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1. Rapid Improvement after Starting Elexacaftor–Tezacaftor–Ivacaftor in Patients with Cystic Fibrosis and Advanced Pulmonary Disease

Author

Pierre-Régis Burgel, Isabelle Durieu, Raphaël Chiron, Sophie Ramel, Isabelle Danner-Boucher, Anne Prevotat, Dominique Grenet, Christophe Marguet, Martine Reynaud-Gaubert, Julie Macey, Laurent Mely, Annlyse Fanton, Sébastien Quetant, Lydie Lemonnier, Jean-Louis Paillasseur, Jennifer Da Silva, Clémence Martin, Claire Andrejak, Arnaud Becourt, Julie Mounard, Claire Poulet, Cinthia Rames, Marie Talleux, Marie-Chantal Chevalier, Estelle Darviot, Marie Jouvenot, Caroline Marien, Audrey Paris, Cécile Pelatan, Christine Person, Pascaline Priou, Françoise Troussier, Thierry Urban, Marie-Laure Dalphin, Jean-Charles Dalphin, Alice Ladaurade, Didier Pernet, Bénédicte Richaud-Thiriez, Pauline Roux-Claude, Nathalia Blanc, Vincent Boisserie-Lacroix, Stephanie Bui, Cyrielle Collet, Stéphane Debelleix, Emmanuel Bergot, Jacques Brouard, Karine Campbell, Muriel Laurans, Virginie Ribault, Corinne Borderon, Marie-Christine Heraud, Guillaume Labbe, Sylvie Montcouquiol, Isabelle Petit, Marc Ruivard, Céline Delestrain, Benoit Douvry, Ralph Epaud, Bernard Maitre, Natascha Remus, Guillaume Beltramo, Anne Houzel, Frédéric Huet, Stéphanie Perez, Amale Boldron-Ghaddar, Manuela Scalbert, Rabah Bouzioukh, Charles Simon, Boubou Camara, Rébecca Hamidfar, Catherine Llerena, Isabelle Pin, Antoine Deschildre, Alice Gicquello, Olivier Le Rouzic, Clara Leroy, Nicolas Paris, Thierry Perez, Caroline Thumerelle, Dominique Turck, Nathalie Wizla, Magali Dupuy-Grasset, Jane Languepin, Alexandra Masson-Rouchaud, Céline Menetrey, Stéphane Durupt, Sophie L’Excellent, Raphaele Nove-Josserand, Camille Ohlmann, Phillipe Reix, Quitterie Reynaud, Marie-Christine Werck-Gallois, Mélissandre Baravalle, Bérangère Coltey, Nadine Desmazes-Dufeu, Jean-Christophe Dubus, Clarisse Gautier, Jean-Baptiste Rey, Nathalie Stremler, Davide Caimmi, Margot Devrait, Johan Moreau, Yves Billon, Aurore Blondé, Anne Guillaumot, Sébastien Kiefer, Laura Peretti, Aurélie Tatopoulos, Angélica Tiotiu, Myriam Benhamida, Tiphaine Bihouee, Emmanuel Eschapasse, Adrien Tissot, Marie Giannantonio, Sylvie Leroy, Carole Piccini-Bailly, Johana Pradelli, Jonathan Messika, Véronique Boussaud, Nicolas Carlier, Isabelle Honoré, Dominique Hubert, Reem Kanaan, Céline Bailly-Botuha, Frédérique Chedevergne, Jacques De Blic, Christophe Delacourt, David Drummond, Brigitte Fauroux, Chantal Karila, Muriel Le Bourgeois, Isabelle Sermet, Bertrand Delaisi, Michèle Gerardin, Veronique Houdouin, Laurence Leclainche, Guillaume Aubertin, Laura Berdah, Annick Clement, Harriet Corvol, Nadia Nathan, Blandine Prevost, Nicolas Richard, Aline Tamalet, Jessica Taytard, Guillaume Thouvenin, Barbara Tourniaire, Michel Abely, Katia Bessaci-Kabouya, Sandra Dury, Bruno Ravoninjatovo, Alain Dabadie, Michel Dagorne, Eric Deneuville, Marie Jamin, Mélanie Ribault, Clémentine Vigier, Chantal Belleguic, Graziella Brinchault, Benoit Desrues, Audrey Barzic, Anne Dirou-Prigent, Jean Le Bihan, Krista Revert, Thomas Ropars, Laure Couderc, Stéphane Dominique, Hélène Morisse-Pradier, Stéphanie Pramil, Luc Thiberville, Nathalie Allou, Laurent Enaud, Elsa Gachelin, Eric Huchot, Annabelle Payet, Caroline Perisson, Saguiraly Piyaraly, Sophie Valois, Audrey Herzog, Romain Kessler, Michele Porzio, Laurence Weiss, Laurence Beaumont, Olivier Brugiere, Sylvie Colin, de Verdiere, Elise Cuquemelle, Sandra De Miranda, Adbdul Monem Hamid, François Parquin, Clément Picard, Antoine Roux, Charlotte Roy, François Bremont, Alain Didier, Marion Dupuis, Guillaume Faviez, Géraldine Labouret, Marie Mittaine, Marlène Murris-Espin, Léa Roditis, Laure Cosson, Patrice Diot, Thomas Flament, Charlotte Giraut, Julie Mankikian, Baptiste Arnouat, Gaétane Mousset, Véronique Storni, Philippe Vigneron, Emmanuelle Coirier-Duet, Asma Gabsi, Institut Cochin (IC UM3 (UMR 8104 / U1016)), Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Université Paris Cité (UPCité), Hôpital Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Hospices Civils de Lyon (HCL), Université de Lyon, Hôpital Arnaud de Villeneuve [CHRU Montpellier], Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Fondation ILDYS (ILDYS), Institut du Thorax [Nantes], Centre hospitalier universitaire de Nantes (CHU Nantes), Hôpital Albert Calmette, Université de Lille, Droit et Santé-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Hôpital Foch [Suresnes], CHU Rouen, Normandie Université (NU), INSERM-TRANSFERT [Paris] (IT), Institut National de la Santé et de la Recherche Médicale (INSERM), Université de Rouen Normandie (UNIROUEN), Hôpital Nord [CHU - APHM], Aix Marseille Université (AMU), CHU Bordeaux [Bordeaux], Hôpital Renée Sabran [CHU - HCL], CHU Dijon, Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon), Centre Hospitalier Universitaire [Grenoble] (CHU), Vaincre la Mucoviscidose, Association de lutte contre la Mucoviscidose, EFFI-STAT, URC/CIC Paris Descartes Necker Cochin, Hôpital Necker, Institut Desbrest de santé publique (IDESP), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM), CHU Trousseau [APHP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Supported by Vaincre la Mucoviscidose, Fondation Sauver la Vie, Universite Paris Descartes, Filiere Maladies Rares Muco-CFTR, and Legs PascalBonnet., Participating Investigators of the FrenchCystic Fibrosis Reference Network StudyGroup:Claire Andrejak, Arnaud Becourt, JulieMounard, Claire Poulet, Cinthia Rames, MarieTalleux (Amiens), Marie-Chantal Chevalier,Estelle Darviot, Marie Jouvenot, Caroline Marien,Audrey Paris, C ecile Pelatan, Christine Person,Pascaline Priou, Franc ̧oise Troussier, ThierryUrban (Angers-Le Mans), Marie-Laure Dalphin,Jean-Charles Dalphin, Alice Ladaurade, DidierPernet, B en edicte Richaud-Thiriez, PaulineRoux-Claude (Besanc ̧on), Nathalia Blanc,Vincent Boisserie-Lacroix, Stephanie Bui,Cyrielle Collet, St ephane Debelleix, Julie Macey(Bordeaux), Emmanuel Bergot, JacquesBrouard, Karine Campbell, Muriel Laurans,Virginie Ribault (Caen), Corinne Borderon,Marie-Christine Heraud, Guillaume Labbe,SylvieMontcouquiol, Isabelle Petit, Marc Ruivard(Clermont-Ferrand), C eline Delestrain, BenoitDouvry, Ralph Epaud, Bernard Maitre, NataschaRemus (Cr eteil), Guillaume Beltramo, AnnlyseFanton, Anne Houzel, Fr ed eric Huet, St ephaniePerez (Dijon), AmaleBoldron-Ghaddar, ManuelaScalbert (Dunkerque), Rabah Bouzioukh,Laurent Mely, Charles Simon (Giens), BoubouCamara, R ebecca Hamidfar, Catherine Llerena,Isabelle Pin, S ebastien Quetant (Grenoble), Antoine Deschildre, Alice Gicquello, Olivier LeRouzic, Clara Leroy, Nicolas Paris, Thierry Perez,Anne Prevotat, Caroline Thumerelle, DominiqueTurck, Nathalie Wizla (Lille), Magali Dupuy-Grasset, Jane Languepin, Alexandra Masson-Rouchaud, C eline Menetrey (Limoges), IsabelleDurieu, St ephane Durupt, Sophie L’Excellent,Raphaele Nove-Josserand, Camille Ohlmann,Phillipe Reix, Quitterie Reynaud, Marie-ChristineWerck-Gallois (Lyon), M elissandre Baravalle,B erang ere Coltey, Nadine Desmazes-Dufeu,Jean-Christophe Dubus, Clarisse Gautier, Jean-Baptiste Rey, Martine Reynaud-Gaubert,Nathalie Stremler (Marseille), Davide Caimmi,Rapha€el Chiron, Margot Devrait, Johan Moreau(Montpellier), Yves Billon, Aurore Blond e, AnneGuillaumot, S ebastien Kiefer, Laura Peretti,Aur elie Tatopoulos, Ang elica Tiotiu (Nancy), Myriam Benhamida, Tiphaine Bihouee, IsabelleDanner-Boucher, Emmanuel Eschapasse,Adrien Tissot (Nantes), Marie Giannantonio,Sylvie Leroy, Carole Piccini-Bailly, JohanaPradelli (Nice), Jonathan Messika (Paris, Bichat), V eronique Boussaud, Pierre-R egis Burgel,Nicolas Carlier, Isabelle Honor e, DominiqueHubert, Reem Kanaan, Cl emence Martin (Paris,Cochin), C eline Bailly-Botuha, Fr ed eriqueChedevergne, Jacques De Blic, ChristopheDelacourt, David Drummond, Brigitte Fauroux,Chantal Karila, Muriel Le Bourgeois, IsabelleSermet (Paris, Necker), Bertrand Delaisi,Mich ele Gerardin, Veronique Houdouin,Laurence Leclainche (Paris, Robert Debr e), Guillaume Aubertin, Laura Berdah, AnnickClement, Harriet Corvol, Nadia Nathan, BlandinePrevost, Nicolas Richard, Aline Tamalet, JessicaTaytard, Guillaume Thouvenin, BarbaraTourniaire (Paris, Trousseau), Michel Abely,Katia Bessaci-Kabouya, Sandra Dury, BrunoRavoninjatovo (Reims), Alain Dabadie, MichelDagorne, Eric Deneuville, Marie Jamin, M elanieRibault, Cl ementine Vigier (Rennes – SaintBrieuc), Chantal Belleguic, Graziella Brinchault,Benoit Desrues (Rennes), Audrey Barzic, AnneDirou-Prigent, Jean Le Bihan, Sophie Ramel,Krista Revert, Thomas Ropars (Roscoff), LaureCouderc, St ephane Dominique, ChristopheMarguet, H el ene Morisse-Pradier, St ephaniePramil, Luc Thiberville (Rouen), Nathalie Allou,Laurent Enaud, Elsa Gachelin, Eric Huchot,Annabelle Payet, Caroline Perisson, SaguiralyPiyaraly, Sophie Valois (La R eunion), AudreyHerzog, Romain Kessler, Michele Porzio,Laurence Weiss (Strasbourg), LaurenceBeaumont, Olivier Brugiere, Sylvie Colin deVerdiere, Elise Cuquemelle, Sandra De Miranda,Dominique Grenet, Adbdul Monem Hamid,Franc ̧ois Parquin, Cl ementPicard, Antoine Roux,Charlotte Roy (Suresnes), Franc ̧ois Bremont,Alain Didier, Marion Dupuis, Guillaume Faviez,G eraldine Labouret, Marie Mittaine, Marl eneMurris-Espin, L ea Roditis (Toulouse), LaureCosson, Patrice Diot, Thomas Flament, CharlotteGiraut, JulieMankikian(Tours), Baptiste Arnouat,Ga etane Mousset, V eronique Storni, PhilippeVigneron (Vannes-Lorient), and Emmanuelle Coirier-Duet, and Asma Gabsi (Versailles)

