Étude de phase 2b évaluant l'innocuité et l'efficacité de l'AP01 chez les participants atteints de PPF
Une étude de phase 2b randomisée, en double aveugle, contrôlée par placebo, évaluant l'innocuité et l'efficacité de la solution de pirfénidone pour inhalation (AP01) chez les participants atteints de fibrose pulmonaire progressive (FPP)
A randomized, double-blind, placebo-controlled clinical study to evaluate the safety and efficacy of 2 doses of inhaled pirfenidone (AP01) versus placebo on top of standard of care in participants with PPF over 52 weeks.
Aperçu de l'étude
Statut
Les conditions
- Fibrose pulmonaire
- Maladie pulmonaire interstitielle
- Pneumopathie d'hypersensibilité
- Fibrose pulmonaire, maladie pulmonaire interstitielle
- Maladie pulmonaire interstitielle chez les patients atteints de polyarthrite rhumatoïde
- Fibrose pulmonaire progressive
- Fibrose Pulmonaire Secondaire à la Sclérose Systémique
- Maladie pulmonaire interstitielle avec sclérose systémique
- Maladie pulmonaire interstitielle due à une maladie du tissu conjonctif (Trouble)
- Maladie pulmonaire interstitielle avec phénotype fibrotique progressif dans des maladies classées ailleurs
Intervention / Traitement
Description détaillée
This is a randomized, double-blind, placebo-controlled clinical study to evaluate the safety and efficacy of 2 doses of AP01 (pirfenidone solution for inhalation) versus placebo on top of standard of care in participants with PPF over 52 weeks. Up to 300 eligible participants will be randomized to 1 of 3 treatment arms: AP01 high dose, AP01 low dose, or placebo.
Type d'étude
Inscription (Réel)
Phase
- Phase 2
Contacts et emplacements
Lieux d'étude
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Bavaria
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Munich, Bavaria, Allemagne, 81241
- Pneumologisches Studienzentrum München-West
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München, Bavaria, Allemagne, 81925
- Muenchen Klinik Bogenhausen - Klinik für Pneumologie und Pneumologische Onkologie
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Rosenheim, Bavaria, Allemagne, 83022
- RoMed Klinikum Rosenheim
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Lower Saxony
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Hanover, Lower Saxony, Allemagne, 30625
- Medizinische Hochschule Hannover
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Main Hessia
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Frankfurt, Main Hessia, Allemagne, 60389
- Studienzentrum Dr. Claus Keller
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North Rhine-Westphalia
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Essen, North Rhine-Westphalia, Allemagne, 45239
- Ruhrlandklinik Essen, Klinik fuer Pneumologie
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Rhineland-Palatinate
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Mainz, Rhineland-Palatinate, Allemagne, 55131
- Universitätsmedizin Mainz - Zentrum für Thoraxerkrankungen
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Saxony
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Leipzig, Saxony, Allemagne, 04103
- Uniklinikum Leipzig Medizinische Klinik II - Bereich
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State of Berlin
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Berlin, State of Berlin, Allemagne, 12351
- Vivantes Klinikum Neukölln - Klinik für Innere Medizin - Pneumologie und Infektiologie
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Buenos Aires
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Buenos Aires, Buenos Aires, Argentine, 1427
- Fundacion Respirar
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Buenos Aires, Buenos Aires, Argentine, C1056AB
- CINME
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Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentine, C1199ABH
- Hospital Italiano de Buenos Aires
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Mar del Plata, Buenos Aires, Argentine, 7600
- Instituto Ave Pulmo, Fundacion Enfisema
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Monte Grande, Buenos Aires, Argentine, 1842
- Clinica Monte Grande
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Quilmes, Buenos Aires, Argentine, B1878
- Centro Respiratorio Quilmes
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Córdoba Province
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Córdoba, Córdoba Province, Argentine, 5003
- Instituto de Medicina Respiratoria
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Tucumán Province
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San Miguel de Tucumán, Tucumán Province, Argentine, 4000
- CIMER Centro Integral de Medicina Respiratoria
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San Miguel de Tucumán, Tucumán Province, Argentine, 4000
- Investigaciones En Patologias Respiratorias
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Canberra, Australie, 2605
- Canberra Hospital
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New South Wales
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Camperdown, New South Wales, Australie, 2050
- Royal Prince Alfred Hospital
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Kingswood, New South Wales, Australie, 2745
- Nepean Lung & Sleep
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New Lambton, New South Wales, Australie, 2305
- John Hunter Hospital
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Sydney, New South Wales, Australie, 2109
- Macquarie University Clinical Trials Unit
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Westmead, New South Wales, Australie, 2145
- Westmead Hospital
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Perth West Australia
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Nedlands, Perth West Australia, Australie, 6009
- Institute for Respiratory Health
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Queensland
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Brisbane, Queensland, Australie, 4032
