88 results on '"Vogelmeier Claus"'
Search Results
2. DUPILUMAB REDUCES EXACERBATIONS AND IMPROVES LUNG FUNCTION AND QUALITY OF LIFE IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE AND TYPE 2 INFLAMMATION: THE NOTUS TRIAL
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BHATT, SURYA P, RABE, KLAUS F, HANANIA, NICOLA A, VOGELMEIER, CLAUS, BAFADHEL, MONA, CHRISTENSON, STEPHANIE, PAPI, ALBERTO, SINGH, DAVE, LAWS, ELIZABETH, AKINLADE, BOLANLE, MALONEY, JENNIFER, LU, XIN, BAUER, DEBORAH, BANSAL, ASHISH, ABDULAI, RAOLAT, and ROBINSON, LACEY
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- 2024
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3. IN THE PHASE 3 BOREAS TRIAL, DUPILUMAB REDUCED FENO LEVELS OVER TIME IN PATIENTS WITH MODERATE OR SEVERE SEVERE CHRONIC OBSTRUCTIVE PULMONARY DISEASE WITH TYPE 2 INFLAMMATION
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BHATT, SURYA P, CHRISTENSON, STEPHANIE, HANANIA, NICOLA A, BAFADHEL, MONA, RABE, KLAUS F, VOGELMEIER, CLAUS, PAPI, ALBERTO, SINGH, DAVE, LAWS, ELIZABETH, DAKIN, PAULA, BANSAL, ASHISH, LU, XIN, BAUER, DEBORAH, MALONEY, JENNIFER, ROBINSON, LACEY, and ABDULAI, RAOLAT
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- 2024
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4. IN PATIENTS WITH MODERATE OR SEVERE CHRONIC OBSTRUCTIVE PULMONARY DISEASE AND TYPE 2 INFLAMMATION, DUPILUMAB DOES NOT IMPACT BLOOD EOSINOPHIL LEVELS: PHASE 3 BOREAS TRIAL
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BAFADHEL, MONA, CHRISTENSON, STEPHANIE, HANANIA, NICOLA A, BHATT, SURYA P, VOGELMEIER, CLAUS, PAPI, ALBERTO, SINGH, DAVE, LAWS, ELIZABETH, DAKIN, PAULA, BANSAL, ASHISH, LU, XIN, BAUER, DEBORAH, MALONEY, JENNIFER, ROBINSON, LACEY, and ABDULAI, RAOLAT
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- 2024
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5. DUPILUMAB IMPROVES HEALTH-RELATED QUALITY OF LIFE IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE AND TYPE 2 INFLAMMATION: POOLED BOREAS AND NOTUS RESULTS
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BHATT, SURYA P, RABE, KLAUS F, HANANIA, NICOLA A, VOGELMEIER, CLAUS, BAFADHEL, MONA, CHRISTENSON, STEPHANIE, PAPI, ALBERTO, SINGH, DAVE, LAWS, ELIZABETH, DAKIN, PAULA, MALONEY, JENNIFER, LU, XIN, BAUER, DEBORAH, BANSAL, ASHISH, ABDULAI, RAOLAT, and ROBINSON, LACEY
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- 2024
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6. DUPILUMAB REDUCES EXACERBATIONS AND IMPROVES LUNG FUNCTION IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE AND EMPHYSEMA
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BHATT, SURYA P, RABE, KLAUS F, HANANIA, NICOLA A, VOGELMEIER, CLAUS, BAFADHEL, MONA, CHRISTENSON, STEPHANIE, PAPI, ALBERTO, SINGH, DAVE, LAWS, ELIZABETH, DAKIN, PAULA, MALONEY, JENNIFER, LU, XIN, BAUER, DEBORAH, BANSAL, ASHISH, ROBINSON, LACEY, and ABDULAI, RAOLAT
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- 2024
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7. DUPILUMAB IMPROVES RESPIRATORY SYMPTOMS IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE AND TYPE 2 INFLAMMATION: POOLED RESULTS FROM BOREAS AND NOTUS
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BHATT, SURYA P, RABE, KLAUS F, HANANIA, NICOLA A, VOGELMEIER, CLAUS, BAFADHEL, MONA, CHRISTENSON, STEPHANIE, PAPI, ALBERTO, SINGH, DAVE, LAWS, ELIZABETH, DAKIN, PAULA, MALONEY, JENNIFER, LU, XIN, BAUER, DEBORAH, BANSAL, ASHISH, ABDULAI, RAOLAT, and ROBINSON, LACEY
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- 2024
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8. COPD and multimorbidity: recognising and addressing a syndemic occurrence.
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Fabbri, Leonardo M, Celli, Bartolome R, Agustí, Alvar, Criner, Gerard J, Dransfield, Mark T, Divo, Miguel, Krishnan, Jamuna K, Lahousse, Lies, Montes de Oca, Maria, Salvi, Sundeep S, Stolz, Daiana, Vanfleteren, Lowie E G W, and Vogelmeier, Claus F
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NON-communicable diseases ,SYNDEMICS ,CHRONIC obstructive pulmonary disease ,COMORBIDITY ,SYMPTOMS ,RESPIRATORY insufficiency - Abstract
Most patients with chronic obstructive pulmonary disease (COPD) have at least one additional, clinically relevant chronic disease. Those with the most severe airflow obstruction will die from respiratory failure, but most patients with COPD die from non-respiratory disorders, particularly cardiovascular diseases and cancer. As many chronic diseases have shared risk factors (eg, ageing, smoking, pollution, inactivity, and poverty), we argue that a shift from the current paradigm in which COPD is considered as a single disease with comorbidities, to one in which COPD is considered as part of a multimorbid state—with co-occurring diseases potentially sharing pathobiological mechanisms—is needed to advance disease prevention, diagnosis, and management. The term syndemics is used to describe the co-occurrence of diseases with shared mechanisms and risk factors, a novel concept that we propose helps to explain the clustering of certain morbidities in patients diagnosed with COPD. A syndemics approach to understanding COPD could have important clinical implications, in which the complex disease presentations in these patients are addressed through proactive diagnosis, assessment of severity, and integrated management of the COPD multimorbid state, with a patient-centred rather than a single-disease approach. [ABSTRACT FROM AUTHOR]
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- 2023
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9. GOLD 2024: a brief overview of key changes.
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Agusti, Alvar and Vogelmeier, Claus F.
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COUGH ,MEDICAL personnel ,GOLD ,INTERSTITIAL lung diseases ,CHRONIC obstructive pulmonary disease ,OBSTRUCTIVE lung diseases ,GOLDWORK - Published
- 2023
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10. Hausärztliches Telemonitoring bei akuten Erkrankungen am Beispiel von COVID-19 – qualitative Interviewstudie
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Chabiera, Peter Jan, Holtz, Svea, Köhler, Susanne Maria, Deutsch, Kim, Oftring, Zoe S., Lawin, Dennis, Vogelmeier, Claus F., Dauletbayev, Nurlan, Niekrenz, Lukas, Dreher, Michael, Gloeckl, Rainer, Koczulla, Rembert, Rohde, Gernot, Gerlach, Ferdinand M., Kuhn, Sebastian, and Müller, Beate Sigrid
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Hintergrund: Weltweit wurde in der COVID-19-Pandemie Telemonitoring zur Betreuung von COVID-19-Erkrankten eingesetzt. Im Projekt COVID-19@Home wurde ein Telemonitoringkonzept unter anderem im hausärztlichen Setting implementiert. Ziel der Arbeit: In diesem Artikel werden Erfahrungen, Barrieren und förderliche Faktoren der Implementation des Telemonitoringkonzepts aus hausärztlicher Sicht dargestellt. Material und Methoden: Patientenseitig wurde eine App mit bis zu 5 Messgeräten zur Bestimmung der Vitalparameter verwendet. Die Praxen erhielten Zugriff auf ein Webportal mit Einsicht in Messwerte und Symptome sowie Anbindung an eine Supportstruktur. Die ärztlichen Teilnehmenden wurden zu semistrukturierten Interviews eingeladen, die mittels qualitativer Inhaltsanalyse ausgewertet wurden. Ergebnisse: Acht Praxen mit 51 Patientinnen und Patienten nahmen teil, 7 der 8 ärztlichen Teilnehmenden willigten in ein Interview ein. Eine telemedizinische Begleitung wurde insbesondere dann als Mehrwert empfunden, wenn sie die Arbeitsbelastung oder die eigene Unsicherheit im Kontakt mit Risikopatientinnen und -patienten verringerte. Zusätzliche Aufgaben durch das Telemonitoring wurden meist außerhalb der Sprechstunden vom ärztlichen Personal durchgeführt. Die Messwerte wurden mindestens täglich überprüft. Datenqualität und -zuverlässigkeit wurden überwiegend als gut wahrgenommen. Die Meinungen zur Anzahl der Messgeräte divergierten jedoch. Diskussion: Eine Akzeptanz der Hausärzteschaft für Telemonitoring bei einer Akuterkrankung ist dann zu erwarten, wenn die Integration in den Arbeitsalltag gelingt und zielgruppenspezifische, begleitende Supportstrukturen vorhanden sind. Zur Optimierung der Aufwand-Nutzen-Relation sollten in zukünftigen Studien klare Einschlusskriterien für Patientengruppen, die von einer telemedizinischen Begleitung profitieren, definiert werden.