Subjects
Lung Diseases, Male, elexacaftor, Indoles, Cystic Fibrosis, Pyridines, medicine.medical_treatment, Regulator, Aminophenols, Critical Care and Intensive Care Medicine, [SDV.MHEP.PSR]Life Sciences [q-bio]/Human health and pathology/Pulmonology and respiratory tract, Cystic fibrosis, Gastroenterology, Membrane Potentials, Ivacaftor, 0302 clinical medicine, Prospective Studies, 030212 general & internal medicine, Chloride Channel Agonists, Aged, 80 and over, Middle Aged, Transmembrane protein, Drug Combinations, Quinolines, Female, France, medicine.drug, Adult, Pulmonary and Respiratory Medicine, congenital, hereditary, and neonatal diseases and abnormalities, medicine.medical_specialty, cystic fibrosis transmembrane conductance regulator modulators, Adolescent, Pulmonary disease, Young Adult, 03 medical and health sciences, Internal medicine, lung transplantation, medicine, Humans, Lung transplantation, In patient, Aged, [SDV.MHEP.PED]Life Sciences [q-bio]/Human health and pathology/Pediatrics, business.industry, Editorials, medicine.disease, 030228 respiratory system, Tezacaftor, Pyrazoles, business
Abstract

International audience; Rationale: Elexacaftor-tezacaftor-ivacaftor is a CFTR (cystic fibrosis [CF] transmembrane conductance regulator) modulator combination, developed for patients with CF with at least one Phe508del mutation. Objectives: To evaluate the effects of elexacaftor-tezacaftor- ivacaftor in patients with CF and advanced respiratory disease. Methods: A prospective observational study, including all patients aged ⩾12 years and with a percent-predicted FEV1 (ppFEV1)

Published
2021
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2. Safety and Dose Study of Targeted Lung Denervation in Moderate/Severe COPD Patients

Author

Valipour, Arschang, Shah, Pallav L, Pison, Christophe, Ninane, Vincent, Janssens, Wim, Perez, Thierry, Kessler, Romain, Deslee, Gaetan, Garner, Justin, Abele, Christine, Hartman, Jorine E, Slebos, Dirk-Jan, Chen, A, Gorden, J, Issa, Z, McDonald, G, Pulling, C, Aalbers, R, Ferrera, D, Leh, L, Firlinger, Irene, Kothakuzhakal, Kiran, Duller, Marina, Muylle, Inge, Rummens, Peter, De Cock, Frederique, Dooms, Christophe, DeBent, Kristien, Briault, Amandine, Arbib, Francois, Jondot, Marie, Ferretti, Gilbert, Fournier, Clement, Matran, Regis, Catto, Michele, Bautin, Nathalie, De Broucker, Virginie, Willemin, Marie, Prevotat, Anne, Wemeau, Ludivine, Gicquello, Alice, Foulon, Morgane, Camara, Hasna, Vallerand, Herve, Dury, Sandra, Gras, Delphine, Bonnaire-Verdier, Margaux, Hirschi, Sandrine, Porzio, Michele, Degot, Tristan, Canuet, Mathieu, Schuller, Armelle, Stauder, Julien, Azouaou, Sahra Ali, Srikanthan, Karthi, Caneja, Cielito, Thornton, John, Ten Hacken, Nick, Hartman, Jorine, Augustijn, Sonja, Klooster, Karin, Groningen Research Institute for Asthma and COPD (GRIAC), Department of Respiratory and Critical Care Medicine, Ludwig-Boltzmann-Institute for COPD and Respiratory Epidemiology, Otto-Wagner-Spital, Vienna, Royal Brompton and Harefield NHS Trust, Chelsea and Westminster Hospital, and Imperial College, London, Centre Hospitalier Universitaire [Grenoble] (CHU), Laboratory of Fundamental and Applied Bioenergetics = Laboratoire de bioénergétique fondamentale et appliquée (LBFA), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Grenoble Alpes [2016-2019] (UGA [2016-2019]), CHU Saint-Pierre, Université libre de Bruxelles, Bruxelles, Department of Respiratory Diseases, KU Leuven, University Hospitals Leuven, Leuven, Centre d’Infection et d’Immunité de Lille - INSERM U 1019 - UMR 9017 - UMR 8204 (CIIL), Centre National de la Recherche Scientifique (CNRS)-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille)-Université de Lille-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut Pasteur de Lille, Réseau International des Instituts Pasteur (RIIP)-Réseau International des Instituts Pasteur (RIIP), Service de Pneumologie, Nouvel Hôpital Civil, Université de Strasbourg, Strasbourg, Hôpital Maison Blanche, Centre Hospitalier Universitaire de Reims (CHU Reims), University Medical Center Groningen [Groningen] (UMCG), Imperial College London, Université libre de Bruxelles (ULB), Institut Pasteur de Lille, and Réseau International des Instituts Pasteur (RIIP)-Réseau International des Instituts Pasteur (RIIP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lille-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille)-Centre National de la Recherche Scientifique (CNRS)

