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1. Impact of Air Pollution on Asthma: A Scoping Review

Author

Olaia Bronte-Moreno, Francisco-Javier González-Barcala, Xavier Muñoz-Gall, Ana Pueyo-Bastida, Jacinto Ramos-González, and Isabel Urrutia-Landa

Subjects
Asma, Contaminación ambiental, Contaminante, Exacerbación, Material particulado, Alergeno inhalado, Diseases of the respiratory system, RC705-779
Abstract

Asthma is the most common chronic respiratory disease and a major public health problem. Although the causal relationship between air pollution and asthma remains controversial, a large number of studies have provided increasingly consistent evidence of the involvement of air pollutants in asthma onset and exacerbations. We conducted a keyword search-based literature review using PubMed, Scopus and Web of Science databases for studies with titles or abstracts containing predefined terms. This narrative review discusses the current evidence on the pathological effects of pollution throughout life and the mechanisms involved in the onset, development, and exacerbation of asthma, and presents current measures and interventions for pollution damage control. Further global efforts are still needed to improve air quality. Resumen: El asma es la enfermedad respiratoria crónica más común, y un importante problema de salud pública. Aunque la relación causal entre la contaminación del aire y el asma sigue siendo controvertida, una gran cantidad de estudios han proporcionado evidencia cada vez más consistente de la participación de los contaminantes del aire en el inicio y las exacerbaciones del asma. Realizamos una revisión de la literatura basada en búsqueda de palabras clave utilizando las bases de datos PubMed, Scopus y Web of Science para estudios con títulos o resúmenes que contienen términos predefinidos. Esta revisión narrativa analiza la evidencia actual sobre los efectos patológicos de la contaminación a lo largo de la vida y los mecanismos involucrados en el inicio, desarrollo y exacerbación del asma, y presenta las medidas e intervenciones actuales para el control de daños por contaminación. Todavía se necesitan más esfuerzos globales para mejorar la calidad del aire.

Published
2023
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2. Uso de glucocorticoides sistémicos para el tratamiento del asma grave: Consenso multidisciplinar español

Author

Javier Domínguez-Ortega, Julio Delgado Romero, Xavier Muñoz Gall, Amparo Marco, and Marina Blanco-Aparicio

Subjects
Asthma, Glucocorticoids, Consensus, Delphi, Treatment withdrawal, Side effects, Diseases of the respiratory system, RC705-779
Abstract

Resumen: Antecedentes y objetivo: Los glucocorticoides sistémicos (GCS) se han utilizado ampliamente para tratar el asma desde que se describió por primera vez su eficacia en esta enfermedad. Actualmente sabemos que su uso está asociado con la aparición de efectos adversos (EA), como la osteoporosis o la insuficiencia suprarrenal. Este es un estudio observacional basado en la metodología Delphi. El cuestionario constaba de 4 bloques principales: generalidades de los GCS; tratamiento de mantenimiento; tratamiento en ciclos cortos, y EA. Materiales y métodos: Un panel de 48 expertos profesionales alergólogos y neumólogos respondieron a 2 rondas de un cuestionario de 68 enunciados. Resultados: Se consensuaron definiciones y hubo acuerdos sobre el uso apropiado de los GCS en el tratamiento del asma grave. Los expertos consensuaron que el uso de los GCS se debe minimizar en lo posible y estuvieron de acuerdo en un esquema de retirada gradual y progresivo en caso de terapias de mantenimiento. Además, destacaron la necesidad de estandarizar el procedimiento de control de la medida de GCS administrado tanto en ciclos cortos como en terapias de mantenimiento a fin de controlar mejor la carga acumulada de los pacientes que reciben dicho tratamiento y evitar la aparición de EA. Conclusiones: Este documento de consenso pretende aunar las recomendaciones de los expertos en el manejo del asma respaldadas por la evidencia científica con el objetivo de impulsar la reducción en el uso de GCS en el ámbito español. Abstract: Background and aim: Since their effectiveness was initially demonstrated, oral corticosteroids (OCS) have been routinely used to treat asthma. We now know that their usage is linked to the development of side effects such osteoporosis and adrenal insufficiency. This is an observational study based on Delphi methodology. The questionnaire was divided into 4 sections: OCS generalities, maintenance treatment, short-term treatment, and adverse events. Materials and methods: Two rounds of a 68-item questionnaire were completed by a panel of 48 allergists and pneumologists. Results: Definitions were agreed upon, as was the proper use of OCS in the treatment of severe asthma. The experts agreed that the use of OCS should be minimized as much as possible and that in the event of maintenance treatments, a slow and progressive tapering strategy should be used. They also emphasized the importance of standardizing the technique for measuring the amount of SCG delivered in both cases. Conclusions: This consensus document attempts to bring together scientifically supported suggestions from specialists in the management of asthma to reduce the use of OCS in Spain.

Published
2022
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3. Factores que condicionan la pérdida de control al reducir escalones terapéuticos en el tratamiento del asma moderada-grave en la práctica clínica habitual: estudio español multicéntrico

Author

Martínez-Moragón, E., Delgado, J., Mogrovejo, S., Fernández-Sánchez, T., Jesús, Jiménez López, Ángel, Moscardó Orenes Miguel, Patricia, Prieto Montaño, Miguel, Torrecillas Toro, Begoña, Cueva Oliver, Ángel, Ferrer Torres, Purificación, González Delgado, Wilfox, Jiménez Rodríguez Teodorikez, Brian, Vila Auli, José, Zapata Yebenes Juan, Teresa, Audicana Berasategui María, Marta, Frias Jiménez, Nieves, Hurtado de Mendoza Ruibio, Marta, Velasco Azagra, Antonio, Álvarez Fernández Jose, Sara, Acero Sainz, Rosa, Blanco González M., Estela, Gómez Nieves María, Diego, Aisa Carpio, Núria, Angrill Sellés, Cristina, Berastegui García, Astrid, Crespo Lessmann, David, De La Rosa Carrillo, Jordi, Juanola Pla, Alejandra, López Giraldo, Olga, Luengo Sánchez, Carlos, Martínez Rivera, Pilar, Martínez Olondris, Xavier, Muñoz Gall, Ester, Pinto Nogués, Francisco, Planas Coimerma, Karina, Portillo Carroz, Antoni, Riba Blanch, Luisa, Rivera Ortún M., Dan, Sánchez Berenguer, Joan, Serra Batlles, Pere, Serra Mitjà, Ana, Sogo Sagardía, Lorena, Soto Retes, Joan, Valldeperas Combas, Xavier, Vila Giralte, Ignacio, Ansotegui Zubeldia, Ignacio, Antepara Ercoreca, Miguel, Herrerías Peña, Milagros, Iriberri Pascual María, Carmen, Jaca Michelena, Adolfo, Lahuerta Castro, Amaia, Laita Legarreta, Paula, Losada Llorente, Joaquina, Prieto Prieto, Vanessa, Zorrilla Lorenzo, Lidia, Alonso Gil, Pablo, García Muñoz Juan, Marisa, Marcos Durantez, Teresa, Peña Miguel, Tahar, Ahmida, Isabel, Alvarado Izquierdo María, Michael, Alwakil Olbah, Aurelio, Arnedillo Muñoz, Ignacio, García Núñez, Diego, Gutiérrez Fernández, Antonio, Letran Camacho, Luis, Fernández Pellon, Maria, Morchon Miguel Eva, Félix, Ortiz Portal, Isabela, Raducan, Antonio, Royo Prats Juan, Dolores, Salvador Segarra María, Frederic, Tatay Soler, Alberto, Levy Naon, Pedro, Galindo Bonilla, Luis, Gil Muñoz Francisco, Patricia, Mata Calderón, Manuel, Entrenas Costa Luis, Marina, Blanco Aparicio, Manuel, García Pazos Jose, Vanessa, García Paz, Francisco-Javier, González Barcala, Pilar, Iriarte Sotes, Jorge, Marcos Rodríguez Pedro, Fernando, Molina Nieto, Ramón, Nuñez Orjales, Carracedo, Sevillano Martín, Juan, Suárez Antelo, Julia, Tábara Rodríguez, Santiago, Aparicio Español, Carlos, Sabadell Nieto, Gladis, Sabater Talaverano, Mar, Escribano Rodríguez M., Fernando, Florido López José, Ángeles, Lara Jiménez María, José, Rojas Vílchez María, Susana, Chic Palacín, Silvia, Dorronsoro Quintana, Antonio, Navarro Echeverria Jose, Eduardo, Figueroa de la Guardia, Belén, Hinojosa Jara, Victoria, Moreno García, Lucía, Valverde Vazquez, Joaquín, Cegoñino de Sus, Santonio, Compaired Villa Jose, Alfonso, Almagro López Juan, Eduardo, Arcalá Campillo, María, Cruz Molina Jose, Dolores, Soto Venegas Antonia, Patricia, Benito Martínez, Begoña, Blanco Reinosa, Beatriz, Fernández Parra, Domingo, Fernández García, Virginia, Serrano Gutiérrez, Adolfo, Velez Ruiz de Lobera, Silvia, Lara Alcon, Francisco, Carballada González, Teresa, González Fernández, Joaquín, Martín Lázaro, Noemí, Mengual Macenlle, Soledad, Alonso Viteri, Darío, Antolín Amerigo, Irina, Bobolea, Puerto, Cano Aguirre M. del, Remedios, Cardenas Contreras, Fernando, Carrillo Arias, Mercedes, Cimarra Álvarez, Belén, De Higes Martínez Eva, Magdalena, Díaz Campos Rocío, Mar, Gandolfo Cano María del, Leticia, García Rodríguez, Andrés, García Romero de Tejada Jose, Eloina, González Mancebo, Emma, González Seco, Fernando, González Torralba, Aythamy, Henríquez Santana, Lys, Herráez Herrera Pilar de, Ruth, Herrero Mosquete María, Pedro, Landete Rodríguez, Belén, López-Muñiz Ballesteros, Ester, Mohedano Vicente, Beatriz, Morales Chacón, Antonio, Moreno Fernández, Esther, Muñoz García, Elena, Ojeda Castillejo, Fernando, Pedraza Serrano, Yesenia, Peña Acevedo Acevedo, Raquel, Pérez Rojo, Natividad, Quílez Ruiz-Rico, Ángela, Ramos Pinedo, Beatriz, Rodríguez Jiménez, Mercedes, Rodríguez Rodríguez, Ana, Rosado Ingelmo, Antonio, Ruiz Peña, José, Sánchez González María, Jesús, Trujillo Trujillo María, Laura, Vázquez Fuertes, Concepción, Vila Albelda, Alexandra, Yago Meniz, Ismael, Aguilar Perez Grovas Ricardo, José, Alcázar Ramírez Alcázar Ramírez, Manuel, Barceló Muñoz José, Miguel, Bentabol Manzanares, Gustavo, De Luiz Martínez, Francisco, Linde de Luna, Alfonso, Miranda Paez, Ezequiel, Ortega Sáenz de Tejada, Alicia, Padilla Galo, Manuel, Pérez Estrada Cornejo, Carmen, Soria Esojo, Francisco, Abellán Alemán Ángel, Consuelo, Alcalde Rumayor María, Rubén, Andújar Espinosa, Roberto, Bernabeu Mora, Javier, Campano Lancharro Francisco, Tamara, Gutiérrez Urra, Sonia, Herrero Martín, Alfredo, Resano Lizaldre, and Raquel, Dacal Quintas

