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2. Oral corticosteroid elimination via a personalised reduction algorithm in adults with severe, eosinophilic asthma treated with benralizumab (PONENTE): a multicentre, open-label, single-arm study

Author

Menzies-Gow, Andrew, Gurnell, Mark, Heaney, Liam G, Corren, Jonathan, Bel, Elisabeth H, Maspero, Jorge, Harrison, Timothy, Jackson, David J, Price, David, Lugogo, Njira, Kreindler, James, Burden, Annie, de Giorgio-Miller, Alex, Padilla, Kelly, Martin, Ubaldo J, and Garcia Gil, Esther

Published
2022
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7. Long-term safety and efficacy of benralizumab in patients with severe, uncontrolled asthma: 1-year results from the BORA phase 3 extension trial

Author

Yañez, Anahí, Fernández, Marcelo, Tolcachier, Alberto, Belloni, Juan, Taborda, Jorge, De Salvo, Maria, Maspero, Jorge, Victorio, Carlos, Navarta, Miguel Chirino, Grilli, Monica, Rodríguez, Pablo, Otaola, María, Cambursano, Víctor, Malamud, Patricia, Stok, Ana, Arce, German, Roza, Osiris, Scherbovsky, Fernando, Elias, Pedro, Saez, Maria Salazan, Peters, Matthew, Phillips, Martin, Upham, John, Gibson, Peter, Thien, Francis, Douglass, Jo, Thomas, Paul, Bardin, Philip, Sajkov, Dimitar, Hew, Mark, Langton, David, Pez, Andreia, Fritscher, Carlos, Hetzel, Jorge, Mattos, Waldo, Stelmach, Rafael, Antila, Martti, Fernandes, Ana Luisa, Metev, Hristo, Ivanov, Yavor, Bogdanova, Aneliya, Markova, Ana Dancheva, Peneva, Marinka, Veselinova, Rumyana, Petkova, Tatyana, Petrova, Vanushka, Shopova, Elena, Ivanova, Yuliya, Yotsova, Rumyana, Kirkova, Ginka, Petrova, Galina, Dachev, Svetoslav, Sotirova, Kostadinka, Stoyanova, Mariyana, Yakov, Oleg, Ilieva-Fartunova, Vanya, Lemiere, Catherine, Laviolette, Michel, Yang, William, FitzGerald, J Mark, Pek, Bonavuth, Killorn, William Patrick, Poirier, Claude, Chouinard, Guy, Melenka, Lyle, Leigh, Richard, Nair, Parameswaran, Dorscheid, Delbert, Martin, James, Pavie, Juana, Rosenblut, Andres, Cartagena, Claudia, Quilodran, Carlos, Muñoz, Silvia, Malkusova, Ivana, Veverka, Josef, Holub, Stanislav, Mares, Jaroslav, Kozel, Radovan, Kopecka, Daniela, Zindr, Vladimir, Cerva, Pavel, Chanez, Pascal, Bourdin, Arnaud, Devouassoux, Gilles, Taille, Camille, De Blay, Frédéric, Goupil, Francois, Leroyer, Christophe, Gourcerol, Delphine, Didi, Toufik, Didier, Alain, Garcia, Gilles, Bonniaud, Philippe, Vasram, Riazate Rossanaly, Lommatzsch, Marek, Harnest, Ulf, Linnhoff, Anneliese, Keller, Claus, Hoheisel, Gerhard, Förster, Karin, Schultz, Thomas, Schenkenberger, Isabelle, Kirschner, Joachim, Schmoller, Tibor, Zielen, Stefan, Kornmann, Marc, Beck, Ekkehard, Volgmann, Lutz, Dichmann, Rolf, Overlack, Axel, Winkler, Jörg, Mikloweit, Petra, Ballenberger, Sabine, Rolke, Mathias, Korn, Stephanie, Pabel, Helmut, Hoffmann, Martin, Feimer, Jan, Rabe, Klaus, Deckelmann, Regina, Welte, Tobias, Ohbayashi, Hiroyuki, Hozawa, Soichiro, Shimoda, Terufumi, Yoshida, Makoto, Nagakura, Toshikazu, Kamei, Tadashi, Sano, Yasuyuki, Kagami, Shinichiro, Takahashi, Hisaho, Haida, Michiko, Kimura, Goro, Nakamura, Hiroyuki, To, Yasuo, Shinkai, Masaharu, Shimokawaji, Tadasuke, Kudo, Makoto, Shijyubo, Noriharu, Tochigi, Takao, Kato, Motokazu, Tanaka, Akihiko, Gon, Yasuhiro, Sasaki, Norihisa, Ohdaira, Tetsuro, Omori, Chiharu, Takahashi, Toshiki, Takeuchi, Satomi, Nakajima, Kiyotaka, Makita, Hironi, Kaneko, Masahiro, Furuta, Kenjiro, Taniguchi, Masami, Inobe, Yoshito, Miki, Hiroshi, Nakamura, Yoichi, Miyazawa, Naoki, Yano, Shuichi, Iijima, Masayuki, Yamato, Tsuyoshi, Diaz, Javier, Matsuno, Alberto, Felix, Efrain, Guerreros, Alfredo, Daly, Alejandro, Rodriguez Chariarse, Fernando, Salazar, Danilo, Castro, Socorro, Chavez, William, Estrella, Rolando, Aquino, Teresita, Atienza, Tito, Samoro, Ronnie, Isidro, Marie Grace Dawn, Kuna, Piotr, Antczak, Adam, Bednarek, Michał, Mądra-Rogacka, Danuta, Hofman, Teresa, Jutel, Marek, Pisarczyk-Bogacka, Ewa, Kot, Agata, Mróz, Robert, Czupryńska-Borkowska, Małgorzata, Żurowska-Gębala, Małgorzata, Dyczek, Andrzej, Jasieniak-Pinis, Grażyna, Wojnowski, Piotr, Trębas-Pietraś, Ewa, Dobryniewska, Małgorzata, Stobiecki, Marcin, Tarnowska-Matusiak, Marzenna, Magner, Alina, Kolczyński, Andrzej, Kachel, Tomasz, Bartuzi, Zbigniew, Majorek-Olechowska, Bernadetta, Śliwiński, Paweł, Balicka, Violetta, Hajoł, Elżbieta, Stachera, Jacek, Rachel, Marta, Michnar, Marek, Tałałaj, Jarosław, Springer, Ewa, Napora, Piotr, Grzelewski, Tomasz, Bijata-Bronisz, Renata, Świderska, Anna, Mincewicz, Grzegorz, Sankowski, Zbigniew, Fijołek, Tomasz, Kwaśniewski, Artur, Jerzyńska, Joanna, Cygler, Jerzy, Olesiejuk, Ryszard, Von Steiner, Iwona, Machowiak, Wojciech, Filipek, Krzysztof, Piskorz, Piotr, Uhryn, Ewa, Nittner-Marszalska, Marita, Rybicka-Liszewska, Elżbieta, Bodzenta-Łukaszyk, Anna, Chełmińska, Marta, Krupa-Borek, Izabella, Skucha, Wojciech, Płoszczuk, Anna, Mihaescu, Traian, Petrui, Ioan Dorin, Savu, Angelica, Apti, Ghiulten, Toma, Claudia, Trailescu, Ana, Sokurenko, Sergei, Trofimov, Vasiliy, Leshchenko, Igor, Shaporova, Natalia, Ilyashevich, Inna, Stitsenko, Irina, Vizel, Alexander, Ilkovich, Yulia, Tikhanov, Dmitrii, Goncharova, Svetlana, Ezhov, Andrey, Ignatova, Galina, Izmozherova, Nadezhda, Berdnikova, Nadezhda, Goryachkina, Ludmila, Popova, Veronika, Bolieva, Laura, Rebrov, Andrey, Nosov, Vladimir, Magnitskaya, Olga, Nedogoda, Sergey, Abrosimov, Vladimir, Molotkov, Artem, Reshedko, Galina, Smirnov, Mikhail, Osipenko, Marina, Pavlysh, Elena, Myasoedova, Svetlana, Lenskaya, Liudmila, Chistyakov, Valery, Vishneva, Elena, Uon, Liliya, Zateyschikova, Anna, Laleko, Svetlana, Pak, Tatiana, Bruning, Axel, Naidoo, Visvakuren, Reddy, Jeevren, Van Zyl Smit, Richard, Park, Hae-Sim, Cho, Young Joo, Cho, Sang-Heon, Lee, Sang Haak, Lee, Byung Jae, Kim, Ju Sang, Cho, You Sook, Park, Choon-Sik, Kim, Mi-Kyeong, Koh, Young-Il, Kim, Joo-Hee, Lee, Sook