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1. Organization of Outpatient Care After COVID-19 Hospitalization

Author

Thomas S. Valley, Amanda Schutz, Ithan D. Peltan, Kelly C. Vranas, Kusum S. Mathews, Sarah E. Jolley, Jessica A. Palakshappa, Catherine L. Hough, Jay S. Steingrub, Mark A. Tidswell, Lori-Ann Kozikowski, Cynthia Kardos, Lesley DeSouza, Rebecca M. Baron, Mayra Pinilla-Vera, David M. Rubins, Antonio Arciniegas, Richard Riker, Christine Lord, Marie-Carmelle Elie, Daniel Talmor, Nathan Shapiro, Valerie Banner-Goodspeed, Kathryn A. Hibbert, Kelsey Brait, Natalie Pulido, Alan Jones, James Galbraith, Utsav Nandi, Rebekah Peacock, Jenna Davis, Matthew Prekker, Michael Puskarich, Seth Jones, Anne Roerhl, Audrey Hendrickson, Michael Matthay, Kirsten Kangelaris, Kathleen Liu, Kimberly Yee, Hanjing Zhuo, Gregory Hendey, Steven Chang, Nida Qadir, Andrea Tam, Rebecca Beutler, Trisha Agarwal, Joseph Levitt, Jennifer G. Wilson, Angela Rogers, Jonasel Roque, Rosemary Vojnik, Timothy E. Albertson, James A. Chenoweth, Jason Y. Adams, Brian M. Morrissey, Skyler J. Pearson, Eyad Almasri, Alyssa Hughes, Marc Moss, Adit Ginde, Jeffrey McKeehan, Lani Finck, Michelle Howell, Carrie Higgins, Jason Haukoos, Stephanie Gravitz, Carolynn Lyle, Ivor S. Douglas, Terra Hiller, Audrey Goold, James Finigan, Robert Hyzy, Pauline Park, Michael Sjoding, Stephen Kay, Kristine Nelson, Kelli McDonough, Namita Jayaprakash, Emanuel P. Rivers, Jennifer Swiderek, Jasreen Kaur Gill, Jacqueline Day, Robert Sherwin, James Wooden, Thomas Mazzoco, Michelle Ng Gong, Michael Aboodi, Ayesha Asghar, Omowunmi Amosu, Hiwet Tzehaie, Aluko A. Hope, Jen-Ting Chen, Rahul Nair, Brenda Lopez, Obiageli Offor, Jarrod M. Mosier, Cameron D. Hypes, Elizabeth Salvagio, Christian Bime, Elaine Cristan, Lynne D. Richardson, Neha Goel, Patrick Maher, Samuel Acquah, Donald Cardone, Gary Oldenburg, Andrew Dunn, Duncan Hite, Kristin Hudock, Jose Gomez Arroyo, Tammy Roads, Abhijit Duggal, Eduardo Mireles-Cabodevila, Bryce R.H. Robinson, Nicholas J. Johnson, Stephanie Gundel, Laura Evans, D. Shane O'Mahony, Julie A. Wallick, Isabel Pedraza, Akram Khan, Olivia Krol, Milad Karami Jouzestani, Kelly Vranas, Donald M. Yealy, Derek C. Angus, Alexandra Weissman, David T. Huang, Aimee Boeltz-Skrtich, Steven Moore, Derek Isenberg, D. Clark Files, Chadwick Miller, Kevin Gibbs, Lori Flores, Mary LaRose, Lauren Koehler, Leigha Landreth, Peter Morris, Evan Cassity, Jamie Sturgill, Kirby Mayer, Ashley Montgomery-Yates, Marjolein de Wit, Jessica Mason, Andrew Goodwin, Abigail Grady, Patterson Burch, Kyle B. Enfield, Jeffrey M. Sturek, Mary Marshall, Joseph R. Bledsoe, Samuel M. Brown, Colin K. Grissom, Brent Armbruster, Estelle Harris, John Eppensteiner, Bria Johnston Hall, Grace L. Hall, Lauren McGowan, Andrew Bouffler, Erica Walker, Samuel Francis, Tedra Porter, Bennett P. deBoisblanc, Matthew R. Lammi, David R. Janz, Paula Lauto, Connie Romaine, Marie Sandi, Todd W. Rice, Wesley H. Self, Nancy Ringwood, Alexander Nagrebetsky, Laura Fitzgerald, Roy G. Brower, Lora A. Reineck, Neil R. Aggarwal, and Karen Bienstock

