Lansoprazole for children with poorly controlled asthma: a randomized controlled trial
Writing Committee for the American Lung Association Asthma Clinical Research Centers, Janet T Holbrook, Robert A Wise, Benjamin D Gold, Kathryn Blake, Ellen D Brown, Mario Castro, Allen J Dozor, John J Lima, John G Mastronarde, Marianna M Sockrider, W Gerald Teague, Nicola Hanania, Marianna Sockrider, Laura Bertrand, Mustafa Atik, Luz Giraldo, Blanca A Lopez, Joan Reibman, Emily DiMango, Linda Rogers, Elizabeth Fiorino, Cherie Cammarata, Karen Carapetyan, Jennifer Sormillon, Erin Simpson, Larry Williams, John Sundy, Peter Michelson, Brian Vickery, Ginny Dudek, Rebecca Newton, Amy Dugdale, Catherine Foss, Denise Jaggers, W Gerald Teague, Anne Fitzpatrick, Sumita Khatri, Rachna Patel, Jeannie Peabody, Eric Hunter, Denise Whitlock, Lewis Smith, James Moy, Adrienne Prestridge, Jenny Hixon, Abbi Brees, Janine Judge, Michael Busk, Paula Puntenney, Nancy Busk, Janet Hutchins, Frank Leone, Michelle Hayes-Hampton, Rohit Katial, Marzena Krawiecz, Holly Currier, John Lima, Kathryn Blake, Jason Lang, David Schaeffer, Donald George, Mary Warde, Nancy Archer, Melissa McRae, Amber Santos, Rubin Cohen, Maria Santiago, Ramona Ramdeo, Charles Irvin, Anne E Dixon, David A Kaminsky, Thomas Lahiri, Paul S Shapero, Richard Colletti, Stephanie M Burns, Laurianne V Griffes, Roberta Pratt, Michelle Doucette, Pam Oertel, John Mastronarde, Karen McCoy, Jonathan Parsons, Janice Drake, Rachael A Compton, Laura Raterman, David Cosmar, Allen J Dozor, Sankaran Krishnan, Jay Boyer, Nadav Traeger, Ingrid Gherson, Lisa Monchil, Lynn B Gerald, William C Bailey, Roni Grad, Sue Erwin, Ann Kelley, Debra Laken, Adam Wanner, Richard Lockey, Eliana S Mendes, Shirley McCullough, Michelle Grandstaff-Singleton, Diana Miller, Malcolm N Blumenthal, Gail Brottman, John Hagen, Athena Decker, Debra Lascewski, Sheila Kelleher, Kay A Bachman, Cindy Quintard, Cherylee Sherry, Gary Salzman, Chitra Dinakar, Dennis Pyszczynski, Patti Haney, Mario Castro, Leonard Bacharier, Kaharu Sumino, Jaime J Tarsi, Brenda Patterson, Stephen Wasserman, Joe Ramsdell, Paul Ferguson, Katie Kinninger, Tonya Greene, William C Bailey, Nicholas Anthonisen, W Gerald Teague, Robert Wise, Janet Holbrook, Ellen Brown, Debra Amend-Libercci, Katherine Barry, Marie Daniel, Andrea Lears, Gwen Leatherman, Charlene Levine, Deborah Nowakowski, Nancy Prusakowski, Sobharani Rayapudi, Suzanna Roettger, April Thurman, David Shade, Elizabeth Sugar, Johnson Ukken, Christine Wei, Benjamin Gold, Stephen C Lazarus, William J Calhoun, Michelle Cloutier, Peter Kahrilas, Bennie McWilliams, Andre Rogatko, Christine Sorkness, Elizabeth Lancet, Norman Edelman, Susan Rappaport, Virginia Taggart, Robert Smith, Gail Weinmann, E Neil Schacter, William C Bailey, Mario Castro, Brian Christman, Amy Chuang, Candy Holloway, Judith A Neubauer, Jonathan M Samet, Erik Swenson, Dona J Upson, Daniel J Weiss, Robert Wise, Writing Committee for the American Lung Association Asthma Clinical Research Centers, Janet T Holbrook, Robert A Wise, Benjamin D Gold, Kathryn Blake, Ellen D Brown, Mario Castro, Allen J Dozor, John J Lima, John G Mastronarde, Marianna M Sockrider, W Gerald Teague, Nicola Hanania, Marianna Sockrider, Laura Bertrand, Mustafa Atik, Luz Giraldo, Blanca A Lopez, Joan Reibman, Emily DiMango, Linda Rogers, Elizabeth Fiorino, Cherie Cammarata, Karen Carapetyan, Jennifer Sormillon, Erin Simpson, Larry Williams, John Sundy, Peter Michelson, Brian Vickery, Ginny Dudek, Rebecca Newton, Amy Dugdale, Catherine Foss, Denise Jaggers, W Gerald Teague, Anne Fitzpatrick, Sumita Khatri, Rachna Patel, Jeannie Peabody, Eric Hunter, Denise Whitlock, Lewis Smith, James Moy, Adrienne Prestridge, Jenny Hixon, Abbi Brees, Janine Judge, Michael Busk, Paula Puntenney, Nancy Busk, Janet Hutchins, Frank Leone, Michelle Hayes-Hampton, Rohit Katial, Marzena Krawiecz, Holly Currier, John Lima, Kathryn Blake, Jason Lang, David Schaeffer, Donald George, Mary Warde, Nancy Archer, Melissa McRae, Amber Santos, Rubin Cohen, Maria Santiago, Ramona Ramdeo, Charles Irvin, Anne E Dixon, David A Kaminsky, Thomas Lahiri, Paul S Shapero, Richard Colletti, Stephanie M Burns, Laurianne V Griffes, Roberta