Young, Lee, Sang Pyo, Park, Jung Won, Yoo, Kwang Ha, Yoon, Hyoungkyu, Lee, Jaechun, Hur, Gyu-Young, Lee, Soo Keol, Kim, HeeKyoo, Ramos Barbón, David, Laffond Yges, Elena, Martínez Moragón, Eva, Arias Guillen, Miguel, Saura Vinuesa, Alberto, Sánchez-Toril López, Fernando, Velasco Garrido, José Luis, García-Cosio Piqueras, Borja, Pérez de Llano, Luis, Valero Santiago, Antonio Luis, Rubio, Myriam Calle, Bjermer, Leif, Lundbäck, Bo, Gemicioglu, Bilun, Bavbek, Sevim, Ediger, Dane, Erdinc, Munevver, Hanta, Ismail, Nayci, Sibel, Arinc, Sibel, Iashyna, Liudmyla, Mostovoy, Yuriy, Ostrovskyy, Mykola, Kuryk, Lesia, Lemko, Ivan, Ospanova, Tetyana, Moskalenko, Liubov, Korzh, Oleksii, Blazhko, Viktor, Krakhmalova, Olena, Romaniuk, Liliia, Dytyatkovs'ka, Yevgeniya, Yakovenko, Oleh, Gavrysyuk, Volodymyr, Burhan, Hassan, Saralaya, Dinesh, Scott, Stephen, Morice, Alyn, Jackson-Voyzey, Ewart, Win, Thida, Nasser, Shuab, Harrison, Richard, Chaudhuri, Rekha, Nordstrom, Monica, De, Pradip, Masoli, Matthew, Mansur, Adel, Gunstone, Anthony, Niven, Robert, Harrison, Timothy, Babu, Suresh, Bhuchar, Subodh, Kureishy, Shahrukh, Zwetchkenbaum, John, Kaplan, Lawrence, Bleecker, Eugene, Reyes, Santiago, Fakih, Faisal, Heuer, Marvin, Klein, Ryan, Marcus, Michael, Hussain, Iftikhar, Tanus, Tonny, Raissy, Hengameh, Alpizar, Sady, Rodriguez, Hector, Gleich, Gerald, Bridges, Tracy, Pouzar, Joe, Steven, Gary, Matz, Jonathan, Krstevska, Shana, Ziworitin, Dama, Kaplan, Adolfo, Sublett, James, DeAngelo, James, Darter, Amy, Agaiby, John, Hagan, John, Davis, Enrique, Siri, Dareen, Mcevoy, Charlene, Dharma, Chrisette, Karimjee, Najmuddin, Kelsen, Steven, Frade, Manuel, Silverthorn, Amy, Kline, Joel, Averill, Francis, Ruiz, Jose, Robinette, Emory, Shaikh, Zeeshan, Aguilar, Carlos, Nish, William, Alvarez, German, Ismail, Younus, Parikh, Purvi, Leong, Mila, Murphy, Dennis, Garcia, Francisco, Goldsobel, Alan, Blanco, Antonio, Campbell, Edward, Perez, Guido, Chupp, Geoffrey, Bates, Toby, Perez, Vandely, Wenzel, Sally, Shenoy, Kartik, Katial, Rohit, Bernstein, David, Parikh, Neil, Sims, William, Ferguson, Gary, Pham, David, George, Anu, Beasley, Richard, Perez, Gilberto, Garver, Robert, Garcia-Portela, Miriam, Wong, Stephen, Soong, Weily, Guillot, Richard, Hudes, Golda, Arif, Ahmed, Binker, Josefa, Villareal, Manuel, Ziegner, Ulrike, Ojile, Joseph, Goswami, Sanjeev, Piniella, Carlos, Segal, Ilia, Zafra, Heidi, Lee, Mitchell, Tarpay, Martha, Panuto, John, Merchant, Rajan, Springsteen, Peter, Scialla, Timothy, Shapero, Paul, Allen, Karen, Moss, Mark, Cruz, Humberto, Rumbyrt, Jeffrey, Boyd, Amy, Nathan, Robert, Bernstein, Jonathan, Jacobs, Joshua, Ginchansky, Elliot, Johnston, Janice, Baxter, Barbara, Johnson II, Thomas, Apaliski, Stephen, Corder, Clinton, Fuentes, David, Diaz, Joseph, Ngo, Chau, Le, Lan, Busse, William W, Bleecker, Eugene R, Ferguson, Gary T, Barker, Peter, Sproule, Stephanie, Olsson, Richard F, Martin, Ubaldo J, and Goldman, Mitchell

