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1. Factors Associated with Persistence of Severe Asthma from Late Adolescence to Early Adulthood

Author

Neema Izadi, David Baraghoshi, Douglas Curran-Everett, Robert S. Zeiger, Stanley J. Szefler, Ronina A. Covar, Paul Williams, Mary V. Lasley, Tamara Chinn, Michele Hinatsu, Clifton T. Furukawa, Leonard C. Altman, Frank S. Virant, Michael S. Kennedy, Stephen Tilles, Jonathan W. Becker, C. Warren Bierman, Dan Crawford, Thomas DuHamel, Heather Eliassen, Babi Hammond, Miranda MacLaren, Dominick A. Minotti, Chris Reagan, Gail Shapiro, Marian Sharpe, Ashley Tatum, Grace White, Timothy G. Wighton, Anne Fuhlbrigge, Anne Plunkett, Nancy Madden, Susan Anderson, Mark Boehnert, Anita Feins, Amanda Gentile, Natalia Kandror, Kelly MacAulay, Ernestina Sampong, Scott Weiss, Walter Torda, Martha Tata, Sally Babigian, Peter Barrant, Linda Benson, Jose Caicedo, Tatum Calder, Christine Darcy, Anthony DeFilippo, Cindy Dorsainvil, Julie Erickson, Phoebe Fulton, Mary Grace, Jennifer Gilbert, Dirk Greineder, Stephanie Haynes, Margaret Higham, Deborah Jakubowski, Susan Kelleher, Jay Koslof, Dana Mandel, Patricia Martin, Agnes Martinez, Jean McAuliffe, Erika Nakamoto, Paola Pacella, Paula Parks, Johanna Sagarin, Kay Seligsohn, Susan Swords, Meghan Syring, June Traylor, Melissa Van Horn, Carolyn Wells, Ann Whitman, Hartmut Grasemann, Melody Miki, Melinda Solomon, Padmaja Subbarao, Ian MacLusky, Joe Reisman, Henry Levison, Anita Hall, Yola Benedet, Susan Carpenter, Jennifer Chay, Michelle Collinson, Jane Finlayson-Kulchin, Kenneth Gore, Nina Hipolito, Noreen Holmes, Erica Hoorntje, Sharon Klassen, Joseé Quenneville, Renée Sananes, Christine Wasson, Margaret Wilson, N. Franklin Adkinson, Deborah Bull, Stephanie Philips, Peyton Eggleston, Karen Huss, Leslie Plotnick, Margaret Pulsifer, Cynthia Rand, Elizabeth Aylward, Nancy Bollers, Kathy Pessaro, Barbara Wheeler, Harold S. Nelson, Bruce Bender, Andrew Liu, D. Sundström, Melanie Phillips, Michael P. White, Melanie Gleason, Kristin Brelsford, Jessyca Bridges, Jody Ciacco, Michael Eltz, Jeryl Feeley, Michael Flynn, Tara Junk-Blanchard, Joseph Hassell, Marcia Hefner, Caroline Hendrickson, Daniel Hettleman, Charles G. Irvin, Alan Kamada, Marzena Krawiec, Gary Larsen, Sai Nimmagadda, Kendra Sandoval, Jessica Sheridan, Joseph Spahn, Gayle Spears, Trella Washington, Eric Willcutt, Kirstin Carel, Jayna Doshi, Rich Hendershot, Jeffrey Jacobs, Neal Jain, June-ku Brian Kang, Tracy Kruzick, Harvey Leo, Beth Macomber, Jonathan Malka, Chris Mjaanes, John Prpich, Lora Stewart, Ben Song, Grace Tamesis, Noah Friedman, Michael H. Mellon, Michael Schatz, Terrie Long, Travis Macaraeg, Sandra Christensen, James G. Easton, M. Feinberg, Linda L. Galbreath, Jennifer Gulczynski, Kathleen Harden, Ellen Hansen, Al Jalowayski, Elaine Jenson, Alan Lincoln, Jennie Kaufman, Shirley King, Brian Lopez, Michaela Magiari-Ene, Kathleen Mostafa, Avraham Moscona, Catherine A. Nelle, Jennifer Powers, Elsa Rodriguez, Eva Rodriguez, Karen Sandoval, Nevin W. Wilson, Hengameh H. Raissy, Aaron Jacobs, H. William Kelly, Mary Spicher, Christina Batson, Michelle Harkings, Katie McCallum, Robert Annett, Teresa Archibeque, Naim Bashir, H. Selda Bereket, Marisa Braun, Carrie Bush, Shannon C. Bush, Michael Clayton, Angel Colon-Semidey, Sara Devault, Anna Esparham, Roni Grad, David Hunt, Jeanne Larsson, Sandra McClelland, Bennie McWilliams, Elisha Montoya, Margaret Moreshead, Shirley Murphy, Barbara Ortega, David Weers, Jose Zayas, Robert C. Strunk, Leonard Bacharier, Denise Rodgers, Ellen Albers, Gregg Belle, Gordon R. Bloomberg, W. Patrick Buchanan, Mary Caesar, James M. Corry, Karen DeMuth, Marisa Dolinsky, Edwin B. Fisher, Stephen J. Gaioni, Emily Glynn, Bernadette D. Heckman, Debra Kemp, Lila Kertz, Claire Lawhon, Valerie Morgan, Cynthia Moseid, Tina Oliver-Welker, Diana Richardson, Elizabeth Ryan, Sharon Sagal, Thomas F. Smith, Susan Sylvia, Carl Turner, Deborah K. White, James Tonascia, Patricia Belt, Karen Collins, Betty Collison, John Dodge, Michele Donithan, Cathleen Ewing, Rosetta Jackson, Patrick May, Jill Meinert, Girlie Reyes, Michael Smith, Alice L. Sternberg, Mark L. Van Natta, Annette Wagoner, Laura Wilson, Robert Wise, Katherine Yates, Virginia Taggart, Lois Eggers, James Kiley, Howard Moore, Gang Zheng, Paul Albert, Suzanne Hurd, Sydney Parker, Pamela Randall, Margaret Wu, Michelle Cloutier, John Connett, Leona Cuttler, Frank Gilliland, Clarence E. Davis, Howard Eigen, David Evans, Meyer Kattan, Rogelio Menendez, F. Estelle R. Simons, Sanford Leikin, Robert Strunk, Reuben Cherniack, Thomas R. DuHamel, Curtis L. Meinert, Gail G. Shapiro, and Robert Zeiger