Published
2020
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4. Severe Asthma Standard-of-Care Background Medication Reduction With Benralizumab: ANDHI in Practice Substudy

Author

Renaud Louis, Tim W. Harrison, Pascal Chanez, Francesco Menzella, George Philteos, Borja G. Cosio, Njira L. Lugogo, Gustavo de Luiz, Annie Burden, Timothy Adlington, Nanna Keeling, Justin Kwiatek, Esther Garcia Gil, Wolfgang Pohl, Daniel Doberer, Jean Benoit Martinot, Maud Deschampheleire, Ulrike Himpe, Kenneth Chapman, Amarjit Cheema, Delbert Dorscheid, Clare Ramsey, Jeffrey Rolf, Brandie Walker, Ronald Olivenstein, Claude Poirier, Pierre Larivee, Anne Sofie Bjerrum, Ingrid Titlestad, Ole Hilberg, Maritta Kilpeläinen, Philippe Bonniaud, Camille Taillé, Iuliana-Angelica Tiotiu, Pierre-Olivier Girodet, François-Xavier Blanc, Johana Pradelli, Alain Didier, Cecilia Nocent Ejnaini, Gaetan Deslee, Christophe Pison, Youcef Douadi, Guillaume Mahay, Gilles Devouassoux, Boris Melloni, Pauline-Marie Roux, Arnaud Bourdin, Stephanie Fry, Thomas Schaum, Christian Schulz, Dirk Skowasch, Christian Taube, Tobias Welte, Wolfgang Gleiber, Randolf Brehler, Jens Schreiber, Wolfgang Schuette, Juliane Kronsbein, Reiner Bonnet, Ekkehard Beck, Donato Lacedonia, Gianenrico Senna, Cristiano Caruso, Nunzio Crimi, Francesco Blasi, Pierachille Santus, Giorgio Walter Canonica, Gabriella Guarnieri, Girolamo Pelaia, Manlio Milanese, Claudio Micheletto, Angelo Guido Corsico, Nicola Scichilone, Giuseppe Spadaro, Bas Langeveld, Jurgen Holters, Jan Willem van den Berg, Arthur Smit, Lennart Conemans, Helena van Veen, Gerald Staaks, Sverre Lehmann, Jose Maria Echave-Sustaeta, Christian Domingo Ribas, Gustavo de Luiz Martinez, Ruperto Gonzalez Perez, Juan Luis Garcia Rivero, Xavier Muñoz Gall, Jose Gregorio Soto Campos, Paloma Campo Mozo, Carmen Vidal Pan, Ana Gomez-Bastero Fernandez, Sergio Campos Tellez, Carlos Martinez Rivera, Irina Diana Bobolea, Raquel Morillo Guerrero, Ismael Ali Garcia, Juan Luis Rodriguez Hermosa, Nikolai Stenfors, Alf Tunsäter, Dan Curiac, Christophe von Garnier, Joerg Leuppi, Peter Schmid-Grendelmeier, Shuaib Nasser, Rekha Chaudhuri, Monica Nordstrom, Dinesh Saralaya, Paul Pfeffer, Adel Mansur, Philip Short, Sally Wenzel, William Brett Cherry, Heidi Zafra, Erika Gonzalez, Weily Soong, Benjamin Davis, Neil Kao, Iftikhar Hussain, Diego Jose Maselli Caceres, James Harris, William Calhoun, Ileana Rodicio, David Kaufman, Mark Moss, Eric Sztejman, Samuel DeLeon, Kaharu Sumino, Ravindra Kashyap, Jeffrey Leflein, Rizan Hajal, Faisal Fakih, David Hill, Robert Lin, Mikell Jarratt, Vijay Subramaniam, Robert Sussman, Nayla Mumneh, Joan Reibman, Jared Darveaux, Ricardo Tan, Tonny Tanus, Vinay Sikand, Gailen Marshall, Hemalini Mehta, Jeremy Cole, Brad Goodman, Deborah Goss, Jose Bardelas, Aaron Milstone, Vinay Mehta, Lee Clore, Mark Millard, Michael Palumbo, Dileep Puppala, Mila Leong, Bruce Prenner, Emory Robinette, Hengameh Heidarian Raissy, David Fost, Warren Pleskow, Michael Marcus, Jonathan Ilowite, Wendy Moore, Gary Steven, Luis De la Cruz, Geoffrey Chupp, William Berger, Christopher Randolph, Fernando Holguin, Shahrukh Kureishy, and Edward Campbell

Subjects
Eosinophils, Severe asthma, Benralizumab, Eosinophilic asthma, Open-label extension, Oral corticosteroids, Immunology and Allergy
Published
2023

5. Clinical burden related to oral corticosteroid treatment of severe asthma in Spain: LEVANTE study

Author

Xavier Muñoz Gall, Javier Domínguez-Ortega, Silvia Pascual, Carlos Cabrera López, null Gustavo Resler, Javier Nuevo, and Gema Monteagudo

Subjects
Pulmonary and Respiratory Medicine, Pediatrics, Perinatology and Child Health, Immunology and Allergy
Abstract

Severe asthma treatment with oral corticosteroids (OCS) added to inhaled corticosteroids and a long-acting β2-agonist (ICS-LABA) may result in more treatment burden and increased adverse effects.This ambispective multicenter observational study aimed at describing the clinical burden in patients with severe asthma on stable high-dose ICS-LABA who received OCS during ≥6 months (maintenance group) or ≥2 cycles in the previous 12 months (bursts group). Data collection comprised a retrospective 12-month baseline period and 2 follow-up visits at 3 and 6 months.Eighty-nine patients were evaluable (30 on maintenance, 59 on bursts). At baseline, mean (SD) daily prednisone equivalent exposure in the total population was 24.6 (14.7) mg: 13.8 (9.4) mg on maintenance and 29.9 (14.3) mg on bursts. During the 6-month follow-up period, mean (SD) daily dose in the total cohort was 22.5 (18.8) mg: 17.2 (18.6) mg on maintenance and 28.4 (20.6) mg on bursts. The overall annual severe exacerbations rate during the 12-month baseline period was 2.05 per patient-year and 1.5 per patient-year over the 6-month follow-up, and frequency of hospitalizations and emergency department visits were similar on both maintenance and bursts use.Results show a suboptimal control of severe asthma despite such high doses of OCS and persistence of disease burden regardless of the prescribing pattern in maintenance or bursts. There is therapeutic inertia to continue using OCS despite the increased risk of adverse effects and the availability of biologics.