Published
2019
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15. Adrenal function recovery after durable oral corticosteroid sparing with benralizumab in the PONENTE study

Author

Menzies-Gow, Andrew, Gurnell, Mark, Heaney, Liam G, Corren, Jonathan, Bel, Elisabeth H, Maspero, Jorge, Harrison, Timothy, Jackson, David J, Price, David, Lugogo, Njira, Kreindler, James, Burden, Annie, de Giorgio-Miller, Alex, Faison, Sarai, Padilla, Kelly, Martin, Ubaldo J, Garcia Gil, Esther, PONENTE Study Group, Price, David [0000-0002-9728-9992], Martin, Ubaldo J [0000-0002-0089-7677], and Apollo - University of Cambridge Repository

Subjects
Adrenal Cortex Hormones, Humans, Anti-Asthmatic Agents, Recovery of Function, Asthma, Adrenal Insufficiency
Abstract

BACKGROUND: Oral corticosteroid (OCS) dependence among patients with severe eosinophilic asthma can cause adverse outcomes, including adrenal insufficiency. PONENTE's OCS reduction phase showed that, following benralizumab initiation, 91.5% of patients eliminated corticosteroids or achieved a final dosage ≤5 mg·day-1 (median (range) 0.0 (0.0-40.0) mg). METHODS: The maintenance phase assessed the durability of corticosteroid reduction and further adrenal function recovery. For ∼6 months, patients continued benralizumab 30 mg every 8 weeks without corticosteroids or with the final dosage achieved during the reduction phase. Investigators could prescribe corticosteroids for asthma exacerbations or increase daily dosages for asthma control deteriorations. Outcomes included changes in daily OCS dosage, Asthma Control Questionnaire (ACQ)-6 and St George's Respiratory Questionnaire (SGRQ), as well as adrenal status, asthma exacerbations and adverse events. RESULTS: 598 patients entered PONENTE; 563 (94.1%) completed the reduction phase and entered the maintenance phase. From the end of reduction to the end of maintenance, the median (range) OCS dosage was unchanged (0.0 (0.0-40.0) mg), 3.2% (n=18/563) of patients experienced daily dosage increases, the mean ACQ-6 score decreased from 1.26 to 1.18 and 84.5% (n=476/563) of patients were exacerbation free. The mean SGRQ improvement (-19.65 points) from baseline to the end of maintenance indicated substantial quality-of-life improvements. Of patients entering the maintenance phase with adrenal insufficiency, 32.4% (n=104/321) demonstrated an improvement in adrenal function. Adverse events were consistent with previous reports. CONCLUSIONS: Most patients successfully maintained maximal OCS reduction while achieving improved asthma control with few exacerbations and maintaining or recovering adrenal function.

Published
2022

16. Benralizumab Prevents Recurrent Exacerbations in Patients with Chronic Obstructive Pulmonary Disease: A Post Hoc Analysis

Author

Singh,Dave, Criner,Gerard J, Agustí,Alvar, Bafadhel,Mona, Söderström,Johan, Luporini Saraiva,Gabriela, Song,Yue, Licaj,Idlir, Jison,Maria, Martin,Ubaldo J, Psallidas,Ioannis, Singh,Dave, Criner,Gerard J, Agustí,Alvar, Bafadhel,Mona, Söderström,Johan, Luporini Saraiva,Gabriela, Song,Yue, Licaj,Idlir, Jison,Maria, Martin,Ubaldo J, and Psallidas,Ioannis

Abstract

Dave Singh,1 Gerard J Criner,2 Alvar Agustí,3 Mona Bafadhel,4 Johan Söderström,5 Gabriela Luporini Saraiva,6 Yue Song,6 Idlir Licaj,7 Maria Jison,6 Ubaldo J Martin,6 Ioannis Psallidas8 1Manchester University NHS Foundation Hospital Trust, the University of Manchester, Manchester, UK; 2Lewis Katz School of Medicine, Temple University, Philadelphia, PA, USA; 3Respiratory Institute (Hospital Clinic), IDIBAPS, CIBERES, Catedra Salud Respiratoria (University of Barcelona), Barcelona, Spain; 4School of Immunology and Microbial Sciences, Faculty of Life Sciences and Medicine, King’s College London, London, UK; 5Late-stage Development, Respiratory & Immunology, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden; 6Late-stage Development, Respiratory & Immunology, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USA; 7Cytel Inc, Cambridge, MA, USA; 8Late-Stage Development, Respiratory & Immunology, BioPharmaceuticals R&D, AstraZeneca, Cambridge, UKCorrespondence: Dave Singh, Medicines Evaluation Unit, Langley Building, University Hospital of South Manchester, NHS Foundation Trust, Southmoor Road, Manchester, M23 9QZ, UK, Tel +44 (0)161 946 4073, Email dsingh@meu.org.ukAbstract: Exacerbations in chronic obstructive pulmonary disease (COPD), which tend to occur in clusters and increase with disease severity, come with high societal and economic burdens. Prevention and delay of recurrent exacerbations is an unmet and significant therapeutic need for patients with COPD. GALATHEA (NCT02138916) and TERRANOVA (NCT02155660) were trials assessing efficacy of benralizumab in patients with frequent COPD exacerbations despite treatment. Although these studies found that benralizumab given as an add-on treatment did not significantly reduce annual rates of COPD exacerbations after 56 weeks of treatment, in the following exploratory post hoc analysis of the GALATHEA and TERRANOVA trials we identified a potential responder population in which treatmen