Subjects
Pulmonary and Respiratory Medicine, Male, [SDV.MHEP.PSR]Life Sciences [q-bio]/Human health and pathology/Pulmonology and respiratory tract, law.invention, 03 medical and health sciences, Pulmonary Disease, Chronic Obstructive, 0302 clinical medicine, Quality of life, Randomized controlled trial, law, Bronchoscopy, Parasympathectomy, medicine, Clinical endpoint, Humans, Interventional Pulmonology, 030212 general & internal medicine, Dosing, Adverse effect, Lung, Aged, COPD, business.industry, Radiofrequency ablation, Middle Aged, medicine.disease, Acetylcholine, 3. Good health, medicine.anatomical_structure, 030228 respiratory system, Anesthesia, Lung disease obstructive, Female, Pneumologie, Airway, business
Abstract

Rationale: Targeted lung denervation (TLD) is a novel bronchoscopic treatment for the disruption of parasympathetic innervation of the lungs. Objectives: To assess safety, feasibility, and dosing of TLD in patients with moderate to severe COPD using a novel device design. Methods: Thirty patients with COPD (forced expiratory volume in 1 s 30-60%) were 1:1 randomized in a double-blinded fashion to receive TLD with either 29 or 32 W. Primary endpoint was the rate of TLD-associated adverse airway effects that required treatment through 3 months. Assessments of lung function, quality of life, dyspnea, and exercise capacity were performed at baseline and 1-year follow-up. An additional 16 patients were enrolled in an open-label confirmation phase study to confirm safety improvements after procedural enhancements following gastrointestinal adverse events during the randomized part of the trial. Results: Procedural success, defined as device success without an in-hospital serious adverse event, was 96.7% (29/30). The rate of TLD-associated adverse airway effects requiring intervention was 3/15 in the 32 W versus 1/15 in the 29 W group, p = 0.6. Five patients early in the randomized phase experienced serious gastric events. The study was stopped and procedural changes made that reduced both gastrointestinal and airway events in the subsequent phase of the randomized trial and follow-up confirmation study. Improvements in lung function and quality of life were observed compared to baseline values for both doses but were not statistically different. Conclusions: The results demonstrate acceptable safety and feasibility of TLD in patients with COPD, with improvements in adverse event rates after procedural enhancements., SCOPUS: ar.j, info:eu-repo/semantics/published

Published
2019
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3. Artificial Intelligence in International Arbitration

Author

Myriam Gicquello

Subjects
business.industry, Political science, Arbitration, Proposition, International arbitration, Artificial intelligence, business, Legitimacy, Rule of law, Variety (cybernetics), Adjudication, Meaning (linguistics)
Abstract

This chapter assesses the introduction of artificial intelligence in international arbitration. The contention is that it would not only reinstate confidence in the arbitral system—from the perspective of the parties and the general public—and participate in the development of the rule of law, but also engage with broader systemic considerations in enhancing its legitimacy, fairness, and efficiency. Yet, before addressing the why, what, and how of this proposition, a definition of artificial intelligence is warranted. It should be noted at the outset that this concept has a variety of meanings. Despite the lack of consensus on its meaning, the chapter will thus treat artificial intelligence as encompassing both semi-autonomous and autonomous computer systems dedicated to assisting or replacing human beings in decision-making tasks. It presents the conclusions of two extensive research programs respectively dealing with the performance of statistical models and naturalistic decision-making. From that behavioural analysis, the introduction of artificial intelligence in international arbitration be discussed against the general considerations of international adjudication and the specific goals pertaining to international arbitration.

Published
2020
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4. Real-Life Safety and Effectiveness of Lumacaftor-Ivacaftor in Patients with Cystic Fibrosis

