Overview:
This randomized, double-blind, active-controlled, multicenter study evaluated a fixed-dose combination (FDC) of fluticasone furoate (27.5 mcg) and oxymetazoline hydrochloride (50 mcg) nasal spray, administered once nightly, in patients with moderate-to-severe allergic rhinitis and nasal congestion. The study compared the FDC to fluticasone monotherapy over 28 days, assessing symptom improvement and safety.
The Takeaways:
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The FDC significantly outperformed fluticasone alone in reducing nighttime Total Nasal Symptom Scores (TNSS) across all measured time points, beginning as early as Day 3 and continuing through Day 28 (e.g., Day 28 TNSS: −7.0 [FDC] vs −6.4 [Fluticasone]; P < 0.001).
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A significantly greater proportion of patients experienced complete relief of nasal congestion with the FDC (44.7%) versus fluticasone alone (26.8%) (P < 0.05).
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No increase in rebound congestion or rhinitis medicamentosa was observed after stopping treatment—rates were similar across both groups (P > 0.05).
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The FDC was well tolerated, with a safety profile comparable to fluticasone alone.
Why It Matters:
Oxymetazoline is known for rapid decongestant effects, but concerns around rebound congestion have limited its long-term use. This study shows that when used in combination with a corticosteroid, oxymetazoline can provide enhanced and sustained symptom relief—including complete resolution in nearly half of patients—without causing rebound congestion, even after 28 days of continuous use.
The Link to Allermi:
This study validates Allermi’s core approach: combining low-dose oxymetazoline with corticosteroid to maximize congestion relief while minimizing risks. Allermi's micro-dosed, science-backed formulations are designed to offer consistent efficacy without compromising safety. By customizing spray combinations and dosing frequency, Allermi delivers precise, patient-specific treatments—echoing the success of this fixed-dose combination in clinical practice.
For more details, refer to the full study: Efficacy and Safety of Fluticasone Furoate and Oxymetazoline Nasal Spray: A Novel First Fixed Dose Combination for the Management of Allergic Rhinitis with Nasal Congestion