Published
2023

17. sj-docx-1-aor-10.1177_00034894231177769 – Supplemental material for Psychometric Validation and Meaningful Change Thresholds of the New Nasal Polyposis Symptom Diary

Author

Shih, Vivian H., Slagle, Ashley F., Ivanescu, Cristina, Flore, Giulio, Meyers, Oren, Kreindler, James, Martin, Ubaldo J., and Werkström, Viktoria

Subjects
110315 Otorhinolaryngology, FOS: Clinical medicine
Abstract

Supplemental material, sj-docx-1-aor-10.1177_00034894231177769 for Psychometric Validation and Meaningful Change Thresholds of the New Nasal Polyposis Symptom Diary by Vivian H. Shih, Ashley F. Slagle, Cristina Ivanescu, Giulio Flore, Oren Meyers, James Kreindler, Ubaldo J. Martin and Viktoria Werkström in Annals of Otology, Rhinology & Laryngology

Published
2023
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18. Hemodynamic Monitoring

Author

Martin, Ubaldo J., Diaz-Abad, Montserrat, Krachman, Samuel L., Criner, Gerard J., editor, Barnette, Rodger E., editor, and D'Alonzo, Gilbert E., editor

Published
2010
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21. Acute Renal Injury

Author

Goldman, Jesse, Reichart, James P., Samuels, Ll. Armando, Martin, Ubaldo J., Criner, Gerard J., editor, Barnette, Rodger E., editor, and D'Alonzo, Gilbert E., editor

Published
2010
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25. Mechanical Ventilation

Author

Piatt, Clark U., Martin, Ubaldo J., Criner, Gerard J., Criner, Gerard J., editor, and D’Alonzo, Gilbert E., editor

Published
2002
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30. Efficacy and safety of benralizumab in chronic rhinosinusitis with nasal polyps: A randomized, placebo-controlled trial

Author

Bachert, Claus, primary, Han, Joseph K., additional, Desrosiers, Martin Y., additional, Gevaert, Philippe, additional, Heffler, Enrico, additional, Hopkins, Claire, additional, Tversky, Jody R., additional, Barker, Peter, additional, Cohen, David, additional, Emson, Claire, additional, Martin, Ubaldo J., additional, Shih, Vivian H., additional, Necander, Sofia, additional, Kreindler, James L., additional, Jison, Maria, additional, and Werkström, Viktoria, additional

Published
2022
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34. Late Breaking Abstract - Durable clinical benefit of benralizumab following oral corticosteroid reduction: The PONENTE study

Author

Menzies-Gow, Andrew, primary, Gurnell, Mark, additional, Heaney, Liam G., additional, Corren, Jonathan, additional, Bel, Elisabeth H., additional, Maspero, Jorge, additional, Harrison, Timothy, additional, Jackson, David J., additional, Price, David, additional, Lugogo, Njira, additional, Kreindler, James, additional, Burden, Annie, additional, De Giorgio-Miller, Alex, additional, Padilla, Kelly, additional, Martin, Ubaldo J., additional, and Garcia Gil, Esther, additional

Published
2021
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35. Late Breaking Abstract - Adrenal function improvement after oral corticosteroid reduction in benralizumab-treated severe eosinophilic asthma: PONENTE maintenance phase

Author

Gurnell, Mark, primary, Heaney, Liam G., additional, Menzies-Gow, Andrew, additional, Corren, Jonathan, additional, Bel, Elisabeth H., additional, Maspero, Jorge, additional, Harrison, Timothy, additional, Jackson, David J., additional, Price, David, additional, Lugogo, Njira, additional, Burden, Annie, additional, De Giorgio-Miller, Alex, additional, Padilla, Kelly, additional, Martin, Ubaldo J., additional, Garcia Gil, Esther, additional, and Kreindler, James, additional

Published
2021
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41. Author_Response_1 – Supplemental material for Functional respiratory imaging assessment of glycopyrrolate and formoterol fumarate metered dose inhalers formulated using co-suspension delivery technology in patients with COPD

Author

Backer, Wilfried De, Backer, Jan De, Verlinden, Ilse, Leemans, Glenn, Holsbeke, Cedric Van, Mignot, Benjamin, Jenkins, Martin, Griffis, Dianne, Ivanov, Stefan, Fitzpatrick, Jane, Rose, Earl St, Martin, Ubaldo J., and Reisner, Colin