Author

Pierre-Régis Burgel, Anne Munck, Isabelle Durieu, Raphaël Chiron, Laurent Mely, Anne Prevotat, Marlene Murris-Espin, Michele Porzio, Michel Abely, Philippe Reix, Christophe Marguet, Julie Macey, Isabelle Sermet-Gaudelus, Harriet Corvol, Stéphanie Bui, Lydie Lemonnier, Clémence Dehillotte, Jennifer Da Silva, Jean-Louis Paillasseur, Dominique Hubert, Julie Mounard, Claire Poulet, Cinthia Rames, Christine Person, Françoise Troussier, Thierry Urban, Marie-Laure Dalphin, Jean-Claude Dalphin, Didier Pernet, Bénédicte Richaud-Thiriez, Mickael Fayon, Julie Macey-Caro, Karine Campbell, Muriel Laurans, Corinne Borderon, Marie-Christine Heraud, André Labbé, Sylvie Montcouquiol, Laurence Bassinet, Natascha Remus, Annlyse Fanton, Anne Houzel-Charavel, Frédéric Huet, Stéphanie Perez-Martin, Amale Boldron-Ghaddar, Manuela Scalbert, Boubou Camara, Catherine Llerena, Isabelle Pin, Sébastien Quétant, Aurélie Cottereau, Antoine Deschildre, Alice Gicquello, Thierry Perez, Lidwine Stervinou-Wemeau, Caroline Thumerelle, Benoit Wallaert, Nathalie Wizla, Jane Languepin, Céline Ménétrey, Magalie Dupuy-Grasset, Lucie Bazus, Clelia Buchs, Virginie Jubin, Marie-Christine Werck-Gallois, Catherine Mainguy, Thomas Perrin, Agnès Toutain-Rigolet, Stéphane Durupt, Quitterie Reynaud, Raphaele Nove-Josserand, Melisande Baravalle-Einaudi, Bérangère Coltey, Nadine Dufeu, Jean-Christophe Dubus, Nathalie Stremler, Davide Caimmi, Yves Billon, Jocelyne Derelle, Sébastien Kieffer, Anne-Sophie Pichon, Cyril Schweitzer, Aurélie Tatopoulos, Sarah Abbes, Tiphaine Bihouée, Isabelle Danner-Boucher, Valérie David, Alain Haloun, Adrien Tissot, Sylvie Leroy, Carole Bailly-Piccini, Annick Clément, Aline Tamalet, Isabelle Honoré, Reem Kanaan, Clémence Martin, Cécile Bailly, Frédérique Chédevergne, Jacques De Blic, Brigitte Fauroux, Murielle Le Bourgeois, Bertrand Delaisi, Michèle Gérardin, Michel Abély, Bruno Ravoninjatovo, Chantal Belleguic, Benoit Desrues, Graziella Brinchault, Michel Dagorne, Eric Deneuville, Sylvaine Lefeuvre, Anne Dirou, Jean Le Bihan, Sophie Ramel, Stéphane Dominique, Annabelle Payet, Romain Kessler, Vincent Rosner, Laurence Weiss, Sandra de Miranda, Dominique Grenet, Abdoul Hamid, Clément Picard, François Brémont, Alain Didier, Géraldine Labouret, Marie Mittaine, Marlène Murris-Espin, Laurent Têtu, Laure Cosson, Charlotte Giraut, Anne-Cécile Henriet, Julie Mankikian, Sophie Marchand, Sandrine Hugé, Véronique Storni, Emmanuelle Coirier-Duet, CHU Cochin [AP-HP], Service de Médecine Interne - Centre Hospitalier Lyon Sud, Hospices Civils de Lyon (HCL)-Centre Hospitalier Lyon Sud [CHU - HCL] (CHLS), Hospices Civils de Lyon (HCL), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Centre de Ressources et de Compétences en Mucoviscidose [Lyon] (CRCM [Lyon]), Hospices Civils de Lyon (HCL)-CHU Lyon-Hôpital Renée Sabran [CHU - HCL], Hôpital Albert Calmette, Université de Lille, Droit et Santé-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), CHU Toulouse [Toulouse], Laboratoire de Biométrie et Biologie Evolutive - UMR 5558 (LBBE), Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut National de Recherche en Informatique et en Automatique (Inria)-VetAgro Sup - Institut national d'enseignement supérieur et de recherche en alimentation, santé animale, sciences agronomiques et de l'environnement (VAS)-Centre National de la Recherche Scientifique (CNRS), Service de pédiatrie médicale et médecine de l'adolescent [Rouen], CHU Rouen, Normandie Université (NU)-Normandie Université (NU)-Université de Rouen Normandie (UNIROUEN), Normandie Université (NU), Centre de recherche Croissance et signalisation (UMR_S 845), Université Paris Descartes - Paris 5 (UPD5)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Service de pneumologie [CHU Trousseau], Université Pierre et Marie Curie - Paris 6 (UPMC)-Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-CHU Trousseau [APHP], Centre de Ressources et de Compétences de la Mucoviscidose (CRCM), Hôpital des Enfants, CHU Toulouse [Toulouse]-CHU Toulouse [Toulouse], Association Vaincre La Mucoviscidose, Institut Cochin (IC UM3 (UMR 8104 / U1016)), EFFI-STAT, CIC Cochin Pasteur (CIC 1417), Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-CHU Cochin [AP-HP]-Hôtel-Dieu-Université Paris Descartes - Paris 5 (UPD5)-Groupe hospitalier Broca-Institut National de la Santé et de la Recherche Médicale (INSERM), Hôpital Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), Mucoviscidose: physiopathologie et phénogénomique [CRSA], Centre de Recherche Saint-Antoine (CRSA), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU), CHU Trousseau [APHP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Sorbonne Université - Faculté de Médecine (SU FM), Sorbonne Université (SU), Centre de Ressources et de Compétences en Mucoviscidose [CHU Toulouse] (CRCM Toulouse), Service Pneumologie et allergologie pédiatrique [CHU Toulouse], Pôle Enfants [CHU Toulouse], Centre Hospitalier Universitaire de Toulouse (CHU Toulouse)-Centre Hospitalier Universitaire de Toulouse (CHU Toulouse)-Pôle Enfants [CHU Toulouse], Centre Hospitalier Universitaire de Toulouse (CHU Toulouse)-Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôtel-Dieu-Université Paris Descartes - Paris 5 (UPD5)-Groupe hospitalier Broca-Institut National de la Santé et de la Recherche Médicale (INSERM), Université Pierre et Marie Curie - Paris 6 (UPMC)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-CHU Trousseau [APHP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Sorbonne Université (SU), Institut National de la Santé et de la Recherche Médicale (INSERM)-Groupe hospitalier Broca-Université Paris Descartes - Paris 5 (UPD5)-Hôtel-Dieu-Hôpital Cochin [AP-HP], and Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)

Subjects
Male, Cystic Fibrosis, Gastrointestinal Diseases, [SDV]Life Sciences [q-bio], Aminopyridines, Quinolones, Critical Care and Intensive Care Medicine, Logistic regression, Aminophenols, Cystic fibrosis, Body Mass Index, Ivacaftor, chemistry.chemical_compound, 0302 clinical medicine, Deprescriptions, Forced Expiratory Volume, Medicine, 030212 general & internal medicine, Fatigue, 2. Zero hunger, biology, Lumacaftor, Headache, lumacaftor–ivacaftor, Cystic fibrosis transmembrane conductance regulator, 3. Good health, Anti-Bacterial Agents, Drug Combinations, Treatment Outcome, Administration, Intravenous, Female, France, medicine.drug, Pulmonary and Respiratory Medicine, Adult, medicine.medical_specialty, Metrorrhagia, Adolescent, Nutritional Status, 03 medical and health sciences, Young Adult, Internal medicine, Product Surveillance, Postmarketing, Humans, Benzodioxoles, Adverse effect, Bronchial Spasm, business.industry, Editorials, Myalgia, medicine.disease, Discontinuation, Dyspnea, Logistic Models, 030228 respiratory system, chemistry, Cough, Multivariate Analysis, biology.protein, postmarketing study, business, Body mass index
Abstract

