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201. Pulmonary exacerbation in adults with bronchiectasis: a consensus definition for clinical research

Author

Hill, Adam T., primary, Haworth, Charles S., additional, Aliberti, Stefano, additional, Barker, Alan, additional, Blasi, Francesco, additional, Boersma, Wim, additional, Chalmers, James D., additional, De Soyza, Anthony, additional, Dimakou, Katerina, additional, Elborn, J. Stuart, additional, Feldman, Charles, additional, Flume, Patrick, additional, Goeminne, Pieter C., additional, Loebinger, Michael R., additional, Menendez, Rosario, additional, Morgan, Lucy, additional, Murris, Marlene, additional, Polverino, Eva, additional, Quittner, Alexandra, additional, Ringshausen, Felix C., additional, Tino, Gregory, additional, Torres, Antoni, additional, Vendrell, Montserrat, additional, Welte, Tobias, additional, Wilson, Rob, additional, Wong, Conroy, additional, O'Donnell, Anne, additional, and Aksamit, Timothy, additional

Published
2017
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206. JCF – 2016

Author

Bell, Scott C., primary, Castellani, Carlo, additional, and Flume, Patrick A., additional

Published
2017
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207. Amikacin Liposome Inhalation Suspension for Treatment-Refractory Lung Disease Caused by Complex (CONVERT). A Prospective, Open-Label, Randomized Study.

Author

Griffith, David E, Eagle, Gina, Thomson, Rachel, Aksamit, Timothy R, Hasegawa, Naoki, Morimoto, Kozo, Addrizzo-Harris, Doreen J, O'Donnell, Anne E, Marras, Theodore K, Flume, Patrick A, Loebinger, Michael R, Morgan, Lucy, Codecasa, Luigi R, Hill, Adam T, Ruoss, Stephen J, Yim, Jae-Joon, Ringshausen, Felix C, Field, Stephen K, Philley, Julie V, and Wallace, Richard J Jr

Abstract

Rationale: Improved therapeutic options are needed for patients with treatment-refractory nontuberculous mycobacterial lung disease caused by Mycobacterium avium complex (MAC). Objectives: To evaluate the efficacy and safety of daily amikacin liposome inhalation suspension (ALIS) added to standard guideline-based therapy (GBT) in patients with refractory MAC lung disease. Methods: Adults with amikacin-susceptible MAC lung disease and MAC-positive sputum cultures despite at least 6 months of stable GBT were randomly assigned (2:1) to receive ALIS with GBT (ALIS + GBT) or GBT alone. Once-daily ALIS was supplied in single-use vials delivering 590 mg amikacin to the nebulizer. The primary endpoint was culture conversion, defined as three consecutive monthly MAC-negative sputum cultures by Month 6. Measurements and Main Results: Enrolled patients (ALIS + GBT, n = 224; GBT-alone, n = 112) were a mean 64.7 years old and 69.3% female. Most had underlying bronchiectasis (62.5%), chronic obstructive pulmonary disease (14.3%), or both (11.9%). Culture conversion was achieved by 65 of 224 patients (29.0%) with ALIS + GBT and 10 of 112 (8.9%) with GBT alone (odds ratio, 4.22; 95% confidence interval, 2.08-8.57; P < 0.001). Patients in the ALIS + GBT arm versus GBT alone were more likely to achieve conversion (hazard ratio, 3.90; 95% confidence interval, 2.00-7.60). Respiratory adverse events (primarily dysphonia, cough, and dyspnea) were reported in 87.4% of patients receiving ALIS + GBT and 50.0% receiving GBT alone; serious treatment-emergent adverse events occurred in 20.2% and 17.9% of patients, respectively. Conclusions: Addition of ALIS to GBT for treatment-refractory MAC lung disease achieved significantly greater culture conversion by Month 6 than GBT alone, with comparable rates of serious adverse events. Clinical trial registered with www.clinicaltrials.gov (NCT02344004). [ABSTRACT FROM AUTHOR]

Published
2018
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211. Standardy opieki Europejskiego Towarzystwa Mukowiscydozy: wytyczne i najlepsze praktyki

Author

Smyth, Alan R., primary, Bell, Scott C., additional, Bojcin, Snezana, additional, Bryon, Mandy, additional, Duff, Alistair, additional, Flume, Patrick, additional, Kashirskaya, Nataliya, additional, Munck, Anne, additional, Ratjen, Felix, additional, Schwarzenberg, Sarah Jane, additional, Sermet-Gaudelus, Isabelle, additional, Southern, Kevin W., additional, Taccetti, Giovanni, additional, Ullrich, Gerald, additional, and Wolfe, Sue, additional

