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Real-life use of budesonide/formoterol in clinical practice: a 12-month follow-up assessment in a multi-national study of asthma patients established on single-inhaler maintenance and reliever therapy
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Family Medicine and Preventive Medicine.
2015 (English)In: International journal of clinical pharmacology and therapeutics, ISSN 0946-1965, Vol. 53, no 6, 447-455 p.Article in journal (Refereed) Published
Abstract [en]

Objective: The efficacy and safety of budesonide/formoterol maintenance and reliever therapy (MRT) has been demonstrated in phase III clinical studies, but limited data are available in a real-life setting. We examined the pattern of maintenance and as-needed inhaler use in routine clinical practice among patients with asthma receiving budesonide/formoterol MRT (NCT00505388). Methods: This 12-month European observational study enrolled patients prescribed budesonide/formoterol MRT and grouped them based on regimen: 80/4.5 mu g one inhalation twice daily (b.i.d.); 160/4.5 mu g one inhalation b.i.d.; 160/4.5 mu g two inhalations b.i.d. (all plus as needed). Patient data were collected daily using an interactive voice- or web-response system. The primary outcome measure was total number of budesonide/formoterol inhalations/day. Results: Overall, 4,581 patients were included (64% female; mean age 48.4 years; regimen: 80/4.5 mu g, n = 119; 160/4.5 mu g, n = 3,106; 2 x 160/4.5 mu g, n = 1,355). Mean (median) total numbers of budesonide/formoterol inhalations/day were 2.48 (2.11), 2.53 (2.14); and 4.27 (4.05) for 80/4.5 mu g b.i.d., 160/4.5 mu g b.i.d., and 2 x 160/4.5 mu g b.i.d., respectively; corresponding mean (median) number of as-needed inhalations/day were 0.68 (0.17), 0.73 (0.26), and 1.08 (0.45), respectively. As-needed budesonide/formoterol use was generally low with a mean of 61 - 66% of reliever-free days; over 4 reliever inhalations/day occurred on a mean of 0.4 - 2.5% of days for all budesonide/formoterol MRT regimens. Conclusions: In routine clinical practice, all budesonide/formoterol MRT regimens were associated with a high proportion of reliever-free days and low incidence of high reliever-use days, indicating acceptable levels of asthma control with this symptom-adjusted controller regimen.

Place, publisher, year, edition, pages
2015. Vol. 53, no 6, 447-455 p.
Keyword [en]
inhaled corticosteroid/long-acting beta(2)-agonist, inhaler use, observational study, real-world evidence, treatment
National Category
Pharmacology and Toxicology
URN: urn:nbn:se:uu:diva-259118DOI: 10.5414/CP202224ISI: 000357360300005PubMedID: 25907171OAI: oai:DiVA.org:uu-259118DiVA: diva2:843351
Available from: 2015-07-28 Created: 2015-07-27 Last updated: 2015-07-28Bibliographically approved

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Ställberg, Björn
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