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1. Nintedanib in patients with progressive fibrosing interstitial lung diseases—subgroup analyses by interstitial lung disease diagnosis in the INBUILD trial: a randomised, double-blind, placebo-controlled, parallel-group trial

Author

Abe, S., Aburto, M., Acosta, O., Andrews, C., Antin-Ozerkis, D., Arce, G., Arias, M., Avdeev, S., Barczyk, A., Bascom, R., Bazdyrev, E., Beirne, P., Belloli, E., Bergna, M.A., Bergot, E., Bhatt, N., Blaas, S., Bondue, B., Bonella, F., Britt, E., Buch, K., Burk, J., Cai, H., Cantin, A., Castillo Villegas, D.M., Cazaux, A., Cerri, S., Chaaban, S., Chaudhuri, N., Cottin, V., Crestani, B., Criner, G., Dahlqvist, C., Danoff, S., Dematte D'Amico, J., Dilling, D., Elias, P., Ettinger, N., Falk, J., Fernández Pérez, E.R., Gamez-Dubuis, A., Giessel, G., Gifford, A., Glassberg, M., Glazer, C., Golden, J., Gómez Carrera, L., Guiot, J., Hallowell, R., Hayashi, H., Hetzel, J., Hirani, N., Homik, L., Hope-Gill, B., Hotchkin, D., Ichikado, K., Ilkovich, M., Inoue, Y., Izumi, S., Jassem, E., Jones, L., Jouneau, S., Kaner, R., Kang, J., Kawamura, T., Kessler, R., Kim, Y., Kishi, K., Kitamura, H., Kolb, M., Kondoh, Y., Kono, C., Koschel, D., Kreuter, M., Kulkarni, T., Kus, J., Lebargy, F., León Jiménez, A., Luo, Q., Mageto, Y., Maher, T.M., Makino, S., Marchand-Adam, S., Marquette, C., Martinez, R., Martínez, M., Maturana Rozas, R., Miyazaki, Y., Moiseev, S., Molina-Molina, M., Morrison, L., Morrow, L., Moua, T., Nambiar, A., Nishioka, Y., Nunes, H., Okamoto, M., Oldham, J., Otaola, M., Padilla, M., Park, J.S., Patel, N., Pesci, A., Piotrowski, W., Pitts, L., Poonyagariyagorn, H., Prasse, A., Quadrelli, S., Randerath, W., Refini, R., Reynaud-Gaubert, M., Riviere, F., Rodríguez Portal, J.A., Rosas, I., Rossman, M., Safdar, Z., Saito, T., Sakamoto, N., Salinas Fénero, M., Sauleda, J., Schmidt, S., Scholand, M.B., Schwartz, M., Shapera, S., Shlobin, O., Sigal, B., Silva Orellana, A., Skowasch, D., Song, J.W., Stieglitz, S., Stone, H., Strek, M., Suda, T., Sugiura, H., Takahashi, H., Takaya, H., Takeuchi, T., Thavarajah, K., Tolle, L., Tomassetti, S., Tomii, K., Valenzuela, C., Vancheri, C., Varone, F., Veeraraghavan, S., Villar, A., Weigt, S., Wemeau, L., Wuyts, W., Xu, Z., Yakusevich, V., Yamada, Y., Yamauchi, H., Ziora, D., Wells, Athol U, Flaherty, Kevin R, Brown, Kevin K, Inoue, Yoshikazu, Devaraj, Anand, Richeldi, Luca, Moua, Teng, Crestani, Bruno, Wuyts, Wim A, Stowasser, Susanne, Quaresma, Manuel, Goeldner, Rainer-Georg, Schlenker-Herceg, Rozsa, and Kolb, Martin

Published
2020
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2. Nintedanib in patients with progressive fibrosing interstitial lung diseases—subgroup analyses by interstitial lung disease diagnosis in the INBUILD trial: a randomised, double-blind, placebo-controlled, parallel-group trial