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- 2024
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11. Cumulative occupational exposure to gases and fumes is associated with impairment in lung function and disease-related quality of life in a German COPD patient cohort
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Gerlich, Jessica, Ohlander, Johan, Kromhout, Hans, Vermeulen, Roel, So¨hler, Sandra, Radon, Katja, Nowak, Dennis, Karrasch, Stefan, Adaskina, Nina, Vogelmeier, Claus, Ochmann, Uta, and Jo¨rres, Rudolf A
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ObjectivesThe impact of occupational exposures on lung function impairments and quality of life (QoL) in patients with chronic obstructive pulmonary disease (COPD) was analysed and compared with that of smoking.MethodsData from 1283 men and 759 women (Global Initiative for Chronic Obstructive Lung Disease (GOLD) grades 1–4 or former grade 0, without alpha-1-antitrypsin deficiency) of the COPD and Systemic Consequences Comorbidities Network cohort were analysed. Cumulative exposure to gases/fumes, biological dust, mineral dust or the combination vapours/gases/dusts/fumes was assessed using the ALOHA job exposure matrix. The effect of both occupational and smoking exposure on lung function and disease-specific QoL (St George’s Respiratory Questionnaire) was analysed using linear regression analysis adjusting for age, body mass index, diabetes, hypertension and coronary artery disease, stratified by sex.ResultsIn men, exposure to gases/fumes showed the strongest effects among occupational exposures, being significantly associated with all lung function parameters and QoL; the effects were partially stronger than of smoking. Smoking had a larger effect than occupational exposure on lung diffusing capacity (transfer factor for carbon monoxide) but not on air trapping (residual volume/total lung capacity). In women, occupational exposures were not significantly associated with QoL or lung function, while the relationships between lung function parameters and smoking were comparable to men.ConclusionsIn patients with COPD, cumulative occupational exposure, particularly to gases/fumes, showed effects on airway obstruction, air trapping, gas uptake capacity and disease-related QoL, some of which were larger than those of smoking. These findings suggest that lung air trapping and QoL should be considered as outcomes of occupational exposure to gases and fumes in patients with COPD.Trial registration numberNCT01245933.
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- 2024
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12. EFFICACY AND SAFETY OF DUPILUMAB FOR COPD WITH TYPE 2 INFLAMMATION
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BHATT, SURYA P, RABE, KLAUS F, HANANIA, NICOLA A, VOGELMEIER, CLAUS F, COLE, JEREMY, BAFADHEL, MONA, CHRISTENSON, STEPHANIE, PAPI, ALBERTO, SINGH, DAVE, LAWS, ELIZABETH, MANNENT, LEDA LM, MORTENSEN, ERIC R, MALONEY, JENNIFER, LU, XIN, BAUER, DEBORAH J, BANSAL, ASHISH, ROBINSON, LACEY, and ABDULAI, RAOLAT
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- 2023
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13. REDUCED RISK OF CARDIOPULMONARY EVENTS FOR COPD PATIENTS INITIATING BUDESONIDE/GLYCOPYRROLATE/FORMOTEROL VS MULTIPLE INHALER TRIPLE THERAPY IN THE US: THE SKOPOS-MAZI STUDY
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POLLACK, MICHAEL, RAPSOMANIKI, ELENI, ANZUETO, ANTONIO R, RHODES, KIRSTY, HAWKINS, NATHANIEL, VOGELMEIER, CLAUS, MARSHALL, JONATHAN, and MULLEROVA, HANA
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- 2024
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14. Digitalisierung in der Pneumologie
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Schöbel, Christoph, Große Sundrup, Martina, Straßburg, Svenja, Woehrle, Holger, Vogelmeier, Claus, and Taube, Christian
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Die Digitalisierung wird die Medizin im Ganzen und die Pneumologie im Speziellen verändern. Digitalisierung sollte jedoch kein Selbstzweck sein. Ebenso wenig sollte und kann Digitalisierung die menschliche Komponente in der Medizin ersetzen. Patienten informieren sich jedoch zunehmend über Gesundheitsthemen im Internet, messen ihre Vitalwerte in der Häuslichkeit oder kommen bereits mit einer Diagnose „made by Dr. Google“. Ärzten kommt daher zunehmend eine Beraterfunktion zu, die einer der wichtigsten Aspekte einer menschlichen und empathischen Medizin ist. In diesem Sinne sollten Ärzte daher auch die digitale Transformation der Medizin proaktiv mitgestalten. Vor dem Hintergrund des Mottos des diesjährigen Kongresses werden wir in unserem Beitrag in die kürzere Vergangenheit blicken, aktuelle Entwicklungen aufnehmen und auch einen Blick in die Zukunft einer digitalen und empathischen Pneumologie wagen.
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- 2023
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15. A scoping review of mHealth monitoring of pediatric bronchial asthma before and during COVID-19 pandemic.
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Dauletbaev, Nurlan, Oftring, Zoe S., Akik, Wided, Michaelis-Braun, Lukas, Korel, Julia, Lands, Larry C., Waldmann, Susanne, Müller, Beate S., Dreher, Michael, Rohde, Gernot, Vogelmeier, Claus F., and Kuhn, Sebastian
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Mobile (m) Health technology is well-suited for Remote Patient Monitoring (RPM) in a patient's habitual environment. In recent years there have been fast-paced developments in mHealth-enabled pediatric RPM, especially during the COVID-19 pandemic, necessitating evidence synthesis. To this end, we conducted a scoping review of clinical trials that had utilized mHealth-enabled RPM of pediatric asthma. MEDLINE, Embase and Web of Science were searched from September 1, 2016 through August 31, 2021. Our scoping review identified 25 publications that utilized synchronous and asynchronous mHealth-enabled RPM in pediatric asthma, either involving mobile applications or via individual devices. The last three years has seen the development of evidence-based, multidisciplinary, and participatory mHealth interventions. The quality of the studies has been improving, such that 40% of included study reports were randomized controlled trials. In conclusion, there exists high-quality evidence on mHealth-enabled RPM in pediatric asthma, warranting future systematic reviews and/or meta-analyses of the benefits of such RPM. [ABSTRACT FROM AUTHOR]
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- 2022
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16. Tackling the global burden of lung disease through prevention and early diagnosis.