- Wallace Street Specialist Centre/Lung Research QLD Pty Ltd
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Victoria
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Footscray, Victoria, Australie, 3011
- Lung Research Victoria
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Melbourne, Victoria, Australie, 3004
- Alfred Health
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Leuven, Belgique, 3000
- UZ Leuven
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Liège, Belgique, 4000
- CHU de Liège
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British Columbia
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Vancouver, British Columbia, Canada, V5Z1M9
- Vancouver General Hospital
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Ontario
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Ajax, Ontario, Canada, L1S2J5
- Dynamic Drug Advancement
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Hamilton, Ontario, Canada, L8N 4A6
- St. Joseph's Healthcare Hamilton
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Quebec
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Montreal, Quebec, Canada, H4A 3J1
- Research Institute McGill University Health Center
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Québec, Quebec, Canada, G1V4G5
- Institut universitaire de cardiologie et de pneumologie de Québec-Université Laval
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Trois-Rivières, Quebec, Canada, G8T7A1
- CIC Mauricie
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Barcelona, Espagne, 08908
- Hospital Universitary de Bellvitge
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Cadiz, Espagne, 11009
- Hospital Universitario Puerta del Mar - Leon-Jimenez
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Andalusia
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Granada, Andalusia, Espagne, 18014
- Hospital Universitario Virgen de las Nieves
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Barcelona
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Barcelona, Barcelona, Espagne, 08025
- Hospital de Sant Pau y la Santa Creu
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Cantabria
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Santander, Cantabria, Espagne, 39008
- Hospital Universitario Marqués de Valdecilla
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Madrid
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Madrid, Madrid, Espagne, 28034
- Hospital Universitario Ramon y Cajal
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Madrid, Madrid, Espagne, 28007
- Hospital Gregorio Marañon
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Málaga
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Málaga, Málaga, Espagne, 29010
- Hospital Universitario Virgen de la Victoria
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Principality of Asturias
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Oviedo, Principality of Asturias, Espagne, 33011
- Hospital Universitario Central de Asturias
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Sevilla
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Seville, Sevilla, Espagne, 41013
- Hospital Universitario Virgen del Rocío
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Angers, France, 49933
- CHU Angers
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Le Kremlin-Bicêtre, France, 94270
- APHP - Hopital Bicetre
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Paris, France, 75014
- Hôpital Paris St Jozeph
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Pessac, France, 33604
- Hôpital Haut-Lévêque
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Cedex NA
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Rennes, Cedex NA, France, 35033
- CHU de Rennes
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Indre et Loire
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Tours, Indre et Loire, France, 37000
- CHU Tours
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Lorraine
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Metz, Lorraine, France, 57000
- Robert Schuman Hospital UNEOS
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Lyon
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Lyon, Lyon, France, 69677
- Louis Pradel Hospital
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Montpellier
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Montpellier, Montpellier, France, 34295
- University of Montpellier
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Ancona
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Torrette, Ancona, Italie, 60126
- A.O.U. delle Marche - Ospedale di Torrette
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Campania
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Naples, Campania, Italie, 80131
- Università degli Studi di Napoli Federico II - Ospedale Monaldi
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Naples, Campania, Italie, 80131
- Azienda Ospedaliera dei Colli - Ospedale Monaldi
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Emilia-Romagna
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Bologna, Emilia-Romagna, Italie, 40138
- IRCCS AOU di Bologna - Policlinico Sant' Orsola
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Giulia
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Venezia, Giulia, Italie, 34149
- Azienda Sanitaria Universitaria Giuliano Isontina
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Lombardy
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Pavia, Lombardy, Italie, 27100
- Fondazione IRCCS Policlinico San Matteo - UOC Pneumologia
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Milano
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Milan, Milano, Italie, 20123
- Ospedale San Giuseppe
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Rozzano, Milano, Italie, 20089
- HUMANITAS Research Hospital
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Sicily
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Catania, Sicily, Italie, 95123