Author

Wells, A. U., Flaherty, K. R., Brown, K. K., Inoue, Y., Devaraj, A., Richeldi, Luca, Moua, T., Crestani, B., Wuyts, W. A., Stowasser, S., Quaresma, M., Goeldner, R. -G., Schlenker-Herceg, R., Kolb, M., Abe, S., Aburto, M., Acosta, O., Andrews, C., Antin-Ozerkis, D., Arce, G., Arias, M., Avdeev, S., Barczyk, A., Bascom, R., Bazdyrev, E., Beirne, P., Belloli, E., Bergna, M. A., Bergot, E., Bhatt, N., Blaas, S., Bondue, B., Bonella, F., Britt, E., Buch, K., Burk, J., Cai, H., Cantin, A., Castillo Villegas, D. M., Cazaux, A., Cerri, S., Chaaban, S., Chaudhuri, N., Cottin, V., Criner, G., Dahlqvist, C., Danoff, S., Dematte D'Amico, J., Dilling, D., Elias, P., Ettinger, N., Falk, J., Fernandez Perez, E. R., Gamez-Dubuis, A., Giessel, G., Gifford, A., Glassberg, M., Glazer, C., Golden, J., Gomez Carrera, L., Guiot, J., Hallowell, R., Hayashi, H., Hetzel, J., Hirani, N., Homik, L., Hope-Gill, B., Hotchkin, D., Ichikado, K., Ilkovich, M., Izumi, S., Jassem, E., Jones, L., Jouneau, S., Kaner, R., Kang, J., Kawamura, T., Kessler, R., Kim, Y., Kishi, K., Kitamura, H., Kondoh, Y., Kono, C., Koschel, D., Kreuter, M., Kulkarni, T., Kus, J., Lebargy, F., Leon Jimenez, A., Luo, Q., Mageto, Y., Maher, T. M., Makino, S., Marchand-Adam, S., Marquette, C., Martinez, Sara, Martinez, M., Maturana Rozas, R., Miyazaki, Y., Moiseev, S., Molina-Molina, M., Malcolm, Joan Morrison, Morrow, L., Nambiar, A., Nishioka, Y., Nunes, H., Okamoto, M., Oldham, J., Otaola, M., Padilla, M., Park, J. S., Patel, N., Pesci, Riccardo, Piotrowski, W., Pitts, L., Poonyagariyagorn, H., Prasse, A., Quadrelli, S., Randerath, W., Refini, R., Reynaud-Gaubert, M., Riviere, F., Rodriguez Portal, J. A., Rosas, I., Rossman, M., Safdar, Z., Saito, T., Sakamoto, N., Salinas Fenero, M., Sauleda, J., Schmidt, S., Scholand, M. B., Schwartz, M., Shapera, S., Shlobin, O., Sigal, B., Silva Orellana, A., Skowasch, D., Song, J. W., Stieglitz, S., Stone, H., Strek, M., Suda, T., Sugiura, H., Takahashi, H., Takaya, H., Takeuchi, T., Thavarajah, K., Tolle, L., Tomassetti, S., Tomii, K., Valenzuela, C., Vancheri, C., Varone, Francesco, Veeraraghavan, S., Villar, A., Weigt, S., Wemeau, L., Wuyts, W., Xu, Z., Yakusevich, V., Yamada, Y., Yamauchi, H., Ziora, D., Richeldi L. (ORCID:0000-0001-8594-1448), Martinez R., Morrison L., Pesci A., Varone F., Wells, A. U., Flaherty, K. R., Brown, K. K., Inoue, Y., Devaraj, A., Richeldi, Luca, Moua, T., Crestani, B., Wuyts, W. A., Stowasser, S., Quaresma, M., Goeldner, R. -G., Schlenker-Herceg, R., Kolb, M., Abe, S., Aburto, M., Acosta, O., Andrews, C., Antin-Ozerkis, D., Arce, G., Arias, M., Avdeev, S., Barczyk, A., Bascom, R., Bazdyrev, E., Beirne, P., Belloli, E., Bergna, M. A., Bergot, E., Bhatt, N., Blaas, S., Bondue, B., Bonella, F., Britt, E., Buch, K., Burk, J., Cai, H., Cantin, A., Castillo Villegas, D. M., Cazaux, A., Cerri, S., Chaaban, S., Chaudhuri, N., Cottin, V., Criner, G., Dahlqvist, C., Danoff, S., Dematte D'Amico, J., Dilling, D., Elias, P., Ettinger, N., Falk, J., Fernandez Perez, E. R., Gamez-Dubuis, A., Giessel, G., Gifford, A., Glassberg, M., Glazer, C., Golden, J., Gomez Carrera, L., Guiot, J., Hallowell, R., Hayashi, H., Hetzel, J., Hirani, N., Homik, L., Hope-Gill, B., Hotchkin, D., Ichikado, K., Ilkovich, M., Izumi, S., Jassem, E., Jones, L., Jouneau, S., Kaner, R., Kang, J., Kawamura, T., Kessler, R., Kim, Y., Kishi, K., Kitamura, H., Kondoh, Y., Kono, C., Koschel, D., Kreuter, M., Kulkarni, T., Kus, J., Lebargy, F., Leon Jimenez, A., Luo, Q., Mageto, Y., Maher, T. M., Makino, S., Marchand-Adam, S., Marquette, C., Martinez, Sara, Martinez, M., Maturana Rozas, R., Miyazaki, Y., Moiseev, S., Molina-Molina, M., Malcolm, Joan Morrison, Morrow, L., Nambiar, A., Nishioka, Y., Nunes, H., Okamoto, M., Oldham, J., Otaola, M., Padilla, M., Park, J. S., Patel, N., Pesci, Riccardo, Piotrowski, W., Pitts, L., Poonyagariyagorn, H., Prasse, A., Quadrelli, S., Randerath, W., Refini, R., Reynaud-Gaubert, M., Riviere, F., Rodriguez Portal, J. A., Rosas, I., Rossman, M., Safdar, Z., Saito, T., Sakamoto, N., Salinas Fenero, M., Sauleda, J., Schmidt, S., Scholand, M. B., Schwartz, M., Shapera, S., Shlobin, O., Sigal, B., Silva Orellana, A., Skowasch, D., Song, J. W., Stieglitz, S., Stone, H., Strek, M., Suda, T., Sugiura, H., Takahashi, H., Takaya, H., Takeuchi, T., Thavarajah, K., Tolle, L., Tomassetti, S., Tomii, K., Valenzuela, C., Vancheri, C., Varone, Francesco, Veeraraghavan, S., Villar, A., Weigt, S., Wemeau, L., Wuyts, W., Xu, Z., Yakusevich, V., Yamada, Y., Yamauchi, H., Ziora, D., Richeldi L. (ORCID:0000-0001-8594-1448), Martinez R., Morrison L., Pesci A., and Varone F.