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Agusti, Alvar, Vogelmeier, Claus F, and Halpin, David M G
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GLOBAL burden of disease ,PREVENTIVE medicine ,EARLY diagnosis - Published
- 2022
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17. Tackling the global burden of lung disease through prevention and early diagnosis
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Agusti, Alvar, Vogelmeier, Claus F, and Halpin, David M G
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- 2022
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18. The janus-kinase inhibitor ruxolitinib in SARS-CoV-2 induced acute respiratory distress syndrome (ARDS)
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Neubauer, Andreas, Johow, Johannes, Mack, Elisabeth, Burchert, Andreas, Meyn, Damaris, Kadlubiec, Andrea, Torje, Iuliu, Wulf, Hinnerk, Vogelmeier, Claus F., Hoyer, Joachim, Skevaki, Chrysanthi, Muellenbach, Ralf Michael, Keller, Christian, Schade-Brittinger, Carmen, Rolfes, Caroline, and Wiesmann, Thomas
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Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causes COVID-19 (coronavirus disease 2019), which is associated with high morbidity and mortality, especially in elder patients. Acute respiratory distress syndrome (ARDS) is a life-threatening complication of COVID-19 and has been linked with severe hyperinflammation. Dexamethasone has emerged as standard of care for COVID-19 associated respiratory failure. In a non-randomized prospective phase II multi-center study, we asked whether targeted inhibition of Janus kinase-mediated cytokine signaling using ruxolitinib is feasible and efficacious in SARS-CoV-2- induced ARDS with hyperinflammation. Sixteen SARS-CoV-2 infected patients requiring invasive mechanical ventilation for ARDS were treated with ruxolitinib in addition to standard treatment. Ruxolitinib treatment was well tolerated and 13 patients survived at least the first 28 days on treatment, which was the primary endpoint of the trial. Immediate start of ruxolitinib after deterioration was associated with improved outcome, as was a lymphocyte-to-neutrophils ratio above 0.07. Together, treatment with the janus-kinase inhibitor ruxolitinib is feasible and might be efficacious in COVID-19 induced ARDS patients requiring invasive mechanical ventilation. The trial has been registered under EudraCT-No.: 2020-001732-10 and NCT04359290.
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- 2021
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19. Lungenerkrankung nach Senfgasexposition
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Pott, Hendrik, Steuder, Regina, Hartmann, Katja, Schmeck, Bernd, Holland, Angélique, Vogelmeier, Claus F., and Klemmer, Andreas
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- 2022
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20. Assessing Symptom Burden
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Vogelmeier, Claus F. and Alter, Peter
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Evaluating symptoms is a central part of the chronic obstructive pulmonary disease (COPD) assessment system as suggested by the Global Initiative for Chronic Obstructive Lung Disease (GOLD). Considering the pros and cons of all currently available tests, GOLD suggests using primarily the modified Medical Research Council dyspnea scale or the COPD Assessment Test. Based on the test results, patients are categorized as having a low or high level of symptoms. This level then becomes one of the 2 dimensions of the ABCD grading system, which was designed to match the best initial treatment option to the individual patient’s needs.
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- 2020
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21. Evaluating the Use of Circulating MicroRNA Profiles for Lung Cancer Detection in Symptomatic Patients
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Fehlmann, Tobias, Kahraman, Mustafa, Ludwig, Nicole, Backes, Christina, Galata, Valentina, Keller, Verena, Geffers, Lars, Mercaldo, Nathaniel, Hornung, Daniela, Weis, Tanja, Kayvanpour, Elham, Abu-Halima, Masood, Deuschle, Christian, Schulte, Claudia, Suenkel, Ulrike, von Thaler, Anna-Katharina, Maetzler, Walter, Herr, Christian, Fähndrich, Sebastian, Vogelmeier, Claus, Guimaraes, Pedro, Hecksteden, Anne, Meyer, Tim, Metzger, Florian, Diener, Caroline, Deutscher, Stephanie, Abdul-Khaliq, Hashim, Stehle, Ingo, Haeusler, Sebastian, Meiser, Andreas, Groesdonk, Heinrich V, Volk, Thomas, Lenhof, Hans-Peter, Katus, Hugo, Balling, Rudi, Meder, Benjamin, Kruger, Rejko, Huwer, Hanno, Bals, Robert, Meese, Eckart, and Keller, Andreas
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IMPORTANCE: The overall low survival rate of patients with lung cancer calls for improved detection tools to enable better treatment options and improved patient outcomes. Multivariable molecular signatures, such as blood-borne microRNA (miRNA) signatures, may have high rates of sensitivity and specificity but require additional studies with large cohorts and standardized measurements to confirm the generalizability of miRNA signatures. OBJECTIVE: To investigate the use of blood-borne miRNAs as potential circulating markers for detecting lung cancer in an extended cohort of symptomatic patients and control participants. DESIGN, SETTING, AND PARTICIPANTS: This multicenter, cohort study included patients from case-control and cohort studies (TREND and COSYCONET) with 3102 patients being enrolled by convenience sampling between March 3, 2009, and March 19, 2018. For the cohort study TREND, population sampling was performed. Clinical diagnoses were obtained for 3046 patients (606 patients with non–small cell and small cell lung cancer, 593 patients with nontumor lung diseases, 883 patients with diseases not affecting the lung, and 964 unaffected control participants). No samples were removed because of experimental issues. The collected data were analyzed between April 2018 and November 2019. MAIN OUTCOMES AND MEASURES: Sensitivity and specificity of liquid biopsy using miRNA signatures for detection of lung cancer. RESULTS: A total of 3102 patients with a mean (SD) age of 61.1 (16.2) years were enrolled. Data on the sex of the participants were available for 2856 participants; 1727 (60.5%) were men. Genome-wide miRNA profiles of blood samples from 3046 individuals were evaluated by machine-learning methods. Three classification scenarios were investigated by splitting the samples equally into training and validation sets. First, a 15-miRNA signature from the training set was used to distinguish patients diagnosed with lung cancer from all other individuals in the validation set with an accuracy of 91.4% (95% CI, 91.0%-91.9%), a sensitivity of 82.8% (95% CI, 81.5%-84.1%), and a specificity of 93.5% (95% CI, 93.2%-93.8%). Second, a 14-miRNA signature from the training set was used to distinguish patients with lung cancer from patients with nontumor lung diseases in the validation set with an accuracy of 92.5% (95% CI, 92.1%-92.9%), sensitivity of 96.4% (95% CI, 95.9%-96.9%), and specificity of 88.6% (95% CI, 88.1%-89.2%). Third, a 14-miRNA signature from the training set was used to distinguish patients with early-stage lung cancer from all individuals without lung cancer in the validation set with an accuracy of 95.9% (95% CI, 95.7%-96.2%), sensitivity of 76.3% (95% CI, 74.5%-78.0%), and specificity of 97.5% (95% CI, 97.2%-97.7%). CONCLUSIONS AND RELEVANCE: The findings of the study suggest that the identified patterns of miRNAs may be used as a component of a minimally invasive lung cancer test, complementing imaging, sputum cytology, and biopsy tests.
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- 2020
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22. COPD & COVID-19.
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Halpin, David M.G., Vogelmeier, Claus F., and Agusti, Alvar A.
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- 2021
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23. Eosinopenia as predictor of disease severity in patients with community-acquired pneumonia: an observational study
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Weckler, Barbara Christine, Pott, Hendrik, Race, Alan, Jugkaeo, Nattika, Karki, Kapil, Ringshandl, Stephan, Seidemann, Christian, Schöndorf, Ines, Renz, Harald, Fähndrich, Sebastian, Jung, Anna Lena, Bertrams, Wilhelm, Makoudjou, Adeline, Zöller, Daniela, Finotto, Susetta, Schild, Stefanie, Seuchter, Susanne A., Rohde, Gernot, Trinkmann, Frederik, Greulich, Timm, Vogelmeier, Claus Franz, and Schmeck, Bernd
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- 2024
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24. Exacerbations of chronic obstructive pulmonary disease: time to rename.
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Bafadhel, Mona, Criner, Gerard, Dransfield, Mark T, Janssens, Wim, McDonald, Vanessa M, Vogelmeier, Claus F, Russell, Richard EK, and Collis, Philip
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OBSTRUCTIVE lung diseases - Published
- 2020
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25. Medical Treatment of COPD: An Analysis of Guideline-Adherent Prescribing in a Large National Cohort (COSYCONET).
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Graf, Jana, Jörres, Rudolf A., Lucke, Tanja, Nowak, Dennis, Vogelmeier, Claus F., and Ficker, Joachim H.