- A.O.U. Policlinico G. Rodolico
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Auckland
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Auckland, Auckland, Nouvelle-Zélande, 1051
- Greenlane Clinical Centre
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Canterbury
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Christchurch, Canterbury, Nouvelle-Zélande, 8011
- Health New Zealand
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Dunedine
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Dunedin, Dunedine, Nouvelle-Zélande, 9016
- Dunedin Hospital
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South Tauranga
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Tauranga, South Tauranga, Nouvelle-Zélande, 3112
- Bay of Plenty Clinical School
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Rotterdam, Pays-Bas, 3015 GD
- Erasmus University Medical Center
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Utrecht
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Nieuwegein, Utrecht, Pays-Bas, 3435
- St Antoniusziekenhuis
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Lodz, Pologne, 90-153
- Department of Pneumology of the University Hospital No 1
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Lodz, Pologne, 90-602
- PRYWATNY GABINET LEKARSKI GINEKOLOGIA I POŁOZNICTWO ULTRASONOGRAFIA Prof. Dr hab. Med. Jacek Suzin
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Bydgoszc
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Bydgoszcz, Bydgoszc, Pologne, 85-079
- Vitamed Galaj I Cichomski sp.j.
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Krakow
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Krakow, Krakow, Pologne, 30-688
- University Hospital in Krakow
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Łódź Voivodeship
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Lodz, Łódź Voivodeship, Pologne, 90-349
- AppleTreeClinics Network
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Cambridge, Royaume-Uni, CB2 0BB
- Royal Papworth Hospital
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London, Royaume-Uni, SW3 6HP
- Royal Brompton Hospital
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Manchester, Royaume-Uni, M23 9LT
- Manchester University NHS Foundation Trust
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Nottingham, Royaume-Uni, NG5 1PB
- Nottingham University NHS Trust
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Stoke-on-Trent, Royaume-Uni, ST4 6QG
- University Hospitals of North Midlands NHS Trust, Royal Stoke University Hospital
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East Yorkshire
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Cottingham, East Yorkshire, Royaume-Uni, HU16 5JQ
- Hull University Teaching Hospital NHS Trust
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Heartlands
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Birmingham, Heartlands, Royaume-Uni, B95SS
- Birmingham Heartlands Hospital
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Leicester
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Glenfield, Leicester, Royaume-Uni, LE3 9QP
- Leicester Biomedical Research Centre - Respiratory Theme
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London
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London, London, Royaume-Uni, sw17 0QT
- St George's University Hospitals NHS Foundation Trust
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Midlands
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Birmingham, Midlands, Royaume-Uni, B15 2GW
- ILD Unit, University Hospitals Birmingham NHS Foundation Trust Theme
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Northern Ireland
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Londonderry, Northern Ireland, Royaume-Uni, BT46
- C-TRIC Altnagelvin Hospital
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Oxon
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Oxford, Oxon, Royaume-Uni, OX3 7LE
- Oxford University Hospitals NHS Foundation Trust
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South West
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Exeter, South West, Royaume-Uni, EX2 5DW
- Royal Devon
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West Midlands
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Wolverhampton, West Midlands, Royaume-Uni, WV10 0QP
- The Royal Wolverhampton NHS Trust, New Cross Hospital, Research and Development
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West Yorkshire
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Leeds, West Yorkshire, Royaume-Uni, LS9 7TF
- St James University Hospital - LTHT
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Adana, Turquie (Türkiye), 01240
- Cukurova University Medical Faculty
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Ankara, Turquie (Türkiye), 06010
- Health Sciences University, Gulhane Faculty of Medicine
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İzmir
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Bornova, İzmir, Turquie (Türkiye), 35100
- Ege University Medical Faculty Hospital
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Alabama
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Birmingham, Alabama, États-Unis, 35205
- University of Alabama at Birmingham
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Arizona
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Scottsdale, Arizona, États-Unis, 85259
- Mayo Clinic- Scottsdale
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California
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Los Angeles, California, États-Unis, 90033
- University of Southern California
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Los Angeles, California, États-Unis, 90048
- Cedars-Sinai
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Los Angeles, California, États-Unis, 90095
- UCLA
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Newport Beach, California, États-Unis, 92663
- Newport Native MD, Inc.