Abstract

Background: The INBUILD trial investigated the efficacy and safety of nintedanib versus placebo in patients with progressive fibrosing interstitial lung diseases (ILDs) other than idiopathic pulmonary fibrosis (IPF). We aimed to establish the effects of nintedanib in subgroups based on ILD diagnosis. Methods: The INBUILD trial was a randomised, double-blind, placebo-controlled, parallel group trial done at 153 sites in 15 countries. Participants had an investigator-diagnosed fibrosing ILD other than IPF, with chest imaging features of fibrosis of more than 10% extent on high resolution CT (HRCT), forced vital capacity (FVC) of 45% or more predicted, and diffusing capacity of the lung for carbon monoxide (DLco) of at least 30% and less than 80% predicted. Participants fulfilled protocol-defined criteria for ILD progression in the 24 months before screening, despite management considered appropriate in clinical practice for the individual ILD. Participants were randomly assigned 1:1 by means of a pseudo-random number generator to receive nintedanib 150 mg twice daily or placebo for at least 52 weeks. Participants, investigators, and other personnel involved in the trial and analysis were masked to treatment assignment until after database lock. In this subgroup analysis, we assessed the rate of decline in FVC (mL/year) over 52 weeks in patients who received at least one dose of nintedanib or placebo in five prespecified subgroups based on the ILD diagnoses documented by the investigators: hypersensitivity pneumonitis, autoimmune ILDs, idiopathic non-specific interstitial pneumonia, unclassifiable idiopathic interstitial pneumonia, and other ILDs. The trial has been completed and is registered with ClinicalTrials.gov, number NCT02999178. Findings: Participants were recruited between Feb 23, 2017, and April 27, 2018. Of 663 participants who received at least one dose of nintedanib or placebo, 173 (26%) had chronic hypersensitivity pneumonitis, 170 (26%) an autoimmune IL

Published
2020

3. Nintedanib in patients with progressive fibrosing interstitial lung diseases—subgroup analyses by interstitial lung disease diagnosis in the INBUILD trial: a randomised, double-blind, placebo-controlled, parallel-group trial

Author

Wells, Athol U, primary, Flaherty, Kevin R, additional, Brown, Kevin K, additional, Inoue, Yoshikazu, additional, Devaraj, Anand, additional, Richeldi, Luca, additional, Moua, Teng, additional, Crestani, Bruno, additional, Wuyts, Wim A, additional, Stowasser, Susanne, additional, Quaresma, Manuel, additional, Goeldner, Rainer-Georg, additional, Schlenker-Herceg, Rozsa, additional, Kolb, Martin, additional, Abe, S., additional, Aburto, M., additional, Acosta, O., additional, Andrews, C., additional, Antin-Ozerkis, D., additional, Arce, G., additional, Arias, M., additional, Avdeev, S., additional, Barczyk, A., additional, Bascom, R., additional, Bazdyrev, E., additional, Beirne, P., additional, Belloli, E., additional, Bergna, M.A., additional, Bergot, E., additional, Bhatt, N., additional, Blaas, S., additional, Bondue, B., additional, Bonella, F., additional, Britt, E., additional, Buch, K., additional, Burk, J., additional, Cai, H., additional, Cantin, A., additional, Castillo Villegas, D.M., additional, Cazaux, A., additional, Cerri, S., additional, Chaaban, S., additional, Chaudhuri, N., additional, Cottin, V., additional, Crestani, B., additional, Criner, G., additional, Dahlqvist, C., additional, Danoff, S., additional, Dematte D'Amico, J., additional, Dilling, D., additional, Elias, P., additional, Ettinger, N., additional, Falk, J., additional, Fernández Pérez, E.R., additional, Gamez-Dubuis, A., additional, Giessel, G., additional, Gifford, A., additional, Glassberg, M., additional, Glazer, C., additional, Golden, J., additional, Gómez Carrera, L., additional, Guiot, J., additional, Hallowell, R., additional, Hayashi, H., additional, Hetzel, J., additional, Hirani, N., additional, Homik, L., additional, Hope-Gill, B., additional, Hotchkin, D., additional, Ichikado, K., additional, Ilkovich, M., additional, Inoue, Y., additional, Izumi, S., additional, Jassem, E., additional, Jones, L., additional, Jouneau, S., additional, Kaner, R., additional, Kang, J., additional, Kawamura, T., additional, Kessler, R., additional, Kim, Y., additional, Kishi, K., additional, Kitamura, H., additional, Kolb, M., additional, Kondoh, Y., additional, Kono, C., additional, Koschel, D., additional, Kreuter, M., additional, Kulkarni, T., additional, Kus, J., additional, Lebargy, F., additional, León Jiménez, A., additional, Luo, Q., additional, Mageto, Y., additional, Maher, T.M., additional, Makino, S., additional, Marchand-Adam, S., additional, Marquette, C., additional, Martinez, R., additional, Martínez, M., additional, Maturana Rozas, R., additional, Miyazaki, Y., additional, Moiseev, S., additional, Molina-Molina, M., additional, Morrison, L., additional, Morrow, L., additional, Moua, T., additional, Nambiar, A., additional, Nishioka, Y., additional, Nunes, H., additional, Okamoto, M., additional, Oldham, J., additional, Otaola, M., additional, Padilla, M., additional, Park, J.S., additional, Patel, N., additional, Pesci, A., additional, Piotrowski, W., additional, Pitts, L., additional, Poonyagariyagorn, H., additional, Prasse, A., additional, Quadrelli, S., additional, Randerath, W., additional, Refini, R., additional, Reynaud-Gaubert, M., additional, Riviere, F., additional, Rodríguez Portal, J.A., additional, Rosas, I., additional, Rossman, M., additional, Safdar, Z., additional, Saito, T., additional, Sakamoto, N., additional, Salinas Fénero, M., additional, Sauleda, J., additional, Schmidt, S., additional, Scholand, M.B., additional, Schwartz, M., additional, Shapera, S., additional, Shlobin, O., additional, Sigal, B., additional, Silva Orellana, A., additional, Skowasch, D., additional, Song, J.W., additional, Stieglitz, S., additional, Stone, H., additional, Strek, M., additional, Suda, T., additional, Sugiura, H., additional, Takahashi, H., additional, Takaya, H., additional, Takeuchi, T., additional, Thavarajah, K., additional, Tolle, L., additional, Tomassetti, S., additional, Tomii, K., additional, Valenzuela, C., additional, Vancheri, C., additional, Varone, F., additional, Veeraraghavan, S., additional, Villar, A., additional, Weigt, S., additional, Wemeau, L., additional, Wuyts, W., additional, Xu, Z., additional, Yakusevich, V., additional, Yamada, Y., additional, Yamauchi, H., additional, and Ziora, D., additional

