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    Summary
    EudraCT Number:2022-003784-15
    Sponsor's Protocol Code Number:2022_0422
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2023-01-31
    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 ConcernedFrance - ANSM
    A.2EudraCT number2022-003784-15
    A.3Full title of the trial
    Impact of inhaled BGF 160 on complexity and variability of tidal breathing and oscillatory mechanics in stable COPD patient.
    Impact du traitement inhalé triple BGF 160 sur la complexité et la variabilité du mode ventilatoire et l’oscillométrie chez les patients BPCO en état stable.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Impact of inhaled BGF 160 on complexity and variability of tidal breathing and oscillatory mechanics in stable COPD patient.
    Impact du traitement inhalé triple BGF 160 sur la complexité et la variabilité du mode ventilatoire et l’oscillométrie chez les patients BPCO en état stable.
    A.3.2Name or abbreviated title of the trial where available
    VARI-OSCIL
    VARI-OSCIL
    A.4.1Sponsor's protocol code number2022_0422
    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 SponsorCHU DE LILLE
    B.1.3.4CountryFrance
    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 supportAstraZeneca
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU de Lille (clinical research direction)
    B.5.2Functional name of contact pointRabah TEZKRATT (CRA)
    B.5.3 Address:
    B.5.3.1Street Address6 rue du Professeur Laguesse
    B.5.3.2Town/ cityLille
    B.5.3.3Post code59037
    B.5.3.4CountryFrance
    B.5.4Telephone number+33320444145
    B.5.5Fax number+33320445711
    B.5.6E-mailDRS.PROMOTION@CHRU-LILLE.FR
    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 Trixeo Aérosphère
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca AB
    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 nameTrixéo Aerosphere
    D.3.2Product code BGF 160
    D.3.4Pharmaceutical form Suspension and solution for spray
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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
    Impact of inhaled BGF 160 on complexity and variability of tidal breathing and oscillatory mechanics in stable COPD patient
    Impact du traitement inhalé triple BGF 160 sur la complexité et la variabilité du mode ventilatoire et l’oscillométrie chez les patients BPCO en état stable
    E.1.1.1Medical condition in easily understood language
    Impact of inhaled BGF 160 on complexity and variability of tidal breathing and oscillatory mechanics in stable COPD patient
    Impact du traitement inhalé triple BGF 160 sur la complexité et la variabilité du mode ventilatoire et l’oscillométrie chez les patients BPCO en état stable
    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 21.0
    E.1.2Level LLT
    E.1.2Classification code 10070975
    E.1.2Term Chronic obstructive bronchopneumopathy
    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 evaluate the change in ventilation pattern complexity and variability after 1 month of treatment by BGF 160
    Evaluer le changement de la complexité et de la variabilité du mode ventilatoire après un mois de traitement par BGF 160
    E.2.2Secondary objectives of the trial
    1.To assess the change in Oscillatory mechanics, Flows and Lung volumes one month after administration of BGF 160
    2. To assess the association between clinical response on dyspnea (TDI at V3) and the changes of variability/PFT between V2 and V3
    3. To compare dyspnea and symptoms before administration of BGF 160 (at V2 base (pre-treatment)) and after administration (at V3 peak (2 hours (+/-30min) at one month)
    4.To compare the ventilation pattern variability and complexity at the other time points :
    - V2 baseline vs V2 peak (first dose effect)
    - V2 baseline vsV3 trough (residual effect)
    Objectif secondaire n°1 : Evaluer le changement des paramètres EFR (oscillométrie, débits et distension) après un mois de traitement par BGF 160
    -