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Redding, California, États-Unis, 96001
- Paradigm Clinical Research - Redding
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San Francisco, California, États-Unis, 94143
- University of California - San Francisco
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Colorado
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Aurora, Colorado, États-Unis, 80045
- University of Colorado, Anschutz Medical Campus
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Denver, Colorado, États-Unis, 80206
- National Jewish Health
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Connecticut
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Farmington, Connecticut, États-Unis, 06030
- UCONN Health
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New Haven, Connecticut, États-Unis, 06519
- Yale University
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Florida
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Leesburg, Florida, États-Unis, 34748
- Clinical Site Partners, LCC
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Ocala, Florida, États-Unis, 34470
- Renstar Medical Research
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Winter Park, Florida, États-Unis, 32789
- Clinical Site Partners
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Georgia
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Atlanta, Georgia, États-Unis, 30309
- Piedmont Healthcare, Inc.
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Illinois
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Chicago, Illinois, États-Unis, 60611
- Northwestern University
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Evanston, Illinois, États-Unis, 60201
- Endeavor Health
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Maywood, Illinois, États-Unis, 60153
- Loyola University Medical Center
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Kansas
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Kansas City, Kansas, États-Unis, 66160
- The University of Kansas Medical Center
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Maryland
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Baltimore, Maryland, États-Unis, 21201
- University of Maryland
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Baltimore, Maryland, États-Unis, 21224
- Johns Hopkins University
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Massachusetts
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Boston, Massachusetts, États-Unis, 02215
- Beth Israel Deaconess Medical Center
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Michigan
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Ann Arbor, Michigan, États-Unis, 48109
- University of Michigan
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Minnesota
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Minneapolis, Minnesota, États-Unis, 55455
- University of Minnesota
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Rochester, Minnesota, États-Unis, 55905
- Mayo Clinic Rochester
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Missouri
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Hannibal, Missouri, États-Unis, 63401
- Hannibal Regional Healthcare System
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New York
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Mount Kisco, New York, États-Unis, 10549
- Northern Westchester Hospital
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Mount Kisco, New York, États-Unis, 10549
- Northwell Health - Mount Kisco
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New York, New York, États-Unis, 10032
- Columbia University
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New York, New York, États-Unis, 10029
- Icahn School of Medicine at Mount Sinai
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New York, New York, États-Unis, 10021
- Weill Cornell
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New York, New York, États-Unis, 10017
- NYU Langone Health
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The Bronx, New York, États-Unis, 10467
- Montefiore Medical Center
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North Carolina
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Durham, North Carolina, États-Unis, 27710
- Duke University
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Statesville, North Carolina, États-Unis, 28625
- Piedmont HealthCare, PA
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Wilmington, North Carolina, États-Unis, 28401
- Accellacare
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Winston-Salem, North Carolina, États-Unis, 27103
- Southeastern Research Center
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Ohio
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Cincinnati, Ohio, États-Unis, 45267
- University of Cincinnati
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Cleveland, Ohio, États-Unis, 44195
- Cleveland Clinic
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Oregon
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Beaverton, Oregon, États-Unis, 97008
- The Oregon Clinic Pulmonary West
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Bend, Oregon, États-Unis, 97701
- Summit Health
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Portland, Oregon, États-Unis, 97220
- The Oregon Clinic Pulmonary East
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Portland, Oregon, États-Unis, 97225
- The Oregon Clinic Pulmonary West
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Pennsylvania
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Hershey, Pennsylvania, États-Unis, 17033
- The Pennsylvania State University
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Philadelphia, Pennsylvania, États-Unis, 19107
