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    Summary
    EudraCT Number:2019-004326-19
    Sponsor's Protocol Code Number:69HCL19_0029
    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:2019-11-13
    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 number2019-004326-19
    A.3Full title of the trial
    Pragmatic management of progressive disease in idiopathic pulmonary fibrosis: a randomized trial

    Prise en charge pragmatique de la fibrose pulmonaire idiopathique en progression : essai randomisé
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Management of Progressive Disease in Idiopathic Pulmonary Fibrosis
    Prise en charge pragmatique de la fibrose pulmonaire idiopathique en progression
    A.3.2Name or abbreviated title of the trial where available
    PROGRESSION-IPF
    PROGRESSION-IPF
    A.4.1Sponsor's protocol code number69HCL19_0029
    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 SponsorHospices Civils de Lyon
    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 supportMinistry of Health
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospices Civils de Lyon
    B.5.2Functional name of contact pointRegulatory Project Manager
    B.5.3 Address:
    B.5.3.1Street Address3 QUAI DES CELESTINS
    B.5.3.2Town/ cityLYON
    B.5.3.3Post code69002
    B.5.3.4CountryFrance
    B.5.4Telephone number472406829+33
    B.5.5Fax number472115190+33
    B.5.6E-maildrci_promo@chu-lyon.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 pirfenidone
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/04/241
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Capsule
    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 INNPIRFENIDONE
    D.3.9.1CAS number 53179-13-8
    D.3.9.4EV Substance CodeSUB09907MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number267
    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: 2
    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 nintedanib
    D.2.1.1.2Name of the Marketing Authorisation holderBoehringer Ingelheim International GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/13/1123
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Capsule, soft
    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.3.9.1CAS number 656247-17-5
    D.3.9.3Other descriptive nameNINTEDANIB
    D.3.9.4EV Substance CodeSUB120728
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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
    Idiopathic pulmonary fibrosis
    fibrose pulmonaire idiopathique
    E.1.1.1Medical condition in easily understood language
    Idiopathic pulmonary fibrosis
    Fibrose pulmonaire idiopathique
    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 10021240
    E.1.2Term Idiopathic pulmonary fibrosis
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of combination therapy of pirfenidone and nintedanib as compared to switch monotherapy (pirfenidone or nintedanib) and to no change monotherapy (pirfenidone or nintedanib) based on the slope of the decline in the forced vital capacity (FVC) measured during 24 weeks by hospital spirometry performed at baseline, week 4, week 12 and week 24 in patients with progressive worsening idiopathic pulmonary fibrosis.
    Comparer l'efficacité de l’association pirfenidone et nintedanib par rapport à un changement de monothérapie (pirfenidone ou nintedanib) et par rapport au maintien de la monothérapie (pirfenidone ou nintedanib) chez des patients avec aggravation progressive de leur fibrose pulmonaire idiopathique. L’efficacité sera évaluée par la pente de déclin de la capacité vitale forcée (CVF) mesurée pendant 24 semaines par spirométrie lors des visites à l’hôpital à la randomisation, à 4, 12 et 24 semaines de suivi.
    E.2.2Secondary objectives of the trial
    *To assess the tolerance during 24w of combination therapy versus switch monotherapy and versus no change monotherapy
    *To evaluate the impact of combination therapy as compared to switch monotherapy and to no change monotherapy on time to study drug permanent discontinuation,in death and FVC decline during the 24w follow-up,in hospitalization-free survival during the 24w follow-up, in first non-elective hospitalization from pulmonary cause during the 24w follow-up,in all-cause mortality during the 24w follow-up,in the progression of fibrotic features assessed by imaging by computed tomography at 24w compared to baseline,in supplementary oxygen therapy during the 24w follow-up, in acute exacerbation of IPF during the 24w follow-up,in the change in IPF questionnaires relative to symptoms and impact on quality of life between baseline and week 24
    *To evaluate the efficacy of combination therapy as compared to switch monotherapy and to no change monotherapy on time to treatment failure
    *Evaluer la tolérance pendant 24sem de l’association par rapport à un changement de monothérapie et au maintien de la monothérapie.
    *Evaluer l’impact de l’association par rapport à un changement de monothérapie et au maintien de la monothérapie:
    - sur la durée de traitement jusqu’à son arrêt définitif.
    -sur la mortalité et le déclin de la CVF.
    -sur la survie sans hospitalisation.