Subjects
Pulmonary and Respiratory Medicine, Persistence (psychology), Pediatrics, medicine.medical_specialty, Severe asthma, Friends, macromolecular substances, Critical Care and Intensive Care Medicine, 03 medical and health sciences, Pulmonary Disease, Chronic Obstructive, 0302 clinical medicine, Early adulthood, medicine, Humans, 030212 general & internal medicine, Lung function, Asthma, business.industry, musculoskeletal, neural, and ocular physiology, Original Articles, Late adolescence, medicine.disease, nervous system, 030228 respiratory system, business
Abstract

Rationale: Asthma in children generally starts as being mild but may progress to being severe and may stay severe for unknown reasons. Objectives: To identify factors in childhood that predict the persistence of severe asthma in late adolescence and early adulthood. Methods: The CAMP (Childhood Asthma Management Program) is, to our knowledge, the largest and longest asthma trial to date; it includes 1,041 children aged 5–12 years with mild to moderate asthma. We evaluated 682 program participants with analyzable data in late adolescence (age, 17–19 yr) and early adulthood (age, 21–23 yr). Measurements and Main Results: To best capture the cases of severe asthma, a status of severe asthma was defined by using criteria from the American Thoracic Society and the National Asthma Education and Prevention Program. Logistic regression with stepwise elimination was used to analyze the clinical features, biomarkers, and lung function that are predictive of the persistence of severe asthma. In late adolescence and early adulthood, 12% and 19% of the participants had severe asthma, respectively; only 6% at both time points had severe cases. For every 5% decrease in the postbronchodilator FEV(1)/FVC ratio in childhood, the odds of the persistence of severe asthma increased by 2.36-fold (95% confidence interval [CI], 1.70–3.28; P