Published
2016
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216. Forced Expiratory Volume in 1 Second Variability Helps Identify Patients with Cystic Fibrosis at Risk of Greater Loss of Lung Function

Author

Morgan, Wayne J., primary, VanDevanter, Donald R., additional, Pasta, David J., additional, Foreman, Aimee J., additional, Wagener, Jeffrey S., additional, Konstan, Michael W., additional, Morgan, Wayne, additional, Konstan, Michael, additional, Liou, Ted, additional, McColley, Susanna, additional, McMullen, Ann, additional, Quittner, Alexandra, additional, Regelmann, Warren, additional, Ren, Clement, additional, Rosenfeld, Margaret, additional, Sawicki, Greg, additional, Schechter, Michael, additional, VanDevanter, Donald, additional, Wagener, Jeffrey, additional, Woo, Marlyn, additional, Brasfield, Dana, additional, Lyrene, Raymond, additional, Sindel, Lawrence, additional, Roberts, Dion, additional, Carroll, John, additional, Warren, Robert, additional, Nassri, Louay, additional, Anderson, Paula, additional, Brown, Mark, additional, Silverthorn, Amy, additional, Radford, Peggy, additional, Gong, Gerald, additional, Legris, Gregory, additional, Greene, Gerald, additional, Sudhakar, Reddivalam, additional, Platzker, Arnold, additional, Nickerson, Bruce, additional, Hardy, Karen, additional, Harwood, Ivan, additional, Shay, Gregory, additional, Quick, Bryon, additional, Lieberthal, Allan, additional, Moss, Richard, additional, Landon, Chris, additional, Fanous, Yvonne, additional, Lieberman, Jay, additional, Spiritus, Eugene, additional, Chipps, Bradley, additional, McDonald, Ruth, additional, Pian, Mark, additional, Cropp, Gerd, additional, Lewis, Nancy, additional, Nielson, Dennis, additional, Shapiro, Bertrand, additional, Wagener, Jeff, additional, Accurso, Frank, additional, Saavedra, Milene, additional, Daigle, Karen, additional, Hen, Jacob, additional, Palazzo, Regina, additional, Dodds, Kathryn, additional, Pad-man, Raj, additional, Goodill, John, additional, Winnie, Glenna, additional, Davies, Lea, additional, Kriseman, Tony, additional, Sallent, Jorge, additional, Chiaro, Joseph, additional, Kubiet, Martin, additional, Goldfinger, Sue, additional, Schwartzman, Morton, additional, Diaz, Carlosenrique, additional, Maupin, Kevin, additional, Riff, Eduardo, additional, Geller, David, additional, Livingston, Floyd, additional, Mavunda, Kunjana, additional, Birriel, Jose, additional, Faverio, Luis, additional, Rosenberg, David, additional, Schaeffer, David, additional, Sherman, James, additional, Wagner, Mary, additional, Light, Michael, additional, Schnapf, Bruce, additional, Montgomery, Gary, additional, Kirchner, Kevin, additional, Weatherly, Mark, additional, Caplan, Daniel, additional, Guill, Margaret, additional, Hudson, Valera, additional, Akhter, Javeed, additional, Davison, Donald, additional, Boas, Steven, additional, Chung, Youngran, additional, Latner, Rennee, additional, Aljadeff, Gabriel, additional, Chan, Youngran, additional, Kraut, Jerome, additional, Stone, Arvey, additional, Still, John Lloyd, additional, Sharma, Girish, additional, Eagleton, Lanie, additional, Hopkins, Patricia, additional, Chatrath, Umesh, additional, Lester, Lucille, additional, Kim, Young-Jee, additional, Anthony, Veena, additional, Eigan, Howard, additional, Howenstine, Michelle, additional, James, Pushpom, additional, Gergesha, Edward, additional, Harris, James, additional, Plant, Robert, additional, Zivkovich, Veljko, additional, Collins, Angela, additional, Nassif, Edward, additional, Ahrens, Richard, additional, Doornbos, Daniel, additional, Kanarek, Joseph, additional, Leff, Richard, additional, Shaw, Pamela, additional, Demoss, Elanor, additional, Riva, Maria, additional, Sullivan, Leonard, additional, Anstead, Michael, additional, Kanga, Jamshed, additional, Eid, Nemr, additional, Morton, Ron, additional, Hilman, Bettina, additional, Jones, Kim, additional, Davis, Scott, additional, Harder, Ralph, additional, Lever, Tom, additional, Cairns, Anne Marie, additional, Caldwell, Edgar, additional, Zuckerman, Jonathan, additional, Mogayzel, Peter, additional, Rosenstein, Beryl, additional, McQuestion, John, additional, Perry, Donna, additional, Rosenberg, Samuel, additional, Gerstle, Robert, additional, Colin, Andrew, additional, Wohl, Mary