    Objectif secondaire n° 2 : étudier l’association entre la réponse clinique sur la dyspnée (TDI à V3 ) et (a) les variations des paramètres de complexité et de variabilité du mode ventilatoire (b) les variations des paramètres EFR ), après un mois de traitement par BGF 160
    Objectif secondaire n°3 : comparer les symptômes avant et après BGF 160 à 1 mois (V2 base vs V3 pic)
    Objectif secondaire 4: Comparer la variabilité et la complexité du mode ventilatoire et des paramètres EFR entre les autres temps :
    1) V2 base vs V2 Pic : effet première dose
    2) V2 base vs V3 creux : Effet résiduel
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Provision of signed informed consent prior to any study specific procedure
    - Female or male subjects aged 40-75 years inclusive at the time of enrolment (Visit 1)
    - Documented history of COPD with a post-bronchodilator FEV1/FVC <0.70 and a post-bronchodilator 30 % < FEV1 <70% of predicted normal value (according to ERS 1993 reference values for spirometry ) at screening
    - Smoking history > 10 pack-years
    - Baseline significant dyspnea with a mMRC ≥ 2
    - Patient ayant donné son consentement avant toute procédure liée à l’étude
    - Homme ou femme âgé de 40 à 75 ans à la visite d’inclusion
    - BPCO documentée avec un rapport VEMS/CVF post bronchodilatateur < 0,7 et un 30 % pred < VEMS < 70 % pred
    - Tabagisme > 10 paquets-années
    - Dyspnée significative avec une baseline mMRC ≥ 2
    E.4Principal exclusion criteria
    - History or current diagnosis of asthma or ACOS (asthma-COPD overlap syndrome)
    - Respiratory infection or COPD exacerbation within 6 weeks (2 months if it resulted in hospitalization) prior to screening
    - Clinically significant or relevant cardiovascular conditions, laboratory tests, electrocardiogram (ECG) parameters:
    o Unstable angina/acute coronary syndrome, or Coronary Artery Bypass Grafting (CABG), Percutaneous Coronary Intervention (PCI) or myocardial infarction within the past 6 months.
    o Congestive heart failure New York Heart Association (NYHA) class III/IV.
    o Structural heart disease (hypertrophic cardiomyopathy, significant valvular disease).
    o Paroxysmal (within the past 6 months) or symptomatic chronic cardiac tachyarrhythmia.
    o Left bundle branch or high-degree AV block (second degree AV block type 2 and third degree AV block) unless the patient has a pacemaker.
    o Sinus node dysfunction with pauses.
    o Ventricular pre-excitation and/or Wolff-Parkinson-White syndrome.
    o QTcF interval >470 msec (QT interval corrected using Fridericia's formula; QTcF=QT/[RR1/3]).
    o Any other ECG abnormality deemed clinically significant by the Investigator.
    o Bradycardia with ventricular rate < 45 bpm.
    o Uncontrolled hypertension (> 165/95 mmHg).
    - Clinically relevant respiratory conditions (other than COPD)
    - Severe renal impairment eGFR < 30
    - Hepatic impairment
    - Narrow-angle glaucoma that, in the opinion of the Investigator, has not been adequately treated.
    - Symptomatic prostatic hypertrophy or bladder neck obstruction/urinary retention that is clinically significant
    - Patients not able to perform IOS, spirometry, plethysmography, or VT acquisition (10 min)
    - Any contraindication to LABA or LAMA drugs or to Inhaled corticosteroids
    - Pregnancy or breastfeeding
    - Woman of childbearing age without effective contraception
    - Any type of cancer within 5 years
    - Patients under guardianship
    - Refuse or incapacity to give an informed consent
    - Absence of social insurance

    o Paroxysmal (within the past 6 months) or symptomatic chronic cardiac tachyarrhythmia.
    o Left bundle branch or high-degree AV block (second degree AV block type 2 and third degree AV block) unless the patient has a pacemaker.
    o Sinus node dysfunction with pauses.
    o Ventricular pre-excitation and/or Wolff-Parkinson-White syndrome.
    o QTcF interval >470 msec (QT interval corrected using Fridericia's formula; QTcF=QT/[RR1/3]).
    o Any other ECG abnormality deemed clinically significant by the Investigator.
    o Bradycardia with ventricular rate < 45 bpm.
    o Uncontrolled hypertension (> 165/95 mmHg).