Published
2021

2. 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

3. Airway obstruction worsens in young adults with asthma who become obese

Author

Robert C. Strunk, Ryan Colvin, Leonard B. Bacharier, Anne Fuhlbrigge, Erick Forno, Ana Maria Arbelaez, Kelan G. Tantisira, Paul Williams, Mary V. Lasley, Tamara Chinn, Michele Hinatsu, Clifton T. Furukawa, Leonard C. Altman, Frank S. Virant, Michael S. Kennedy, Stephen Tilles, Jonathan W. Becker, C. Warren Bierman, Dan Crawford, Thomas DuHamel, Heather Eliassen, Babi Hammond, Miranda MacLaren, Dominick A. Minotti, Chris Reagan, Gail Shapiro, Marian Sharpe, Ashley Tatum, Grace White, Timothy G. Wighton, Anne Plunkett, Nancy Madden, Susan Anderson, Mark Boehnert, Anita Feins, Amanda Gentile, Natalia Kandror, Kelly MacAulay, Ernestina Sampong, Scott Weiss, Walter Torda, Martha Tata, Sally Babigian, Peter Barrant, Linda Benson, Jose Caicedo, Tatum Calder, Christine Darcy, Anthony DeFilippo, Cindy Dorsainvil, Julie Erickson, Phoebe Fulton, Mary Grace, Jennifer Gilbert, Dirk Greineder, Stephanie Haynes, Margaret Higham, Deborah Jakubowski, Susan Kelleher, Jay Koslof, Dana Mandel, Patricia Martin, Agnes Martinez, Jean McAuliffe, Erika Nakamoto, Paola Pacella, Paula Parks, Johanna Sagarin, Kay Seligsohn, Susan Swords, Meghan Syring, June Traylor, Melissa Van Horn, Carolyn Wells, Ann Whitman, Hartmut Grasemann, Melody Miki, Melinda Solomon, Padmaja Subbarao, Ian MacLusky, Joe Reisman, Henry Levison, Anita Hall, Yola Benedet, Susan Carpenter, Jennifer Chay, Michelle Collinson, Jane Finlayson-Kulchin, Kenneth Gore, Nina Hipolito, Noreen Holmes, Erica Hoorntje, Sharon Klassen, Joseé Quenneville, Renée Sananes, Christine Wasson, Margaret Wilson, N. Franklin Adkinson, Deborah Bull, Stephanie Philips, Peyton Eggleston, Karen Huss, Leslie Plotnick, Margaret Pulsifer, Cynthia Rand, Elizabeth Aylward, Nancy Bollers, Kathy Pessaro, Barbara Wheeler, Stanley Szefler, Ronina Covar, Harold S. Nelson, Bruce Bender, Andrew Liu, D. Sundström, Melanie Phillips, Michael P. White, Melanie Gleason, Kristin Brelsford, Jessyca Bridges, Jody Ciacco, Michael Eltz, Jeryl Feeley, Michael Flynn, Tara Junk-Blanchard, Joseph Hassell, Marcia Hefner, Caroline Hendrickson, Daniel Hettleman, Charles G. Irvin, Alan Kamada, Marzena Krawiec, Gary Larsen, Sai Nimmagadda, Kendra Sandoval, Jessica Sheridan, Joseph Spahn, Gayle Spears, Trella Washington, Eric Willcutt, Ivan Cardona, Kirstin Carel, Jayna Doshi, Rich Hendershot, Jeffrey Jacobs, Neal Jain, June-ku Brian Kang, Tracy Kruzick, Harvey Leo, Beth Macomber, Jonathan Malka, Chris Mjaanes, John Prpich, Lora Stewart, Ben Song, Grace Tamesis, Robert S. Zeiger, Noah Friedman, Michael H. Mellon, Michael Schatz, Terrie Long, Travis Macaraeg, Sandra Christensen, James G. Easton, M. Feinberg, Linda L. Galbreath, Jennifer Gulczynski, Kathleen Harden, Ellen Hansen, Al Jalowayski, Elaine Jenson, Alan Lincoln, Jennie Kaufman, Shirley King, Brian Lopez, Michaela Magiari-Ene, Kathleen Mostafa, Avraham Moscona, Catherine A. Nelle, Jennifer Powers, Elsa Rodriguez, Eva Rodriguez, Karen Sandoval, Nevin W. Wilson, Hengameh H. Raissy, Aaron Jacobs, H. William Kelly, Mary Spicher, Christina Batson, Michelle Harkings, Katie McCallum, Robert Annett, Teresa Archibeque, Naim Bashir, H. Selda Bereket, Marisa Braun, Carrie Bush, Shannon C. Bush, Michael Clayton, Angel Colon-Semidey, Sara Devault, Anna Esparham, Roni Grad, David Hunt, Jeanne Larsson, Sandra McClelland, Bennie McWilliams, Elisha Montoya, Margaret Moreshead, Shirley Murphy, Barbara Ortega, David Weers, Jose Zayas, Leonard Bacharier, Denise Rodgers, Ellen Albers, Gregg Belle, Gordon R. Bloomberg, W. Patrick Buchanan, Mary Caesar, James M. Corry, Karen DeMuth, Marisa Dolinsky, Edwin B. Fisher, Stephen J. Gaioni, Emily Glynn, Bernadette D. Heckman, Debra Kemp, Lila Kertz, Claire Lawhon, Valerie Morgan, Cynthia Moseid, Tina Oliver-Welker, Diana Richardson, Elizabeth Ryan, Sharon Sagal, Thomas F. Smith, Susan Sylvia, Carl Turner, Deborah K. White, James Tonascia, Patricia Belt, Karen Collins, Betty Collison, John Dodge, Michele Donithan, Cathleen Ewing, Rosetta Jackson, Patrick May, Jill Meinert, Girlie Reyes, Michael Smith, Alice L. Sternberg, Mark L. Van Natta, Annette Wagoner, Laura Wilson, Robert Wise, Katherine Yates, Virginia Taggart, Lois Eggers, James Kiley, Howard Moore, Gang Zheng, Paul Albert, Suzanne Hurd, Sydney Parker, Pamela Randall, Margaret Wu, Michelle Cloutier, John Connett, Leona Cuttler, Frank Gilliland, Clarence E. Davis, Howard Eigen, David Evans, Meyer Kattan, Rogelio Menendez, F. Estelle R. Simons, Sanford Leikin, Robert Strunk, Reuben Cherniack, Thomas R. DuHamel, Curtis L. Meinert, Gail G. Shapiro, and Robert Zeiger