Ellen, additional, Lapey, Allan, additional, Yee, William, additional, O'Sullivan, Brian, additional, Zwerdling, Robert, additional, Abdulhamid, Ibrahim, additional, O'Hagan, Adrian, additional, Schuen, John, additional, Kurlandsky, Lawrence, additional, Honicky, Richard, additional, Homnick, Douglas, additional, Marks, John, additional, Pichurko, Bohdan, additional, Maxvold, Norma, additional, Nasr, Samya, additional, Simon, Richard, additional, Tsai, Wan, additional, Kissner, Dana, additional, McNamara, John, additional, Henry, Nancy, additional, Marker, Stephen, additional, Pryor, Michael, additional, Walker, Lynn, additional, Woodward, Jim, additional, Mizell, Louis, additional, Miller, Suzanne, additional, Rosenbluth, Daniel, additional, Black, Philip, additional, McCubbin, Michael, additional, Cohen, Alan, additional, Ferkol, Thomas, additional, Mallory, George, additional, Rejent, Anthony, additional, Rubin, Bruce, additional, Graff, Gavin, additional, Konig, Peter, additional, Colombo, John, additional, Murphy, Peter, additional, Boyle, William, additional, Parker, Worth, additional, Patton, Chandler, additional, Zanni, Robert, additional, Atlas, Arthur, additional, Turcios, Nelson, additional, Laraya-Cuasay, Lourdes, additional, Bisberg, Dorothy, additional, Aguila, Helen, additional, Allen, Sarah, additional, James, David, additional, Perkett, Elizabeth, additional, Thompson, Marsha, additional, Budhecha, Sonia, additional, Diaz, Ruben, additional, Rosen, Jonathan, additional, Kaslovsky, Robert, additional, Percciacante, Ronald, additional, Borowitz, Drucy, additional, Cronin, Joseph, additional, McMahon, Colin, additional, Quittell, Lynne, additional, Giusti, Robert, additional, Cohen, Rubin, additional, DeCelie-Germana, Joan, additional, Gorvoy, Jack, additional, Patel, Kalpan, additional, Kattan, Meyer, additional, Dozor, Allen, additional, DiMango, Emily, additional, Berdella, Maria, additional, Anbar, Ran, additional, Ianuzzi, Debra, additional, Sexton, James, additional, Tayag-Kier, Catherine, additional, McBride, John, additional, Voter, Karen, additional, Dimaio, Mary, additional, Georgitis, John, additional, Majure, Joseph Marc, additional, Martinez, Maria, additional, McIntosh, Clarke, additional, Leigh, Margaret, additional, Black, Hugh, additional, Hughes, James, additional, Kantak, Anand, additional, Wilmott, Robert, additional, Omlor, Gregory, additional, Stone, Robert, additional, McCoy, Karen, additional, Acton, James, additional, Doershuk, Carl, additional, Fink, Robert, additional, Steffan, Michael, additional, Vauthy, Pierre, additional, Joseph, Patricia, additional, Reyes, Santiago, additional, Kramer, John, additional, Royall, James, additional, Eisenberg, Jay, additional, Wall, Michael, additional, Fiel, Stanley, additional, Scanlin, Thomas, additional, Phadke, Shroti, additional, Weinberg, Joel, additional, Sexauer, William, additional, Wolf, Stephen, additional, Holsclaw, Douglas, additional, Klein, Debra, additional, Warren, Stuart, additional, Kinsey, Robert, additional, Perez, Carlos, additional, Ganeshanathan, Muttiah, additional, Shinnick, James, additional, Panitch, Howard, additional, Varlotta, Laurie, additional, Robinson, Cynthia, additional, Santana, Jose Rodriguez, additional, Passero, Mary Ann, additional, Gwinn, Jane, additional, Baker, Robert, additional, Bowman, Michael, additional, Flume, Patrick, additional, Brown, Daniel, additional, Marville, Roxanne, additional, Wallace, James, additional, Parry, Rodney, additional, Ellenburg, Don, additional, Rogers, John, additional, Mohon, Ricky, additional, Ledbetter, Joel, additional, Hanissian, Aram, additional, Schoumacher, Robert, additional, Campbell, Preston, additional, Harris, Christopher, additional, Slovis, Bonnie, additional, Stokes, Dennis, additional, Hale, Kathryn, additional, Katz, Marcia, additional, Seilheimer, Dan, additional, Sockrider, Marianne, additional, Frank, Allan, additional, Daniel, James, additional, Cunningham, James, additional, Browning, Iley, additional, Bray, John, additional, Dove, Amanda, additional, Mandujano, Fernando, additional, Tremper, Larry, additional, Morse, Martha, additional, Willey-Courand, Donna, additional, Copenhaver, Steven, additional, Pohl, John, additional, McWilliams, Bennie, additional, Martine-Logvinoff, Marie, additional, Wallace, Marsh, additional, Klein, Robert, additional, Amaro, Rodolfo, additional, Couch, Leslie, additional, Brown, Michael, additional, Prestidge, Claude, additional, Inscore, Stephen, additional, Lipton, Andrew, additional, Chatfield, Barbara, additional, Liou, Theodore, additional, Marshall, Bruce, additional, Lahiri, Thomas, additional, Swartz, Donald, additional, Whittaker, Laurie, additional, Karlson, Karl, additional, Ropoll, Ignacio, additional, Rubio, Thomas, additional, Schmidt, Joel, additional, Thomas, David, additional, Osborn, John, additional, Froh, Deborah, additional, Gaston, Benjamin, additional, Elliott, Greg, additional, Gibson, Ronald, additional, Ramsey, Bonnie, additional, McCarthy, Michael, additional, Larson, Lawrence, additional, Ricker, David, additional, Robbins, Mark, additional, Aitken, Moira, additional, Emerson, Julia, additional, Aronoff, Stephen, additional, Moffett, Kathryn, additional, Biller, Julie, additional, Splaingard, Mark, additional, Sullivan, Bradley, additional, Pritchard, Paul, additional, Adair, Stu, additional, Holzwarth, Peter, additional, Dopico, Guillermo, additional, Meyer, Keith, additional, Green, Christopher, additional, and Rock, Michael, additional