Published
2022

6. Challenges for asthma units in response to COVID-19: a qualitative group dynamics analysis

Author

Irina Bobolea, Mariana Muñoz-Esquerre, Gaspar Dalmau Duch, Xavier Muñoz Gall, Astrid Crespo-Lessmann, Ricardo Pifarre Teixido, Gladis Sabater Talaverano, Ana Sogo Sabardía, Pilar Ausín, Ebymar Arismendi, Xavier Aguilar, and Carlos Martínez Rivera

Subjects
Pulmonary and Respiratory Medicine, Telemedicine, Referral, media_common.quotation_subject, MEDLINE, Context (language use), 03 medical and health sciences, 0302 clinical medicine, Nursing, Health care, Humans, Immunology and Allergy, Medicine, 030212 general & internal medicine, Hospital pharmacy, Empowerment, Pandemics, media_common, Accreditation, Biological Products, business.industry, COVID-19, Asthma, 030228 respiratory system, Pediatrics, Perinatology and Child Health, business
Abstract

OBJECTIVE: To develop a set of recommendations for the management of severe asthma during COVID-19 pandemic. METHODS: Eleven pneumologists and allergologists who were staff members of officially accredited asthma units in Catalonia (Spain) participated in a cross-section study based on three 2-hour virtual workshops (first: brainstorming, second: identification of impacts and challenges summarized in 10 topics, third: establishment of final recommendations by consensus). RESULTS: Impacts and challenges identified were improvement of referral protocols between different levels of care; assessment of the minimum number of function tests to be performed and promote the performance of spirometry in primary care; implementation of videoconferencing, mobile apps, telephone calls, or integral virtual platforms for the follow-up of patients, and definition of the model of care (face-to-face, telematics, mixed) according to the patient's individual needs; self-administration of biologics for domiciliary treatment; and empowerment of the role of nursing and hospital pharmacy in particular for follow-up and self-administration of biologics. The main recommendations included coordination between primary care and specialized care consultation, optimization of lung function testing, implementation of telemedicine, and the role of nursing and hospital pharmacy. CONCLUSION: The specific proposals in response to the effect of COVID-19 pandemic focused on four areas of interest (coordination between primary care and specialized care, optimization of lung function testing, implementation of telemedicine, and empowerment of the role of nursing and hospital pharmacy) may be generalized to other health care settings, and help to introduce new ways of caring asthma patients in the COVID-19 context.

Published
2021

7. Cost-effectiveness analysis of anti–IL-5 therapies of severe eosinophilic asthma in Spain

Author

Xavier Muñoz-Gall, Gijs van de Wetering, Shibing Yang, Andrea García, José Luis Izquierdo-Alonso, Francisco-Javier González-Barcala, Esther Mariscal, Institut Català de la Salut, [González-Barcala FJ] Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela, Spain. Respiratory Medicine, Universidad de Santiago de Compostela, Santiago de Compostela, Spain. [Muñoz-Gall X] Servei de Pneumologia, Vall d’Hebron Hospital Universitari, Barcelona, Spain. CIBER of Respiratory Diseases (CIBERes), Madrid, Spain. Departament de Biologia Cel•lular, Fisiologia i Immunologia, Universitat Autònoma de Barcelona, Bellaterra, Spain. [Mariscal E, García A] GlaxoSmithKline, Madrid, Spain. [Yang S] GlaxoSmithKline, Collegeville, PA, USA. [van de Wetering G] Pharmerit International, Rotterdam, the Netherlands. [Izquierdo-Alonso JL] Medicine and Specialities Department, Universidad de Alcalá (Alcalá de Henares, Madrid), Hospital Universitario Guadalajara, Guadalajara, Spain, and Vall d'Hebron Barcelona Hospital Campus

Subjects
medicine.medical_specialty, Standard of care, Cost effectiveness, Cost-Benefit Analysis, Eosinophilic asthma, 03 medical and health sciences, 0302 clinical medicine, Adrenal Cortex Hormones, Internal medicine, Eosinophilia, economía y organizaciones para la atención de la salud::economía::costes y análisis de costes::análisis coste-beneficio [ATENCIÓN DE SALUD], medicine, hormonas, sustitutos de hormonas y antagonistas de hormonas::hormonas::hormonas de la corteza suprarrenal [COMPUESTOS QUÍMICOS Y DROGAS], Humans, Other subheadings::/therapeutic use [Other subheadings], Eosinofília, health care economics and organizations, enfermedades hematológicas y linfáticas::enfermedades hematológicas::trastornos leucocitarios::eosinofilia [ENFERMEDADES], Hormones, Hormone Substitutes, and Hormone Antagonists::Hormones::Adrenal Cortex Hormones [CHEMICALS AND DRUGS], Otros calificadores::/uso terapéutico [Otros calificadores], business.industry, 030503 health policy & services, Health Policy, Cost-effectiveness analysis, Asthma, Anti il 5, Hormones esteroides - Ús terapèutic, Health Care Economics and Organizations::Economics::Costs and Cost Analysis::Cost-Benefit Analysis [HEALTH CARE], Spain, 030220 oncology & carcinogenesis, Cost-eficàcia, Hemic and Lymphatic Diseases::Hematologic Diseases::Leukocyte Disorders::Eosinophilia [DISEASES], Quality-Adjusted Life Years, 0305 other medical science, business, Mepolizumab, medicine.drug
Abstract

Asma eosinofílica greu; Comparació indirecta del tractament; Mepolizumab Severe eosinophilic asthma; Indirect treatment comparison; Mepolizumab Asma eosinofílica severa; Comparación de tratamiento indirecto; Mepolizumab Aim To analyse the cost-effectiveness of MEP with standard of care (SoC) versus other anti-IL-5 therapies approved for the treatment of severe eosinophilic asthma (SEA) patients, within the Spanish National Health System (NHS) perspective. Methods A Markov model with a 4-week cycle length was used to compare MEP with BEN and RES as therapies added to SoC in the management of SEA, in terms of cost per QALY gained and incremental cost-effectiveness ratio (ICER). Costs (€2019) were obtained from public sources, while utilities and transition probabilities were retrieved from literature, e.g. network meta-analysis. Continuation criteria for biological treatment and reduction of oral corticosteroids (OCS) was set at 50% minimum reduction of exacerbation rate. Adverse events related to chronic OCS use included diabetes, osteoporosis, cataracts, acute myocardial infarct, and peptic ulcer. The analysis was performed over a 5-year time horizon from the National Healthcare System (NHCS) perspective, with a yearly discount rate of 3% applied to both costs and QALYs. Probabilistic sensitivity analysis and univariate deterministic sensitivity analysis were performed to address uncertainty around the cost-effectiveness results. Results On top of SoC, the model indicates that MEP is dominant (lower cost, higher benefit) compared to BEN and RES: For BEN and RES, respectively, treatment with MEP had a point estimate of 0.076 and 0.075 additional QALYs, and savings of €3,173.47 and €7,772.95 per patient. The findings were robust to variation as estimated using sensitivity analysis. Conclusions MEP is a cost-effective treatment in comparison with BEN and RES added to SoC for patients with SEA in the Spanish setting. This study was funded by GlaxoSmithKline [Study code: HO-19-19968].

