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Comparative Study
. 2025 Aug-Sep:245:108172.
doi: 10.1016/j.rmed.2025.108172. Epub 2025 May 28.

Comparative effectiveness of inhaled fluticasone propionate/salmeterol and budesonide/formoterol fixed-dose combinations in asthma control - a retrospective United States database analysis

Nicola A Hanania  1 , Richard Stanford  2 , Adrian Rendon  3 , Bilun Gemicioglu  4 , Leandro Fritscher  5 , Watchara Boonsawat  6 , Anurita Mamjudar  7 , Nnaemeka Odo  8 , Mohamed Hamouda  9
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Free article
Comparative Study

Comparative effectiveness of inhaled fluticasone propionate/salmeterol and budesonide/formoterol fixed-dose combinations in asthma control - a retrospective United States database analysis

Nicola A Hanania et al. Respir Med. 2025 Aug-Sep.
Free article

Abstract

Background: Asthma affects over 260 million people globally, with significant health impacts. The Global Initiative for Asthma (GINA) 2024 report recommends inhaled corticosteroid/long-acting β2-agonist (ICS/LABA) combinations, including fluticasone propionate/salmeterol (FP/SAL) and budesonide/formoterol (BUD/FOR), for maintenance treatment. Both combinations have demonstrated clinical benefits, with previous clinical trials and real-world studies showing comparable asthma control with FP/SAL and BUD/FOR. This United States (US)-based study compares the real-world effectiveness of FP/SAL and BUD/FOR on asthma control and treatment adherence.

Methods: This retrospective cohort study analyzed data from the US Optum's Market Clarity database (July 1, 2010, to December 31, 2019), with integrated medical, pharmacy claims, and clinical electronic health records. Patients aged ≥18 years with asthma at GINA Steps 3-4, and ≥1 pharmacy claim for FP/SAL or BUD/FOR (index) were included. Patients on other ICS/LABA therapy ≥12 months prior to index were excluded. Inverse probability of treatment weighting adjusted for confounders. Outcomes were stratified by asthma severity.

Results: A total of 57,000 patients were included (FP/SAL: 28,639; BUD/FOR: 28,361). Baseline characteristics were balanced post-weighting. Asthma control was similar between cohorts, with no significant differences in Asthma Control Test scores or short-acting β2-agonist fills during the 12-month period following the index. Treatment adherence, assessed using proportion of days covered (≥0.8), was higher in the FP/SAL cohort (5.4 %) versus the BUD/FOR cohort (4.4 %; p < 0.001).

Conclusions: FP/SAL and BUD/FOR were similarly effective for asthma control in real-world settings, while FP/SAL was generally associated with greater medication adherence, a key factor for long-term control.

Keywords: Asthma; Budesonide/formoterol; Effectiveness; Fluticasone propionate/salmeterol; Retrospective.

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Conflict of interest statement

Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: NH received honoraria for serving as consultant for Amgen, Astra Zeneca, GSK, and Sanofi/Regeneron, and received research grant support from Astra Zeneca, Genentech, GSK, and Sanofi. RS has received personal payment and honoraria from GSK as a steering committee member for this study. AR has received payment or honoraria for lectures, presentations, speaker bureaus, manuscript writing or educational events from Astra Zeneca, Chiesi, GSK, and Sanofi. BG's institute has received payment or honoraria for lectures, presentations, speaker bureaus, manuscript writing or educational events from Abdi İbrahim, Astra Zeneca, Deva, GSK, Novartis, and Sanofi, and for participation in a data safety monitoring board or advisory board from Abdi İbrahim and GSK. BG has also taken unpaid roles as the Chair of Turkish BOARD of Pulmonology in Turkey and GARD (Global Alliance against chronic respiratory diseases) Turkey Coordinator. LF has received payment from GSK as a steering committee member for this study. WB has received payment or honoraria for lectures, presentations, speaker bureaus, manuscript writing or educational events from GSK Thailand and Novartis Thailand. AM and MH are GSK employees; MH holds financial equities in GSK. NO is an employee of Optum and received honoraria for serving as consultant for GSK to conduct this study.

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