Azelastine for Allergic Rhinitis
Azelastine nasal spray is a highly effective intranasal antihistamine for allergic rhinitis with rapid onset of action (15-30 minutes), particularly useful for patients requiring quick symptom relief or those who remain symptomatic on oral antihistamines, though intranasal corticosteroids remain the most effective monotherapy overall. 1, 2
Efficacy Profile
Azelastine demonstrates superior efficacy compared to oral antihistamines and provides clinically significant relief of all major nasal symptoms including nasal congestion. 1, 2
- Azelastine is effective for rhinorrhea, sneezing, nasal itching, and notably provides relief of nasal congestion—a symptom where oral antihistamines typically fail 1, 2
- The medication works within 15-30 minutes of administration, making it appropriate for as-needed (PRN) use in episodic allergic rhinitis 1, 2, 3
- Effectiveness equals or exceeds oral second-generation antihistamines like loratadine, cetirizine, and fexofenadine 1, 4
- Azelastine is less effective than intranasal corticosteroids for overall nasal symptom control 1
FDA-Approved Indications and Dosing
- Seasonal allergic rhinitis: Adults and children ≥5 years 5
- Vasomotor rhinitis: Adults and children ≥12 years 5
- Azelastine 0.1% (Astelin): 1-2 sprays per nostril twice daily for ages ≥6 years
- Azelastine 0.15% (Astepro): 1-2 sprays per nostril twice daily for ages ≥6 years
- Both continuous daily use and PRN dosing are appropriate given the rapid onset 1
Combination Therapy: The Superior Option for Moderate-to-Severe Disease
For patients with moderate-to-severe allergic rhinitis, combining azelastine with fluticasone propionate nasal spray provides 40% greater symptom reduction than either agent alone and should be strongly considered as first-line therapy. 2, 6, 7
- The combination reduces Total Nasal Symptom Scores by 5.31-5.7 points compared to 3.25-4.54 for azelastine alone and 3.84-5.1 for fluticasone alone 2
- This combination is particularly beneficial for patients who have failed oral antihistamine therapy 2, 8
- The 2017 Joint Task Force provides a recommendation (albeit weak due to cost and study design concerns) for using intranasal corticosteroid plus intranasal antihistamine combination for initial treatment of moderate-to-severe seasonal allergic rhinitis 7
Clinical Positioning Algorithm
For mild symptoms or episodic allergic rhinitis:
- Start with azelastine monotherapy given its rapid onset and effectiveness for PRN use 1, 2
- Particularly useful when quick relief is needed within 15-30 minutes 2, 3
For moderate-to-severe symptoms:
- Initiate combination therapy with azelastine plus fluticasone for superior symptom control 2, 6, 7
- If combination unavailable or cost-prohibitive, intranasal corticosteroid monotherapy remains the most effective single agent 1, 7
For patients failing oral antihistamines:
- Switch to azelastine nasal spray monotherapy rather than adding another oral medication 2, 8
- Studies demonstrate azelastine effectively improves symptoms in patients who remained symptomatic on fexofenadine 8
For mixed rhinitis (allergic + nonallergic):
- Azelastine is an appropriate choice as it is FDA-approved for both allergic and vasomotor rhinitis 1, 5
Safety Profile and Common Pitfalls
Azelastine is well-tolerated with minimal systemic side effects, though bitter taste is the most common complaint. 2, 5, 3
- Bitter taste (dysgeusia): Occurs in 8-19% of patients 7, 5, 3
- Somnolence: Rates range from 0.4-3%, comparable to placebo in recent studies, though older data showed rates up to 11.5% 2, 5
- Counsel patients about potential somnolence when initiating therapy, particularly if operating machinery 2
- Epistaxis and nasal irritation are minimal compared to intranasal corticosteroids 7
Long-Term Safety Considerations
The azelastine-fluticasone combination offers distinct safety advantages for long-term use, particularly in patients with glaucoma, cataracts, or osteoporosis, due to azelastine's lack of systemic corticosteroid effects. 6
- Instruct patients to use contralateral spray technique (right hand for left nostril, left hand for right nostril) to aim spray away from the nasal septum, reducing epistaxis risk four-fold 6
- Periodic nasal examination (every 6-12 months) is recommended to check for septal erosions when using combination therapy 6
- Systemic absorption of fluticasone is negligible, making the combination safe for prolonged use 6
Critical Caveats
- While azelastine monotherapy is effective, it is less effective than intranasal corticosteroids for overall nasal symptom control 1
- The combination therapy's quality of life improvement does not always exceed the minimal clinically important difference compared to monotherapies, and cost must be considered 7
- Azelastine has limited efficacy in nonallergic rhinitis syndromes (except vasomotor rhinitis), making other options preferable for mixed rhinitis where the nonallergic component predominates 1