Subjects
Hospitalization, Pulmonary and Respiratory Medicine, Ambulatory Care, COVID-19, Humans, Cardiology and Cardiovascular Medicine, Critical Care and Intensive Care Medicine
Published
2022
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2. Acute effect of inhaled iloprost on exercise dynamic hyperinflation in COPD patients: A randomized crossover study

Author

A. Hamid Boulares, Samuel C. Okpechi, Judd E. Shellito, Matthew R. Lammi, Connie Romaine, John B. Zamjahn, Hahn H. Luu, Bennett P. deBoisblanc, Jessica L. Johnson, Mohamed A. Ghonim, Andy Pellett, Johnny D'Aquin, and Kusma Pyakurel

Subjects
Pulmonary and Respiratory Medicine, Male, Placebo, Article, Pulmonary Disease, Chronic Obstructive, Oxygen Consumption, Double-Blind Method, Administration, Inhalation, medicine, Humans, Lung volumes, Iloprost, Dynamic hyperinflation, Exercise, Aged, Inflammation, COPD, Cross-Over Studies, business.industry, Total Lung Capacity, VO2 max, respiratory system, Middle Aged, medicine.disease, Crossover study, Pulmonary hypertension, Oxidative Stress, Anesthesia, Exercise Test, Female, business, Lung Volume Measurements, medicine.drug
Abstract

Background and objective We tested whether the prostacyclin analog inhaled iloprost modulates dead space, dynamic hyperinflation (DH), and systemic inflammation/oxidative stress during maximal exercise in subjects with chronic obstructive pulmonary disease (COPD) who were not selected based on pulmonary hypertension (PH). Methods Twenty-four COPD patients with moderate-severe obstruction (age 59 ± 7 years, FEV1 53 ± 13% predicted) participated in a randomized, double-blind, placebo-controlled crossover trial. Each subject received a single nebulized dose of 5.0 μg iloprost or placebo on non-consecutive days followed by maximal cardiopulmonary exercise tests. The primary outcome was DH quantified by end-expiratory lung volume/total lung capacity ratio (EELV/TLC) at metabolic isotime. Results Inhaled iloprost was well-tolerated and reduced submaximal alveolar dead-space fraction but did not significantly reduce DH (0.70 ± 0.09 vs 0.69 ± 0.07 following placebo and iloprost, respectively, p = 0.38). Maximal exercise time (9.1 ± 2.3 vs 9.3 ± 2.2 min, p = 0.31) and peak oxygen uptake (17.4 ± 6.3 vs 17.9 ± 6.9 mL/kg/min, p = 0.30) were not significantly different following placebo versus iloprost. Conclusions A single dose of inhaled iloprost was safe and reduced alveolar dead space fraction; however, it was not efficacious in modulating DH or improving exercise capacity in COPD patients who were not selected for the presence of PH.

Published
2021

3. The Long-Term Oxygen Treatment Trial for Chronic Obstructive Pulmonary Disease: Rationale, Design, and Lessons Learned