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Background: Chronic obstructive pulmonary disease (COPD) is common around the world and carries a high morbidity and mortality. Symptom- and risk-oriented drug treatment is recommended, both in Germany and in other countries. It is not yet known to what extent the treatment that is actually delivered in Germany corresponds to the current recommendations in the guidelines. Methods: As recommended by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) in 2017, 2281 patients of the national COPD cohort COSYCONET (COPD and Systemic Consequences--Comorbidities Network) were classified into Gold classes A--D on the basis of disease-specific manifestations and the frequency of exacerbations. Moreover, the regular use of medications was documented and categorized according to active substance groups. For all groups, the documented treatment that was actually given was compared to the recommended treatment. Results: 67.6% of the patients received a combination of a long-acting anticholinergic drug (LAMA) and a long-acting beta-mimetic drug (LABA), while 65.8% received inhaled corticosteroids (ICS), 11.7% theophylline, and 12.6% oral corticosteroids (OCS). Despite recommendations to the contrary, 66% of the patients in Groups A and B (low exacerbation rates) were treated with ICS; some of these patients carried an additional diagnosis of bronchial asthma. There was evidence of undertreatment mainly in groups C and D (high exacerbation rate), because many of the patients in these groups were not treated with LAMA or LAMA/LABA as recommended. Conclusion: The observed deviations from the recommended treatment, some of which were substantial, might lead to suboptimal treatment outcomes as well as to avoidable side effects of medication. [ABSTRACT FROM AUTHOR]
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- 2018
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26. Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Lung Disease 2017 Report: GOLD Executive Summary.
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Vogelmeier, Claus F., Criner, Gerard J., Martinez, Fernando J., Anzueto, Antonio, Barnes, Peter J., Bourbeau, Jean, Celli, Bartolome R., Chen, Rongchang, Decramer, Marc, Fabbri, Leonardo M., Frith, Peter, Halpin, David M.G., Varela, M. Victorina López, Nishimura, Masaharu, Roche, Nicolas, Rodriguez-Roisin, Roberto, Sin, Don D., Singh, Dave, Stockley, Robert, and Vestbo, Jørgen
- Abstract
Copyright of Archivos de Bronconeumología (English Edition) is the property of Sociedad Espanola de Neumologia y Cirugia Toracica (SEPAR) and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
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- 2017
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27. Ruxolitinib for the treatment of SARS-CoV-2 induced acute respiratory distress syndrome (ARDS)
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Neubauer, Andreas, Wiesmann, Thomas, Vogelmeier, Claus F., Mack, Elisabeth, Skevaki, Chrysanthi, Gaik, Christine, Keller, Christian, Figiel, Jens, Sohlbach, Kristina, Rolfes, Caroline, Renz, Harald, Wulf, Hinnerk, and Burchert, Andreas
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- 2020
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28. Exacerbations of chronic obstructive pulmonary disease: time to rename
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Bafadhel, Mona, Criner, Gerard, Dransfield, Mark T, Janssens, Wim, McDonald, Vanessa M, Vogelmeier, Claus F, Russell, Richard EK, and Collis, Philip
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- 2020
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29. Genome-Wide MicroRNA Expression Profiles in COPD: Early Predictors for Cancer Development
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Keller, Andreas, Fehlmann, Tobias, Ludwig, Nicole, Kahraman, Mustafa, Laufer, Thomas, Backes, Christina, Vogelmeier, Claus, Diener, Caroline, Biertz, Frank, Herr, Christian, Jörres, Rudolf A., Lenhof, Hans-Peter, Meese, Eckart, and Bals, Robert
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Chronic obstructive pulmonary disease (COPD) significantly increases the risk of developing cancer. Biomarkerstudies frequently follow a case-control set-up in which patients diagnosed with a disease are compared to controls. Longitudinal cohort studies such as the COPD-centered German COPD and SYstemic consequences-COmorbidities NETwork (COSYCONET) study provide the patient and biomaterial base for discovering predictive molecular markers. We asked whether microRNA(miRNA) profiles in blood collected from COPD patients prior to a tumor diagnosis could support an early diagnosis of tumor development independent of the tumor type. From 2741 participants of COSYCONET diagnosed with COPD, we selected 534 individuals including 33 patients who developed cancer during the follow-up period of 54 months and 501 patients who did not develop cancer, but had similar age, gender and smoking history. Genome-wide miRNA profiles were generated and evaluated using machine learning techniques. For patients developing cancer we identified nine miRNAs with significantly decreased abundance (two-tailed unpaired t-test adjusted for multiple testing P< 0.05), including members of the miR-320 family. The identified miRNAs regulate different cancer-related pathways including the MAPK pathway (P= 2.3 × 10−5). We also observed the impact of confounding factors on the generated miRNA profiles, underlining the value of our matched analysis. For selected miRNAs, qRT-PCR analysis was applied to validate the results. In conclusion, we identified several miRNAs in blood of COPD patients, which could serve as candidates for biomarkers to help identify COPD patients at risk of developing cancer.
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- 2018
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30. Genome-wide MicroRNA Expression Profiles in COPD: Early Predictors for Cancer Development
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Keller, Andreas, Fehlmann, Tobias, Ludwig, Nicole, Kahraman, Mustafa, Laufer, Thomas, Backes, Christina, Vogelmeier, Claus, Diener, Caroline, Biertz, Frank, Herr, Christian, Jörres, Rudolf A., Lenhof, Hans-Peter, Meese, Eckart, and Bals, Robert
- Abstract
Chronic obstructive pulmonary disease (COPD) significantly increases the risk of developing cancer. Biomarkerstudies frequently follow a case-control set-up in which patients diagnosed with a disease are compared to controls. Longitudinal cohort studies such as the COPD-centered German COPD and SYstemic consequences-COmorbidities NETwork (COSYCONET) study provide the patient and biomaterial base for discovering predictive molecular markers. We asked whether microRNA(miRNA) profiles in blood collected from COPD patients prior to a tumor diagnosis could support an early diagnosis of tumor development independent of the tumor type. From 2741 participants of COSYCONET diagnosed with COPD, we selected 534 individuals including 33 patients who developed cancer during the follow-up period of 54 months and 501 patients who did not develop cancer, but had similar age, gender and smoking history. Genome-wide miRNA profiles were generated and evaluated using machine learning techniques. For patients developing cancer we identified nine miRNAs with significantly decreased abundance (two-tailed unpaired t-test adjusted for multiple testing P < 0.05), including members of the miR-320 family. The identified miRNAs regulate different cancer-related pathways including the MAPK pathway (P = 2.3 × 10−5). We also observed the impact of confounding factors on the generated miRNA profiles, underlining the value of our matched analysis. For selected miRNAs, qRT-PCR analysis was applied to validate the results. In conclusion, we identified several miRNAs in blood of COPD patients, which could serve as candidates for biomarkers to help identify COPD patients at risk of developing cancer.
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- 2018
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31. Case-finding for alpha1-antitrypsin deficiency in Kazakh patients with COPD
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Zhumagaliyeva, Ardak, Ottaviani, Stefania, Greulich, Timm, Gorrini, Marina, Vogelmeier, Claus, Karazhanova, Ludmila, Nurgazina, Gulmira, DeSilvestri, Annalisa, Kotke, Victor, Barzon, Valentina, Zorzetto, Michele, Corsico, Angelo, and Ferrarotti, Ilaria
- Abstract
Alpha-1-antitrypsin deficiency (AATD) is an under-diagnosed condition in patients with chronic obstructive pulmonary disease (COPD). The aim of this study was to screen for AATD in Kazakh patients with COPD using dried blood spot specimens. The alpha1-antitrypsin (AAT) concentration was determined by nephelometry, PCR was used to detect PiS and PiZ alleles; and isoelectric focusing was used to confirm questionable genotype results and detect rare AAT variants. To this aim, 187 Kazakh subjects with COPD were recruited. Blood samples were collected as dried blood spot. Genotyping of 187 samples revealed 3 (1.6%) PI*MZ and 1 (0.53%) PI*MS, Phenotyping identified also two sample (1.1%) with phenotype PiMI. Allelic frequencies of pathological mutations Z, S and I resulted 0.8%, 0.3%, 0.5%, respectively, in COPD Kazakh population. This study proved that AATD is present in the Kazakh population. These results support the general concept of targeted screening for AAT deficiency in countries like Kazakhstan, with a large population of COPD patients and low awareness among care-givers about this genetic condition.