    - Clinically relevant respiratory conditions (other than COPD)
    - Severe renal impairment eGFR < 30
    - Hepatic impairment
    - Narrow-angle glaucoma that, in the opinion of the Investigator, has not been adequately treated.
    - Symptomatic prostatic hypertrophy or bladder neck obstruction/urinary retention that is clinically significant
    - Patients not able to perform IOS, spirometry, plethysmography, or VT acquisition (10 min)
    - Any contraindication to LABA or LAMA drugs or to Inhaled corticosteroids
    - Pregnancy or breastfeeding
    - Woman of childbearing age without effective contraception
    - Any type of cancer within 5 years
    - Patients under guardianship
    - Refuse or incapacity to give an informed consent
    - Absence of social insurance
    - Freedom privacy
    - - Histoire d’asthme
    - Infection ou exacerbation dans les 6 semaines (2 mois si hospitalisation) avant le screening
    - Affections cardiovasculaires cliniquement significatives ou pertinentes :
    • Angor instable / syndrome coronarien aigu, ou pontage coronarien, angioplastie coronaire ou infarctus du myocarde au cours des 6 derniers mois
    • Insuffisance cardiaque congestive de classe III/IV selon la classification de la New York Heart Association (NYHA)
    • Cardiopathie structurale (cardiomyopathie hypertrophique, maladie valvulaire significative)
    • Tachycardie paroxystique (dans les 6 derniers mois) ou tachycardie chronique symptomatique
    • Bloc de branche gauche ou bloc AV de haut degré (bloc AV de second degré type 2 et bloc AV de troisième degré) sauf si le patient est équipé d'un pacemaker
    • Dysfonctionnement du nœud sinusal avec pauses
    • Pré-excitation ventriculaire et / ou syndrome de Wolff-Parkinson-White
    • Interval QTcF >470msec (intervalle QT corrigée en utilisant la formule de Fridericia : QTcF= QT/[RR1/3])
    • Toutes autres anomalies de l’ECG considérées comme significative par l’investigateur
    • Bradycardie avec un rythme ventriculaire <45 bpm
    • Hypertension non contrôlée (>165/95 mmHg)
    - Affections respiratoires cliniquement pertinentes (autre que la BPCO)
    - Insuffisance rénale sévère eGFR <30
    - Insuffisance hépatique
    - Glaucome à angle aigu
    - Hypertrophie prostatique symptomatique ou obstruction du col de la vessie / rétention urinaire cliniquement significative
    - Patient incapable d’effectuer les mesures EFR envisagées
    - Toute contre-indication au traitement bronchodilatateur ou corticoïde inhalé à l’étude
    - Femme enceinte ou allaitante
    - Femme en âge de procréer sans contraception efficace
    - Tout type de cancer dans les 5 dernières années
    - Patient sous tutelle ou curatelle
    - Refus ou incapacité du patient à donner son consentement éclairé
    - Patient non affilié à un régime de sécurité sociale
    E.5 End points
    E.5.1Primary end point(s)
    Analysis of tidal volume (VT) complexity (noise limit as main parameter ) :
    Comparison of the noise limit between V2 baseline (pre-treatment) and V3 peak (2 hours (+/-30min) post dose )
    différence entre la mesure à V2 base (pré traitement) et celle à V3 pic (2h (+/-30min) post dose à un mois) pour les 4 paramètres suivants : Noise limit (correspondant à la quantité de bruit blanc à ajouter au signal ventilatoire brut pour rejeter l’hypothèse de non linéarité de ce signal) entre V2 base et V3 Pic (2h (+/-30min) post dose). Ce paramètre est un indicateur de la complexité contenue dans le signal ventilatoire et son augmentation post traitement traduit un effet positif sur la mécanique ventilatoire (gain de variabilité), fréquence respiratoire, volume courant et exposant de Liapounov (permettant de quantifier la stabilité ou l'instabilité du mode ventilatoire par rapport à son état initial).