Published
2020
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4. Integrative Genomics Analysis Identifies ACVR1B as a Candidate Causal Gene of Emphysema Distribution

Author

Boueiz, Adel, primary, Pham, Betty, additional, Chase, Robert, additional, Lamb, Andrew, additional, Lee, Sool, additional, Naing, Zun Zar Chi, additional, Cho, Michael H., additional, Parker, Margaret M., additional, Sakornsakolpat, Phuwanat, additional, Hersh, Craig P., additional, Crapo, James D., additional, Stergachis, Andrew B., additional, Tal-Singer, Ruth, additional, DeMeo, Dawn L., additional, Silverman, Edwin K., additional, Zhou, Xiaobo, additional, Castaldi, Peter J., additional, Make, Barry J., additional, Regan, Elizabeth A., additional, Beaty, Terri, additional, Begum, Ferdouse, additional, Cho, Michael, additional, Boueiz, Adel, additional, Foreman, Marilyn G., additional, Halper-Stromberg, Eitan, additional, Hayden, Lystra P., additional, Hetmanski, Jacqueline, additional, Hobbs, Brian D., additional, Hokanson, John E., additional, Laird, Nan, additional, Lange, Christoph, additional, Lutz, Sharon M., additional, McDonald, Merry-Lynn, additional, Qiao, Dandi, additional, Wan, Emily S., additional, Won, Sungho, additional, Prokopenko, Dmitry, additional, Al Qaisi, Mustafa, additional, Coxson, Harvey O., additional, Gray, Teresa, additional, Han, MeiLan K., additional, Hoffman, Eric A., additional, Humphries, Stephen, additional, Jacobson, Francine L., additional, Judy, Philip F., additional, Kazerooni, Ella A., additional, Kluiber, Alex, additional, Lynch, David A., additional, Newell, John D., additional, Ross, James C., additional, Estepar, Raul San Jose, additional, Schroeder, Joyce, additional, Sieren, Jered, additional, Stinson, Douglas, additional, Stoel, Berend C., additional, Tschirren, Juerg, additional, Van Beek, Edwin, additional, van Ginneken, Bram, additional, van Rikxoort, Eva, additional, Washko, George, additional, Wilson, Carla G., additional, Jensen, Robert, additional, Everett, Douglas, additional, Crooks, Jim, additional, Moore, Camille, additional, Strand, Matt, additional, Hughes, John, additional, Kinney, Gregory, additional, Pratte, Katherine, additional, Young, Kendra A., additional, Bhatt, Surya, additional, Bon, Jessica, additional, Make, Barry, additional, Martinez, Carlos, additional, Murray, Susan, additional, Regan, Elizabeth, additional, Soler, Xavier, additional, Bowler, Russell P., additional, Kechris, Katerina, additional, Banaei-Kashani, Farnoush, additional, Ivanov, Y., additional, Kostov, K., additional, Bourbeau, J., additional, Fitzgerald, M., additional, Hernandez, P., additional, Killian, K., additional, Levy, R., additional, Maltais, F., additional, O’Donnell, D., additional, Krepelka, J., additional, Vestbo, J., additional, Wouters, E., additional, Quinn, D., additional, Bakke, P., additional, Kosnik, M., additional, Agusti, A., additional, Sauleda, J., additional, Feschenko, Y., additional, Gavrisyuk, V., additional, Yashina, L., additional, Monogarova, N., additional, Calverley, P., additional, Lomas, D., additional, MacNee, W., additional, Singh, D., additional, Wedzicha, J., additional, Anzueto, A., additional, Braman, S., additional, Casaburi, R., additional, Celli, B., additional, Giessel, G., additional, Gotfried, M., additional, Greenwald, G., additional, Mirage, Rancho, additional, Hanania, N., additional, Mahler, D., additional, Make, B., additional, Rennard, S., additional, Rochester, C., additional, Scanlon, P., additional, Schuller, D., additional, Sciurba, F., additional, Sharafkhaneh, A., additional, Siler, T., additional, Silverman, E., additional, Wanner, A., additional, Wise, R., additional, ZuWallack, R., additional, Coxson, H., additional, Crim, C., additional, Edwards, L., additional, Tal-Singer, R., additional, Yates, J., additional, Miller, B., additional, Bakke, Per, additional, and Gulsvik, Amund, additional