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- 2017
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32. Diagnostic Performance of a Machine Learning Algorithm (Asthma/Chronic Obstructive Pulmonary Disease [COPD] Differentiation Classification) Tool Versus Primary Care Physicians and Pulmonologists in Asthma, COPD, and Asthma/COPD Overlap
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Kocks, Janwillem W.H., Cao, Hui, Holzhauer, Björn, Kaplan, Alan, FitzGerald, J. Mark, Kostikas, Konstantinos, Price, David, Reddel, Helen K., Tsiligianni, Ioanna, Vogelmeier, Claus F., Bostel, Sebastien, and Mastoridis, Paul
- Abstract
The differential diagnosis of asthma and chronic obstructive pulmonary disease (COPD) poses a challenge in clinical practice and its misdiagnosis results in inappropriate treatment, increased exacerbations, and potentially death.
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- 2023
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33. Blood eosinophil count and exacerbations in severe chronic obstructive pulmonary disease after withdrawal of inhaled corticosteroids: a post-hoc analysis of the WISDOM trial.
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Watz, Henrik, Tetzlaff, Kay, Wouters, Emiel F M, Kirsten, Anne, Magnussen, Helgo, Rodriguez-Roisin, Roberto, Vogelmeier, Claus, Fabbri, Leonardo M, Chanez, Pascal, Dahl, Ronald, Disse, Bernd, Finnigan, Helen, and Calverley, Peter M A
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EOSINOPHILS ,CORTICOSTEROIDS ,OBSTRUCTIVE lung diseases - Abstract
Summary Background Blood eosinophil counts might predict response to inhaled corticosteroids (ICS) in patients with chronic obstructive pulmonary disease (COPD) and a history of exacerbations. We used data from the WISDOM trial to assess whether patients with COPD with higher blood eosinophil counts would be more likely to have exacerbations if ICS treatment was withdrawn. Methods WISDOM was a 12-month, randomised, parallel-group trial in which patients received 18 μg tiotropium, 100 μg salmeterol, and 1000 μg fluticasone propionate daily for 6 weeks and were then randomly assigned (1:1) electronically to receive either continued or reduced ICS over 12 weeks. We did a post-hoc analysis after complete ICS withdrawal (months 3–12) to compare rate of exacerbations and time to exacerbation outcomes on the basis of blood eosinophil subgroups of increasing cutoff levels. The WISDOM trial is registered at ClinicalTrials.gov , number NCT00975195 . Findings In the 2296 patients receiving treatment after ICS withdrawal, moderate or severe exacerbation rate was higher in the ICS-withdrawal group versus the ICS-continuation group in patients with eosinophil counts (out of total white blood cell count) of 2% or greater (rate ratio 1·22 [95% CI 1·02–1·48]), 4% or greater (1·63 [1·19–2·24]), and 5% or greater (1·82 [1·20–2·76]). The increase in exacerbation rate became more pronounced as the eosinophil cutoff level rose, with significant treatment-by-subgroup interaction reached for 4% and 5% only. Similar results were seen with eosinophil cutoffs of 300 cells per μL and 400 cells per μL, and mutually exclusive subgroups. Interpretation Blood eosinophil counts at screening were related to the exacerbation rate after complete ICS withdrawal in patients with severe to very severe COPD and a history of exacerbations. Our data suggest that counts of 4% or greater or 300 cells per μL or more might identify a deleterious effect of ICS withdrawal, an effect not seen in most patients with eosinophil counts below these thresholds. Funding Boehringer Ingelheim. [ABSTRACT FROM AUTHOR]
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- 2016
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34. COPD and multimorbidity: recognising and addressing a syndemic occurrence
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Fabbri, Leonardo M, Celli, Bartolome R, Agustí, Alvar, Criner, Gerard J, Dransfield, Mark T, Divo, Miguel, Krishnan, Jamuna K, Lahousse, Lies, Montes de Oca, Maria, Salvi, Sundeep S, Stolz, Daiana, Vanfleteren, Lowie E G W, and Vogelmeier, Claus F
- Abstract
Most patients with chronic obstructive pulmonary disease (COPD) have at least one additional, clinically relevant chronic disease. Those with the most severe airflow obstruction will die from respiratory failure, but most patients with COPD die from non-respiratory disorders, particularly cardiovascular diseases and cancer. As many chronic diseases have shared risk factors (eg, ageing, smoking, pollution, inactivity, and poverty), we argue that a shift from the current paradigm in which COPD is considered as a single disease with comorbidities, to one in which COPD is considered as part of a multimorbid state—with co-occurring diseases potentially sharing pathobiological mechanisms—is needed to advance disease prevention, diagnosis, and management. The term syndemics is used to describe the co-occurrence of diseases with shared mechanisms and risk factors, a novel concept that we propose helps to explain the clustering of certain morbidities in patients diagnosed with COPD. A syndemics approach to understanding COPD could have important clinical implications, in which the complex disease presentations in these patients are addressed through proactive diagnosis, assessment of severity, and integrated management of the COPD multimorbid state, with a patient-centred rather than a single-disease approach.
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- 2023
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35. Blood eosinophil count and exacerbations in severe chronic obstructive pulmonary disease after withdrawal of inhaled corticosteroids: a post-hoc analysis of the WISDOM trial
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Watz, Henrik, Tetzlaff, Kay, Wouters, Emiel F M, Kirsten, Anne, Magnussen, Helgo, Rodriguez-Roisin, Roberto, Vogelmeier, Claus, Fabbri, Leonardo M, Chanez, Pascal, Dahl, Ronald, Disse, Bernd, Finnigan, Helen, and Calverley, Peter M A
- Abstract
Blood eosinophil counts might predict response to inhaled corticosteroids (ICS) in patients with chronic obstructive pulmonary disease (COPD) and a history of exacerbations. We used data from the WISDOM trial to assess whether patients with COPD with higher blood eosinophil counts would be more likely to have exacerbations if ICS treatment was withdrawn.
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- 2016
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36. From Heart Failure to Highly Unsaturated Fatty Acid Deficiency and Vice Versa: Bidirectional Heart and Liver Interactions
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Alter, Peter, Glück, Tobias, Figiel, Jens H., Koczulla, A. Rembert, Vogelmeier, Claus F., and Rupp, Heinz
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In several trials, beneficial prognostic effects of highly unsaturated fatty acids (HUFAs) in heart failure were shown. Because other studies showed no incremental benefit in nearly preserved cardiac function, the question arises, whether the degree of cardiac dysfunction is involved. It is hypothesized that increased left ventricular (LV) wall stress affects the endogenous hepatic HUFA metabolism, which in turn exhibits adverse cardiac consequences.
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- 2016
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37. Understanding the GOLD 2011 Strategy as applied to a real-world COPD population.
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Vestbo, Jørgen, Vogelmeier, Claus, Small, Mark, and Higgins, Victoria
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- 2014
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38. Effect of ADRB2 polymorphisms on the efficacy of salmeterol and tiotropium in preventing COPD exacerbations: a prespecified substudy of the POET-COPD trial.