Published
2021

8. Onset of effect and impact on health-related quality of life, exacerbation rate, lung function, and nasal polyposis symptoms for patients with severe eosinophilic asthma treated with benralizumab (ANDHI): a randomised, controlled, phase 3b trial

Author

Harrison, Tim W, Chanez, Pascal, Menzella, Francesco, Canonica, Giorgio Walter, Louis, Renaud, Cosio, Borja G, Lugogo, Njira L, Mohan, Arjun, Burden, Annie, McDermott, Lawrence, Garcia Gil, Esther, Zangrilli, James G, Wolfgang Pohl, Robert Voves, Maud Deschampheleire, Renaud Louis, Jean-Benoit Martinot, Rudi Peché, Kenneth Chapman, Amarjit Cheema, Delbert Dorscheid, J Mark FitzGerald, Remi Gagnon, William Patrick Killorn, Ronald Olivenstein, George Philteos, Clare Ramsey, J Douglass Rolf, Brandie Walker, Ole Hilberg, Tina Skjold, Ingrid Titlestad, Auli Hakulinen, Maritta Kilpeläinen, Michèle Ben Hayoun, Philippe Bonniaud, Arnaud Bourdin, Pascal Chanez, Frédéric De Blay, Gaëtan Deslee, Gilles Devouassoux, Alain Didier, Youcef Douadi, Stéphanie Fry, Gilles Garcia, Pierre-Olivier Girodet, Christophe Leroyer, Antoine Magnan, Guillaume Mahay, Cécilia Nocent, Christophe Pison, Pauline-Marie Roux, Camille Taillé, Juliana-Angelica Tiotiu, Ekkehard Beck, Margret Jandl, Christian Kaehler, Frank Kässner, Frank Koesters, Juliane Kronsbein, Thomas Schaum, Christian Schulz, Dirk Skowasch, Christian Taube, Tobias Welte, Andrés de Roux, Bianca Beghé, Francesco Blasi, Giorgio Walter Canonica, Giovanna Carpagnano, Cristiano Caruso, Angelo Guido Corsico, Elio Constantino, Nunzio Crimi, Piero Maestrelli, Francesco Menzella, Manlio Milanese, Alberto Papi, Girolamo Pelaia, Laura Pini, Pierachille Santus, Eleonora Savi, Nicola Scichilone, Gianenrico Senna, Giuseppe Spadaro, Adriano Vaghi, Steven Gans, Jurgen Hölters, B Langeveld, Willem Pieters, G H A Staaks, Ilonka van Veen, J W K van den Berg, Gunnar Einvik, Sverre Lehmann, Ismael Ali García, Carlos Almonacid, Irina Bobolea, Paloma Campo Mozo, Gustavo de Luiz, Christian Domingo Ribas, José María Echave-Sustaeta María-Tomé, Juan Luis García Rivero, Borja García-Cosío Piqueras, Ana Gómez-Bastero Fernández, Ruperto González Pérez, Aythamy Henríquez Santa, Carlos Martínez Rivera, Xavier Muñoz Gall, Jacinto Ramos, Jose Gregorio Soto Campos, Carmen Vidal Pan, Nikolai Stenfors, Alf Tunsäter, Ines Vinge, Rekha Chaudhuri, Timothy Harrison, Adel Mansur, Shuaib Nasser, Monica Nordstrom, Paul Pfeffer, Dinesh Saralaya, Philip Short, Arun Adlakha, Oral Alpan, Francis Averill, Anil Badhwar, Jose Bardelas, Barbara Baxter, George Bensch, William Berger, Jonathan Bernstein, Tracy Bridges, Ryan Brimeyer, William Calhoun, Edward Campbell, William Brett Cherry, Geoffrey Chupp, Lee Clore, John Cohn, Jeremy Cole, John Condemi, James Cury, Benjamin Davis, Samuel DeLeon, Luis Delacruz, Joseph Diaz, David Erb, Emeka Eziri, Faisal Fakih, Douglas Fiedler, David Fost, Stephen Fritz, Erika Gonzalez, Brad Goodman, Peter Gottlieb, Gregory Gottschlich, Richard Gower, Rizan Hajal, James Harris, Hengameh Heidarian-Raissy, Albrecht Heyder, David Hill, Fernando Holguin, Iftikhar Hussain, Jonathan Illowite, Joshua Jacobs, Mikell Jarratt, Harold Kaiser, Neil Kao, Ravindra Kashyap, David Kaufman, Edward Kent, Kenneth Kim, Ryan Klein, Monica Kraft, Ritsu Kono, Shahrukh Kureishy, Jeffrey Leflein, Mila Leong, Huamin Li, Robert Lin, Njira Lugogo, Michael Marcus, Diego Jose Maselli Caceres, Vinay Mehta, Curtis Mello, Mark Millard, Aaron Milstone, Arjun Mohan, Wendy Moore, Mark Moss, Nayla Mumneh, Thomas O'Brien, David Ostransky, Michael Palumbo, Purvi Parikh, Sudhir Parikh, Amit Patel, Guido Perez, Warren Pleskow, Bruce Prenner, Dileep Puppala, John Ramey, Joan Reibman, Ramon Reyes, Emory Robinette, Ileana Rodicio, Stephen Ryan, Sudhir Sekhsaria, Barry Sigal, Vinay Sikand, Weily Soong, Selwyn Spangenthal, Roy St John, Gary Steven, Vijay Subramaniam, Kaharu Sumino, Eric Sztejman, Ricardo A Tan, Tonny Tanus, Charles Thompson, Carl Thornblade, Manuel Villareal, Sally Wenzel, Heidi Zafra, Tomasz Ziedalski, Centre recherche en CardioVasculaire et Nutrition = Center for CardioVascular and Nutrition research (C2VN), Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), Physiologie & médecine expérimentale du Cœur et des Muscles [U 1046] (PhyMedExp), Université de Montpellier (UM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Pathologies Pulmonaires et Plasticité Cellulaire - UMR-S 1250 (P3CELL), Université de Reims Champagne-Ardenne (URCA)-Institut National de la Santé et de la Recherche Médicale (INSERM), Tim W, Harrison, Pascal, Chanez, Francesco, Menzella, Giorgio Walter, Canonica, Renaud, Loui, Borja G, Cosio, Njira L, Lugogo, Arjun, Mohan, Annie, Burden, Lawrence, Mcdermott, Esther, Garcia Gil, Zangrilli, G, Jame, Pohl, Wolfgang, Voves, Robert, Deschampheleire, Maud, Louis, Renaud, Martinot, Jean-Benoit, Peché, Rudi, Chapman, Kenneth, Cheema, Amarjit, Dorscheid, Delbert, Mark FitzGerald, J, Gagnon, Remi, Patrick Killorn, William, Olivenstein, Ronald, Philteos, George, Ramsey, Clare, Douglass Rolf, J, Walker, Brandie, Hilberg, Ole, Skjold, Tina, Titlestad, Ingrid, Hakulinen, Auli, Kilpeläinen, Maritta, Ben Hayoun, Michèle, Bonniaud, Philippe, Bourdin, Arnaud, Chanez, Pascal, De Blay, Frédéric, Deslee, Gaëtan, Devouassoux, Gille, Didier, Alain, Douadi, Youcef, Fry, Stéphanie, Garcia, Gille, Girodet, Pierre-Olivier, Leroyer, Christophe, Magnan, Antoine, Mahay, Guillaume, Nocent, Cécilia, Pison, Christophe, Roux, Pauline-Marie, Taillé, Camille, Tiotiu, Juliana-Angelica, Beck, Ekkehard, Jandl, Margret, Kaehler, Christian, Kässner, Frank, Koesters, Frank, Kronsbein, Juliane, Schaum, Thoma, Schulz, Christian, Skowasch, Dirk, Taube, Christian, Welte, Tobia, de