronchopulmonaire allergique, syndrome de Churg-Strauss, syndrome hyperéosinophilique).
    4 Fumeurs actuels ou anciens fumeurs ayant des antécédents tabagiques ≥20 paquets-année.
    5 Antécédents d'alcoolisme ou de toxicomanie dans les 12 mois précédant la Visite 1.
    6 Infection helminthique diagnostiquée au cours des 24 semaines précédant la Visite 1 n’ayant pas été traitée par le traitement de référence ou n’ayant pas répondu au traitement de référence.
    7 Antécédents d'anaphylaxie à n’importe quel traitement biologique.
    8 Antécédents connus d’allergie ou de réaction à l’un des constituants de la formulation du traitement à l'étude.
    9 Antécédents d’immunodéficience connue, y compris antécédents de test positif pour le virus de l’immunodéficience humaine (VIH).
    10 Cancer actuel ou antécédents de cancer, sauf :
    • Les patients ayant présenté un carcinome basocellulaire, un cancer épidermoïde localisé de la peau ou un cancer in situ du col utérin sont éligibles, à condition qu’ils soient en rémission et que le traitement curatif soit terminé au moins 12 mois avant la date d'obtention du consentement éclairé.
    • Les patients ayant présenté d’autres cancers sont éligibles, à condition qu’ils soient en rémission et que le traitement curatif soit terminé au moins 5 ans avant la date d'obtention du consentement éclairé.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of patients who reduced their Symbicort® maintenance dose at the end of the reduction period (Week 32) to:
    - Medium-dose Symbicort® maintenance and reliever therapy (SMART), or
    - Low-dose SMART, or
    - Symbicort® anti-inflammatory reliever only
    Proportion de patients ayant réduit leur dose d’entretien par Symbicort® à la fin de la période de réduction (Semaine 32) pour :
    o Traitement d’entretien et de crise par Symbicort® (SMART) à dose moyenne, ou
    o SMART à dose faible, ou
    o Traitement anti-inflammatoire de crise par Symbicort® uniquement.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Refer section E.5.1
    cf section E.5.1
    E.5.2Secondary end point(s)
    - Change from baseline in ACQ-5 score at the end of the reduction period
    - Change from baseline in AQLQ(S)+12 at the end of the reduction period
    - Proportion of patients with no deterioration in AQLQ(S)+12 (deterioration defined as a decrease of at least 0.5 units compared to baseline) at the end of the reduction period
    - Proportion of patients with no deterioration in ACQ-5 (deterioration defined as an increase of at least 0.5 units compared to baseline) at the end of the reduction period
    - Change from baseline in pre-bronchodilator FEV1during the study period
    - Annualised asthma exacerbation rate during the study period
    - Cumulative total daily ICS dose (maintenance + reliever) for:
    o The reduction period
    o The maintenance period
    o The study period
    - Total daily ICS dose (maintenance + reliever) at the end of the reduction period
    - Proportion of patients using the same Symbicort® daily dose at the end of the maintenance period (Week 48) that they achieved at the end of the reduction period (Week 32)
    - Supportive outcomes:
    o Number of exacerbations occurring from end of the reduction period to end of the maintenance period
    o Total daily ICS dose from the end of the reduction period to the end of the maintenance period
    o Change in ACQ-5, AQLQ(S)+12, and FEV1from the end of the reduction period to the end of the maintenance period
    • Changement par rapport à l’inclusion du score ACQ-5 à la fin de la période de réduction.
    • Changement par rapport à l’inclusion du score AQLQ(S)+12 à la fin de la période de réduction.
    • Proportion de patients sans détérioration du score AQLQ(S)+12 (détérioration définie comme une diminution d'au moins 0,5 unités par rapport à l’inclusion) à la fin de la période de réduction.
    • Proportion de patients sans détérioration du score ACQ-5 (détérioration définie comme une augmentation d'au moins 0,5 unités par rapport à l’inclusion) à la fin de la période de réduction.
    • Changement par rapport à l’inclusion du VEMS pré-bronchodilatateur pendant la période de l’étude.
    • Taux annualisé d’exacerbation de l’asthme pendant la période de l'étude.
    • Dose d’ICS quotidienne totale cumulée (entretien + crise) pour :
    o La période de réduction.
    o La période d’entretien.
    o La période de l’étude.
    • Dose quotidienne totale d’ICS (entretien + crise) à la fin de la période de réduction.
    • Proportion de patients utilisant la même dose quotidienne de Symbicort® à la fin de la période d’entretien (Semaine 48) qu’à la fin de la période de réduction (Semaine 32).
    • Résultats auxiliaires :
    o Nombre d’exacerbations survenant entre la fin de la période de réduction et la fin de la période d’entretien.
    o Dose quotidienne totale d’ICS entre la fin de la période de réduction et la fin de la période d’entretien.
    o Changement des scores ACQ-5 et AQLQ(S)+12 et du VEMS entre la fin de la période de réduction et la fin de la période d’entretien.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Refer section E.5.2
    cf section E.5.2
    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 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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    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
    The end of study is defined as the last expected visit/contact of the last patient undergoing the study
    LPLV
    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 months5
    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 months6
    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: 200
    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 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 state47
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 240
    F.4.2.2In the whole clinical trial 240
    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)
    There are no plans to provide study treatment after termination of the study. Study drugs are commercially available.
    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 Decision2020-01-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-01-21
    P. End of Trial
    P.End of Trial StatusOngoing
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