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Rabe, Klaus F, Fabbri, Leonardo M, Israel, Elliot, Kögler, Harald, Riemann, Kathrin, Schmidt, Hendrik, Glaab, Thomas, and Vogelmeier, Claus F
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BETA adrenoceptors ,OBSTRUCTIVE lung disease treatment ,DISEASE exacerbation ,AMINO acids ,THERAPEUTICS - Abstract
Summary: Background: The effect of β
2 -adrenergic receptor (ADRB2) polymorphisms on the treatment response to longacting bronchodilators in chronic obstructive pulmonary disease (COPD) is unclear. We aimed to establish whether ADRB2 polymorphisms differentially affected COPD exacerbation outcomes in response to tiotropium versus salmeterol. Methods: We did a prespecified analysis of the ADRB2 polymorphisms Arg16Gly and Gln27Glu within the 1 year randomised, double-blind, double-dummy, parallel-group Prevention Of Exacerbations with Tiotropium in COPD (POET-COPD) trial, comparing the effects of treatment with tiotropium or salmeterol on exacerbations in 7376 patients with COPD. One blood sample was collected for pharmacogenetic testing from each patient who elected to participate in the substudy. Random assignment of patients to treatment groups was not stratified according to genotypes. Genomic DNA was extracted from whole-blood specimens and samples were genotyped for the two SNPs, rs1042713 (Arg16Gly) and rs1042714 (Gln27Glu). All assays were done in technical duplicates and 10% of samples that were randomly chosen were repeated as technical duplicates in a second independent genotyping process. Our primary endpoint was the risk of a first exacerbation of COPD based on time to first exacerbation data. An exacerbation of COPD was defined as the increase or new onset of more than one symptom of COPD (cough, sputum, wheezing, dyspnoea, or chest tightness), with at least one of the symptoms lasting for 3 days or more and needing treatment with antibiotics or systemic glucocorticoids (moderate exacerbations), or admission to hospital (severe exacerbations). POET-COPD is registered with ClinicalTrials.gov, number NCT00563381. Findings: 5125 patients gave informed consent for genotyping. The distributions of ADRB2 genotypes were well matched among groups. Polymorphisms at aminoacid 27 did not affect exacerbation outcomes. In the salmeterol group, patients with Arg16Arg genotype had a significantly reduced exacerbation risk compared with patients with Arg16Gly (p=0·0130) and Gly16Gly (p=0·0018) genotypes (proportion of patients with at least one exacerbation was 32·3% in Arg16Arg, 39·8% in Arg16Gly, and 42·1% in Gly16Gly). By contrast, exacerbation risk was not modified by polymorphisms at aminoacid 16 in the tiotropium group. The effect of the Arg16Gly polymorphism on treatment response to salmeterol was dependent on the use of inhaled corticosteroids (ICS). In patients untreated with ICS at baseline, Arg16Gly and Arg16Arg genotypes were associated with significantly prolonged time to first exacerbation compared with Gly16Gly (vs Arg16Gly p=0·0164; Arg16Arg p=0·0316; proportion of patients with at least one exacerbation was 28·3% in Arg16Arg, 31·6% in Arg16Gly, and 39·2% in Gly16Gly), whereas in patients on ICS at baseline, only the Arg16Arg genotype was associated with significantly prolonged time to first exacerbation compared with Gly16Gly (p=0·0198; not Arg16Gly p=0·64; proportion of patients with at least one exacerbation was 35·9% in Arg16Arg, 46·7% in Arg16Gly, and 44·8% in Gly16Gly). The respiratory disorders, in particular worsening of COPD, were the most common serious adverse events. Interpretation: Patients with the Arg16Arg genotype had better exacerbation outcomes in response to salmeterol than Gly16Gly and Arg16Gly genotypes, suggesting a potential differential Arg16Gly genotype effect on treatment response to longacting β-agonists (LABAs). However, the use of ADRB2 polymorphisms for predicting LABA treatment response is still limited and further prospective validation will be needed to advance the mechanistic understanding of β-adrenergic polymorphisms and their association with clinical features of COPD. Funding: Boehringer Ingelheim and Pfizer. [Copyright &y& Elsevier]- Published
- 2014
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39. Alpha1-antitrypsin deficiency -- Diagnostic testing and disease awareness in Germany and Italy.
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Greulich, Timm, Ottaviani, Stefania, Bals, Robert, Lepper, Philipp M., Vogelmeier, Claus, Luisetti, Maurizio, and Ferrarotti, Ilaria
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Background: Alpha
1 -antitrypsin (AAT) deficiency, although largely under-diagnosed, is the underlying cause of approximately 1% of COPD cases. Lack of awareness leads to long delays in diagnostic testing. Subsequently, lifestyle and treatment choices with potentially positive effects on prognosis may be postponed. Methods: Data on the testing and diagnostic practices for AAT deficiency were derived from the University of Pavia, Italy, and the University of Marburg, Germany. In addition, a survey of physicians was undertaken to explore their awareness and attitudes toward AAT deficiency. Results: In Pavia and Marburg, 125 and 729 patients, respectively, were identified with severe AAT deficiency between July 2006 and June 2011. The median time interval between the onset of symptoms and diagnosis was 6 years (interquartile range [IQR], 11; range, 0-40) and 7 years (IQR, 13; range, 0-73), respectively. Augmentation therapy was initiated almost immediately in Germany while treatment was delayed by 3 months in Italy (IQR, 5.25; range, 1-118). Survey data (Italy, n = 181; Germany, n = 180) revealed that pulmonologists had greater knowledge of AAT deficiency than internists and general practitioners, however, overall, only 18-25% of physicians tested all COPD patients. One-third of the respondents stated that they "sometimes" offered augmentation therapy to patients diagnosed with AAT deficiency. Conclusions: Major obstacles to AAT deficiency testing are physicians' attitudes and lack of understanding of the condition. A greater adherence to the guidelines that recommend diagnostic testing of all COPD patients, coupled with simpler testing protocols, may decrease delays and positively impact patient outcomes.protocols, may decrease delays and positively impact patient outcomes. [ABSTRACT FROM AUTHOR]- Published
- 2013
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40. Efficacy and safety of once-daily QVA149 compared with twice-daily salmeterol–fluticasone in patients with chronic obstructive pulmonary disease (ILLUMINATE): a randomised, double-blind, parallel group study.
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Vogelmeier, Claus F, Bateman, Eric D, Pallante, John, Alagappan, Vijay KT, D'Andrea, Peter, Chen, Hungta, and Banerji, Donald
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SALMETEROL ,FLUTICASONE ,OBSTRUCTIVE lung diseases patients ,RANDOMIZED controlled trials ,BLIND experiment ,OBSTRUCTIVE lung disease treatment ,BRONCHODILATOR agents ,DRUG dosage ,SAFETY - Abstract
Summary: Background: QVA149 is an inhaled fixed-dose combination therapy under development for the treatment of chronic obstructive pulmonary disease (COPD). It combines indacaterol (a longacting β
2 -agonist) with glycopyrronium (a longacting muscarinic antagonist) as a dual bronchodilator. We aimed to compare the efficacy, safety, and tolerability of QVA149 versus salmeterol–fluticasone (SFC) over 26 weeks in patients with moderate-to-severe COPD. Methods: In this multicentre double-blind, double-dummy, parallel-group study, 523 patients (age 40 years or older, Global Initiative for Chronic Obstructive Lung Disease [GOLD] stages II–III, without exacerbations in the previous year) were randomly assigned (1:1; via automated, interactive response technology and stratified for smoking status) to once-daily QVA149 110/50 μg or twice-daily SFC 50/500 μg for 26 weeks. Efficacy was assessed in the full analysis set (randomised patients who received at least one dose of study drug); safety was assessed in all patients who received at least one dose of study drug. The primary endpoint was to demonstrate the superiority of QVA149 compared with SFC for the standardised area under the curve from 0 to 12 h post dose for forced expiratory volume in 1 second (FEV1 AUC0–12h ) after 26 weeks of treatment. This trial was registered at ClinicalTrial.gov, NCT01315249. Findings: Between March 25, 2011, and March 12, 2012, 259 patients were randomly assigned to receive QVA149 and 264 to receive SFC. At week 26, FEV1 AUC0–12h was significantly higher with QVA149 than with SFC (treatment difference 0·138 L; 95% CI 0·100–0·176; p<0·0001). Overall incidence of adverse events (including COPD exacerbations) was 55·4% (143 of 258) for the QVA149 group and 60·2% (159 of 264) for the SFC group. Incidence of serious adverse events was similar between treatment groups (QVA149, 13 of 258 [5·0%]; SFC 14 of 264 [5·3%]); COPD worsening was the most frequent serious adverse event (one of 13 [0·4%] and three of 14 [1·1%], respectively). Interpretation: Once-daily QVA149 provides significant, sustained, and clinically meaningful improvements in lung function versus twice-daily SFC, with significant symptomatic benefit. These results indicate the potential of dual bronchodilation as a treatment option for non-exacerbating symptomatic COPD patients. Funding: Novartis Pharma AG. [ABSTRACT FROM AUTHOR]- Published
- 2013
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41. Effect of tiotropium vs. salmeterol on exacerbations: GOLD II and maintenance therapy naïve patients.