Published
2019
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5. Biomarkers of collagen turnover are related to annual change in FEV1 in patients with chronic obstructive pulmonary disease within the ECLIPSE study

Author

Leeming, Diana J., Byrjalsen, Inger, Sand, Jannie M.B., Bihlet, Asger R., Lange, Peter, Thal-Singer, Ruth, Miller, Bruce E., Karsdal, Morten A., Vestbo, Jørgen, Ivanov, Y., Kostov, K., Bourbeau, J., Fitzgerald, M., Hernández, P., Killian, K., Levy, R., Maltais, F., O'Donnell, D., Krepelka, J., Vestbo, J., Wouters, E., Quinn, D., Bakke, P., Kosnik, M., Agusti, A., Sauleda, Jaume, Feschenko, Y., Gavrisyuk, V., Yashina, L., MacNee, W., Singh, D., Wedzicha, J., Anzueto, A., Braman, S., Casaburi, R., Celli, B., Giessel, G., Gotfried, M., Greenwald, G., Hanania, N., Mahler, D., Make, B., Rennard, S., Rochester, C., Scanlon, P., Schuller, D., Sciurba, F., Sharafkhaneh, A., Siler, T., and Silverman, E.

Subjects
Pulmonary and Respiratory Medicine, Male, Chronic bronchitis, medicine.medical_specialty, medicine.drug_class, Collagen Type VI, Collagen Type I, Serology, 03 medical and health sciences, Pulmonary Disease, Chronic Obstructive, 0302 clinical medicine, Internal medicine, Bronchodilator, Forced Expiratory Volume, Medicine, Humans, COPD, 030212 general & internal medicine, Serological marker, Lung function change, Aged, lcsh:RC705-779, biology, business.industry, Surrogate endpoint, C-reactive protein, lcsh:Diseases of the respiratory system, Extracellular matrix, respiratory system, Middle Aged, medicine.disease, Prognosis, Matrix Metalloproteinases, Peptide Fragments, respiratory tract diseases, Clinical trial, C-Reactive Protein, 030228 respiratory system, biology.protein, Observational study, Female, business, Biomarkers, Research Article
Abstract

Background Change in forced expiratory volume in one second (FEV1) is important for defining severity of chronic obstructive pulmonary disease (COPD). Serological neoepitope markers of collagen turnover may predict rate of change in FEV1. Methods One thousand COPD subjects from the observational, multicentre, three-year ECLIPSE (Evaluation of COPD Longitudinally to Identify Predictive Surrogate Endpoints) study (NCT00292552, trial registration in February 2006) were included. Matrix metalloproteinase (MMP)-generated fragments of collagen type I, and type VI (C1M and C6M) were assessed in month six serum samples. A random-coefficient model with both a random intercept and a random slope was used to test the ability of the markers to predict post-dose bronchodilator FEV1 (PD-FEV1) change over two years adjusting for sex, age, BMI, smoking, bronchodilator reversibility, prior exacerbations, emphysema and chronic bronchitis status at baseline. Results Annual change of PD-FEV1 was estimated from a linear model for the two-year study period. Serum C1M and C6M were independent predictors of lung function change (p = 0.007/0.005). Smoking, bronchodilator reversibility, plasma hsCRP and emphysema were also significant predictors. The effect estimate between annual change in PD-FEV1 per one standard deviation (1SD) increase of C1M and C6M was +10.4 mL/yr. and +8.6 mL/yr. C1M, and C6M, had a significant association with baseline FEV1. Conclusion We demonstrated that markers of tissue turnover were significantly associated with lung function change. These markers may function as prognostic biomarkers and possibly as efficacy biomarkers in clinical trials focusing on lung function change in COPD. Trial registration NCT00292552, Retrospectively registered, trial registration in February 2006. Electronic supplementary material The online version of this article (10.1186/s12890-017-0505-4) contains supplementary material, which is available to authorized users.

Published
2017

6. Blood eosinophil count thresholds and exacerbations in patients with chronic obstructive pulmonary disease

Author

Yun, Jeong H., primary, Lamb, Andrew, additional, Chase, Robert, additional, Singh, Dave, additional, Parker, Margaret M., additional, Saferali, Aabida, additional, Vestbo, Jørgen, additional, Tal-Singer, Ruth, additional, Castaldi, Peter J., additional, Silverman, Edwin K., additional, Hersh, Craig P., additional, Crapo, James D., additional, Make, Barry J., additional, Regan, Elizabeth A., additional, Beaty, Terri, additional, Begum, Ferdouse, additional, Busch, Robert, additional, Cho, Michael, additional, DeMeo, Dawn L., additional, Boueiz, Adel R., additional, Foreman, Marilyn G., additional, Halper-Stromberg, Eitan, additional, Hansel, Nadia N., additional, Hardin, Megan E., additional, Hayden, Lystra P., additional, Hetmanski, Jacqueline, additional, Hobbs, Brian D., additional, Hokanson, John E., additional, Laird, Nan, additional, Lange, Christoph, additional, Lutz, Sharon M., additional, McDonald, Merry-Lynn, additional, Qiao, Dandi, additional, Santorico, Stephanie, additional, Wan, Emily S., additional, Won, Sungho, additional, Al Qaisi, Mustafa, additional, Coxson, Harvey O., additional, Gray, Teresa, additional, Han, MeiLan K., additional, Hoffman, Eric A., additional, Humphries, Stephen, additional, Jacobson, Francine L., additional, Judy, Philip F., additional, Kazerooni, Ella A., additional, Kluiber, Alex, additional, Lynch, David A., additional, Newell, John D., additional, Ross, James C., additional, San Jose Estepar, Raul, additional, Schroeder, Joyce, additional, Sieren, Jered, additional, Stinson, Douglas, additional, Stoel, Berend C., additional, Tschirren, Juerg, additional, Van Beek, Edwin, additional, van Ginneken, Bram, additional, van Rikxoort, Eva, additional, Washko, George, additional, Wilson, Carla G., additional, Jensen, Robert, additional, Everett, Douglas, additional, Crooks, Jim, additional, Moore, Camille, additional, Strand, Matt, additional, Hughes, John, additional, Kinney, Gregory, additional, Pratte, Katherine, additional, Young, Kendra A., additional, Curtis, Jeffrey L., additional, Martinez, Carlos H., additional, Pernicano, Perry G., additional, Hanania, Nicola, additional, Alapat, Philip, additional, Atik, Mustafa, additional, Bandi, Venkata, additional, Boriek, Aladin, additional, Guntupalli, Kalpatha, additional, Guy, Elizabeth, additional, Nachiappan, Arun, additional, Parulekar, Amit, additional, Hersh, Craig, additional, Barr, R. Graham, additional, Austin, John, additional, D'Souza, Belinda, additional, Pearson, Gregory D.N., additional, Rozenshtein, Anna, additional, Thomashow, Byron, additional, MacIntyre, Neil, additional, McAdams, H. Page, additional, Washington, Lacey, additional, McEvoy, Charlene, additional, Tashjian, Joseph, additional, Wise, Robert, additional, Brown, Robert, additional, Horton, Karen, additional, Lambert, Allison, additional, Putcha, Nirupama, additional, Casaburi, Richard, additional, Adami, Alessandra, additional, Budoff, Matthew, additional, Fischer, Hans, additional, Porszasz, Janos, additional, Rossiter, Harry, additional, Stringer, William, additional, Sharafkhaneh, Amir, additional, Lan, Charlie, additional, Wendt, Christine, additional, Bell, Brian, additional, Berkowitz, Eugene, additional, Westney, Gloria, additional, Bowler, Russell, additional, Rosiello, Richard, additional, Pace, David, additional, Criner, Gerard, additional, Ciccolella, David, additional, Cordova, Francis, additional, Dass, Chandra, additional, D'Alonzo, Gilbert, additional, Desai, Parag, additional, Jacobs, Michael, additional, Kelsen, Steven, additional, Kim, Victor, additional, Mamary, A. James, additional, Marchetti, Nathaniel, additional, Satti, Aditi, additional, Shenoy, Kartik, additional, Steiner, Robert M., additional, Swift, Alex, additional, Swift, Irene, additional, Vega-Sanchez, Maria Elena, additional, Dransfield, Mark, additional, Bailey, William, additional, Bhatt, Surya, additional, Iyer, Anand, additional, Nath, Hrudaya, additional, Wells, J. Michael, additional, Ramsdell, Joe, additional, Friedman, Paul, additional, Soler, Xavier, additional, Yen, Andrew, additional, Comellas, Alejandro P., additional, Newell, John, additional, Thompson, Brad, additional, Kazerooni, Ella, additional, Billings, Joanne, additional, Begnaud, Abbie, additional, Allen, Tadashi, additional, Sciurba, Frank, additional, Bon, Jessica, additional, Chandra, Divay, additional, Fuhrman, Carl, additional, Weissfeld, Joel, additional, Anzueto, Antonio, additional, Adams, Sandra, additional, Maselli-Caceres, Diego, additional, Ruiz, Mario E., additional, Ivanov, Y., additional, Kostov, K., additional, Bourbeau, J., additional, Fitzgerald, M., additional, Hernandez, P., additional, Killian, K., additional, Levy, R., additional, Maltais, F., additional, O'Donnell, D., additional, Krepelka, J., additional, Vestbo, J., additional, Wouters, E., additional, Quinn, D., additional, Bakke, P., additional, Kosnik, M., additional, Agusti, A., additional, Sauleda, J., additional, de Mallorca, P., additional, Feschenko, Y., additional, Gavrisyuk, V., additional, Kiev, L. Yashina, additional, Monogarova, N., additional, Calverley, P., additional, Lomas, D., additional, MacNee, W., additional, Singh, D., additional, Wedzicha, J., additional, Anzueto, A., additional, Braman, S., additional, Casaburi, R., additional, Celli, B., additional, Giessel, G., additional, Gotfried, M., additional, Greenwald, G., additional, Hanania, N., additional, Mahler, D., additional, Make, B., additional, Rennard, S., additional, Rochester, C., additional, Scanlon, P., additional, Schuller, D., additional, Sciurba, F., additional, Sharafkhaneh, A., additional, Siler, T., additional, Silverman, E., additional, Wanner, A., additional, Wise, R., additional, ZuWallack, R., additional, Coxson, H., additional, Crim, C., additional, Edwards, L., additional, Singer, R. Tal, additional, Yates, J., additional, Miller, B., additional, and Tal-Singer, R., additional