Subjects
110203 Respiratory Diseases, FOS: Clinical medicine, 111702 Aged Health Care, FOS: Health sciences, 111599 Pharmacology and Pharmaceutical Sciences not elsewhere classified
Abstract

Supplemental material, Author_Response_1 for Functional respiratory imaging assessment of glycopyrrolate and formoterol fumarate metered dose inhalers formulated using co-suspension delivery technology in patients with COPD by Wilfried De Backer, Jan De Backer, Ilse Verlinden, Glenn Leemans, Cedric Van Holsbeke, Benjamin Mignot, Martin Jenkins, Dianne Griffis, Stefan Ivanov, Jane Fitzpatrick, Earl St Rose, Ubaldo J. Martin and Colin Reisner in Therapeutic Advances in Respiratory Disease

Published
2020
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42. Reviewer_1_v.1 – Supplemental material for Functional respiratory imaging assessment of glycopyrrolate and formoterol fumarate metered dose inhalers formulated using co-suspension delivery technology in patients with COPD

Author

Backer, Wilfried De, Backer, Jan De, Verlinden, Ilse, Leemans, Glenn, Holsbeke, Cedric Van, Mignot, Benjamin, Jenkins, Martin, Griffis, Dianne, Ivanov, Stefan, Fitzpatrick, Jane, Rose, Earl St, Martin, Ubaldo J., and Reisner, Colin

Subjects
110203 Respiratory Diseases, FOS: Clinical medicine, 111702 Aged Health Care, FOS: Health sciences, 111599 Pharmacology and Pharmaceutical Sciences not elsewhere classified
Abstract

Supplemental material, Reviewer_1_v.1 for Functional respiratory imaging assessment of glycopyrrolate and formoterol fumarate metered dose inhalers formulated using co-suspension delivery technology in patients with COPD by Wilfried De Backer, Jan De Backer, Ilse Verlinden, Glenn Leemans, Cedric Van Holsbeke, Benjamin Mignot, Martin Jenkins, Dianne Griffis, Stefan Ivanov, Jane Fitzpatrick, Earl St Rose, Ubaldo J. Martin and Colin Reisner in Therapeutic Advances in Respiratory Disease

Published
2020
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43. Onset of Effect, Changes in Airflow Obstruction and Lung Volume, and Health-Related Quality of Life Improvements with Benralizumab for Patients with Severe Eosinophilic Asthma: Phase IIIb Randomized, Controlled Trial (SOLANA) [Corrigendum]

Author

Panettieri Jr,Reynold A, Welte,Tobias, Shenoy,Kartik V, Korn,Stephanie, Jandl,Margret, Kerwin,Edward M, Feijoo,Rosa, Barker,Peter, Olsson,Richard F, Martin,Ubaldo J, Panettieri Jr,Reynold A, Welte,Tobias, Shenoy,Kartik V, Korn,Stephanie, Jandl,Margret, Kerwin,Edward M, Feijoo,Rosa, Barker,Peter, Olsson,Richard F, and Martin,Ubaldo J

Abstract

Panettieri RA Jr, Welte T, Shenoy KV, et al. J Asthma Allergy. 2020;13:115–126.The authors have advised that the symbol shown on page 124, discussion section, left column, line 5 “≥20%” should read “<20%”.Read the original article

Published
2020

44. Onset of Effect, Changes in Airflow Obstruction and Lung Volume, and Health-Related Quality of Life Improvements with Benralizumab for Patients with Severe Eosinophilic Asthma: Phase IIIb Randomized, Controlled Trial (SOLANA)

Author

Panettieri Jr,Reynold A, Welte,Tobias, Shenoy,Kartik V, Korn,Stephanie, Jandl,Margret, Kerwin,Edward M, Feijoo,Rosa, Barker,Peter, Olsson,Richard F, Martin,Ubaldo J, Panettieri Jr,Reynold A, Welte,Tobias, Shenoy,Kartik V, Korn,Stephanie, Jandl,Margret, Kerwin,Edward M, Feijoo,Rosa, Barker,Peter, Olsson,Richard F, and Martin,Ubaldo J