International audience; Rationale: Lumacaftor-ivacaftor is a CFTR (cystic fibrosis transmembrane conductance regulator) modulator combination recently approved for patients with cystic fibrosis (CF) homozygous for the Phe508del mutation.Objectives: To evaluate the safety and effectiveness of lumacaftor-ivacaftor in adolescents (≥12 yr) and adults (≥18 yr) in a real-life postapproval setting.Methods: The study was conducted in the 47 CF reference centers in France. All patients who initiated lumacaftor-ivacaftor from January 1 to December 31, 2016, were eligible. Patients were evaluated for lumacaftor-ivacaftor safety and effectiveness over the first year of treatment following the French CF Learning Society's recommendations.Measurements and Main Results: Among the 845 patients (292 adolescents and 553 adults) who initiated lumacaftor-ivacaftor, 18.2% (154 patients) discontinued treatment, often owing to respiratory (48.1%, 74 patients) or nonrespiratory (27.9%, 43 patients) adverse events. In multivariable logistic regression, factors associated with increased rates of discontinuation included adult age group, percent predicted FEV1 (ppFEV1) less than 40%, and numbers of intravenous antibiotic courses during the year before lumacaftor-ivacaftor initiation. Patients with continuous exposure to lumacaftor-ivacaftor showed an absolute increase in ppFEV1 (+3.67%), an increase in body mass index (+0.73 kg/m2), and a decrease in intravenous antibiotic courses by 35%. Patients who discontinued treatment had significant decrease in ppFEV1, without improvement in body mass index or decrease in intravenous antibiotic courses.Conclusions: Lumacaftor-ivacaftor was associated with improvement in lung disease and nutritional status in patients who tolerated treatment. Adults who discontinued lumacaftor-ivacaftor, often owing to adverse events, were found at high risk of clinical deterioration.

Published
2019
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5. Safety and Adverse Events after Targeted Lung Denervation for Symptomatic Moderate to Severe Chronic Obstructive Pulmonary Disease (AIRFLOW) : A Multicenter Randomized Controlled Clinical Trial

Author

Dirk-Jan Slebos, Pallav L. Shah, Felix J. F. Herth, Christophe Pison, Christian Schumann, Ralf-Harto Hübner, Peter I. Bonta, Romain Kessler, Wolfgang Gesierich, Kaid Darwiche, Bernd Lamprecht, Thierry Perez, Dirk Skowasch, Gaetan Deslee, Armelle Marceau, Frank C. Sciurba, Reinoud Gosens, Jorine E. Hartman, Karthi Srikanthan, Marina Duller, Arschang Valipour, Christine Abele, Irene Firlinger, Kiran Kothakuzhakal, Roland Kropfmueller, Kornelia Holzmann, Sandra Rathmeier, Ralf Hubner, Leonore Erdmann, Bettina Temmesfeld-Wollbrück, Christoph Ruwwe Glösenkamp, Frank Reichenberger, Christa Niehaus, Felix Herth, Ralf Eberhardt, Daniela Gompelmann, Brigitte Rump, Stephan Eisenmann, Ulrike Kaiser, Birte Schwarz, Ulrike Sampel, Robert Kaiser, Kathryn Schumann-Stoiber, Sabine Ring, Amandine Briault, Francois Arbib, Marie Jondot, Clement Fournier, Regis Matran, Michele Catto, Nathalie Bautin, Virginie De Broucker, Marie Willemin, Anne Prevotat, Ludivine Wemeau, Alice Gicquello, Morgane Foulon, Hasna Camara, Herve Vallerand, Sandra Dury, Delphine Gras, Margaux Bonnaire-Verdier, Sandrine Hirschi, Michele Porzio, Tristan Degot, Mathieu Canuet, Armelle Schuller, Julien Stauder, Sahra Ali Azouaou, Hervé Mal, Yolande Costa, Justin Garner, Cielito Caneja, John Thornton, Nick Ten Hacken, Jorine Hartman, Karin Klooster, Sonja Augustijn, Peter Bonta, Jouke Annema, Marianne van de Pol, Annika Goorsenberg, CCA - Imaging and biomarkers, AII - Inflammatory diseases, and Pulmonology

Subjects
Pulmonary and Respiratory Medicine, Male, medicine.medical_specialty, Radiofrequency ablation, medicine.drug_class, Medizin, Critical Care and Intensive Care Medicine, law.invention, 03 medical and health sciences, Pulmonary Disease, Chronic Obstructive, 0302 clinical medicine, Bronchoscopy, Double-Blind Method, law, Internal medicine, Forced Expiratory Volume, medicine, Anticholinergic, Humans, 030212 general & internal medicine, Adverse effect, Aged, Denervation, COPD, Radiofrequency Ablation, Lung, medicine.diagnostic_test, business.industry, Editorials, Middle Aged, medicine.disease, 3. Good health, Bronchodilator Agents, respiratory tract diseases, Clinical trial, medicine.anatomical_structure, Treatment Outcome, 030228 respiratory system, Cardiology, Female, business
Abstract