Published
2016
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222. Pediatric and Adult Recommendations Vary for Sibling Testing in Cystic Fibrosis.

Author

Brown, Kimberly L. and Flume, Patrick A.

Abstract

Four to 5 % of cystic fibrosis (CF) patients are diagnosed as adults and often have subtler symptoms. Their siblings are at genetic risk to also have a subtler disease state. Diagnostic testing is recommended for siblings of newly diagnosed infants, but recommendations are less clear for later diagnoses. This study explored sibling testing recommendations in pediatric and adult practice using a survey that was emailed to CF clinicians. There were 58 respondents. Results revealed that 82.5% of pediatric and 36.4% of adult care respondents reported always recommending diagnostic testing for siblings of a newly diagnosed patient. In adult care, another 33.3% reported recommending diagnostic testing if the sibling has symptoms. In pediatric care, whether the sibling had newborn screening was most influential. Most pediatric respondents prefer the sweat chloride test, while 40% in adult practice prefer familial mutation analysis. Perceived barriers included cost, insurance coverage and logistical concerns in both settings, parental emotional state in pediatrics, and concern making recommendations for someone who is not the patient in adult care. Genetic counselors may be able to meet familial needs in CF care, including sibling testing. Many newly diagnosed patients/families do not see a genetic counselor, especially in adult care. These data reveal opportunities for practice guidelines and standardization. [ABSTRACT FROM AUTHOR]

Published
2018
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223. Nontuberculous Mycobacteria in Cystic Fibrosis.

Author

Furukawa, Brian S. and Flume, Patrick A.

Subjects
*CYSTIC fibrosis, *MYCOBACTERIAL diseases, *DISEASE progression, *LUNG diseases, *LUNG microbiology, *MYCOBACTERIAL disease diagnosis, *MYCOBACTERIAL disease treatment, *SPUTUM microbiology, *COMPUTED tomography, *GRAM-positive bacteria, *LUNG transplantation, *DISEASE complications
Abstract

Nontuberculous mycobacteria (NTM) can cause chronic pulmonary infection in susceptible hosts. Individuals with cystic fibrosis (CF), a multisystem disease predominated by progressive structural lung disease, are particularly vulnerable. Only recently have NTM been recognized for their potential to cause lung deterioration in CF patients. The reported prevalence varies widely from 4 to 40%, significantly more common than in the general population, but this varies because of multiple factors including inconsistent screening practices. Mycobacterium abscessus complex and Mycobacterium avium complex are the two most common species recovered. Defining NTM pulmonary disease in a CF patient can present challenges as it can be difficult to distinguish from the other potentially pathogenic organisms in the lung microbiome. In general, treatment regimens do not differ from the non-CF population but the clinician should be aware of potential interactions with other CF therapies. Recent population-level genomics has raised serious concern for indirect person-to-person transmission of several dominating NTM clones worldwide, raising awareness for increase prevention strategies when CF patients potentially congregate, such as clinic visits. Lung transplantation is controversial in those with NTM present in sputum culture but the available evidence suggests that this is not an absolute contraindication. [ABSTRACT FROM AUTHOR]

Published
2018
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224. Regulatory Support Improves Subsequent IRB Approval Rates in Studies Initially Deemed Not Ready for Review: A CTSA Institution’s Experience.