Abstract

Reynold A Panettieri Jr, 1 Tobias Welte, 2 Kartik V Shenoy, 3 Stephanie Korn, 4 Margret Jandl, 5 Edward M Kerwin, 6 Rosa Feijoo, 7 Peter Barker, 8 Richard F Olsson, 9 Ubaldo J Martin 8 On behalf of the SOLANA Study Investigators 1Pulmonary, Allergy and Critical Care Division, University of Pennsylvania, Philadelphia, PA, USA; 2Department of Respiratory Medicine, Member of the German Center of Lung Research, Medizinische Hochschule Hannover, Hannover, Germany; 3Department of Thoracic Medicine and Surgery, Lewis Katz School of Medicine at Temple University, Philadelphia, PA, USA; 4Pulmonary Department, Universitätsmedizin Mainz, Langenbeckstr, Mainz, Germany; 5Hamburger Institut Für Therapieforschung, Hamburg, Germany; 6Clinical Trials Division, Clinical Research Institute of Southern Oregon (Crisor), Medford, OR, USA; 7Departamento De Medicina Interna Oriente, Universidad De Chile, Santiago, Chile; 8Research and Development, AstraZeneca, Gaithersburg, MD, USA; 9R&D, Innovative Medicines and Early Development, Early Clinical Development, AstraZeneca, Gothenburg, SwedenCorrespondence: Reynold A PanettieriUniversity of Pennsylvania, 125 South 31st Street, Philadelphia, PA 19104, USATel +1 215 573-9860Fax +1 215 746-1224Email rp865@rbhs.rutgers.eduObjective: In the SOLANA trial, we sought to physiologically characterize benralizumab’s onset of effect and maintenance of that effect for patients with severe eosinophilic asthma.Methods: SOLANA (NCT02869438) was a multicenter, randomized, double-blind, parallel-group, placebo-controlled, Phase IIIb study conducted at 49 centers in six countries (Chile, Germany, Hungary, the Philippines, South Korea, and the United States). Eligible patients with baseline blood eosinophil counts ≥ 300 cells/μL were randomized to subcutaneous benralizumab (30 mg) or placebo administered at Days 0, 28, and 56. The primary endpoint was the average change from baseline in prebronchodilator forced

Published
2020

45. Efficacy And Safety Of Glycopyrrolate/Formoterol Fumarate Metered Dose Inhaler (GFF MDI) Formulated Using Co-Suspension Delivery Technology In Chinese Patients With COPD

Author

Chen,Rongchang, Zhong,Nanshan, Wang,Hao-Yan, Zhao,Li, Mei,Xiaodong, Qin,Zhiqiang, Huang,Juan, Assam,Pryseley N, Maes,Andrea, Siddiqui,Shahid, Martin,Ubaldo J, Reisner,Colin, Chen,Rongchang, Zhong,Nanshan, Wang,Hao-Yan, Zhao,Li, Mei,Xiaodong, Qin,Zhiqiang, Huang,Juan, Assam,Pryseley N, Maes,Andrea, Siddiqui,Shahid, Martin,Ubaldo J, and Reisner,Colin

Abstract

Rongchang Chen,1 Nanshan Zhong,2 Hao-Yan Wang,3 Li Zhao,4 Xiaodong Mei,5 Zhiqiang Qin,6 Juan Huang,7 Pryseley N Assam,8 Andrea Maes,9 Shahid Siddiqui,10 Ubaldo J Martin,10 Colin Reisner9 1Shenzhen Institute of Respiratory Diseases, Shenzhen People’s Hospital, Shenzhen, Guangdong, People’s Republic of China; 2Guangzhou Institute of Respiratory Health, State Key Laboratory of Respiratory Diseases, National Clinical Research Centre for Respiratory Diseases, First Affiliated Hospital of Guangzhou Medical University, Guangzhou, People’s Republic of China; 3Beijing Friendship Hospital, Capital Medical University, Beijing, People’s Republic of China; 4Sheng Jing Hospital of China Medical University, Shenyang, Liaoning, People’s Republic of China; 5Anhui Provincial Hospital, Hefei, Anhui, People’s Republic of China; 6The People’s Hospital of Guangxi Zhuang Autonomous Region, Nanning City, Guangxi Zhuang Autonomous Region, People’s Republic of China; 7Formerly of AstraZeneca, Shanghai, People’s Republic of China; 8AstraZeneca, Shanghai, People’s Republic of China; 9AstraZeneca, Morristown, NJ, USA; 10AstraZeneca, Gaithersburg, MD, USACorrespondence: Nanshan ZhongGuangzhou Institute of Respiratory Health, State Key Laboratory of Respiratory Diseases, National Clinical Research Centre for Respiratory Diseases, First Affiliated Hospital of Guangzhou Medical University, 151 Yanjiang Road, Guangzhou 510120, Guangdong, People’s Republic of ChinaTel +86 20 83062719Email nanshan@vip.163.comBackground: Glycopyrrolate/formoterol fumarate metered dose inhaler (GFF MDI) is a long-acting muscarinic antagonist/long-acting β2-agonist fixed-dose combination therapy delivered by MDI, formulated using innovative co-suspension delivery technology. The PINNACLE-4 study evaluated the efficacy and safety of GFF MDI in patients with moderate-to-very severe chronic obstructive pulm

