Azelastine hydrochloride and Fluticasone propionate Combination Nasal Spray Safe and Effective in Allergic Rhinitis

3 Jul, 20

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Introduction

The current guidelines recommend H1-antihistamines as the first line therapy for allergic rhinitis (AR) and intranasal corticosteroids (INS) as the gold standard for moderate to severe cases. However, an effective symptom control is not attained by most of the AR patients. The antihistamine property of azelastine hydrochloride (AZE) together with the anti-inflammatory property of fluticasone propionate (FP) might be beneficial in these patients and help in achieving effective symptom control.

Aim

The efficacy and safety of AZE nasal spray in combination with FP was compared to AZE monotherapy in patients with moderate to severe AR.

Methods

Study Design

Prospective, randomized, open-label, parallel-group, comparative study

Treatment Strategy

Patients aged 18-65 years with moderate to severe AR
Randomized into 2 groups of 35 patients each
Group A received 137 µg AZE, two sprays in each nostril twice daily
Group B received combination of 137 µg AZE and 50 µg FP, two sprays per nostril twice daily
The cohort underwent physical, clinical, nasal and ocular assessments at baseline (visit 1)
Treatment duration was for 2 weeks with a follow up at end of 2 weeks (visit 2)

Endpoints

Mean change in total symptom score (TSS) from baseline
Total nasal symptom score (TNSS)
Total ocular symptom score (TOSS)
Adverse events (AEs)

Results

The mean change in efficacy endpoints at visit 2 from baseline are shown in table 1.

Table 1. Mean change in efficacy endpoints at visit 2

	Group A		Group B
	Baseline	Visit 2	Baseline	Visit 2
TNSS	9.88+0.99	5.78+2.35	9.97+0.92	2.71+1.36
TOSS	5.8+1.32	1.60+1.19	6.08+1.37	1.04+0.87
TSS	15.68+1.98	5.78+2.35	16.0+1.86	3.22+1.64

At visit 2, group B demonstrated significant reductions in TNSS, TOSS and TSS as compared to group A; p<0.0001, p<0.0016 and p<0.0001 respectively
Both the groups tolerated the nasal sprays well
Common AEs were bitter taste and headache
There were no serious AEs

Conclusion

The nasal spray containing azelastine hydrochloride (AZE) and fluticasone propionate (FP) was safe and offered better symptomatic improvement as compared to AZE monotherapy in patients with allergic rhinitis (AR).

Natl J Physiol Pharm Pharmacol. 2019; 9(5): 356-360. Doi: 10.5455/njppp.2019.9.0204820022019.