Author

Sonne, Susan, Gentilin, Stephanie, Sampson, Royce R., Bell, Leslie, Mauney, Toni, Young, Summer, Bright, Katherine, and Flume, Patrick

Subjects
INSTITUTIONAL review boards, TRANSLATIONAL research, MEDICAL ethics, PERFORMANCE evaluation
Abstract

We evaluated the impact of a regulatory support service (known as the Regulatory Knowledge and Support [RKS] program), part of the Medical University of South Carolina’s Clinical and Translational Science Award, on the success of Institutional Review Board (IRB) applications that have previously been deemed by the IRB to be Not Ready for Review (NRR). At the time of this evaluation, 77 studies had been deemed NRR, 53 of which came from trainees and junior faculty. All the applications that received regulatory support either received IRB approval or were deemed to not be research, and therefore did not require IRB review. In all, 39.1% (n = 18) of the research teams who did not accept regulatory support successfully received IRB approval. Providing regulatory support, particularly to trainees and junior faculty, may be associated with better success in obtaining IRB approval as well as preventing the unnecessary submission of projects that are not research and would therefore not require IRB review or approval. [ABSTRACT FROM AUTHOR]

Published
2018
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225. Recovery of lung function following a pulmonary exacerbation in patients with cystic fibrosis and the G551D-CFTR mutation treated with ivacaftor.

Author

Flume, Patrick A., Wainwright, Claire E., Elizabeth Tullis, D., Rodriguez, Sally, Niknian, Minoo, Higgins, Mark, Davies, Jane C., and Wagener, Jeffrey S.

Subjects
*CYSTIC fibrosis, *PULMONARY function tests, *DISEASE exacerbation, *CYSTIC fibrosis transmembrane conductance regulator, *GENETIC mutation, *DRUG efficacy
Abstract

Background Pulmonary exacerbations (PEx) are associated with acute loss of lung function that is often not recovered after treatment. We investigated lung function recovery following PEx for ivacaftor- and placebo-treated subjects. Methods Short- and long-term pulmonary function recovery data after PEx were summarized from a placebo-controlled trial in 161 cystic fibrosis patients ≥ 12 years old with the G551D - CFTR mutation ( NCT00909532 ). Short-term recovery was measured 2 to 8 weeks after treatment, and long-term recovery was determined at the end-of-study, both compared with baseline measured just prior to the PEx. Results Fewer patients receiving ivacaftor experienced a PEx than patients receiving placebo (33.7% vs. 56.4%; P = 0.004) and had a lower adjusted incidence rate of PEx (0.589 vs. 1.382; P < 0.001). The proportion of PEx followed by full short-term recovery of percent predicted forced expiratory volume in 1 s was similar (ivacaftor vs. placebo, 57.1% vs. 53.7), as was the proportion of patients having long-term recovery (46.4% vs. 47.7%). Conclusions Ivacaftor treatment reduces the frequency of PEx but does not improve on the rate of complete lung function recovery after PEx when compared with placebo. [ABSTRACT FROM AUTHOR]

Published
2018
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226. Efficacy and safety of the elexacaftor plus tezacaftor plus ivacaftor combination regimen in people with cystic fibrosis homozygous for the F508delmutation: a double-blind, randomised, phase 3 trial

Author

Heijerman, Harry G M, McKone, Edward F, Downey, Damian G, Van Braeckel, Eva, Rowe, Steven M, Tullis, Elizabeth, Mall, Marcus A, Welter, John J, Ramsey, Bonnie W, McKee, Charlotte M, Marigowda, Gautham, Moskowitz, Samuel M, Waltz, David, Sosnay, Patrick R, Simard, Christopher, Ahluwalia, Neil, Xuan, Fengjuan, Zhang, Yaohua, Taylor-Cousar, Jennifer L, McCoy, Karen S, McCoy, Karen, Donaldson, Scott, Walker, Seth, Chmiel, James, Rubenstein, Ronald, Froh, Deborah K., Neuringer, Isabel, Jain, Manu, Moffett, Kathryn, Taylor-Cousar, Jennifer L., Barnett, Bruce, Mueller, Gary, Flume, Patrick, Livingston, Floyd, Mehdi, Nighat, Teneback, Charlotte, Welter, John, Jain, Raksha, Kissner, Dana, Patel, Kapilkumar, Calimano, Francisco J., Johannes, Jimmy, Daines, Cori, Keens, Thomas, Scher, Herschel, Chittivelu, Subramanyam, Reddivalam, Sudhakar, Klingsberg, Ross Carl, Johnson, Larry G., Verhulst, Stijn, Macedo, Patricia, Downey, Damien, Connett, Gary, Nash, Edward, Withers, Nicholas, Lee, Timothy, Bakker, Marleen, Heijerman, Harry, Vermeulen, Francois, Van Braeckel, Eva, Knoop, Christiane, De Wachter, Elke, van der Meer, Renske, Merkus, Petrus, and Majoor, Christof