Published
2018
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7. Genetic Association and Risk Scores in a Chronic Obstructive Pulmonary Disease Meta-analysis of 16,707 Subjects

Author

Busch, Robert, primary, Hobbs, Brian D., additional, Zhou, Jin, additional, Castaldi, Peter J., additional, McGeachie, Michael J., additional, Hardin, Megan E., additional, Hawrylkiewicz, Iwona, additional, Sliwinski, Pawel, additional, Yim, Jae-Joon, additional, Kim, Woo Jin, additional, Kim, Deog K., additional, Agusti, Alvar, additional, Make, Barry J., additional, Crapo, James D., additional, Calverley, Peter M., additional, Donner, Claudio F., additional, Lomas, David A., additional, Wouters, Emiel F., additional, Vestbo, Jørgen, additional, Tal-Singer, Ruth, additional, Bakke, Per, additional, Gulsvik, Amund, additional, Litonjua, Augusto A., additional, Sparrow, David, additional, Paré, Peter D., additional, Levy, Robert D., additional, Rennard, Stephen I., additional, Beaty, Terri H., additional, Hokanson, John, additional, Silverman, Edwin K., additional, Cho, Michael H., additional, Crapo, James, additional, Silverman, Edwin, additional, Make, Barry, additional, Regan, Elizabeth, additional, Beaty, Terri, additional, Laird, Nan, additional, Lange, Christoph, additional, Cho, Michael, additional, Santorico, Stephanie, additional, DeMeo, Dawn, additional, Hansel, Nadia, additional, Hersh, Craig, additional, Castaldi, Peter, additional, McDonald, Merry-Lynn, additional, Wan, Emily, additional, Hardin, Megan, additional, Hetmanski, Jacqueline, additional, Parker, Margaret, additional, Foreman, Marilyn, additional, Hobbs, Brian, additional, Busch, Robert, additional, El-Bouiez, Adel, additional, Qiao, Dandi, additional, Halper-Stromberg, Eitan, additional, Begum, Ferdouse, additional, Won, Sungho, additional, Lutz, Sharon, additional, Lynch, David A., additional, Coxson, Harvey O., additional, Han, MeiLan K., additional, Hoffman, Eric A., additional, Humphries, Stephen, additional, Jacobson, Francine L., additional, Judy, Philip F., additional, Kazerooni, Ella A., additional, Newell, John D., additional, Ross, James C., additional, San Jose Estepar, Raul, additional, Stoel, Berend C., additional, Tschirren, Juerg, additional, Rikxoort, Eva van, additional, Ginneken, Bram van, additional, Washko, George, additional, Wilson, Carla G., additional, Al Qaisi, Mustafa, additional, Gray, Teresa, additional, Kluiber, Alex, additional, Mann, Tanya, additional, Sieren, Jered, additional, Stinson, Douglas, additional, Schroeder, Joyce, additional, Van Beek, Edwin, additional, Jensen, Robert, additional, Everett, Douglas, additional, Faino, Anna, additional, Strand, Matt, additional, Wilson, Carla, additional, Hokanson, John E., additional, Kinney, Gregory, additional, Young, Kendra, additional, Pratte, Katherine, additional, Duca, Lindsey, additional, Curtis, Jeffrey L., additional, Martinez, Carlos H., additional, Pernicano, Perry G., additional, Hanania, Nicola, additional, Alapat, Philip, additional, Bandi, Venkata, additional, Atik, Mustafa, additional, Boriek, Aladin, additional, Guntupalli, Kalpatha, additional, Guy, Elizabeth, additional, Parulekar, Amit, additional, Nachiappan, Arun, additional, Jacobson, Francine, additional, Barr, R. Graham, additional, Thomashow, Byron, additional, Austin, John, additional, D'Souza, Belinda, additional, Pearson, Gregory D. N., additional, Rozenshtein, Anna, additional, MacIntyre, Neil, additional, Washington, Lacey, additional, McAdams, H. Page, additional, McEvoy, Charlene, additional, Tashjian, Joseph, additional, Wise, Robert, additional, Brown, Robert, additional, Horton, Karen, additional, Putcha, Nirupama, additional, Casaburi, Richard, additional, Adami, Alessandra, additional, Porszasz, Janos, additional, Fischer, Hans, additional, Budoff, Matthew, additional, Rossiter, Harry, additional, Sharafkhaneh, Amir, additional, Lan, Charlie, additional, Wendt, Christine, additional, Bell, Brian, additional, Westney, Gloria, additional, Berkowitz, Eugene, additional, Bowler, Russell, additional, Lynch, David, additional, Rosiello, Richard, additional, Pace, David, additional, Criner, Gerard, additional, Ciccolella, David, additional, Cordova, Francis, additional, Dass, Chandra, additional, D'Alonzo, Gilbert, additional, Desai, Parag, additional, Jacobs, Michael, additional, Kelsen, Steven, additional, Kim, Victor, additional, Mamary, A. James, additional, Marchetti, Nathaniel, additional, Satti, Aditi, additional, Shenoy, Kartik, additional, Steiner, Robert M., additional, Swift, Alex, additional, Swift, Irene, additional, Vega-Sanchez, Maria Elena, additional, Dransfield, Mark, additional, Bailey, William, additional, Wells, J. Michael, additional, Bhatt, Surya, additional, Nath, Hrudaya, additional, Ramsdell, Joe, additional, Friedman, Paul, additional, Soler, Xavier, additional, Yen, Andrew, additional, Comellas, Alejandro, additional, Newell, John, additional, Thompson, Brad, additional, Han, MeiLan, additional, Kazerooni, Ella, additional, Martinez, Carlos, additional, Billings, Joanne, additional, Allen, Tadashi, additional, Sciurba, Frank, additional, Chandra, Divay, additional, Weissfeld, Joel, additional, Fuhrman, Carl, additional, Bon, Jessica, additional, Anzueto, Antonio, additional, Adams, Sandra, additional, Maselli-Caceres, Diego, additional, Ruiz, Mario E., additional, Sauleda, Jaume, additional, Calverley, Peter M. A., additional, Rennard, Stephen, additional, Ivanov, Y., additional, Kostov, K., additional, Bourbeau, J., additional, Fitzgerald, M., additional, Hernandez, P., additional, Killian, K., additional, Levy, R., additional, Maltais, F., additional, O'Donnell, D., additional, Krepelka, J., additional, Vestbo, J., additional, Wouters, E., additional, Quinn, D., additional, Bakke, P., additional, Kosnik, M., additional, Agusti, A., additional, Sauleda, J., additional, Feschenko, Y., additional, Gavrisyuk, V., additional, Yashina, L., additional, Monogarova, N., additional, Calverley, P., additional, Lomas, D., additional, MacNee, W., additional, Singh, D., additional, Wedzicha, J., additional, Anzueto, A., additional, Braman, S., additional, Casaburi, R., additional, Celli, B., additional, Giessel, G., additional, Gotfried, M., additional, Greenwald, G., additional, Hanania, N., additional, Mahler, D., additional, Make, B., additional, Rennard, S., additional, Rochester, C., additional, Scanlon, P., additional, Schuller, D., additional, Sciurba, F., additional, Sharafkhaneh, A., additional, Siler, T., additional, Silverman, E., additional, Wanner, A., additional, Wise, R., additional, ZuWallack, R., additional, Coxson, H., additional, Crim, C., additional, Edwards, L., additional, Tal Singer, R., additional, Yates, J., additional, Miller, B., additional, Tal-Singer, R., additional, Benditt, J., additional, Criner, G., additional, DeCamp, M., additional, Diaz, P., additional, Ginsburg, M., additional, Kaiser, L., additional, Katz, M., additional, Krasna, M., additional, MacIntyre, N., additional, McKenna, R., additional, Martinez, F., additional, Mosenifar, Z., additional, Reilly, J., additional, Ries, A., additional, and Utz, J., additional