Subjects
Adult, Male, Risk, Vital capacity, Pediatrics, medicine.medical_specialty, Adolescent, Childhood obesity, Article, Pulmonary function testing, Body Mass Index, FEV1/FVC ratio, Young Adult, Nedocromil, medicine, Immunology and Allergy, Humans, Obesity, Young adult, Budesonide, Child, Asthma, business.industry, Airway obstruction, medicine.disease, respiratory tract diseases, Respiratory Function Tests, Airway Obstruction, Child, Preschool, Physical therapy, Disease Progression, Female, business, Body mass index, Follow-Up Studies
Abstract

Few studies have examined how developing obesity in early adulthood affects the course of asthma.We analyzed lung function and asthma impairment and risk among nonobese children with asthma, comparing those who were obese in young adulthood with those who remained nonobese.We carried out the post hoc analysis of 771 subjects with mild to moderate asthma who were not obese (pediatric definition, body mass index [BMI]95th percentile) when enrolled in the Childhood Asthma Management Program at ages 5-12 years. The subjects were then followed to age 20 years or more. For visits at ages 20 years or more, spirometry values as percent predicted and recent asthma symptom scores and prednisone exposure were compared between 579 subjects who were nonobese at all visits and 151 who were obese (adult definition of BMI ≥ 30 kg/m(2)) on at least 1 visit (median number of visits when obese = 4, IQR 2-7).Compared with participants who were nonobese (BMI 23.4 ± 2.6 kg/m(2)), those who became obese (BMI 31.5 ± 3.8 kg/m(2)) had significant decreases in forced expiratory volume in the first second (FEV1)/forced vital capacity (FVC) (P.0003) and FEV1 (P = .001), without differences in FVC (P = .15) during visits at ages 20 years or more. For each unit increase of BMI, FEV1 percent predicted decreased by 0.29 (P = .0009). The relationship between BMI and lung function was not confounded by sex or BMI at baseline. Asthma impairment (symptom scores) and risk (prednisone use) did not differ between the 2 groups.Becoming obese in early adulthood was associated with increased airway obstruction, without impact on asthma impairment or risk.

Published
2015

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