Abstract

Cystic fibrosis transmembrane conductance regulator (CFTR) modulators correct the basic defect caused by CFTR mutations. Improvements in health outcomes have been achieved with the combination of a CFTR corrector and potentiator in people with cystic fibrosis homozygous for the F508delmutation. The addition of elexacaftor (VX-445), a next-generation CFTR corrector, to tezacaftor plus ivacaftor further improved F508del-CFTR function and clinical outcomes in a phase 2 study in people with cystic fibrosis homozygous for the F508delmutation.

Published
2019
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230. A randomized, open-label, multicenter study of liposomal amikacin for inhalation in adult patients with nontuberculous mycobacteria (NTM) lung infections caused bymycobacterium aviumcomplex (MAC)

Author

Griffith, David, primary, Flume, Patrick, additional, Winthrop, Kevin, additional, Thomson, Rachel, additional, Wagner, Dirk, additional, Van Ingen, Jakko, additional, Micioni, Liza, additional, McGinnis II, John P., additional, Fernandez, Carlos, additional, and Eagle, Gina, additional

Published
2015
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232. Lumacaftor–Ivacaftor in Patients with Cystic Fibrosis Homozygous for Phe508delCFTR

Author

Wainwright, Claire E., primary, Elborn, J. Stuart, additional, Ramsey, Bonnie W., additional, Marigowda, Gautham, additional, Huang, Xiaohong, additional, Cipolli, Marco, additional, Colombo, Carla, additional, Davies, Jane C., additional, De Boeck, Kris, additional, Flume, Patrick A., additional, Konstan, Michael W., additional, McColley, Susanna A., additional, McCoy, Karen, additional, McKone, Edward F., additional, Munck, Anne, additional, Ratjen, Felix, additional, Rowe, Steven M., additional, Waltz, David, additional, and Boyle, Michael P., additional

Published
2015
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234. A phase 3, open-label, randomized trial to evaluate the safety and efficacy of levofloxacin inhalation solution (APT-1026) versus tobramycin inhalation solution in stable cystic fibrosis patients

Author

Stuart Elborn, J., primary, Geller, David E., additional, Conrad, Douglas, additional, Aaron, Shawn D., additional, Smyth, Alan R., additional, Fischer, Rainald, additional, Kerem, Eitan, additional, Bell, Scott C., additional, Loutit, Jeffery S., additional, Dudley, Michael N., additional, Morgan, Elizabeth E., additional, VanDevanter, Donald R., additional, and Flume, Patrick A., additional

Published
2015
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237. Optimising inhaled mannitol for cystic fibrosis in an adult population

Author

Flume, Patrick A., primary, Aitken, Moira L., additional, Bilton, Diana, additional, Agent, Penny, additional, Charlton, Brett, additional, Forster, Emma, additional, Fox, Howard G., additional, Hebestreit, Helge, additional, Kolbe, John, additional, Zuckerman, Jonathan B, additional, and Button, Brenda M., additional

Published
2015
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242. Aztreonam for inhalation solution in patients with non-cystic fibrosis bronchiectasis (AIR-BX1 and AIR-BX2): two randomised double-blind, placebo-controlled phase 3 trials

Author

Barker, Alan F, primary, O'Donnell, Anne E, additional, Flume, Patrick, additional, Thompson, Philip J, additional, Ruzi, Jonathan D, additional, de Gracia, Javier, additional, Boersma, Wim G, additional, De Soyza, Anthony, additional, Shao, Lixin, additional, Zhang, Jenny, additional, Haas, Laura, additional, Lewis, Sandra A, additional, Leitzinger, Sheila, additional, Montgomery, A Bruce, additional, McKevitt, Matthew T, additional, Gossage, David, additional, Quittner, Alexandra L, additional, and O'Riordan, Thomas G, additional

Published
2014
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243. A Preliminary Quality of Life Questionnaire-Bronchiectasis