Roux, André, Beghé, Bianca, Blasi, Francesco, Walter Canonica, Giorgio, Carpagnano, Giovanna, Caruso, Cristiano, Guido Corsico, Angelo, Constantino, Elio, Crimi, Nunzio, Maestrelli, Piero, Menzella, Francesco, Milanese, Manlio, Papi, Alberto, Pelaia, Girolamo, Pini, Laura, Santus, Pierachille, Savi, Eleonora, Scichilone, Nicola, Senna, Gianenrico, Spadaro, Giuseppe, Vaghi, Adriano, Gans, Steven, Hölters, Jurgen, Langeveld, B, Pieters, Willem, A Staaks, G H, van Veen, Ilonka, K van den Berg, J W, Einvik, Gunnar, Lehmann, Sverre, Ali García, Ismael, Almonacid, Carlo, Bobolea, Irina, Campo Mozo, Paloma, de Luiz, Gustavo, Domingo Ribas, Christian, María Echave-Sustaeta María-Tomé, José, Luis García Rivero, Juan, García-Cosío Piqueras, Borja, Gómez-Bastero Fernández, Ana, González Pérez, Ruperto, Henríquez Santa, Aythamy, Martínez Rivera, Carlo, Muñoz Gall, Xavier, Ramos, Jacinto, Gregorio Soto Campos, Jose, Vidal Pan, Carmen, Stenfors, Nikolai, Tunsäter, Alf, Vinge, Ine, Chaudhuri, Rekha, Harrison, Timothy, Mansur, Adel, Nasser, Shuaib, Nordstrom, Monica, Pfeffer, Paul, Saralaya, Dinesh, Short, Philip, Adlakha, Arun, Alpan, Oral, Averill, Franci, Badhwar, Anil, Bardelas, Jose, Baxter, Barbara, Bensch, George, Berger, William, Bernstein, Jonathan, Bridges, Tracy, Brimeyer, Ryan, Calhoun, William, Campbell, Edward, Brett Cherry, William, Chupp, Geoffrey, Clore, Lee, Cohn, John, Cole, Jeremy, Condemi, John, Cury, Jame, Davis, Benjamin, Deleon, Samuel, Delacruz, Lui, Diaz, Joseph, Erb, David, Eziri, Emeka, Fakih, Faisal, Fiedler, Dougla, Fost, David, Fritz, Stephen, Gonzalez, Erika, Goodman, Brad, Gottlieb, Peter, Gottschlich, Gregory, Gower, Richard, Hajal, Rizan, Harris, Jame, Heidarian-Raissy, Hengameh, Heyder, Albrecht, Hill, DAVID STANLEY, Holguin, Fernando, Hussain, Iftikhar, Illowite, Jonathan, Jacobs, Joshua, Jarratt, Mikell, Kaiser, Harold, Kao, Neil, Kashyap, Ravindra, Kaufman, David, Kent, Edward, Kim, Kenneth, Klein, Ryan, Kraft, Monica, Kono, Ritsu, Kureishy, Shahrukh, Leflein, Jeffrey, Leong, Mila, Li, Huamin, Lin, Robert, Lugogo, Njira, Marcus, Michael, Jose Maselli Caceres, Diego, Mehta, Vinay, Mello, Curti, Millard, Mark, Milstone, Aaron, Mohan, Arjun, Moore, Wendy, Moss, Mark, Mumneh, Nayla, O'Brien, Thoma, Ostransky, David, Palumbo, Michael, Parikh, Purvi, Parikh, Sudhir, Patel, Amit, Perez, Guido, Pleskow, Warren, Prenner, Bruce, Puppala, Dileep, Ramey, John, Reibman, Joan, Reyes, Ramon, Robinette, Emory, Rodicio, Ileana, Ryan, Stephen, Sekhsaria, Sudhir, Sigal, Barry, Sikand, Vinay, Soong, Weily, Spangenthal, Selwyn, St John, Roy, Gary, Steven, Subramaniam, Vijay, Sumino, Kaharu, Sztejman, Eric, A Tan, Ricardo, Tanus, Tonny, Thompson, Charle, Thornblade, Carl, Villareal, Manuel, Wenzel, Sally, Zafra, Heidi, Ziedalski, Tomasz, UCL - SSS/IREC/MONT - Pôle Mont Godinne, UCL - (MGD) Service de pneumologie, Harrison T.W., Chanez P., Menzella F., Canonica G.W., Louis R., Cosio B.G., Lugogo N.L., Mohan A., Burden A., McDermott L., Garcia Gil E., Zangrilli J.G., Pohl W., Voves R., Deschampheleire M., Martinot J.-B., Peche R., Chapman K., Cheema A., Dorscheid D., FitzGerald J.M., Gagnon R., Killorn W.P., Olivenstein R., Philteos G., Ramsey C., Rolf J.D., Walker B., Hilberg O., Skjold T., Titlestad I., Hakulinen A., Kilpelainen M., Ben Hayoun M., Bonniaud P., Bourdin A., De Blay F., Deslee G., Devouassoux G., Didier A., Douadi Y., Fry S., Garcia G., Girodet P.-O., Leroyer C., Magnan A., Mahay G., Nocent C., Pison C., Roux P.-M., Taille C., Tiotiu J.-A., Beck E., Jandl M., Kaehler C., Kassner F., Koesters F., Kronsbein J., Schaum T., Schulz C., Skowasch D., Taube C., Welte T., de Roux A., Beghe B., Blasi F., Carpagnano G., Caruso C., Corsico A.G., Constantino E., Crimi N., Maestrelli P., Milanese M., Papi A., Pelaia G., Pini L., Santus P., Savi E., Scichilone N., Senna G., Spadaro G., Vaghi A., Gans S., Holters J., Langeveld B., Pieters W., Staaks G.H.A., van Veen I., van den Berg J.W.K., Einvik G., Lehmann S., Ali Garcia I., Almonacid C., Bobolea I., Campo Mozo P., de Luiz G., Domingo Ribas C., Echave-Sustaeta Maria-Tome J.M., Garcia Rivero J.L., Garcia-Cosio Piqueras B., Gomez-Bastero Fernandez A., Gonzalez Perez R., Henriquez Santa A., Martinez Rivera C., Munoz Gall X., Ramos J., Gregorio Soto Campos J., Vidal Pan C., Stenfors N., Tunsater A., Vinge I., Chaudhuri R., Harrison T., Mansur A., Nasser S., Nordstrom M., Pfeffer P., Saralaya D., Short P., Adlakha A., Alpan O., Averill F., Badhwar A., Bardelas J., Baxter B., Bensch G., Berger W., Bernstein J., Bridges T., Brimeyer R., Calhoun W., Campbell E., Cherry W.B., Chupp G., Clore L., Cohn J., Cole J., Condemi J., Cury J., Davis B., DeLeon S., Delacruz L., Diaz J., Erb D., Eziri E., Fakih F., Fiedler D., Fost D., Fritz S., Gonzalez E., Goodman B., Gottlieb P., Gottschlich G., Gower R., Hajal R., Harris J., Heidarian-Raissy H., Heyder A., Hill D., Holguin F., Hussain I., Illowite J., Jacobs J., Jarratt M., Kaiser H., Kao N., Kashyap R., Kaufman D., Kent E., Kim K., Klein R., Kraft M., Kono R., Kureishy S., Leflein J., Leong M., Li H., Lin R., Lugogo N., Marcus M., Maselli Caceres D.J., Mehta V., Mello C., Millard M., Milstone A., Moore W., Moss M., Mumneh N., O'Brien T., Ostransky D., Palumbo M., Parikh P., Parikh S., Patel A., Perez G., Pleskow W., Prenner B., Puppala D., Ramey J., Reibman J., Reyes R., Robinette E., Rodicio I., Ryan S., Sekhsaria S., Sigal B., Sikand V., Soong W., Spangenthal S., St. John R., Steven G., Subramaniam V., Sumino K., Sztejman E., Tan R.A., Tanus T., Thompson C., Thornblade C., Villareal M., Wenzel S., Zafra H., Ziedalski T., and Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM)-Centre National de la Recherche Scientifique (CNRS)