    -sur la durée avant première hospitalisation non programmée de cause pulmonairerespiratoire.
    -sur la mortalité toute cause.
    -sur la progression de la fibrose par tomodensitométrie à 24sem par rapport à la randomisation.
    - sur la supplémentation en oxygène.
    -sur le délai jusqu’à une exacerbation aiguë de FPI.
    -sur l’évolution des questionnaires FPI sur les symptômes et l’impact sur la qualité de vie entre la randomisation et 24 sem
    *Evaluer l’efficacité de l’association par rapport à un changement de monothérapie et au maintien de la monothérapie sur la durée de traitement jusqu’à son échec.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    - To evaluate the impact of combination therapy as compared to switch monotherapy and to no change monotherapy in the change in serum biomarkers between baseline and week 12 and week 24.
    - To evaluate if the variation of biomarkers between baseline and week 12 is predictive of the disease progression at week 24.
    - Evaluer l’impact pendant 24 semaines de l’association pirfenidone et nintedanib par rapport à un changement de monothérapie et au maintien de la monothérapie sur l’évolution des biomarqueurs entre la randomisation, 12 et 24 semaines.
    - Evaluer si la variation des biomarqueurs entre la randomisation et 12 semaines permet de prédire la progression de la maladie à 24 semaines.
    E.3Principal inclusion criteria
    - Patient aged ≥ 50 years.
    - Diagnosis of Idiopathic Pulmonary Fibrosis according to ATS/ERS/JRS/ALAT criteria (Raghu G et al, AJRCCM 2018). High-resolution computed tomography (HRCT) and histopathology patters are classified according to the table in protocol.
    - Patient with Idiopathic Pulmonary Fibrosis diagnosed since no more than 5 years.
    - Patient who fulfill at least 1 of the 4 criteria for IPF progression in the 12 months (+/- one month) before screening, despite antifibrotic treatment in clinical practice (if yes check the option(s)). These criteria are:
    0 Relative decline in FVC ≥10% predicted
    0 Relative decline in FVC ≥5-<10% predicted and worsened respiratory symptoms
    0 Relative decline in FVC ≥5-<10% predicted and increased extent of fibrotic changes on chest imaging
    0 Worsened respiratory symptoms and increased extent of fibrotic changes on chest imaging
    - Patient must have been on a stable dose of pirfenidone or nintedanib prescribed as first-line therapy for at least 6 months, with good tolerance of 1602 to 2403 mg per day of pirfenidone or 200 to 300 mg per day of nintedanib.
    - Patient who has a FVC ≥ 50% of predicted (according to the GLI standard).
    - Patient who has an uncorrected and/or Hemoglobin (Hb)- corrected and/or Hb uncorrected Diffusing capacity of the Lung for carbon monoxide (DLCO) ≥ 30% of predicted.
    - Patient who has a forced expiratory volume in 1 second (FEV1)/FVC ratio ≥ 0.70.
    - Patient who has a life expectancy of at least 9 months according to the investigator opinion.
    - Patient who has provided his written informed consent to participate in the study.
    - Patient affiliated to a social insurance regimen.
    - Patient d’âge ≥ à 50 ans.
    - Diagnostic de Fibrose Pulmonaire Idiopathique selon les critères ATS/ERS/JRS/ALAT (Raghu G et al, AJRCCM 2018). Les aspects en tomodensitométrie haute résolution et histopathologiques sont classés selon le tableau dans le protocole.
    - Patient ayant une fibrose pulmonaire idiopathique diagnostiquée depuis un maximum de 5 ans (inclus).
    - Patient remplissant au moins 1 des 4 critères de progression de la fibrose pulmonaire idiopathique dans les 12 mois (+/- un mois) précédant la visite de sélection, malgré un traitement antifibrotique (si oui, cochez la ou les option(s)). Ces critères sont:
    0 Déclin relatif de la CVF ≥ 10% de la valeur théorique
    0 Déclin relatif de la CVF ≥5-<10% de la valeur théorique et aggravation des symptômes respiratoires
    0 Déclin relatif de la CVF ≥5-<10% de la valeur théorique et augmentation de l’extension de la fibrose au scanner thoracique
    0 Aggravation des symptômes respiratoires et augmentation de l’extension de la fibrose au scanner thoracique
    - Patient traité en première intention depuis au moins 6 mois par pirfenidone ou nintedanib avec une bonne tolérance et à dose stable de 1602 à 2403 mg par jour de pirfenidone ou de 200 à 300 mg par jour de nintedanib.