Published
2017
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8. THE ANABOLIC AGENT, OXANDROLONE, REVERSES THE WEIGHT LOSS ASSOCIATED WITH COPD

Author

Lee, D, Kramer, T, Yeh, S, Covelli, H, Serfilippi, G, Giessel, G, and Gotfried, M

Subjects
Lung diseases, Obstructive -- Complications and side effects -- Prevention, Oxandrolone -- Evaluation -- Complications and side effects, Weight loss -- Prevention -- Complications and side effects, Health, Evaluation, Prevention, Complications and side effects
Abstract

D Lee, MD; T Kramer, MD(*); S Yeh, MD; H Corelli, MD; G Serfilippi, MD; G Giessel, MD; M Gotfried, MD and along with the M012 study group. Wilmington Health [...]

Published
2000

9. New insights into the optimal management of COPD: extracts from CHEST 2021 annual meeting (October 17-20, 2021).

Author

Quint J, Montonen J, Singh D, Wachtel H, Attick S, Palli S, Frazer M, Willey V, and Giessel G

Subjects
Administration, Inhalation, Adrenal Cortex Hormones therapeutic use, Adrenergic beta-2 Receptor Agonists, Bronchodilator Agents therapeutic use, Drug Therapy, Combination, Humans, Muscarinic Antagonists therapeutic use, Pandemics, Plant Extracts therapeutic use, Pulmonary Disease, Chronic Obstructive diagnosis, Pulmonary Disease, Chronic Obstructive drug therapy, Pulmonary Disease, Chronic Obstructive epidemiology, COVID-19 Drug Treatment
Abstract

Introduction: Discordance between real-world prescribing patterns and global treatment guidelines for the treatment of chronic obstructive pulmonary disease (COPD) with inhaled single or dual long-acting bronchodilator maintenance therapy is increasingly being reported in the literature, particularly with regard to addition of inhaled corticosteroids (ICS). Patient-related factors, e.g. inhalation technique and inspiratory flow, are key to disease control in COPD. Treatment discordance and patient-related factors can lead to high-cost side effects and sub-optimal treatment benefit; furthermore, the COVID-19 pandemic has led to new challenges in COPD management., Areas Covered: This article summarizes a series of presentations sponsored by Boehringer Ingelheim and delivered at the annual CHEST congress 2021 (October 17-20, 2021) that explored new insights into the optimal management of COPD., Expert Opinion/commentary: There is a concerning high degree of discordance with GOLD recommendations. Dual therapy without addition of ICS does not increase exacerbation risk and could reduce pneumonia risk, and unnecessary prescription of triple therapy has financial implications. Clinic-based spirometry may not reflect the home setting, and training is required; inhalers that operate independently of users' inhalation profiles should be considered. Integration of digital healthcare solutions into clinical studies is suggested in the post-COVID setting, although further evaluation is required.

Published
2022
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