Author

Roger D. Yusen, Gerard J. Criner, Alice L. Sternberg, David H. Au, Anne L. Fuhlbrigge, Richard K. Albert, Richard Casaburi, James K. Stoller, Kathleen F. Harrington, J. Allen D. Cooper, Philip Diaz, Steven Gay, Richard Kanner, Neil MacIntyre, Fernando J. Martinez, Steven Piantadosi, Frank Sciurba, David Shade, Thomas Stibolt, James Tonascia, Robert Wise, William C. Bailey, Ernestina Sampong, Karin Sloan, Ashley Wagner, Susan Anderson, Marilyn Moy, Osarenoma Okunbor, Scott Marlow, Yvonne Meli, Richard Rice, Loutfi S. Aboussouan, Robert Castele, Joseph Parambil, Sumita Khatri, Aman Pande, Joe Zein, Thomas Olbrych, Stephan Alkins, Christine Jocko, Franck Rahaghi, Jean Barton, Jennifer Underwood, Barry Make, John Davies, Richard Mularski, Allison Naleway, Sarah Vertrees, Janos Porszasz, Peggy Walker, Renee Indelicato, Lennard Specht, Kathleen Ellstrom, Jamie Portillo, David Horak, Brian Tiep, Mary Barnett, Janice Drake, Mahasti Rittinger, Rachael Compton, Scott Miller, Ralph J. Panos, Laura A. Lach, Gerard Criner, Carla Grabianowski, Francis Cordova, Parag Desai, Samuel Krachman, James Mamary, Nathaniel Marchetti, Aditi Satti, Eileen Mumm, Michelle Vega-Olivo, Jenny Hua, Vanna Tauch, Lii-Yoong Criner, Michael Jacobs, Peter Rising, Paul Simonelli, Michele Mitchell, Matthew Lammi, Connie Romaine, Howard Lee, Mary Ianacone, Steven Scharf, Wanda Bell-Farrell, M. Jeffery Mador, Ayesha Rahman, Mumtaz Zaman, Lisa Hill, Alec Platt, J. Allen Cooper, Kathleen Harrington, Mark Dransfield, Patti Smith, Donald Davis, Peruvemba Sriram, Katherine Herring, Fernando Martinez, Meilan Han, Kelly Rysso, Catherine Meldrum, K. P. Ravikrishnan, Daniel Keena, Jennifer DeRidder, Beth Kring, Antonio Anzueto, Alex Aguilera, Timothy Houlihan, Reda Girgis, Jennifer Cannestra, Benjamin Kelly, Mary Beth Scholand, G. Martin Villegas, Judy Carle, Edmunds Udris, Randall Curtis, David Au, Laura C. Feemster, Richard Goodman, Brianna Moss, Lynn Reinke, Moira Aitken, Bruce Culver, Mario Castro, Brigitte Mittler, Jeanne Heaghney, Myron Jacobs, Min Joo, Nina Bracken, Edward Diamond, Mary K. Joseph, Xavier Soler, Arianna Villa, Daniel Layish, Edwin Silverman, Roxanne Kelly, Daniel Cossette, Patricia Belt, Amanda Blackford, Betty Collison, John Dodge, Michele Donithan, Cathleen Ewing, Rosetta Jackson, K Patrick May, Jill Meinert, Girlie Reyes, Michael Smith, Mark Van Natta, Laura Wilson, Annette Wagoner, Katherine P. Yates, Rosemarie Hakim, Antonello Punturieri, Julie Bamdad, Thomas Croxton, Joanne Deshler, Pamela McCord-Reynolds, Mario Stylianou, Gail Weinmann, Gordon Bernard, James Anderson, Bernard Lo, Andrew Ries, Stuart Stoloff, Byron Thomashow, Barbara Tilley, and Kevin Weiss

Subjects
Pulmonary and Respiratory Medicine, Adult, Male, medicine.medical_specialty, Randomization, Time Factors, medicine.medical_treatment, Population, law.invention, Hypoxemia, Treatment and control groups, 03 medical and health sciences, Pulmonary Disease, Chronic Obstructive, 0302 clinical medicine, Patient Admission, Randomized controlled trial, law, Oxygen therapy, Medicine, Humans, Multicenter Studies as Topic, 030212 general & internal medicine, education, Aged, Randomized Controlled Trials as Topic, Clinical Study Design, Aged, 80 and over, education.field_of_study, Geography, business.industry, Oxygen Inhalation Therapy, Middle Aged, Long-Term Care, United States, Clinical trial, Oxygen, 030228 respiratory system, Sample size determination, Emergency medicine, Physical therapy, Quality of Life, Female, medicine.symptom, business
Abstract

The Long-Term Oxygen Treatment Trial demonstrated that long-term supplemental oxygen did not reduce time to hospital admission or death for patients who have stable chronic obstructive pulmonary disease and resting and/or exercise-induced moderate oxyhemoglobin desaturation, nor did it provide benefit for any other outcome measured in the trial. Nine months after initiation of patient screening, after randomization of 34 patients to treatment, a trial design amendment broadened the eligible population, expanded the primary outcome, and reduced the goal sample size. Within a few years, the protocol underwent minor modifications, and a second trial design amendment lowered the required sample size because of lower than expected treatment group crossover rates. After 5.5 years of recruitment, the trial met its amended sample size goal, and 1 year later, it achieved its follow-up goal. The process of publishing the trial results brought renewed scrutiny of the study design and the amendments. This article expands on the previously published design and methods information, provides the rationale for the amendments, and gives insight into the investigators' decisions about trial conduct. The story of the Long-Term Oxygen Treatment Trial may assist investigators in future trials, especially those that seek to assess the efficacy and safety of long-term oxygen therapy. Clinical trial registered with clinicaltrials.gov (NCT00692198).