Rationale: Targeted lung denervation (TLD) is a bronchoscopic radiofrequency ablation therapy for chronic obstructive pulmonary disease (COPD), which durably disrupts parasympathetic pulmonary nerves to decrease airway resistance and mucus hypersecretion.Objectives: To determine the safety and impact of TLD on respiratory adverse events.Methods: We conducted a multicenter, randomized, sham bronchoscopy-controlled, double-blind trial in patients with symptomatic (modified Medical Research Council dyspnea scale score, ≥2; or COPD Assessment Test score, ≥10) COPD (FEV1, 30-60% predicted). The primary endpoint was the rate of respiratory adverse events between 3 and 6.5 months after randomization (defined as COPD exacerbation, tachypnea, wheezing, worsening bronchitis, worsening dyspnea, influenza, pneumonia, other respiratory infections, respiratory failure, or airway effects requiring therapeutic intervention). Blinding was maintained through 12.5 months.Measurements and Main Results: Eighty-two patients (50% female; mean ± SD: age, 63.7 ± 6.8 yr; FEV1, 41.6 ± 7.3% predicted; modified Medical Research Council dyspnea scale score, 2.2 ± 0.7; COPD Assessment Test score, 18.4 ± 6.1) were randomized 1:1. During the predefined 3- to 6.5-month window, patients in the TLD group experienced significantly fewer respiratory adverse events than those in the sham group (32% vs. 71%, P = 0.008; odds ratio, 0.19; 95% confidence interval, 0.0750-0.4923, P = 0.0006). Between 0 and 12.5 months, these findings were not different (83% vs. 90%; P = 0.52). The risk of COPD exacerbation requiring hospitalization in the 0- to 12.5-month window was significantly lower in the TLD group than in the sham group (hazard ratio, 0.35; 95% confidence interval, 0.13-0.99; P = 0.039). There was no statistical difference in the time to first moderate or severe COPD exacerbation, patient-reported symptoms, or other physiologic measures over the 12.5 months of follow-up.Conclusions: Patients with symptomatic COPD treated with TLD combined with optimal pharmacotherapy had fewer study-defined respiratory adverse events, including hospitalizations for COPD exacerbation.Clinical trial registered with www.clinicaltrials.gov (NCT02058459).

Published
2019

6. Syndrome interstitiel unilatéral atypique

Author

A. Gicquello, C. Delpierre, B. Bouchindhomme, B. Wallaert, and F. Mouquet

Subjects
Pulmonary and Respiratory Medicine, medicine.medical_specialty, Fatal outcome, business.industry, medicine.medical_treatment, Respiratory disease, MEDLINE, Disease, medicine.disease, Text mining, medicine.anatomical_structure, X ray computed, Vascular resistance, Medicine, Radiology, business, Cardiac catheterization
Published
2011
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7. Cardiorespiratory Response to Different Exercise Tests in Interstitial Lung Disease

Author

Valérie Bougault, Alice Gicquello, Benoit Wallaert, Baptiste Chéhère, Université de Brest, ORPHY, 29200 Brest, France, Laboratoire Motricité Humaine Expertise Sport Santé (LAMHESS), Université Nice Sophia Antipolis (... - 2019) (UNS), COMUE Université Côte d'Azur (2015-2019) (COMUE UCA)-COMUE Université Côte d'Azur (2015-2019) (COMUE UCA)-Université de Toulon (UTLN)-Université Côte d'Azur (UCA), Centre de compétences des maladies pulmonaires rares de l'adulte [CHU Lille] (CRMPR), Service de Pneumologie et Immuno-Allergologie [CHU LIlle], Pole Cardio-vasculaire et pulmonaire [CHU Lille], Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille)-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille)-Pole Cardio-vasculaire et pulmonaire [CHU Lille], and Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille)-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille)

Subjects
Male, medicine.medical_specialty, Pain, Physical Therapy, Sports Therapy and Rehabilitation, 03 medical and health sciences, 0302 clinical medicine, Heart Rate, Internal medicine, medicine, Blood lactate, [SDV.MHEP.PHY]Life Sciences [q-bio]/Human health and pathology/Tissues and Organs [q-bio.TO], Humans, Orthopedics and Sports Medicine, In patient, Lactic Acid, Respiratory system, [SDV.EE.SANT]Life Sciences [q-bio]/Ecology, environment/Health, Leg, Exercise Tolerance, Muscle fatigue, Pulmonary Gas Exchange, Pulse (signal processing), business.industry, Interstitial lung disease, Cardiorespiratory fitness, 030229 sport sciences, Middle Aged, medicine.disease, Oxygen uptake, Surgery, Oxygen, Dyspnea, 030228 respiratory system, MESH: Dyspnea, Exercise Test, Cardiology, Female, Lung Diseases, Interstitial, business, MESH: Exercise Test, MESH: Pulmonary Gas Exchange, MESH: Lung Diseases, Interstitial
Abstract

International audience; Introduction: The 6-min stepper test (6MST) has been used as an alternative to the 6-min walk test (6MWT) to assess exercise tolerance in patients with interstitial lung disease (ILD). Recent data suggest that the tests may involve different energy pathways and cardiorespiratory responses. We thus aimed to compare the cardiorespiratory responses of ILD patients during the 6MWT and the 6MST.Methods: Thirty-one patients with ILD were randomized to perform both tests in the order 6MST → 6MWT (n = 16) or 6MWT → 6MST (n = 15). Gas exchange, HR, and pulse O2 saturation (SpO2) were measured continuously, and dyspnoea, leg discomfort, and blood lactate concentration were assessed before and immediately after each test.Results: Oxygen uptake (V˙O2) was lower (P = 0.002) and respiratory equivalent ratio for O2 (V˙E/V˙O2) and RER were higher (both P < 0.001) during the 6MST compared with the 6MWT. The 6MST was also associated with higher blood lactate concentrations (6MST, 4.16 ± 1.95 mmol·L; 6MWT, 2.84 ± 1.17 mmol·L; P = 0.01), higher leg discomfort scores (6MST 5 ± 3 points, 6MWT 3 ± 2 points; P < 0.001), and smaller decreases in SpO2 (6MST -5% ± 5%, 6MWT -9% ± 6%; P < 0.001).Conclusions: ILD patients exhibited greater ventilatory responses and lower arterial O2 desaturation during the 6MST compared with the 6MWT. The higher lactate concentrations and perceived muscle fatigue observed during the 6MST may indicate the presence of intertest differences in active muscle metabolism that could contribute to the distinct cardiorespiratory responses.