Author

Quittner, Alexandra L., primary, Marciel, Kristen K., additional, Salathe, Matthias A., additional, O'Donnell, Anne E., additional, Gotfried, Mark H., additional, Ilowite, Jonathan S., additional, Metersky, Mark L., additional, Flume, Patrick A., additional, Lewis, Sandra A., additional, McKevitt, Matthew, additional, Montgomery, A. Bruce, additional, O'Riordan, Thomas G., additional, and Barker, Alan F., additional

Published
2014
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244. European Cystic Fibrosis Society Standards of Care: Best Practice guidelines

Author

Smyth, Alan R., primary, Bell, Scott C., additional, Bojcin, Snezana, additional, Bryon, Mandy, additional, Duff, Alistair, additional, Flume, Patrick, additional, Kashirskaya, Nataliya, additional, Munck, Anne, additional, Ratjen, Felix, additional, Schwarzenberg, Sarah Jane, additional, Sermet-Gaudelus, Isabelle, additional, Southern, Kevin W., additional, Taccetti, Giovanni, additional, Ullrich, Gerald, additional, and Wolfe, Sue, additional

Published
2014
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245. Deletion of airway cilia results in noninflammatory bronchiectasis and hyperreactive airways

Author

Gilley, Sandra K., primary, Stenbit, Antine E., additional, Pasek, Raymond C., additional, Sas, Kelli M., additional, Steele, Stacy L., additional, Amria, May, additional, Bunni, Marlene A., additional, Estell, Kimberly P., additional, Schwiebert, Lisa M., additional, Flume, Patrick, additional, Gooz, Monika, additional, Haycraft, Courtney J., additional, Yoder, Bradley K., additional, Miller, Caroline, additional, Pavlik, Jacqueline A., additional, Turner, Grant A., additional, Sisson, Joseph H., additional, and Bell, P. Darwin, additional

Published
2014
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246. Treatment of lung infection in patients with cystic fibrosis:current and future strategies

Author

Döring, Gerd, Flume, Patrick, Heijerman, Harry, Elborn, J Stuart, Döring, Gerd, Flume, Patrick, Heijerman, Harry, and Elborn, J Stuart

Abstract

In patients with cystic fibrosis (CF) lung damage secondary to chronic infection is the main cause of death. Treatment of lung disease to reduce the impact of infection, inflammation and subsequent lung injury is therefore of major importance. Here we discuss the present status of antibiotic therapy for the major pathogens in CF airways, including prophylaxis against infection, eradication of early infection, suppression of chronic infection, and the treatment of infective exacerbations. We outline measures to optimize maintenance treatment for infection in the light of novel antibiotic drug formulations. We discuss new developments in culture-independent microbiological diagnostic techniques and the use of tools for monitoring the success of antibiotic treatment courses. Finally, cost-effectiveness analyses for antibiotic treatment in CF patients are discussed.

Published
2012

247. Pooled analysis of two large randomised phase III inhaled mannitol studies in cystic fibrosis

Author

Bilton, Diana, primary, Bellon, Gabriel, additional, Charlton, Brett, additional, Cooper, Peter, additional, De Boeck, Kris, additional, Flume, Patrick A., additional, Fox, Howard G., additional, Gallagher, Charles G., additional, Geller, David E., additional, Haarman, Eric G., additional, Hebestreit, Helge U., additional, Kolbe, John, additional, Lapey, Allen, additional, Robinson, Phil, additional, Wu, Jian, additional, Zuckerman, Jonathan B., additional, and Aitken, Moira L., additional

Published
2013
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248. Continuous alternating inhaled antibiotics for chronic pseudomonal infection in cystic fibrosis.

Author

Flume, Patrick A., Clancy, John P., Retsch-Bogart, George Z., Tullis, D. Elizabeth, Bresnik, Mark, Derchak, P. Alex, Lewis, Sandra A., and Ramsey, Bonnie W.

Subjects
*CYSTIC fibrosis diagnosis, *ANTIBIOTICS, *PSEUDOMONAS diseases, *DRUG administration, *TOBRAMYCIN, *CLINICAL trials
Abstract

Background Inhaled antibiotics are standard of care for treating chronic pseudomonal respiratory infections in cystic fibrosis patients, initially approved for intermittent administration. However, use of continuous inhaled antibiotic regimens of differing combinations is growing. Methods This double-blind trial compared continuous alternating therapy (CAT) to an intermittent treatment regimen. Subjects were treated with 3 cycles of 28-days inhaled aztreonam (AZLI) or placebo 3-times daily alternating with 28-days open-label tobramycin inhalation solution (TIS). Results 90 subjects were randomized over 18 months. Study enrollment was limited, in part because of evolving practices by clinicians of adopting a CAT regimen in clinical practice; consequently the study was underpowered. AZLI/TIS treatment reduced exacerbation rates by 25.7% (p = 0.25; primary endpoint) and rates of respiratory hospitalizations by 35.8% compared with placebo/TIS (p = 0.14). AZLI/TIS CAT therapy was well tolerated. Conclusions This trial illustrates challenges with studying treatment regimens in a constantly evolving CF care environment. Nonetheless, the results of this trial indicate that AZLI/TIS CAT is well tolerated and may provide additional clinical benefit in CF patients compared with intermittent use of TIS alone. Clinicaltrials.gov: NCT01641822. [ABSTRACT FROM AUTHOR]