Published
2018

4. Effect of a soy isoflavone supplement on lung function and clinical outcomes in patients with poorly controlled asthma: a randomized clinical trial

Author

Adante Hart, Samang Ung, Callan J. Burzynski, Susan Rappaport, Bennie McWilliams, Elizabeth Lancet, Sabrena Mervin-Blake, Michael O. Daines, Tara F. Carr, Jennifer Kustwin, David M. Shade, Nicholas Eberlein, Elise Pangborn, Connie Romaine, Ellen D. Brown, Patricia D. Rebolledo, Andre Rogatko, Anna Adler, Adam Wanner, Stephanie M. Burns, Jonathan Cruse, Deanna M. Green, Janette C. Priefert, Gail Weinmann, W. Gerald Teague, John Welter, Deborah Keaney Chassaing, Leonard B. Bacharier, Tonya Greene, Nienchun Wu, Daniel A. Searing, Edward T. Naureckas, Lilian Cadet, Jason E. Lang, Laura Bertrand, Weijiang Shen, Robert A. Wise, April Thurman, Janet Hutchins, Andrea Lears, Amber Martineau, John S. Sundy, Nancy Prusakowski, Christine A. Sorkness, Kaharu Sumino, Nina Phillips, Andreas Schmid, Flavia C.L. Hoyte, Silvia Lopez, Marie C. Sandi, Cristine E. Berry, Edward B. Mougey, Gwen Leatherman, Scott H. Sicherer, Lisa Monchil, Lucius Robinson, Dima Ezmigna, Gang Zheng, Paula J. Puntenney, Joan Reibman, V. Susan Robertson, Lisa Webber, Nicholas R. Anthonisen, Blanca A. Lopez, Michael F. Land, Kristina Rivera, Jessica Ghidorzi, Denise Thompson-Batt, Christian Bime, Brian P. Vickery, Xavier Soler, Marilyn Scharbach, Agnes Banquet, Johana Arana, Richard S. Tejedor, Suzanna Roettger, Jonathan P. Parsons, Ben Xu, Ankoor S. Shah, Denise Jaggers, Thomas Lahiri, Eliana S. Mendes, Lucy Wang, Eveline Y. Wu, David Cosmar, Gary I. Salzman, Elizabeth De La Riva-Velasco, Alicia Newcomer, John G. Mastronarde, Elizabeth A. Sugar, Razan Yasin, Mary A. Nevin, Fernando D. Martinez, Anne S Casper, Melissa M. Scheuerman, William J. Calhoun, Jesus A. Wences, James N. Moy, Virginia S. Taggart, Nicola A. Hanania, Anne E. Dixon, Asem Abdeljalil, William C. Bailey, Jessica Williams, Monroe J. King, Sarah M. Croker, Kenneth S. Knox, Mary Warde, Rubin I. Cohen, Sankaran Krishnan, Mario Castro, Newel Bryce-Robinson, Karen Carapetyan, Christine Y. Wei, Roni Grad, Stephen C. Lazarus, Nancy Busk, Patti Haney, Richard F. Lockey, Lewis J. Smith, Michael Campos, Jaime Tarsi, Wayne J. Morgan, James L. Goodwin, Norman H. Edelman, Charles G. Irvin, Noopur Singh, Janet T. Holbrook, Johnson Ukken, David A. Kaminsky, Ravi Kalhan, Kyle I. Happel, Joe Ramsdell, Mustafa A. Atik, Nancy Archer, Raymond G. Slavin, Maria Teresa Santiago, Paul Ferguson, Virginia Zagaja, Rachael A. Compton, Joseph Santiago, Katherine Chee, Brenda M. Patterson, Ramona Ramdeo, Monica T. Varela, Joseph Boyer, Allen J. Dozor, Catherine M Foss, Robert Smith, Michael Busk, Maureen Dreyfus, Marie Daniel, Sobharani Rayapudi, Shirley McCullough, Jenny Hixon, Stephen Wasserman, Holly Currier, Andrea Paco, Tara M. Formisano, Nadav Traeger, Ingrid Gherson, Thomas Matthews, Subhadra Siegel, Michelle Freemer, J.N. Saams, Rosemary Weese, Alexis L Rea, Y. Cathy Kim, Michelle M. Cloutier, Deborah Nowakowski, Kristin W. Wavell, Dennis Pyszczynski, Kathryn V. Blake, Peter J. Kahrilas, Marianna Sockrider, Rohit K. Katial, Mark A. Brown, Suzette T. Gjonaj, Zenobia Gonsalves, Arleen Antoine, Lynn B. Gerald, Emily DiMango, Linda Rogers, Debra Amend-Libercci, Abbi Brees, Deanna Seymour, Abid Bhat, John J. Lima, Stephanie Allen, Diana B. Lowenthal, Katie Kinninger, Rebecca McCrery, Janice Drake, Cori L. Daines, Charlene Levine, Elizabeth K. Fiorino, Monica M. Vasquez, Terri Montgomery, Donna Wolf, and Trisha Larson

