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Free Content Add-on tiotropium versus step-up inhaled corticosteroid plus long-acting beta-2‐agonist in real-world patients with asthma


A step-up approach (increasing inhaled corticosteroid [ICS] dose and/or add-on treatment) is recommended for asthma that is uncontrolled despite ICS plus long-acting beta-2‐agonist (LABA) combination treatment. Understanding the impact of different treatment options on health outcomes can help guide treatment decision-making.


To compare the effectiveness of add-on tiotropium 1.25 µg (two puffs once daily) versus an increased ICS plus LABA dose in a real-world cohort of patients with asthma initiated on ICS plus LABA.


De-identified data from patients ages ≥12 years and with asthma who were initiated on ICS plus LABA, and then had tiotropium added (Tio group; index date) or an ICS plus LABA dose increased (inc-ICS group; index date) were collected from two medical and pharmacy claims data bases (2014‐2018). To account for population/group differences, propensity score matching was performed. The primary end point was the exacerbation risk after the index date. Secondary end points included exacerbation rates 6 and 12 months postindex, health-care resource utilization, costs, and short-acting beta-2‐agonist (SABA) refills 12 months postindex.


Overall, 7857 patients (Tio group, 2619; inc-ICS group, 5238) were included. The exacerbation risk was 35% lower in the Tio group than in the inc-ICS group (hazard ratio 0.65 [95% confidence interval, 0.43‐0.99]; p = 0.044). Exacerbation rates in the Tio group also were significantly lower within 6 and 12 months postindex (64% and 73%, respectively). All-cause and asthma-related emergency department (ED) visits were 47% and 74% lower, respectively (p < 0.0001 for both), and all-cause and asthma-related hospitalizations were 48% (p < 0.01) and 76% (p < 0.001) lower, respectively, in the Tio group. Also, significantly fewer patients in the Tio group versus the inc-ICS group required SABA refills (56% versus 67%, p < 0.0001).


Add-on tiotropium significantly decreased the risk and rate of exacerbations, decreased all-cause and asthma-related ED visits and hospitalizations, and reduced SABA refills compared with increasing the ICS plus LABA dose. The findings supported the use of add-on tiotropium for patients with uncontrolled asthma taking ICS plus LABA.

Keywords: Emergency room; exacerbation; healthcare resource use; hospitalization; inhaled corticosteroid; long-acting β2-agonist; real-world study; short-acting β2-agonist; tiotropium; uncontrolled asthma

Document Type: Research Article

Affiliations: 1: From the Capital Allergy and Respiratory Disease Center, Sacramento, California; 2: Division of Pulmonary, Allergy, and Critical Care, Department of Medicine, NorthShore University HealthSystem, Chicago, Illinois; 3: Division of Allergy, Pulmonary and Critical Care, Department of Medicine, University of Wisconsin, Madison, Wisconsin; 4: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut; 5: Department of Public Health Sciences, Henry Ford Health System, Detroit, Michigan; 6: eMAX Health, White Plains, New York; and 7: Allergy and Immunology, The Allergy and Asthma Center, East Providence, Rhode Island

Publication date: July 1, 2020

This article was made available online on May 15, 2020 as a Fast Track article with title: "Add-on tiotropium versus step-up inhaled corticosteroid plus long-acting beta-2–agonist in real-world patients with asthma".

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