A Randomized, Double-Blind Trial of a Novel Dual-Acting Inhaled Corticosteroid and Long-Acting Beta-2 Agonist Polymer in Severe Asthma

International Journal of Medical Advances and Discoveries | Vol. 17, No. 4, April 2026 | pp. 28–36

DOI: 10.46882/2026/IJMAD/000115

Original Research Article

Title: A Randomized, Double-Blind Trial of a Novel Dual-Acting Inhaled Corticosteroid and Long-Acting Beta-2 Agonist Polymer in Severe Asthma

Names of Authors: Fiona R. Macpherson¹, Alastair C. Vance², Siddharth M. Nair¹

Authors’ Affiliations: ¹Institute of Cellular Medicine, University of Edinburgh, Edinburgh, UK; ²Division of Pulmonology, Glenfield Hospital, Leicester, UK

Abstract: Severe refractory asthma requires high doses of inhaled therapies that face patient compliance limits and variable deposition in the smaller airways. This randomized, double-blind, parallel-group active-controlled trial evaluated the clinical efficacy and safety of a novel co-suspended dual-acting microparticle polymer formulation, containing fluticasone propionate and formoterol fumarate (FP/FF-Polymer), versus conventional dry-powder inhaler (DPI) delivery in 310 patients with severe persistent asthma. Participants were randomized 1:1 to receive either FP/FF-Polymer or standard DPI FP/FF twice daily for 24 continuous weeks. The primary endpoint was the mean change from baseline in forced expiratory volume in 1 second (FEV1) at week 24. Patients utilizing the microparticle polymer formulation demonstrated a significantly higher increase in mean FEV1 compared to the control group (+280 ± 35 mL vs. +140 ± 28 mL, p < 0.001). Weekly asthma exacerbation rates fell by 44% in the experimental arm (p = 0.003). Impulse oscillometry metrics confirmed a 38% reduction in small airway resistance (R5–R20) for the polymer group, reflecting enhanced peripheral drug deposition. The safety and tolerability profile was comparable across both cohorts, with dysphonia (4.5%) and oral candidiasis (3.2%) remaining within expected limits. The co-suspended FP/FF-polymer matrix markedly improves small airway mechanics and reduces exacerbations in severe asthma.

Keywords: Severe asthma, Inhaled corticosteroid, Long-acting beta agonist, Pulmonary function, Small airway resistance, FEV1

Manuscript Timeline: Received: January 08, 2026; Revised: February 20, 2026; Accepted: March 11, 2026; Published: April 17, 2026

Citation: Macpherson, F. R., Vance, A. C., & Nair, S. M. (2026). A Randomized, Double-Blind Trial of a Novel Dual-Acting Inhaled Corticosteroid and Long-Acting Beta-2 Agonist Polymer in Severe Asthma. International Journal of Medical Advances and Discoveries, 17(4), 28–36. doi.org

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