Subjects
Pulmonary and Respiratory Medicine, Spirometry, Adult, Male, medicine.medical_specialty, Exacerbation, [SDV]Life Sciences [q-bio], Population, Settore MED/10 - Malattie Dell'Apparato Respiratorio, Placebo, Antibodies, Monoclonal, Humanized, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Double-Blind Method, Internal medicine, medicine, Humans, 030212 general & internal medicine, Anti-Asthmatic Agents, Patient Reported Outcome Measures, education, Sinusitis, Asthma, education.field_of_study, medicine.diagnostic_test, business.industry, Middle Aged, medicine.disease, Benralizumab, 3. Good health, Eosinophils, 030228 respiratory system, chemistry, Asthma Control Questionnaire, Disease Progression, Quality of Life, Female, business
Abstract

Background: ANDHI was done to assess the efficacy of benralizumab, including onset of effect and impact on health-related quality of life (HRQOL), exacerbation rate, lung function, and nasal polyposis symptoms. Methods: This phase 3b, randomised, double-blind, parallel-group, placebo-controlled ANDHI study was completed in adults (aged 18–75 years) with severe eosinophilic asthma with at least 2 exacerbations in the previous year, despite high-dose inhaled corticosteroid plus additional controllers, screening blood eosinophil counts of at least 150 cells per μL, and an Asthma Control Questionnaire 6 (ACQ-6) score of 1·5 or more. Patients who met eligibility criteria were randomly assigned (2:1; stratified by previous exacerbation count [two, or three or more], maintenance oral corticosteroid use, and region), using an integrated web-based response system, to receive benralizumab at 30 mg every 8 weeks (first three doses given 4 weeks apart) or matched placebo for 24 weeks. Primary efficacy measure was annualised asthma exacerbation rate, with rate ratio (RR) calculated over the approximate 24-week follow-up. Secondary efficacy measures included change from baseline to end of treatment (week 24) in St George's Respiratory Questionnaire (SGRQ) total score (key secondary endpoint), FEV1, peak expiratory flow (PEF), ACQ-6, Predominant Symptom and Impairment Assessment (PSIA), Clinician Global Impression of Change (CGI-C), Patient Global Impression of Change (PGI-C), and Sino-Nasal Outcome Test-22 (SNOT-22). All efficacy analyses, except for SNOT-22, were summarised and analysed using the full analysis set on an intention-to-treat population (all randomly assigned patients receiving investigational product, regardless of protocol adherence or continued participation in the study). SNOT-22 was summarised for the subgroup of patients with physician-diagnosed nasal polyposis with informed consent. This study is registered with ClinicalTrials.gov, NCT03170271. Findings: Between July 7, 2017, and Sept 25, 2019, 656 patients received benralizumab (n=427) or placebo (n=229). Baseline characteristics were consistent with severe eosinophilic asthma. Benralizumab significantly reduced exacerbation risk by 49% compared with placebo (RR estimate 0·51, 95% CI 0·39–0·65; p5%) were nasopharyngitis (30 [7%]), headache (37 [9%]), sinusitis (28 [7%]), bronchitis (22 [5%]), and pyrexia (26 [6%]). Fewer serious adverse events were reported for benralizumab (23 [5%]) versus placebo (25 [11%]), and the only common serious adverse event (experienced by >1% of patients) was worsening of asthma, which was reported for nine (2%) patients in the benralizumab group and nine (4%) patients in the placebo group. Interpretation: Our results extend the efficacy profile of benralizumab for patients with severe eosinophilic asthma, showing early clinical benefits in patient-reported outcomes, HRQOL, lung function, and nasal polyposis symptoms. Funding: AstraZeneca.

Published
2021

9. Mepolizumab improves lung function under real-world settings in REALITI-A study

Author

Ronan O’Reilly, Shibing Yang, Bonavuth Pek, Faustina Funke, Aoife C. Maxwell, Peter Howarth, Melissa K. Van Dyke, Stephen Pollard, Giorgio Walter Canonica, Xavier Muñoz Gall, Rekha Chaudhuri, Florence Schleich, Sandra Joksaite, and Robert Price

Subjects
Spirometry, medicine.medical_specialty, medicine.diagnostic_test, business.industry, Medizin, Eosinophilic asthma, Repeated measures design, Clinical trial, Sample size determination, Internal medicine, medicine, business, Mepolizumab, Blood eosinophil, Lung function, medicine.drug
Abstract

Introduction: Mepolizumab (MEPO) improves lung function in clinical trials but patient selection for these studies is restricted. No restrictions apply in standard clinical practice, and data from real-life settings is limited. Aims: To evaluate the effectiveness of MEPO in improving lung function in real-life settings. Methods: REALITI-A enrolled patients with severe eosinophilic asthma (SEA) who initiated MEPO from 51 centers in 7 countries. FEV1 was measured by standard spirometry during routine clinic visits. Baseline FEV1 was defined as the latest measure prior to MEPO initiation. Post-initiation FEV1 were averages of FEV1 measures for each subject during the prospective observation periods. Changes from baseline were evaluated using mixed model repeated measures. FEV1 changes were also evaluated by baseline blood eosinophil counts (BEC). Results: FEV1 data was available from 298 and 174 patients at baseline and 9-12 months. Baseline FEV1 least square (LS) mean (95% CI) was 2.0L (1.9-2.1). FEV1 mean changes (95% CI) from baseline at 0-3, 3-6, 6-9 and 9-12 months were respectively 92.5 ml (38.1–147.0), 88.9 ml (29.2-148.6), 89.9 ml (24.4–155.4) and 123.3 ml (56.5–190.0). Significant increases were evident in subjects with BEC≥300 cells/µL (n=238), with a LS mean increase (95% CI) of 128.3 ml (25.7-231.0) at 9-12 months from baseline; sample size for subgroups with lower BEC is too small to draw meaningful conclusions. Conclusions: SEA patients, treated with MEPO in real life settings, demonstrated improvement in lung function that was sustained across the year of observation. This improvement was evident in those with baseline BEC of ≥300 cells/µL. Funding: GSK [204710]

Published
2020

10. Rural and Urban Asthma: Are they Different?

Author

Christian Eduardo Romero Mesones, Galo David Granados Rosales, Xavier Muñoz Gall, Miquel de Homdedeu Cortes, María Jesús Cruz Carmona, Iñigo Ojanguren Arranz, Donghai Ma, and Silvia Sánchez Díez

Subjects
education.field_of_study, medicine.medical_specialty, Future studies, business.industry, Population, Asthma symptoms, medicine.disease, respiratory tract diseases, Screening questionnaire, Environmental health, Epidemiology, Medicine, Rural area, business, education, Rural population, Asthma
Abstract

Aim: To study the possible differences in asthma of individuals living in urban or rural areas and what factors can condition these differences. Methods: Two populations (urban and rural) were studied. This is a descriptive, epidemiological study. In a first phase, a respiratory symptoms screening questionnaire was administered. In a second phase, patients who had shown a pattern of association in the set of asthma-related variables in the initial questionnaire were selected. These patients were given a second questionnaire aimed at knowing the characteristics of asthma. Results: 137 patients (78 [15%] in the rural population, 59 [11%] in the urban population) had symptoms compatible with asthma with the screening questionnaire. The second questionnaire was administered to 65 and 50 people in the rural and urban population, respectively. The percentage of patients with asthma symptoms was similar in rural and urban population. The most prevalent symptoms were wheezing (58.3%) and dyspnea on exertion (54.8%). Patients who live in urban areas have a higher prevalence of cough and more frequently go to emergency services. In both populations there were a greater number of symptoms in contact with irritants and environmental pollutants. Only individuals in the urban population showed a higher prevalence of symptoms in contact with allergens. Conclusions: There are differences in the characteristics of asthma between patients living in rural and urban areas. The inhabitants of urban areas seem to have an exacerbating asthmatic phenotype, mainly related to allergens. Future studies should aim to study the allergen-pollution relationship in these patients.