Published
2016
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249. Safety and efficacy of prolonged levofloxacin inhalation solution (APT-1026) treatment for cystic fibrosis and chronic Pseudomonas aeruginosa airway infection.

Author

Elborn, J. Stuart, Flume, Patrick A., Cohen, Fredric, Loutit, Jeffery, and VanDevanter, Donald R.

Subjects
*CYSTIC fibrosis, *CYSTIC fibrosis treatment, *PSEUDOMONAS aeruginosa, *AIRWAY (Anatomy), *FLUOROQUINOLONES, *PATIENTS
Abstract

Background Levofloxacin inhalation solution (LIS) is the first aerosolized fluoroquinolone licensed for treatment of patients with cystic fibrosis (CF) and chronic Pseudomonas aeruginosa lung infection. This study evaluated the safety and efficacy of extended LIS treatment. Methods Patients completing a multinational, randomized study comparing LIS and tobramycin inhalation solution (TIS) were enrolled in an open-label extension in which all patients received three additional cycles of 28 days of LIS 240 mg twice daily followed by 28 days off drug. Endpoints included mean relative change in percent predicted forced expiratory volume in 1 s (FEV 1 ), time to pulmonary exacerbation, and patient-reported quality of life. Results Extended treatment with LIS in 88 patients was well tolerated with no new safety signals and evidence of positive effects on FEV 1 and quality of life. Conclusion Patients receiving extended LIS treatment continued to show favorable efficacy with no additional safety concerns. [ABSTRACT FROM AUTHOR]

Published
2016
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250. A phase 3, multi-center, multinational, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of levofloxacin inhalation solution (APT-1026) in stable cystic fibrosis patients.

Author

Flume, Patrick A., VanDevanter, Donald R., Morgan, Elizabeth E., Dudley, Michael N., Loutit, Jeffery S., Bell, Scott C., Kerem, Eitan, Fischer, Rainald, Smyth, Alan R., Aaron, Shawn D., Conrad, Douglas, Geller, David E., and Elborn, J. Stuart

Subjects
*CYSTIC fibrosis, *LUNG infections, *ANTIBIOTICS, *PSEUDOMONAS, *MEDICATION safety, *DRUG efficacy, *RANDOMIZED controlled trials, *PATIENTS
Abstract

Rationale For patients with cystic fibrosis (CF), the use of inhaled antibiotics has become standard of care to suppress chronic Pseudomonas airways infection. There are limited antibiotic options formulated and approved for inhaled use and antibiotic efficacies attenuate over time, making additional inhaled antibiotic classes desirable. APT-1026 (levofloxacin inhalation solution, LIS) is a fluoroquinolone in development for management of chronic P. aeruginosa airways infection in patients with CF. Objectives To compare the safety and efficacy of a 28-day course of treatment with LIS 240 mg or placebo BID in persons ≥ 12 years old with CF and chronic P. aeruginosa infection. Methods A multinational, randomized (2:1), double-blinded study of LIS and placebo over 28 days in CF patients ≥ 12 years with chronic P. aeruginosa infection. Time to exacerbation was the primary endpoint. FEV 1 (% predicted) and patient-reported quality of life were among secondary endpoints. Main results Baseline demographics for 330 subjects (LIS = 220) were similar although significantly more patients randomized to LIS had experienced multiple exacerbations in the year prior to study entry. There was no statistically significant difference in protocol-defined pulmonary exacerbations between treatment arms. Relative change in FEV 1 % predicted from baseline was significantly greater for patients randomized to LIS compared to those randomized to placebo (mean difference 1.31%, p = 0.01 [95% CI 0.27, 2.34%]). LIS was well-tolerated, with dysguesia the most frequent adverse event. Conclusions LIS did not demonstrate a difference in time to next exacerbation when compared to placebo. Reasons for this result are discussed but may be due to an imbalance in the frequency of prior pulmonary exacerbations between the two groups. An improvement in FEV 1 (% predicted) at 28 days was observed and LIS was well tolerated. LIS is safe and has a potential role in the management of CF patients with chronic P. aeruginosa. [ABSTRACT FROM AUTHOR]

Published
2016
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