Published
2016
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8. Cardiorespiratory responses during the 6-minute walk and stepper tests in patients with interstitial lung disease

Author

Baptiste Chehere, Benoit Wallaert, Alice Gicquello, and Valérie Bougault

Subjects
medicine.medical_specialty, Lung, Muscle fatigue, business.industry, Interstitial lung disease, Oxygen pulse, Cardiorespiratory fitness, medicine.disease, Surgery, medicine.anatomical_structure, Internal medicine, Heart rate, medicine, Cardiology, Breathing, Respiratory system, business
Abstract

Background: Exercise-induced arterial O 2 desaturation impacts the management of interstitial lung diseases (ILD). Recent data suggest that arterial O 2 desaturation is more severe during the 6-minute walk test (6MWT) than during the 6-minute stepper test (6MST) in ILD patients. Aims: We hypothesized that a higher ventilation (VE) during the 6MST facilitates the alveolo-arterial oxygen diffusion, minimizing O 2 desaturation. Our aim was to investigate differences in ventilator responses and gas exchange during 6MST and 6MWT. Methods: Twenty-nine patients with ILD performed a 6MWT and a 6MST in a random order. Gas exchange, heart rate (HR), and oxygen pulse saturation (SpO 2 ) were measured continuously and leg discomfort (LD) was quoted on a 10-point Borg Scale, before and at the end of each test. Results: At rest no difference in HR, VE and VO 2 was observed before both tests. As expected, the decrease in SpO 2 was significantly lower during the 6MST than during the 6MWT (-5 ± 5% vs -9 ± 7%, p 2 ) was lower (p=0.01), but VE/VO 2 and respiratory exchange ratios were higher during 6MST than during 6MWT (p vs 3 ± 2, p=0.003). Conclusion: The higher VE/VO 2 ratio may have contributed to the lower O 2 desaturation during the 6MST. The higher muscle fatigue perceived during 6MST, possibly also indicated differences of active muscle metabolism, which probably contributed to the different ventilatory responses and arterial O 2 desaturation between both tests.

Published
2015
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9. Long-term evaluation of home-based pulmonary rehabilitation in patients with COPD

Author

Olivier Le Rouzic, Carole Langlois, Benoit Wallaert, Alice Gicquello, Frédéric Bart, Jean Marie Grosbois, and Cécile Chenivesse

Subjects
Male, Program evaluation, self-management, medicine.medical_specialty, medicine.medical_treatment, Home Care Services, Hospital-Based, Comorbidity, Anxiety, International Journal of Chronic Obstructive Pulmonary Disease, Pulmonary Disease, Chronic Obstructive, Quality of life, Forced Expiratory Volume, Surveys and Questionnaires, medicine, COPD, Humans, Pulmonary rehabilitation, Lung, Original Research, Aged, Retrospective Studies, Psychiatric Status Rating Scales, Self-management, Rehabilitation, Depression, business.industry, Retrospective cohort study, home, General Medicine, Middle Aged, medicine.disease, pulmonary rehabilitation, Exercise Therapy, respiratory tract diseases, Self Care, Treatment Outcome, quality of life, Physical therapy, Female, business, Program Evaluation
Abstract

Jean Marie Grosbois,1,2 Alice Gicquello,3 Carole Langlois,4 Olivier Le Rouzic,3 Frédéric Bart,2 Benoit Wallaert,2,3 Cécile Chenivesse5 1FormAction Santé, rue Pietralunga, Pérenchies, 2Service de Pneumologie, CH Béthune, 3Service de Pneumologie et Immunoallergologie, Centre des Compétences des Maladies Pulmonaires Rares, Hôpital Calmette, CHRU Lille, 4Unité de Biostatistiques, CHRU Lille, 5AP-HP, Groupe Hospitalier Pitié-Salpêtrière Charles Foix, Service de Pneumologie et Réanimation Médicale, Boulevard de l’Hôpital, Paris, France Introduction: Personalized, global pulmonary rehabilitation (PR) management of patients with COPD is effective, regardless of the place in which this rehabilitation is provided. The objective of this retrospective observational study was to study the long-term outcome of exercise capacity and quality of life during management of patients with COPD treated by home-based PR.Methods: Home-based PR was administered to 211 patients with COPD (mean age, 62.3±11.1years; mean forced expiratory volume in 1second, 41.5%±17.7%). Home-based PR was chosen because of the distance of the patient’s home from the PR center and the patient’s preference. Each patient was individually managed by a team member once a week for 8weeks with unsupervised continuation of physical exercises on the other days of the week according to an individual action plan. Exercise conditioning, therapeutic patient education, and self-management were included in the PR program. The home assessment comprised evaluation of the patient’s exercise capacity by a 6-minute stepper test, Timed Up and Go test, ten times sit-to-stand test, Hospital Anxiety and Depression score, and quality of life (Visual Simplified Respiratory Questionnaire, VQ11, Maugeri Respiratory Failure 28).Results: No incidents or accidents were observed during the course of home-based PR. The 6-minute stepper test was significantly improved after completion of the program, at 6months and 12months, whereas the Timed Up and Go and ten times sit-to-stand test were improved after PR and at 6months but not at 12months. Hospital Anxiety and Depression and quality of life scores improved after PR, and this improvement persisted at 6months and 12months.Conclusion: Home-based PR for unselected patients with COPD is effective in the short term, and this effectiveness is maintained in the medium term (6months) and long term (12months). Home-based PR is an alternative to outpatient management provided all activities, such as exercise conditioning, therapeutic education, and self-management are performed. Keywords: pulmonary rehabilitation, home, COPD, quality of life, anxiety, depression, self-management

Published
2015
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