Subjects
Spirometry, Adult, Male, Allergy, medicine.medical_specialty, Adolescent, Placebo, Article, law.invention, Young Adult, Randomized controlled trial, Double-Blind Method, law, Internal medicine, Forced Expiratory Volume, medicine, Humans, Young adult, Child, Lung, Asthma, medicine.diagnostic_test, business.industry, Plant Extracts, General Medicine, Middle Aged, medicine.disease, Genistein, Isoflavones, Clinical research, Exhaled nitric oxide, Dietary Supplements, Physical therapy, Soybean Proteins, Female, business, Phytotherapy
Abstract

Importance Soy isoflavone supplements are used to treat several chronic diseases, although the data supporting their use are limited. Some data suggest that supplementation with soy isoflavone may be an effective treatment for patients with poor asthma control. Objective To determine whether a soy isoflavone supplement improves asthma control in adolescent and adult patients with poorly controlled disease. Design, Setting, and Participants Multicenter, randomized, double-blind, placebo-controlled trial conducted between May 2010 and August 2012 at 19 adult and pediatric pulmonary and allergy centers in the American Lung Association Asthma Clinical Research Centers network. Three hundred eighty-six adults and children aged 12 years or older with symptomatic asthma while taking a controller medicine and low dietary soy intake were randomized, and 345 (89%) completed spirometry at week 24. Interventions Participants were randomly assigned to receive soy isoflavone supplement containing 100 mg of total isoflavones (n=193) or matching placebo (n=193) in 2 divided doses administered daily for 24 weeks. Main Outcomes and Measures The primary outcome measure was change in forced expiratory volume in the first second (FEV 1 ) at 24 weeks. Secondary outcome measures were symptoms, episodes of poor asthma control, Asthma Control Test score (range, 5-25; higher scores indicate better control), and systemic and airway biomarkers of inflammation. Results Mean changes in prebronchodilator FEV 1 over 24 weeks were 0.03 L (95% CI, −0.01 to 0.08 L) in the placebo group and 0.01 L (95% CI, −0.07 to 0.07 L) in the soy isoflavone group, which were not significantly different ( P = .36). Mean changes in symptom scores on the Asthma Control Test (placebo, 1.98 [95% CI, 1.42-2.54] vs soy isoflavones, 2.20 [95% CI, 1.53-2.87]; positive values indicate a reduction in symptoms), number of episodes of poor asthma control (placebo, 3.3 [95% CI, 2.7-4.1] vs soy isoflavones, 3.0 [95% CI, 2.4-3.7]), and changes in exhaled nitric oxide (placebo, −3.48 ppb [95% CI, −5.99 to −0.97 ppb] vs soy isoflavones, 1.39 ppb [95% CI, −1.73 to 4.51 ppb]) did not significantly improve more with the soy isoflavone supplement than with placebo. Mean plasma genistein level increased from 4.87 ng/mL to 37.67 ng/mL ( P Conclusions and Relevance Among adults and children aged 12 years or older with poorly controlled asthma while taking a controller medication, use of a soy isoflavone supplement, compared with placebo, did not result in improved lung function or clinical outcomes. These findings suggest that this supplement should not be used for patients with poorly controlled asthma. Trial Registration clinicaltrials.gov Identifier:NCT01052116

Published
2015

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