1. Predictors of response to tiotropium versus salmeterol in asthmatic adults.
- Author
-
Peters, Stephen P, Bleecker, Eugene R, Kunselman, Susan J, Icitovic, Nikolina, Moore, Wendy C, Pascual, Rodolfo, Ameredes, Bill T, Boushey, Homer A, Calhoun, William J, Castro, Mario, Cherniack, Reuben M, Craig, Timothy, Denlinger, Loren C, Engle, Linda L, Dimango, Emily A, Israel, Elliot, Kraft, Monica, Lazarus, Stephen C, Lemanske, Robert F, Lugogo, Njira, Martin, Richard J, Meyers, Deborah A, Ramsdell, Joe, Sorkness, Christine A, Sutherland, E Rand, Wasserman, Stephen I, Walter, Michael J, Wechsler, Michael E, Chinchilli, Vernon M, Szefler, Stanley J, and National Heart, Lung, and Blood Institute's Asthma Clinical Research Network
- Subjects
National Heart ,Lung ,and Blood Institute's Asthma Clinical Research Network ,Humans ,Asthma ,Albuterol ,Scopolamine Derivatives ,Bronchodilator Agents ,Anti-Asthmatic Agents ,Prognosis ,Treatment Outcome ,Cross-Over Studies ,Adult ,Middle Aged ,Female ,Male ,Adrenergic beta-2 Receptor Agonists ,Tiotropium Bromide ,Salmeterol Xinafoate ,ACD ,ACRN ,Asthma Clinical Research Network ,Asthma control day ,FVC ,Forced vital capacity ,HFA ,Hydrofluoroalkane ,ICS ,Inhaled corticosteroid ,LABA ,LAMA ,Long-acting muscarinic antagonist ,Long-acting β-agonist ,NHLBI ,National Heart ,Lung ,and Blood Institute ,OR ,Odds ratio ,PEF ,Peak expiratory flow ,TALC ,Tiotropium Bromide as an Alternative to Increased Inhaled Glucocorticoid in Patients Inadequately Controlled on a Lower Dose of Inhaled Corticosteroid (ClinicalTrials.gov number ,NCT00565266) trial ,predictor of response ,responder analysis ,salmeterol ,tiotropium ,Clinical Research ,Lung ,Respiratory ,Immunology ,Allergy - Abstract
BackgroundTiotropium has activity as an asthma controller. However, predictors of a positive response to tiotropium have not been described.ObjectiveWe sought to describe individual and differential responses of asthmatic patients to salmeterol and tiotropium when added to an inhaled corticosteroid, as well as predictors of a positive clinical response.MethodsData from the double-blind, 3-way, crossover National Heart, Lung, and Blood Institute's Asthma Clinical Research Network's Tiotropium Bromide as an Alternative to Increased Inhaled Glucocorticoid in Patients Inadequately Controlled on a Lower Dose of Inhaled Corticosteroid (ClinicalTrials.gov number, NCT00565266) trial were analyzed for individual and differential treatment responses to salmeterol and tiotropium and predictors of a positive response to the end points FEV1, morning peak expiratory flow (PEF), and asthma control days (ACDs).ResultsAlthough approximately equal numbers of patients showed a differential response to salmeterol and tiotropium in terms of morning PEF (n = 90 and 78, respectively) and ACDs (n = 49 and 53, respectively), more showed a differential response to tiotropium for FEV1 (n = 104) than salmeterol (n = 62). An acute response to a short-acting bronchodilator, especially albuterol, predicted a positive clinical response to tiotropium for FEV1 (odds ratio, 4.08; 95% CI, 2.00-8.31; P < .001) and morning PEF (odds ratio, 2.12; 95% CI, 1.12-4.01; P = 0.021), as did a decreased FEV1/forced vital capacity ratio (FEV1 response increased 0.39% of baseline for every 1% decrease in FEV1/forced vital capacity ratio). Higher cholinergic tone was also a predictor, whereas ethnicity, sex, atopy, IgE level, sputum eosinophil count, fraction of exhaled nitric oxide, asthma duration, and body mass index were not.ConclusionAlthough these results require confirmation, predictors of a positive clinical response to tiotropium include a positive response to albuterol and airway obstruction, factors that could help identify appropriate patients for this therapy.
- Published
- 2013