Introduction

The prevalence of allergic rhinitis (AR) in India is significant, leading to considerable medical and social burden with adverse impact on the quality of life of the patients. Nasal congestion is the predominant symptom of AR, affecting the upper respiratory tract. Intranasal corticosteroids (INCS) are effective in relieving nasal congestion, along with other symptoms of AR, but their effect is seen after almost 12 hours of administration. Oxymetazoline, due to its rapid onset of action, is effective within 5-10 min of administration. However, its use should be limited to 3-5 days due to the risk of rebound congestion associated with prolonged use. A fixed-dose combination nasal spray of fluticasone furoate and oxymetazoline was developed considering the limited efficacy of INCS and benefits of oxymetazoline in relieving nasal obstruction.

Aim

The safety and efficacy of the fixed-dose combination nasal spray containing fluticasone furoate and oxymetazoline hydrochloride (FF + OXY) 27.5/50 mcg once daily was assessed in patients with AR in a real-world clinical setting.

Method

Study Design

• Prospective, open-label, single-arm, multicenter, real-world observational study 

Treatment Strategy

• The study recruited patients with clinical diagnosis of AR
• Medical history and data on duration of symptoms, concomitant diseases with medications, nasal and ocular symptoms and rebound congestion was recorded at baseline
• The nasal symptoms evaluated were nasal congestion, itching, rhinorrhea and sneezing
• The ocular symptoms assessed included itching/burning, tearing and redness
• The combination FF + OXY nasal spray was administered in the patients for a maximum duration of 28 days
• The investigators rated the overall effectiveness of the treatment as very good/good/satisfactory/poor using a 4-point Likert scale for each patient

Endpoints

• Change from baseline in
  • Total nasal symptom score (TNSS)
  • Total ocular symptom score (TOSS)
  • Total symptom score (TSS)
• Overall efficacy
• Incidence of adverse events (AEs)

Results

• The study was completed by 388 AR patients; of which about 57% had intermittemt AR and 43% had persistent AR
• The mean duration of first follow-up (FFU) visit was 10.24+6 days and the second follow-up (SFU) visit was 23.37+5 days
• Treatment with FF + OXY resulted in significant reduction in the TNSS, TOSS and TSS as seen in Table 1.

  Table 1. Change from baseline in symptoms at FFU and SFU

  	Baseline	FFU	SFU
  TNSS	7.18 ± 3.38	1.79+2.00	0.20 ± 0.84
  Nasal congestion	2.22+0.97	0.59+0.66	0.05+0.25
  TOSS	2.34 ± 2.29	0.41+0.95	0.09 ± 0.53
  TSS	9.51 ± 4.94	2.20+2.67	0.29 ± 1.32

   

• Reduction in TNSS, TOSS and TOS from baseline to end of study period was 97.21%, 96.15% and 96.97% respectively
• Effectiveness reported by the investigators is shown in Figure 1.

  Figure 1. Effectiveness reported by the investigators

  

• The overall incidence of AEs was 1.28% and no serious AEs were reported

Conclusion

• The fixed-dose combination of once-daily fluticasone furoate and oxymetazoline hydrochloride nasal spray 27.5/50 mcg significantly alleviated nasal congestion and reduced TNSS, TOSS and TSS in patients suffering from AR and these effects were sustained till 28 days
• The combination was safe and well tolerated by all the patients and none had rebound congestion throughout the treatment period

Clin Drug Investig. 2024 Feb;44(2):123-130. Doi: 10.1007/s40261-023-01338-8