Pratt, Michelle Doucette, Pam Oertel, John Mastronarde, Karen McCoy, Jonathan Parsons, Janice Drake, Rachael A Compton, Laura Raterman, David Cosmar, Allen J Dozor, Sankaran Krishnan, Jay Boyer, Nadav Traeger, Ingrid Gherson, Lisa Monchil, Lynn B Gerald, William C Bailey, Roni Grad, Sue Erwin, Ann Kelley, Debra Laken, Adam Wanner, Richard Lockey, Eliana S Mendes, Shirley McCullough, Michelle Grandstaff-Singleton, Diana Miller, Malcolm N Blumenthal, Gail Brottman, John Hagen, Athena Decker, Debra Lascewski, Sheila Kelleher, Kay A Bachman, Cindy Quintard, Cherylee Sherry, Gary Salzman, Chitra Dinakar, Dennis Pyszczynski, Patti Haney, Mario Castro, Leonard Bacharier, Kaharu Sumino, Jaime J Tarsi, Brenda Patterson, Stephen Wasserman, Joe Ramsdell, Paul Ferguson, Katie Kinninger, Tonya Greene, William C Bailey, Nicholas Anthonisen, W Gerald Teague, Robert Wise, Janet Holbrook, Ellen Brown, Debra Amend-Libercci, Katherine Barry, Marie Daniel, Andrea Lears, Gwen Leatherman, Charlene Levine, Deborah Nowakowski, Nancy Prusakowski, Sobharani Rayapudi, Suzanna Roettger, April Thurman, David Shade, Elizabeth Sugar, Johnson Ukken, Christine Wei, Benjamin Gold, Stephen C Lazarus, William J Calhoun, Michelle Cloutier, Peter Kahrilas, Bennie McWilliams, Andre Rogatko, Christine Sorkness, Elizabeth Lancet, Norman Edelman, Susan Rappaport, Virginia Taggart, Robert Smith, Gail Weinmann, E Neil Schacter, William C Bailey, Mario Castro, Brian Christman, Amy Chuang, Candy Holloway, Judith A Neubauer, Jonathan M Samet, Erik Swenson, Dona J Upson, Daniel J Weiss, Robert Wise
Abstract
Context: Asymptomatic gastroesophageal reflux (GER) is prevalent in children with asthma. Untreated GER has been postulated to be a cause of inadequate asthma control in children despite inhaled corticosteroid treatment, but it is not known whether treatment with proton pump inhibitors improves asthma control.
Objective: To determine whether lansoprazole is effective in reducing asthma symptoms in children without overt GER.
Design, setting, and participants: The Study of Acid Reflux in Children With Asthma, a randomized, masked, placebo-controlled, parallel clinical trial that compared lansoprazole with placebo in children with poor asthma control who were receiving inhaled corticosteroid treatment. Three hundred six participants enrolled from April 2007 to September 2010 at 19 US academic clinical centers were followed up for 24 weeks. A subgroup had an esophageal pH study before randomization.
Intervention: Participating children were randomly assigned to receive either lansoprazole, 15 mg/d if weighing less than 30 kg or 30 mg/d if weighing 30 kg or more (n = 149), or placebo (n = 157).
Main outcome measures: The primary outcome measure was change in Asthma Control Questionnaire (ACQ) score (range, 0-6; a 0.5-unit change is considered clinically meaningful). Secondary outcome measures included lung function measures, asthma-related quality of life, and episodes of poor asthma control.
Results: The mean age was 11 years (SD, 3 years). The mean difference in change (lansoprazole minus placebo) in the ACQ score was 0.2 units (95% CI, 0.0-0.3 units). There were no statistically significant differences in the mean difference in change for the secondary outcomes of forced expiratory volume in the first second (0.0 L; 95% CI, -0.1 to 0.1 L), asthma-related quality of life (-0.1; 95% CI, -0.3 to 0.1), or rate of episodes of poor asthma control (relative risk, 1.2; 95% CI, 0.9-1.5). Among the 115 children with esophageal pH studies, the prevalence of GER was 43%. In the subgroup with a positive pH study, no treatment effect for lansoprazole vs placebo was observed for any asthma outcome. Children treated with lansoprazole reported more respiratory infections (relative risk, 1.3 [95% CI, 1.1-1.6]).
Conclusion: In this trial of children with poorly controlled asthma without symptoms of GER who were using inhaled corticosteroids, the addition of lansoprazole, compared with placebo, improved neither symptoms nor lung function but was associated with increased adverse events.
Trial registration: clinicaltrials.gov Identifier: NCT00442013.
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Source: PubMed