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Vogelmeier, Claus, Fabbri, Leonardo M., Rabe, Klaus F., Beeh, Kai-Michael, Schmidt, Hendrik, Metzdorf, Norbert, and Glaab, Thomas
- Abstract
The objective of this study was to investigate the effect of tiotropium compared with salmeterol on exacerbations in patients with moderate (Global Initiative for Chronic Obstructive Lung Disease [GOLD] stage II) chronic obstructive pulmonary disease (COPD) and those naïve to maintenance respiratory therapy in the 1-year Prevention Of Exacerbations with Tiotropium in COPD (POET-COPD®) trial (NCT00563381). Time to first exacerbation (primary endpoint) and rates of exacerbations were analyzed using exploratory Cox and Poisson regression (adjusting for time on treatment). Of 7376 randomized patients, 3614 were GOLD stage II (tiotropium n = 1781; salmeterol n = 1833) and 1343 were maintenance therapy naïve (tiotropium n = 672; salmeterol n = 671). Tiotropium significantly increased time to first exacerbation vs. salmeterol in GOLD stage II patients (hazard ratio [HR], 0.88; 95% confidence interval [CI]: 0.79-0.99; p = 0.028) and maintenance therapy naïve patients (HR, 0.79; 95% CI, 0.65-0.97; p = 0.028). Annual exacerbation rates were also significantly lower with tiotropium in the maintenance naïve subgroup compared with salmeterol (rate ratio [RR], 0.77; 95% CI, 0.63-0.94; p = 0.012). In the GOLD stage II subgroup, the rate of hospitalized exacerbations per year was significantly lower with tiotropium than with salmeterol (RR, 0.70; 95% CI, 0.57-0.85; p < 0.001); tiotropium also significantly prolonged time to first hospitalized exacerbation versus salmeterol in this subgroup (HR, 0.66; 95% CI, 0.48-0.91; p = 0.012). In conclusion, results from this prespecified subgroup analysis support the selection of tiotropium as first-choice maintenance therapy for patients with GOLD stage II COPD. [ABSTRACT FROM AUTHOR]
- Published
- 2013
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42. Perspectives for improving the evaluation and access of therapies for rare lung diseases in Europe.
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Luisetti, Maurizio, Balfour-Lynn, Ian M., Johnson, Simon R., Miravitlles, Marc, Strange, Charlie, Trapnell, Bruce C., van Bronswijk, Hans, and Vogelmeier, Claus
- Abstract
Summary: The approach to treating a rare disease is different to that taken for more common diseases. Small patient cohorts alter clinical trial design and limit enrollment, and the picture for rare lung diseases is further complicated by the fact that most are composed of a variety of clinical phenotypes. Since the outcome measures of lung impairment have considerable test-to-test variability, potential new therapies face a substantial challenge. In this paper we will review the current sources of clinical data for rare lung diseases and the regulatory challenges encountered by their treatment, with particular reference to alpha
1 -antitrypsin deficiency, lymphangioleiomyomatosis, cystic fibrosis, and pulmonary alveolar proteinosis. Strategies will also be identified for the better utilization of available data from patients with rare lung diseases, recognizing that the development cost of new therapies and the number of patients who will ultimately use them may not be aligned. Also important is improved communication between patients and their organizations, basic researchers, clinicians and their registries, drug developers, regulators such as the European Medicines Agency, and national health services. At present, licensing and reimbursement requirements are not aligned, either nationally or internationally, and variations also exist in drug availability between countries because of different national licensing and reimbursement rules. The changes needed to optimize European rare lung disease therapies include a commitment to develop empowered patient communities as advocates for therapy, the development of novel trial designs with new endpoints, and for regulatory bodies to be willing to accept nontraditional models of efficacy for orphan drugs. [ABSTRACT FROM AUTHOR]- Published
- 2012
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43. Alpha-1 antitrypsin is elevated in exhaled breath condensate and serum in exacerbated COPD patients.
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Koczulla, A. Rembert, Noeske, Sarah, Herr, Christian, Koepke, Janine, Jörres, Rudolf A., Nell, Christoph, Schmid, Severin, Vogelmeier, Claus, and Bals, Robert
- Abstract
Summary: Background: Exacerbations of chronic obstructive pulmonary disease (COPD) significantly contribute to COPD-related morbidity. Diagnosis of COPD exacerbations may be improved by analyzing biomarkers such as alpha-1 antitrypsin (AAT). AAT is an acute-phase protein and inhibitor of neutrophil elastase. Deficiency of AAT may result in early-onset respiratory symptoms. Measurement of exhaled breath condensate (EBC) is a noninvasive method to investigate biomarkers present in the epithelial lining fluid, such as AAT. Objective: To investigate whether AAT can be detected and quantified in EBC and to compare AAT levels in the EBC of healthy controls, patients with COPD, and during exacerbations of COPD. Methods: EBC from 10 healthy controls, 17 subjects with COPD, and 18 subjects with exacerbations of COPD was collected with the RTube™ device. AAT from EBC and serum were quantified by ELISA. Results: AAT in EBC was detectable in every individual. Patients with exacerbations of COPD had significantly increased AAT values (mean, 514.33pg/mL, [SD 279.41 ]) compared with healthy controls (mean, 251.32pg/mL, [SD 44.71]) and stable COPD patients (mean, 242.01pg/mL [SD 65.74]) (P =0.0003; P =0.00003). EBC AAT showed only a correlation trend with serum AAT (r =0.3, P =0.054). Conclusions: AAT in EBC was detectable and quantifiable. AAT measured in EBC was significantly increased during exacerbations of COPD and can potentially be used as a biomarker in exacerbations. [Copyright &y& Elsevier]
- Published
- 2012
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44. The discovery of α1-antitrypsin and its role in health and disease.
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Janciauskiene, Sabina M., Bals, Robert, Koczulla, Rembert, Vogelmeier, Claus, Köhnlein, Thomas, and Welte, Tobias
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Summary: α1-Antitrypsin (AAT) is the archetype member of the serine protease inhibitor (SERPIN) supergene family. The AAT deficiency is most often associated with the Z mutation, which results in abnormal Z AAT folding in the endoplasmic reticulum of hepatocytes during biogenesis. This causes intra-cellular retention of the AAT protein rather than efficient secretion with consequent deficiency of circulating AAT. The reduced serum levels of AAT contribute to the development of chronic obstructive pulmonary disease (COPD) and the accumulation of abnormally folded AAT protein increases risk for liver diseases. In this review we show that with the discovery of AAT deficiency in the early 60s as a genetically determined predisposition to the development of early-onset emphysema, intensive investigations of enzymatic mechanisms that produce lung destruction in COPD were pursued. To date, the role of AAT in other than lung and liver diseases has not been extensively examined. Current findings provide new evidence that, in addition to protease inhibition, AAT expresses anti-inflammatory, immunomodulatory and antimicrobial properties, and highlight the importance of this protein in health and diseases. In this review co-occurrence of several diseases with AAT deficiency is discussed. [ABSTRACT FROM AUTHOR]
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- 2011
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45. Lung function reference values in different German populations.
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Koch, Beate, Schäper, Christoph, Ewert, Ralf, Völzke, Henry, Obst, Anne, Friedrich, Nele, Felix, Stephan B., Vogelmeier, Claus F., Schnabel, Eva, Karrasch, Stefan, Wichmann, H.E., Schäfer, Torsten, Schulz, Holger, Heinrich, Joachim, and Gläser, Sven
- Abstract
Summary: Background: Spirometry is a frequently performed lung function test and an important tool in medical surveillance examinations of pulmonary diseases. The interpretation of lung function relies on the comparison to reference values derived from a healthy population. The study aim was to compare the lung function data of three representative population-based German studies (Study of Health in Pomerania [SHIP-1], Cooperative Health Research in the Region of Augsburg [KORA-S3] and European Community Respiratory Health Survey Erfurt [ECRHS-I Erfurt]) with existing European spirometry reference values and to establish a new set of comprehensive German prediction equations. Methods: Spirometry was performed in 4133 participants of three population-based surveys using almost identical standardised methods. Current and former smokers, subjects with cardiopulmonary disorders or on medication with potential influence on lung function were excluded. Sex specific prediction equations were established by quantile regression analyses. Comparison was performed to existing European reference values. Results: The healthy reference sample consisted of 1302 (516 male) individuals, aged 20–80 years. Sex specific comprehensive prediction equations adjusted for age and height are provided. Significant differences were found in comparison to previous studies with pronounced lower values of the current population if applying historic prediction equations. Conclusion: The results contribute to the interpretation of lung function examination in providing a comprehensive set of spirometry reference values obtained in a large number of healthy volunteers. Whereas the differences in between the investigated studies are negligible, striking divergence was detected in comparison to historic and recent European spirometry prediction values. [ABSTRACT FROM AUTHOR]
- Published
- 2011
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46. Efficacy and safety of ciclesonide in the treatment of 24,037 asthmatic patients in routine medical care.