    - Patient ayant une CVF ≥ 50% de la valeur théorique (selon la norme GLI)
    - Patient ayant une capacité de diffusion du monoxyde de carbone (DLCO) corrigée et/ou non corrigée en fonction du taux d’hémoglobine (Hb) ≥ 30% de la valeur théorique.
    - Patient ayant un rapport volume expiratoire maximal seconde (VEMS) / CVF ≥ 0,70.
    - Patient ayant une espérance de vie estimée d’au moins 9 mois selon le jugement de l’investigateur.
    - Patient ayant accepté de participer à l’étude et ayant donné son consentement libre, éclairé et signé.
    - Patient affilié à un régime de sécurité sociale ou assimilé.
    E.4Principal exclusion criteria
    - Patients under judicial protection.
    - Female patient who is pregnant or lactating, or is of child bearing potential (defined as a sexually mature woman not surgically sterilized or not post-menopausal for at least 24 consecutive months if ≤ 55 years or 12 months if > 55 years) and who did not agree to use highly effective methods of birth control throughout the study.
    - Patient who is currently on both pirfenidone and nintedanib.
    - Patient who has already received pirfenidone and nintedanib either concomitantly or successively.
    - Patient who has a contra-indication to pirfenidone or nintedanib.
    - Patient who has a liver function with elevations in ALT and AST >3 × upper limit of normal (ULN).
    - Patient who has a severe renal impairment (Creatinine Clearance <30 ml/min) or end stage renal disease requiring dialysis
    - Patient who has emphysema > 15% on HRCT or the extent of emphysema is greater than the extent of fibrosis according to reported results from the most recent HRCT.
    - Patient who had acute exacerbation of idiopathic pulmonary fibrosis within the previous 3 months.
    - Patient who has a history of cigarette smoking within the previous 3 months.
    - Patient who has received experimental therapy for IPF within the previous 4 weeks.
    - Patient who is receiving systemic corticosteroids equivalent to prednisone > 10 mg/day or equivalent within the previous 2 weeks.
    - Patient who received Immuno-suppressants (e.g. methotrexate, azathioprine, cyclophosphamide, cyclosporine, sirolimus, everolimus or other immunosuppressants) within the previous 4 weeks.
    - Patient who has a history of a malignancy within the previous 2 years, with the exception of basal cell skin neoplasms. In addition, a malignant diagnosis or condition first occurring prior to 2 years must be considered cured, inactive, and not under current treatment.
    - Patient who has any concurrent condition other than IPF that, in the Investigator’s opinion, is unstable and/or would impact the likelihood of survival for the study duration or the subject’s ability to complete the study as designed, or may influence any of the safety or efficacy assessments included in the study.
    - Patient who has baseline resting oxygen saturation of < 88% on room air or supplemental oxygen.
    - Patient who has a known post-bronchodilator (short-acting beta agonist [SABA] –albuterol or salbutamol) increase in FEV1 of >10% and in FVC of >7.5%.
    - Patient who had lung transplantation or who is on a lung transplant list and the investigator anticipates the patient will not be able to complete the study prior to transplant.
    - Patient sous mesure de protection juridique.
    - Patiente enceinte ou allaitante, ou en âge de procréer (définie comme une femme sexuellement mature non stérilisée chirurgicalement ou non ménopausée pendant au moins 24 mois consécutifs si d’âge ≤ 55 ans ou 12 mois consécutifs si d’âge > 55 ans) et qui refuse d’utiliser une méthode de contraception appropriée tout au long de l’étude.
    - Patient actuellement traité par l’association pirfenidone et nintedanib.
    - Patient ayant déjà reçu de la pirfenidone et du nintedanib soit de manière concomitante soit de manière successive.
    - Patient ayant une contre-indication à la pirfenidone ou au nintedanib.
    - Patient ayant un bilan hépatique avec une augmentation des ALAT et ASAT > 3 × la limite supérieure de la normale (LSN).
    - Insuffisance rénale sévère (Clairance de la Créatinine < 30 ml/min) ou en phase terminale nécessitant une dialyse.
    - Patient présentant un emphysème > 15% au scanner thoracique ou dont l’étendue de l’emphysème est supérieure à celle de la fibrose selon les résultats du dernier scanner.
    - Patient ayant eu une exacerbation aiguë de leur fibrose pulmonaire idiopathique dans les 3 derniers mois.