Published
2020

11. Study to evaluate clinical burden related with oral corticosteroids treatment of severe asthma in Spain (LEVANTE)

Author

Silvia Pascual Erquicia, Javier Domínguez Ortega, Gustavo Resler, Xavier Muñoz Gall, Cecilia Jacqueline Martin Panadero, Gema Monteagudo Ruiz, and Carlos Cabrera López

Subjects
medicine.medical_specialty, business.industry, Osteoporosis, Reflux, Aeroallergen, medicine.disease, medicine.disease_cause, Prednisone, Internal medicine, Medicine, Observational study, Nasal polyps, business, Disease burden, medicine.drug, Asthma
Abstract

Background: Severe asthma treatment with oral corticosteroids (OCS) added to ICS-LABA combination, may imply poor control, elevated disease burden and increased adverse reactions Aims: Describe the medical burden in patients with severe uncontrolled asthma treated with high doses of ICS-LABA and frequent or chronic OCS use in Spain Methods: This 6-month observational, prospective, multicentre nation-wide study, included adults patients, with severe asthma treated with stable high-dose ICS-LABA, who received (1:2 proportion) OCS over 6 months (maintenance group, n=30, 33.7%) or ≥2 cycles in previous 12 months (course group, n=59, 66.3%) Results: Total N=89 included. Mean age(SD) 56.6(14.6) years, 75.3% female. Mean (SD) time from diagnosis 18.0(16.4) years. Main comorbidities: gastroesophageal reflux 24.7%, chronic rhinosinusitis 36% (nasal polyps 21.3%) and aeroallergen reactivity 33.7%, osteoporosis 10.1% After 6 months, mean(SD) cumulative prednisone equivalent dose in maintenance(n=27) and courses (n=35) were respectively 2169.2(1600.9) mg and 641.3(1029.5) mg Asthma burden in maintenance and courses groups: exacerbations (37.9% and 58.2%, p=0.078), hospitalizations (6.9% and 9.1%) emergency visits (17.2% and 32.7%p=0.130). Mean[SD] events in maintenance and courses: exacerbations (severe 2.0[1.7] and 1.3[1.6], p=0.137; moderate 0.5[1.2] and 1.2[1.5], p=0.097), hospitalizations (8.0[2.8] and 4.0[2.1], p=0.090), emergency visits (2.4[2.6] and 1.4[0.7], p=0.659) Conclusion: The burden of asthma persists without differences between patients receiving maintenance or OCS courses for 6-month follow up

Published
2020

12. Common errors in inhalation therapy: Impact and solutions

Author

Ignacio de-Granda-Orive, Carlota Rodríguez-García, Victor Bustamante-Madariaga, Francisco-Javier González-Barcala, Xavier Muñoz-Gall, and Esther Barreiro

Subjects
Pulmonary and Respiratory Medicine, medicine.medical_specialty, Poor prognosis, Respiratory Therapy, Pulmonary disease, 03 medical and health sciences, Pulmonary Disease, Chronic Obstructive, 0302 clinical medicine, Inhalers, Inhalation technique, Administration, Inhalation, medicine, Immunology and Allergy, COPD, Humans, 030212 general & internal medicine, Metered Dose Inhalers, Intensive care medicine, Genetics (clinical), Asthma, Inhalation, business.industry, Nebulizers and Vaporizers, medicine.disease, Obstructive lung disease, respiratory tract diseases, 030228 respiratory system, Poor control, business
Abstract

Objective Inhalation therapy is one of the key pillars in the treatment of chronic obstructive diseases, such as asthma and COPD (Chronic obstructive pulmonary disease); however, wide number of errors occur with high frequency in the inhalation manoeuvres among these patient. This review discuss the main errors made with inhalation devices, factors associated with poor IT (inhalation technique), their consequences and possible solutions. Data sources To do this, we performed a search of any publications available in PubMed between the years 2000 and 2019, using the key words: asthma, COPD, obstructive lung disease, inhalers, misuse and errors. Study selections After a review of the titles and abstracts by the working group, the articles chosen were considered the most relevant in providing evidence of the problems and establishing solutions in the inhalation treatment of asthma and COPD. Results There are several publications that associated the errors in the inhalation technique with a poor prognosis both of asthma and COPD. Most authors generally agree in that a poor IT is associated with poor control of the symptoms. Conclusions It is essential to review the IT in all our patients with asthma and COPD due to the high socio-economic impact that it involves; an effort must be made to homogenise the evaluation of IT, so that it helps to transmit a clear message to the patients, as well as to the health professionals on what is and what is not a correct manoeuvre.

Published
2020

13. Identification of diagnostic criteria for chronic hypersensitivity pneumonitis

Author

Julie Morisset, Kerri A. Johannson, Kirk D. Jones, Paul J. Wolters, Harold R. Collard, Simon L. F. Walsh, Brett Ley, Katerina M. Antoniou, Deborah Assayag, Juergen Behr, Francesco Bonella, Kevin K. Brown, Bridget F. Collins, Yvon Cormier, Tamera J. Corte, Ulrich Costabel, Sonye K. Danoff, Kaïssa de Boer, Evans R. Fernandez Perez, Kevin R. Flaherty, Nicole S. L. Goh, Ian Glaspole, Mark G. Jones, Yasuhiro Kondoh, Michael Kreuter, Yves Lacasse, Lisa H. Lancaster, David J. Lederer, Joyce S. Lee, Toby M. Maher, Fernando J. Martinez, Keith C. Meyer, Joshua J. Mooney, Xavier Muñoz Gall, Paul W. Noble, Imre Noth, Justin M. Oldham, Carlos Alberto de Castro Pereira, Venerino Poletti, Moises Selman, Paolo Spagnolo, Elisabetta Renzoni, Luca Richeldi, Christopher J. Ryerson, Jay H. Ryu, Margaret L. Salisbury, Mary E. Strek, Sara Tomassetti, Dominique Valeyre, Carlo Vancheri, Marlies S. Wijsenbeek, Wim Wuyts, and Pulmonary Medicine

Subjects
Pulmonary and Respiratory Medicine, Male, medicine.medical_specialty, Consensus, Internationality, Delphi Technique, Respiratory System, Modified delphi, Delphi method, Interstitial lung disease, Multidisciplinary team, Critical Care and Intensive Care Medicine, Delphi, 03 medical and health sciences, 0302 clinical medicine, Diagnosis, Hypersensitivity pneumonitis, Surveys and Questionnaires, medicine, Humans, 030212 general & internal medicine, Intensive care medicine, business.industry, 11 Medical And Health Sciences, medicine.disease, Chronic disease, 030228 respiratory system, Radiological weapon, Chronic Disease, Physical therapy, Female, business, Alveolitis, Extrinsic Allergic
Abstract

Rationale: Current diagnosis of chronic hypersensitivity pneumonitis (cHP) involves considering a combination of clinical, radiological, and pathological information in multidisciplinary team discussions. However, this approach is highly variable with poor agreement between centers. Objectives: We aimed to identify diagnostic criteria for cHP that reach consensus among international experts. Methods: A three-round modified Delphi survey was conducted between April and August 2017. A total of 45 experts in interstitial lung disease from 14 countries participated in the online survey. Diagnostic items included in round 1 were generated using expert interviews and literature review. During rounds 1 and 2, experts rated the importance of each diagnostic item on a 5-point Likert scale. The a priori threshold of consensus was 75% or greater of experts rating a diagnostic item as very important or important. In the third round, experts graded the items that met consensus as important and provided their level of diagnostic confidence for a series of clinical scenarios. Measurements and Main Results: Consensus was achieved on 18 of the 40 diagnostic items. Among these, experts gave the highest level of importance to the identification of a causative antigen, time relation between exposure and disease, mosaic attenuation on chest imaging, and poorly formed nonnecrotizing granulomas on pathology. In clinical scenarios, the diagnostic confidence of experts in cHP was heightened by the presence of these diagnostic items. Conclusions: This consensus-based approach for the diagnosis of cHP represents a first step toward the development of international guidelines for the diagnosis of cHP.

Published
2018

14. Normativa del asma ocupacional

Author

Ramón Martínez, Enrique Alday Figueroa, Xavier Muñoz Gall, Isabel Isidro Montes, Joaquín Sastre Domínguez, María Jesús Cruz Carmona, Santiago Quirce Gancedo, Khalil Abu Shams, and Juan Bautista Galdiz Iturri

Subjects
Pulmonary and Respiratory Medicine, business.industry, Medicine, business, Humanities
Published
2006

15. Síndrome de disfunción reactiva de las vías respiratorias. Estudio de 18 casos

Author

M. Estrella Drobnic Martínez, Xavier Muñoz Gall, Roser Costa Solà, Ramón Martínez, and Berta Avilés Huertas

Subjects
business.industry, Medicine, Irritant induced asthma, General Medicine, business, Humanities, Bronchial hyperreactivity
Abstract