- Thomas Jefferson University
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Philadelphia, Pennsylvania, États-Unis, 19140
- Temple University
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South Carolina
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Charleston, South Carolina, États-Unis, 29425
- Medical University of South Carolina
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Charleston, South Carolina, États-Unis, 29406
- Lowcountry Lung and Critical Care
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Tennessee
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Franklin, Tennessee, États-Unis, 37067
- Clinical Trials Center of Middle Tennessee
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Nashville, Tennessee, États-Unis, 37204
- Vanderbilt Lung Institute
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Texas
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Dallas, Texas, États-Unis, 75390
- UT Southwestern Medical Center
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Dallas, Texas, États-Unis, 75246
- Baylor Scott & White Research Institute, Baylor University Medical Center
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El Paso, Texas, États-Unis, 79902
- El Paso Pulmonary Association
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Houston, Texas, États-Unis, 77030
- Baylor College of Medicine
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Houston, Texas, États-Unis, 77030
- The University of Texas Health Science Center
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McKinney, Texas, États-Unis, 75069
- Metroplex Pulmonary and Sleep Center, PA
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Utah
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Murray, Utah, États-Unis, 84157
- Intermountain Medical Center
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Salt Lake City, Utah, États-Unis, 84108
- University of Utah Health
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Virginia
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Falls Church, Virginia, États-Unis, 22042
- Inova Healthcare
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Washington
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Seattle, Washington, États-Unis, 98195
- University of Washington
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Participant meets criteria for PPF, as follows:
- In subjects with interstitial lung disease (ILD) of known or unknown etiology other than idiopathic pulmonary fibrosis (IPF) who have radiological evidence of pulmonary fibrosis, PPF is defined as:
Physiological evidence of disease progression with at least 1 of the following criteria despite treatment with approved or unapproved medications commonly used in practice (per Investigator):
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Relative decline in FVC ≥10% predicted within the previous 24 months based on documented historical spirometry assessments
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Relative decline in FVC ≥5% to <10% predicted within the previous 24 months based on documented historical spirometry assessments with at least 1 of the 2 following criteria:
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Worsening respiratory symptoms (Note: Changes attributable to comorbidities e.g., infection, heart failure must be excluded) OR
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Radiological (HRCT) evidence of disease progression per a local or central radiologist (from historical HRCT taken up to 24 months prior to Screening Visit 1), for example:
- Increased extent or severity of traction bronchiectasis and bronchiolectasis
- New ground-glass opacity with traction bronchiectasis
- New fine reticulation
- Increased extent or increased coarseness of reticular abnormality
- New or increased honeycombing
- Increased lobar volume loss
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Worsening of respiratory symptoms (Note: Changes attributable to comorbidities e.g., infection, heart failure must be excluded) AND radiological (HRCT) evidence of disease progression per a local or central radiologist
- Meeting all of the following criteria during the Screening Period:
a. FVC ≥45% of predicted normal at Screening Visit 1, b. Forced expiratory volume at 1 second (FEV1)/FVC ≥0.7 or ≥age-adjusted lower limit of normal at Screening Visit 1, c. Diffusing capacity of lung for carbon monoxide (DLCO) ≥30% of predicted, corrected for hemoglobin at Screening Visit 1, d. Acceptability: Participants can perform acceptable spirometry (i.e., meet American Thoracic Society (ATS)/ European Respiratory Society (ERS) acceptability criteria at both Screening Visits).
• For subjects already on background therapy (nintedanib or nerandomilast 18 mg twice daily [up to 30% of subjects]): Must have been on background therapy for at least 12 weeks prior to Screening with or without dose adjustments and/or drug interruptions during that period. For subjects who have discontinued background therapy prior to Screening: Must have been off for a minimum of 12 weeks.
Exclusion Criteria:
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Current treatment with oral pirfenidone or nerandomilast 9 mg twice daily dose or treatment with oral pirfenidone within 3 months prior to Screening.
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Elevated liver enzymes and liver injury at Screening defined as:
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ˃ 3 times the upper limit of normal (ULN)
- Bilirubin >2.0 x ULN
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Renal disease with a creatinine clearance < 30 mL/min, calculated according to the Chronic Kidney Disease Epidemiology Collaboration formula. Retesting is allowed once.