Published
2020

46. Glycopyrrolate/Formoterol Fumarate Metered Dose Inhaler Improves Lung Function versus Monotherapies in GOLD Category A Patients with COPD: Pooled Data from the Phase III PINNACLE Studies

Author

Martinez,Fernando J., Rabe,Klaus F., Lipworth,Brian J., Arora,Samir, Jenkins,Martin, Martin,Ubaldo J., Reisner,Colin, Martinez,Fernando J., Rabe,Klaus F., Lipworth,Brian J., Arora,Samir, Jenkins,Martin, Martin,Ubaldo J., and Reisner,Colin

Abstract

Fernando J Martinez,1 Klaus F Rabe,2 Brian J Lipworth,3 Samir Arora,4 Martin Jenkins,5 Ubaldo J Martin,6 Colin Reisner6,7 1Joan and Sanford I. Weill Department of Medicine, Weill Cornell Medicine, New York, NY, USA; 2Department of Pneumonology, LungenClinic Grosshansdorf and Christian-Albrechts University Kiel, Airway Research Center North, Member of the German Center for Lung Research (DZL), Grosshansdorf, Germany; 3Division of Molecular and Clinical Medicine, Scottish Centre for Respiratory Research, Ninewells Hospital, University of Dundee, Dundee, Scotland, UK; 4Aventiv Research Inc., Columbus, OH, USA; 5Global Medicines Development, AstraZeneca, Cambridge, UK; 6Research and Development, AstraZeneca, Gaithersburg, MD, USA; 7R&D Biopharmaceuticals, AstraZeneca, Morristown, NJ, USACorrespondence: Fernando J MartinezJoan and Sanford I. Weill Department of Medicine, Weill Cornell Medicine, New York-Presbyterian Hospital/Weill Cornell Medical Center, 525 E 68th Street, Room M-522, Box 130, New York, NY 10065, USATel +1646 962 2748Email fjm2003@med.cornell.eduBackground: The Global Initiative for Chronic Obstructive Lung Disease (GOLD) recommends a short-acting bronchodilator or single long-acting bronchodilator as an initial pharmacological treatment for GOLD category A patients with COPD. We pooled data from the PINNACLE-1, -2, and -4 studies to evaluate the efficacy and safety of the dual bronchodilator fixed-dose combination glycopyrrolate/formoterol fumarate metered dose inhaler (GFF MDI), formulated using co-suspension delivery technology, in GOLD category A patients with moderate-to-very severe COPD.Materials and Methods: PINNACLE-1, -2, and -4 were Phase III, randomized, double-blind, parallel-group, multicenter studies (NCT01854645, NCT01854658, and NCT02343458). Patients received 24 weeks’ treatment with GFF MDI 18/9.6 μg, glycopyrrolate (GP) MDI 18 μg, formoterol fumarate (FF) MDI 9.6 μg, or placebo MDI twice daily. GO

Published
2020

48. Response

Author

Hanania, Nicola A., Celli, Bartolome R., Donohue, James F., and Martin, Ubaldo J.

Published
2012
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49. Blood Eosinophil Counts in Clinical Trials for Chronic Obstructive Pulmonary Disease

Author

Singh, Dave, primary, Bafadhel, Mona, additional, Brightling, Christopher E., additional, Sciurba, Frank C., additional, Curtis, Jeffrey L., additional, Martinez, Fernando J., additional, Pasquale, Cara B., additional, Merrill, Debora D., additional, Metzdorf, Norbert, additional, Petruzzelli, Stefano, additional, Tal-Singer, Ruth, additional, Compton, Christopher, additional, Rennard, Stephen, additional, and Martin, Ubaldo J., additional

Published
2020
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50. Onset of Effect, Changes in Airflow Obstruction and Lung Volume, and Health-Related Quality of Life Improvements with Benralizumab for Patients with Severe Eosinophilic Asthma: Phase IIIb Randomized, Controlled Trial (SOLANA) [Corrigendum]

Author

Panettieri Jr, Reynold A, primary, Welte, Tobias, additional, Shenoy, Kartik V, additional, Korn, Stephanie, additional, Jandl, Margret, additional, Kerwin, Edward M, additional, Feijoo, Rosa, additional, Barker, Peter, additional, Olsson, Richard F, additional, and Martin, Ubaldo J, additional

Published
2020
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