Fundamento y objetivo Estudio descriptivo y evolutivo de una serie de pacientes diagnosticados de sindrome de disfuncion reactiva de las vias respiratorias. Pacientes y metodo Estudio retrospectivo de 18 pacientes diagnosticados de sindrome de disfuncion reactiva de las vias respiratorias. Se recogieron los datos de la historia clinica, el estudio funcional respiratorio, las pruebas de alergia y las analiticas. Se valoro la evolucion clinica, funcional y laboral al ano del diagnostico. Resultados El estudio incluia 12 varones y 6 mujeres con una edad comprendida entre los 27 y los 66 anos. Las actividades implicadas con mayor frecuencia fueron la metalurgia y la limpieza. Los agentes que en mas ocasiones estuvieron involucrados fueron sustancias o agentes quimicos derivados del cloro y del azufre. El tiempo medio desde la exposicion a la aparicion de los sintomas fue, en todos, antes de 1 h en 10 pacientes (55%) y antes de las 24 h. Todos los pacientes relataron que habian presentado disnea, 12 (67%) refirieron sibilancias, 8 (44%) sintomas del area otorrinolaringologica, 8 (44%) sintomas sistemicos como, por ejemplo, cefalea y vomitos, y 4 (22%) sintomas oculares. Aunque todos los pacientes habian recibido asistencia medica tras la inhalacion, el diagnostico correcto se retraso durante meses o anos (tiempo medio: 3,6 anos). En aquel momento 6 de 18 pacientes (33%) mostraron obstruccion bronquial en las pruebas de funcion respiratoria. En la evolucion clinica presentaron mejoria 8 de 18 pacientes (44%), mientras que el resto quedo sin cambios. En el control funcional 8 de 17 (47%) quedaron estacionados, 6 de 17 (35%) mejoraron y 3 de 17 (18%) empeoraron. De los 14 pacientes en que la inhalacion se produjo en el lugar de trabajo, 7 (50%) continuaban trabajando en la misma ocupacion, 5 (36%) estaban de baja y 2 (14%) habian cambiado de lugar dentro de la misma empresa. Conclusiones El sindrome de disfuncion reactiva de las vias aereas a menudo no se sospecha, lo que puede producir un retraso de meses o anos en el diagnostico y en el tratamiento adecuado. Incluso entonces, este deberia considerarse, ya que en mas de una tercera parte de nuestros pacientes se demostro una mejoria clinica y funcional.

Published
2005

16. Asma ocupacional

Author

Ferran Morell Brotad and Xavier Muñoz Gall

Subjects
business.industry, Medicine, business
Published
2010

17. Colaboradores

Author

Ramón Agüero Balbín, Alvar Agustí García-Navarro, Carlos Agustí García-Navarro, José Joaquín Alfaro Abreu, Carlos Almonacid Sánchez, Carlos José Álvarez Martínez, José Luis Álvarez-Sala Walther, Rodolfo Álvarez-Sala Walther, Julio Ancochea Bermúdez, Antonio Antón Albisu, María Belén Arnalich Jiménez, Aurelio Arnedillo Muñoz, Francisco Javier Aspa Marco, Manuel Avellanas Chavala, Adolfo Baloira Villar, Joan Albert Barberà Mir, Emilia Barrot Cortés, José Belda Ramírez, José Belda Sanchis, Salvador Bello Dronda, Isabel Blanco Vich, José Blanquer Olivas, Luis Borderías Clau, Cristina Cabrera Lacalzada, Pedro Cabrera Navarro, Joaquín Calatayud Gastardi, Myriam Calle Rubio, José Antonio Caminero Luna, José Luis Campo-Cañaveral de la Cruz, Esteban Cano Jiménez, Alberto Capelastegui Saiz, José Luis Carreras Delgado, Teresa Carrillo Díaz, Pere Casan Clarà, Ciro Casanova Macario, Enrique Cases Viedma, Ana Córdoba Izquierdo, Jaime Corral Peñafiel, Andrés Cosano Povedano, María Jesús Cruz Carmona, Alfredo de Diego Damiá, Javier de Gracia Roldán, José Ignacio de Granda Orive, Pilar de Lucas Ramos, Javier de Miguel Díez, Eduardo de Miguel Poch, Juan Pablo de Torres Tajes, Salvador Díaz Lobato, Carlos Disdier Vicente, José Antonio Domingo Morera, Jordi Dorca Sargatal, José Luis Duque Medina, Joaquín Durán Cantolla, José María Echave-Sustaeta María-Tomé, Mikel Egurrola Izquierdo, Teresa Elías Hernández, Raúl Embún Flor, Isabel Fernández Navarro, Jaime Fernández-Bujarrabal Villoslada, Miquel Ferrer Monreal, José Ferreres Franco, Tomás Franquet Casas, Jorge Freixinet Gilart, Marta Fuentes Alonso, Juan Bautista Gáldiz Iturri, Miguel Gallego Díaz, Antonio Pablo Gámez García, Borja García-Cosío Piqueras, José María García García, Ricardo García Luján, Ignasi Garcia Olivé, Francisco García Río, Mariano García-Yuste Martín, Javier Gaudó Navarro, Rosa María Girón Moreno, Rosa Gómez García, Ana María Gómez Martínez, María Jesús Gómez Nebreda, Nicolás González Mangado, Amaia Gorostiza Manterola, Begoña Gregorio Crespo, María Rosa Güell i Rous, José Antonio Gutiérrez Lara, Luis Hernández Blasco, Michele Hernández Cabrera, Jesús Hernández Hernández, Rosana Hernando Salvador, Gemma Iruin Irulegui, José Ramón Jarabo Sarceda, Luis Lapeña Gutiérrez, Montserrat León Fábregas, José Antonio López García-Asenjo, Raquel López Reyes, Antolín López Viña, Hugo Loureiro Koechlin, Eduardo Márquez Martín, Francisca Lourdes Márquez Pérez, María del Rocío Martín López, Concepción Martín Serrano, Miguel Ángel Martínez García, Cristina Martínez González, Graciella Martínez Pallí, Juan Fernando Masa Jiménez, José María Matilla González, Mercè Mayos Pérez, Rosario Menéndez Villanueva, José Carlos Meneses Pardo, Mercedes Merino Sánchez, Marc Miravitlles Fernández, Luis Molinos Martín, José María Montserrat Canal, Ferran Morell Brotad, José Antonio Mosquera Pestaña, Joaquim Mullol i Miret, Xavier Muñoz Gall, Dolores Nauffal Manzur, Isabel Nerín de la Puerta, María Asunción Nieto Barbero, Remedios Otero Candelera, Isabel Otero González, Juan José Palacios Gutiérrez, Germán Peces-Barba Romero, José Luis Pérez Arellano, Esteban Pérez Rodríguez, Miguel Perpiñá Tordera, José María Pino García, Vicente Plaza Moral, José Manuel Porcel Pérez, Luis Puente Maestu, María Carme Puy Rión, Carmen Puzo Ardanuy, Olga Rajas Naranjo, Ramón Rami Porta, Juan José Ríos Blanco, Juan José Rivas de Andrés, Eulogio Rodríguez Becerra, Felipe Rodríguez de Castro, José Miguel Rodríguez González-Moro, Juan Luis Rodríguez Hermosa, Francisco Rodríguez Panadero, José Antonio Rodríguez Portal, Robert Rodríguez Roisin, Pedro Rodríguez Suárez, Gema Rodríguez Trigo, Jordi Roig Cutillas, Santiago Romero Candeira, Juan Ruiz Manzano, José Miguel Sahuquillo Arce, Antonio Salcedo Posadas, Neus Salord Oleo, Julio Sánchez de Cos Escuín, Juan José Soler Cataluña, Antonio Sueiro Bendito, Julia Tárrega Camarasa, Alfons Torrego Fernández, Antonio José Torres García, Antoni Torres Martí, Fernando Uresandi Romero, María Piedad Ussetti Gil, Antonio Valero Santiago, Andrés Varela de Ugarte, Montserrat Vendrell Relat, Héctor Verea Hernando, Rafael Vidal Pla, José Luis Viejo Bañuelos, Santiago José Villanueva Serrano, Felipe Villar Álvarez, Carlos Villasante Fernández-Montes, Victoria Villena Garrido, Antoni Xaubet Mir, and Rafael Zalacaín Jorge

Published
2010

18. [Guidelines for occupational asthma]

Author

María Jesús Cruz Carmona, Khalil Abu Shams, Xavier Muñoz Gall, Enrique Alday Figueroa, Juan Bautista Galdiz Iturri, Ramón Martínez, Isabel Isidro Montes, Joaquín Sastre Domínguez, and Santiago Quirce Gancedo

Subjects
medicine.medical_specialty, Clinical Trials as Topic, business.industry, General Medicine, medicine.disease, Asthma, Respiratory Function Tests, Occupational Diseases, Family medicine, medicine, Humans, Anti-Asthmatic Agents, business, Occupational asthma
Published
2006

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