    - Patient ayant un antécédent de tabagisme dans les 3 derniers mois.
    - Patient ayant reçu un traitement expérimental de la fibrose pulmonaire idiopathique dans les 4 dernières semaines.
    - Patient ayant reçu des corticoïdes par voie systémique > 10 mg/jour de prednisone ou équivalent dans les 2 dernières semaines.
    - Patient ayant reçu des immunosuppresseurs (c’est-à-dire méthotrexate, azathioprine, cyclophosphamide, cyclosporine, sirolimus, évérolimus ou d’autres immunosuppresseurs) dans les 4 dernières semaines.
    - Patient ayant un antécédent de cancer au cours des 2 dernières années, à l'exception d’un carcinome basocellulaire. De plus, un premier cancer survenant au-delà de 2 ans doit être considéré comme guéri, inactif et ne doit plus être traité.
    - Patient présentant une affection intercurrente autre que la FPI et qui, de l’avis de l’investigateur, est instable et / ou aurait un impact sur sa probabilité de survie pendant la durée de l’étude ou sur sa capacité à mener l’étude à son terme, ou pourrait avoir un effet sur l’évaluation de la sécurité et/ou de l'efficacité du traitement à l’étude.
    - Patient dont la saturation en oxygène au repos est < 88% en air ambiant ou malgré une supplémentation en oxygène.
    - Patient présentant une élévation du VEMS de > 10% et de la CVF de > 7,5% suite à un bronchodilatateur (Bêta-2 stimulants d’action brève - albuterol ou salbutamol).
    - Patient ayant eu une transplantation pulmonaire ou patient inscrit sur liste d’attente de transplantation pulmonaire et qui ne serait pas en mesure de terminer l'étude avant la transplantation selon le jugement de l'investigateur.
    E.5 End points
    E.5.1Primary end point(s)
    Slope of the decline in the forced vital capacity (FVC) measured during 24 weeks by hospital spirometry performed on the same spirometer at baseline, week 4, week 12 and week 24.




    Pente de déclin de la capacité vitale force (CVF) mesurée pendant 24 semaines par spirométrie à l’hôpital réalisée sur le même spiromètre lors de la randomisation, à 4, 12 et 24 semaines de suivi.


    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 0, week 4, week 12 and week 24
    Jour 0, à 4, 12 et 24 semaines de suivi
    E.5.2Secondary end point(s)
    - Tolerance of antifibrotic therapy expressed as the proportion of patients who continue intent-to-treat therapy at week 24, at a minimal daily dose of two thirds of the full treatment dose (e.g. 200 mg/day of nintedanib and/or 1602 mg/day of pirfenidone), with temporary interruptions of no more than 28 consecutive days.
    - Time to permanent study drug discontinuation, defined as the interval from study treatment randomization to study drug permanent discontinuation or the end of follow-up. Study drug discontinuation will be considered in case of permanent termination of drug treatment allocated by randomization, transient discontinuation for longer than 28 consecutive days, or dose reduction below two thirds of the full treatment dose (i.e. 200 mg per day of nintedanib or 1602 mg per day or pirfenidone).
    - Time to treatment failure, defined as the time from study treatment randomization to the first occurrence during the 24 weeks follow-up of any of the following events:
    o Death from any cause,
    o Non-elective hospitalization from pulmonaryrespiratory cause (which will beis predefined by a set of criteria in protocol),
    o Acute exacerbation of idiopathic pulmonary fibrosis (idiopathic or triggered),
    o Decrease (based on relative decline) from baseline of ≥ 10% in FVC,
    o Permanent study drug discontinuation (see above) (all-cause).
    or the end of follow-up.
    - Proportion of patients with ≥ 10% FVC relative decline or death at week 24
    - Hospitalization-free survival, defined as the time from randomization to the first occurrence during the 24 weeks follow-up of any of the following events:
    o Death from any cause,
    o All-cause unscheduled hospital admission,
    or the end of follow-up.
    - Time from randomization to the first non-elective hospitalization from respiratory pulmonary cause (which iswill be predefined by a set of criteria in protocol) during the 24 weeks follow-up or the end of follow-up.
    - Time from randomization to death from any cause during the 24 weeks of the study or the end of follow-up.
    - Progression of disease evaluated by the change from baseline in volume of fibrotic features at imaging by computed tomography assessed at 24 weeks.
    - Time from randomization to initiation of supplementary oxygen therapy during the 24 weeks of the study or the end of follow-up.