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Vogelmeier, Claus F., Hering, Thomas, Lewin, Thomas, Sander, Peter, and Bethke, Thomas D.
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Summary: Background: The efficacy and safety profile of ciclesonide (CIC) in the treatment of asthma was evaluated in a large patient population in a real-life setting in Germany. Methods: 24,037 patients with persistent mild/moderate bronchial asthma were enrolled into three observational studies with identical design. Data were pooled and analyzed. Patients received ciclesonide (160 μg/day) and were observed for 3 months. FEV
1 , PEF, NO, asthma episodes, use of rescue medication and adverse drug reactions (ADR) were recorded. Results: Mean (95% CI) FEV1 significantly increased from 80.7 [80.5; 80.9]% of predicted at baseline to 90.1 [89.9; 90.2]% after 3 months (n = 20,297), mean PEF significantly increased from 338 [335; 340] l/min to 392 [390; 395] l/min (n = 8100). NO was significantly reduced from 53.6 [51.8; 55.4] ppb to 26.2 [25.2; 27.1] ppb (n = 971). The percentage of patients with daily symptoms declined from 24.3% to 1.9%, night-time symptoms from 13.3% to 1.3%, and β2 -agonists use from 26.9% to 8.8%. ADRs were reported by 51 patients (0.2%). Most frequent ADRs were: dysphonia (n = 11), cough (n = 10), dyspnoea, throat irritation, and oral candidiasis (n = 5 each). 46 patients terminated the study prematurely, 41 due to ADR and 5 due to unknown/missing reason. One patient died due to cardiac failure (no causal relation). Conclusion: These observational studies under real-life conditions support findings from controlled clinical studies regarding efficacy and tolerability of ciclesonide in patients with mild to moderate bronchial asthma. No unexpected ADRs were detected. [ABSTRACT FROM AUTHOR]- Published
- 2011
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47. Tracheostomy and related host–patogen interaction are associated with airway inflammation as characterized by tracheal aspirate analysis.
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Pignatti, Patrizia, Balestrino, Antonella, Herr, Christian, Bals, Robert, Moretto, Dania, Corradi, Massimo, Alinovi, Rossella, Delmastro, Monica, Vogelmeier, Claus, Nava, Stefano, Moscato, Gianna, and Balbi, Bruno
- Abstract
Summary: In the last years an increasing number of subjects experienced respiratory failure and underwent tracheostomy. The aim of the present study was to analyze tracheal aspirates from the inflammatory point of view. Samples were collected from 38 consecutive tracheostomized patients: 13 COPD, 6 with neurologic disorders and 19 with other different causes of respiratory failure. We analyzed cells and soluble mediators related to inflammation and/or infection. We also compared results obtained in the tracheal aspirate of COPD patients with the same determination in the sputum of another group of non-tracheostomized COPD patients (n =41). Regardless of the underlying diagnosis, most of the samples were Pseudomonas aeruginosa positive and cells and soluble mediator did not differ. Treatment with steroids was associated with lower amount of total cells, neutrophils and lymphocytes, whereas treatment with antibiotics was not. Tracheal aspirate neutrophils correlated with PaCO
2 values; neutrophils and eosinophils correlated with their percentages in blood. As compared with sputa obtained from another group of culture-positive non-tracheostomized COPDs, tracheal aspirates showed similar cell count, proportions of inflammatory cells, and infection/inflammatory mediators. In conclusion tracheal aspirates presented high amounts of viable cells and soluble mediators independently to the cause of respiratory failure leading to tracheotomy and they represent suitable specimens to study infection/inflammation interactions. [Copyright &y& Elsevier]- Published
- 2009
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48. Formoterol mono- and combination therapy with tiotropium in patients with COPD: A 6-month study.
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Vogelmeier, Claus, Kardos, Peter, Harari, Sergio, Gans, Steven J.M., Stenglein, Stephan, and Thirlwell, Jackie
- Abstract
Summary: Although guidelines recommend combining long-acting bronchodilators in COPD, data are limited. We examined the clinical efficacy and safety of formoterol, tiotropium and the combination in patients with COPD. Eight hundred and forty-seven patients with COPD (mean FEV
1 52% predicted; FEV1 /FVC 53%) were randomized to receive one of the following four treatments for 24weeks: formoterol 10μg b.i.d. plus tiotropium 18μg o.d.; formoterol 10μg b.i.d.; tiotropium 18μg o.d., or placebo. The study was partially blinded (formoterol and placebo). For the primary endpoint, FEV1 2h post-dose after 24weeks, there were small differences in favour of the combination therapy versus formoterol (0.07L, p =0.044) or tiotropium (0.06L, p =0.066). All three treatments were superior to placebo (p <0.001). The combination was statistically superior to monotherapy for: the primary endpoint (p =0.044 vs. formoterol); FEV1 5min after the first dose (p <0.001) and at 12weeks (p <0.05 vs. tiotropium); and peak expiratory flow averaged over the first 6weeks (p <0.001 vs. both). The three active treatments were significantly more effective than placebo for secondary endpoints: COPD-related ‘bad days’, symptoms, use of rescue medication and peak expiratory flow, and aspects of health-related quality of life. The overall incidence of adverse events was similar with all active treatments, although COPD-related adverse events were more common with tiotropium. Combined bronchodilator therapy may be a valuable treatment option for patients with COPD. [Copyright &y& Elsevier]- Published
- 2008
- Full Text
- View/download PDF
49. Identification of individuals with alpha-1-antitrypsin deficiency by a targeted screening program.
- Author
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Bals, Robert, Koczulla, Rembert, Kotke, Viktor, Andress, Juergen, Blackert, Karlheinz, and Vogelmeier, Claus
- Abstract
Summary: Background: Alpha-1-antitrypsin deficiency (AATD) is significantly underdiagnosed. The early detection of AATD would enable affected persons to make lifestyle changes such as quitting smoking. It was the aim of the study to determine whether the combination of an awareness program with the offer of a cost-free diagnostic test results in the identification of a significant number of individuals with severe AATD. Methodology: We combined a series of measures to promote awareness with the offer of a diagnostic test at no charge. Test blood was applied to a filter paper and sent to our laboratory. The level of AAT was measured by nephelometry, the presence of the S- or Z-allele was determined by PCR, and phenotyping was performed by isoelectric focusing. Results: During 37 months 17688 testing kits were distributed and 2722 were sent back to our laboratory. We identified 335 patients with severe AATD including 16 individuals with rare genotypes. Prescreening by determining the AAT serum levels by the submitting physician increased the detection rate as compared to similar programs that screened unselected individuals. Summary: These data show that the combination of an awareness program with the offer of free diagnostic testing results in the identification of a large number individuals with severe AATD. [Copyright &y& Elsevier]
- Published
- 2007
- Full Text
- View/download PDF
50. Effect of ADRB2polymorphisms on the efficacy of salmeterol and tiotropium in preventing COPD exacerbations: a prespecified substudy of the POET-COPD trial
- Author
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Rabe, Klaus F, Fabbri, Leonardo M, Israel, Elliot, Kögler, Harald, Riemann, Kathrin, Schmidt, Hendrik, Glaab, Thomas, and Vogelmeier, Claus F
- Abstract
The effect of β2-adrenergic receptor (ADRB2) polymorphisms on the treatment response to longacting bronchodilators in chronic obstructive pulmonary disease (COPD) is unclear. We aimed to establish whether ADRB2polymorphisms differentially affected COPD exacerbation outcomes in response to tiotropium versus salmeterol.
- Published
- 2014
- Full Text
- View/download PDF
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