    E.5.1.1Timepoint(s) of evaluation of this end point
    During patients visits
    Au cours des visites des patients
    E.5.2Secondary end point(s)
    Outcome Measure 1:Change between V2 base (pre-treatment) and V3 peak (2 hours (+/-30min) post dose) of :
    - Impulse oscillometry or forced oscillation: resistances at 5Hz, reactance at 5Hz
    - Spirometry: Changes in FEV1
    - Plethysmographic Functional residual capacity (FRC)
    Outcome Measure 2:Changes between V2 base measurement (pre-treatment) and V3 peak (2 hours (+/-30min) measurement for noise limit, respiratory frequency, volume, largest Lyapounov component, resistances at 5Hz, reactance at 5Hz, FEV1and FRC versus TDI at V3 (in term of continuous variable and in term of binary variable “responder/non responder”; a response is defined by a change in TDI ≥+1 between baseline and V3)
    Outcome Measure 3:
    - dyspnea scores:
    - Baseline dyspnea index ( BDI)
    - Transition dyspnea index (TDI)
    - Modified dyspnea profile ( MDP)
    - CAT score
    - Likert scale for dyspnea and general health
    Outcome Measure 4:Noise limit, respiratory frequency, volume, largest Lyapounov compone, resistances at 5Hz, reactance at 5Hz, FEV1, FRC ,and VAS dyspnea/chest tightness
    Critères d’évaluation 1 : différence entre la mesure à V2 base (pré traitement) et celle à V3 pic (2h (+/-30min) post dose) pour les paramètres suivants :
    - Oscillométrie : résistances à 5 Hz, réactance à 5 Hz.
    - Spirométrie : VEMS
    - capacité résiduelle fonctionnelle (CRF pléthysmographique)

    Critères d’évaluation2 : TDI à V3 (quantitatif) et dichotomisée (réponse oui si variation de TDI ≥+1) versus différence des mesures entre V2 base et V3 pic pour (a) le noise limit, la fréquence respiratoire, le volume courant et l’exposant de Liapounov et pour (b) la résistance à 5hz, la réactance à 5hz, leVEMS et le CRF.

    Critères d’évaluation3 : score de dyspnée et symptômes évalué par le Baseline Dyspnea index (BDI)
    - Transition dyspnea index (TDI)
    - Modified Dyspnea Profile (MDP)
    - Echelle de Likert sur l’évolution de la dyspnée et de la santé globale
    - Questionnaire CAT


    Critères d’évaluation4 : noise limit, fréquence respiratoire, volume courant, exposant de Liapounov, résistance à 5hz, réactance à 5hz, VEMS, CRF , EVA dyspnée et oppression thoracique
    E.5.2.1Timepoint(s) of evaluation of this end point
    During patients visits
    Au cours des visites des patients
    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 Yes
    E.6.13.1Other scope of the trial description
    Physiopathologie
    Physiopathologie
    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 No
    E.8.1.1Randomised No
    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 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 concerned4
    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
    The study may be stopped if, in the judgment of study sponsor, trial
    subjects are placed at undue risk because of clinically significant
    findings that:
    - meet individual stopping criteria or are otherwise considered
    significant
    - are assessed as causally related to study drug,
    - are not considered to be consistent with continuation of the study
    L'étude peut être interrompue si, de l'avis du promoteur de l'étude, les sujets de l'essai sont exposés à un risque excessif en raison d'un problème clinique important.

    - répondent aux critères d'arrêt individuels ou sont autrement considérés comme
    significatives
    - sont évalués comme ayant un lien de causalité avec le médicament à l'étude,
    - ne sont pas considérées comme compatibles avec la poursuite de l'étude.
    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 months2
    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 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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 state35
    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)
    Patients will return to standard of care.
    Les patients retourneront aux traitements de référence.
    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 Decision2023-02-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-05-15
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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