    - Time from randomization to acute exacerbation of idiopathic pulmonary fibrosis (idiopathic or triggered) during the 24 weeks of the study or the end of follow-up.
    - Absolute change in IPF questionnaires relative to symptoms and impact on quality of life between baseline and week 24 assessed by : King’s Brief Interstitial Lung Disease Questionnaire (K-BILD), EQ-5D-5L Questionnaire, Living with Pulmonary Fibrosis (L-PF) Symptoms and Impact questionnaires, and analogy scale and Likert scale for the evaluation of dyspnea, cough and respiratory health.
    - La tolérance du traitement antifibrotique sera évaluée par la proportion de patients poursuivant le traitement en intention de traiter jusqu’à la semaine 24, c’est-à-dire à une dose quotidienne minimale de deux tiers de la dose complète (par exemple 200 mg / jour de nintedanib et / ou 1602 mg / jour de pirfenidone), avec des arrêts temporaires ne dépassant pas 28 jours consécutifs.
    - La durée de traitement jusqu’à son arrêt définitif est définie comme l'intervalle entre la randomisation et l'arrêt définitif du traitement à l'étude ou la fin du suivi. L’arrêt du traitement à l’étude est défini comme un arrêt définitif du traitement attribué lors de la randomisation, un arrêt transitoire pendant plus de 28 jours consécutifs ou une réduction de dose inférieure au deux tiers de la dose complète (soit 200 mg par jour de nintedanib ou 1602 mg par jour de pirfenidone).
    - La durée de traitement jusqu’à son échec est définie comme l'intervalle entre la randomisation et la première survenue de l'un des événements suivants pendant les 24 semaines de suivi :
    o Décès toute cause,
    o Hospitalisation non programmée d'origine pulmonairrespiratoire (qui sera prédéfinie par un ensemble de critères),
    o Exacerbation aiguë de la fibrose pulmonaire idiopathique (idiopathique ou secondaire),
    o Diminution de la CVF ≥ 10% par rapport à la randomisation (déclin relatif)
    o Arrêt définitif du traitement à l'étude (voir ci-dessus) (toute cause).
    ou la fin du suivi.
    - Proportion de patients ayant un déclin relatif de CVF ≥ 10% ou étant décédés à la 24e semaine
    - La survie sans hospitalisation est définie comme l'intervalle entre la randomisation et la première survenue de l'un des événements suivants pendant les 24 semaines de suivi :
    o Décès toute cause,
    o Admission non programmée à l'hôpital de toute cause,
    ou la fin du suivi.
    - Intervalle entre la randomisation et la première hospitalisation non programmée de cause respiratoire pulmonaire (qui estsera prédéfinie par un ensemble de critères dans le protocole) pendant les 24 semaines de suivi, ou la fin du suivi.
    - Intervalle entre la randomisation et le décès toute cause pendant les 24 semaines de suivi ou la fin du suivi.
    - La progression de la maladie sera évaluée par tomodensitométrie sur l’extension de la fibrose à 24 semaines par rapport à la randomisation.
    - Intervalle entre la randomisation et l’instauration d’une supplémentation en oxygène pendant les 24 semaines de suivi ou la fin du suivi.
    - Intervalle entre la randomisation et la survenue d’une exacerbation aiguë de la fibrose pulmonaire idiopathique (idiopathique ou secondaire) pendant les 24 semaines de suivi ou la fin du suivi.
    - Evolution des scores obtenues aux questionnaires de FPI sur les symptômes et l'impact sur la qualité de vie entre la randomisation et 24 semaines : Questionnaire de King sur la maladie pulmonaire interstitielle (K-BILD), Questionnaire EQ-5D-5L, Questionnaire de l’impact de la fibrose pulmonaire sur la qualité de vie (L-PF Impacts), Questionnaire portant sur les symptômes de la fibrose pulmonaire (L-PF Symptoms), et échelles analogiques et échelles de Likert sur l'évaluation de la dyspnée, de la toux et de la santé respiratoire.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 0, week 4, week 8, week 12 and week 24
    Jour 0, à 4,8, 12 et 24 semaines de suivi
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 concerned27
    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
    Dernière visite du dernier patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months43
    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 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: 189
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 189
    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 state378
    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
    aucun
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation OrphaLung network
    G.4.3.4Network Country France
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-01-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-01-27
    P. End of Trial
    P.End of Trial StatusOngoing
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