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Diagnosis of idiopathic pulmonary fibrosis (IPF) based on the ATS diagnostic algorithm for IPF. UIP that is not idiopathic, for example related to rheumatoid arthritis (RA), familial interstitial lung disease (ILD), or other is not exclusionary.
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Greater extent of emphysema than of fibrotic ILD on HRCT. Note: CT results must be confirmed through the central over read process.
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Significant clinical worsening of PPF between Screening Visit 1 and Visit 3
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Participants who cannot meet protocol-specified Baseline stability criteria. FVC Baseline stability is defined as the FVC assessments at Visit 3 being within ±12% of the mean of the FVC assessments obtained at the 2 preceding visits. At Visit 3, if the pre-dose FVC is outside of ±12% range, the participant will not be randomized and will be considered a screen failure.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: AP01 High Dose BID
Pirfenidone Solution for Inhalation |
Oral inhalation solution
Autres noms:
|
|
Expérimental: AP01 Low Dose BID
Pirfenidone Solution for Inhalation |
Oral inhalation solution
Autres noms:
|
|
Comparateur placebo: Placebo BID
Placebo solution for inhalation |
Placebo oral inhalation solution |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
To evaluate the effect of AP01 high dose twice a day (BID) or AP01 low dose twice a day (BID) compared to placebo twice a day (BID)
Délai: Week 52
|
Change from baseline in forced vital capacity (FVC) (mL) |
Week 52
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
To evaluate the effect of AP01 high dose and AP01 low dose compared to placebo on disease progression (defined as absolute FVC percent predicted decline of ≥10% prior to Week 52)
Délai: 52 weeks
|
Time to disease progression |
52 weeks
|
|
To evaluate the effect of AP01 high dose, AP01 low dose compared to placebo on quality of life (QoL)
Délai: 52 weeks
|
Absolute change from Baseline in QoL measurements as assessed by Living with Pulmonary Fibrosis Symptoms and Impact Questionnaire (L-PF) total score. The L-PF is a 44-item questionnaire to assess how impacted a participant is by disease symptoms on a scale from 0 (Not at all) to 4 (Extremely). The higher the summary score, the greater the impairment. |
52 weeks
|
|
To evaluate the change from baseline in quantitative lung fibrosis score.
Délai: 52 weeks
|
Change in lung fibrosis score. |
52 weeks
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
To evaluate the safety of AP01 high dose and AP01 low dose compared to placebo
Délai: 52 weeks
|
Incidents of adverse events (AEs), serious adverse events (SAEs), and treatment-emergent deaths |
52 weeks
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Directeur d'études: Avalyn Pharma, Inc., Avalyn Pharma Inc.
Publications et liens utiles
Publications générales
- West A, Chaudhuri N, Barczyk A, Wilsher ML, Hopkins P, Glaspole I, Corte TJ, Sterclova M, Veale A, Jassem E, Wijsenbeek MS, Grainge C, Piotrowski W, Raghu G, Shaffer ML, Nair D, Freeman L, Otto K, Montgomery AB. Inhaled pirfenidone solution (AP01) for IPF: a randomised, open-label, dose-response trial. Thorax. 2023 Sep;78(9):882-889. doi: 10.1136/thorax-2022-219391. Epub 2023 Mar 22.
- Kolb M, Corte TJ, Feldman J, Nathan SD, Reisner C, Nair D, Woodhead F, Lazarus H, Conoscenti C. Design of the MIST study: a double-blind, randomised, placebo-controlled phase 2b trial of pirfenidone solution for inhalation in patients with progressive pulmonary fibrosis. BMJ Open Respir Res. 2025 Dec 25;12(1):e003059. doi: 10.1136/bmjresp-2024-003059.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
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Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Processus pathologiques
- Maladies du système immunitaire
- Maladies des voies respiratoires
- Maladies pulmonaires
- Hypersensibilité respiratoire
- Hypersensibilité immédiate
- Hypersensibilité
- Fibrose
- Conditions pathologiques, signes et symptômes
- Fibrose pulmonaire
- Maladies pulmonaires interstitielles
- Alvéolite allergique extrinsèque
Autres numéros d'identification d'étude
- AP01-007
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
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