Hundreds of millions of people worldwide suffer from allergies. The term allergic rhinitis is used to describe symptoms of allergies which include itchy, runny nose, congestion, and sneezing.
Eye symptoms may also occur and they include itchy, watery eyes, and redness.
- Currently, there are 4 main classes of drugs used to treat allergies:
- Nasal steroids (fluticasone, Flonase®, Nasonex®, etc.)
- Nasal antihistamines (azelastine, Astelin®)
- Oral antihistamines (Claritin®, Allegra®, etc.)
- Leukotriene inhibitors (Singulair®)
The study detailed below compared Dymista (fluticasone + azelastine) to its individual components and placebo in 3398 patients with allergic rhinitis
- Three separate randomized controlled trials compared the effects of 4 different nasal sprays in a total of 3398 patients with allergic rhinitis. The combined results of the three trials
are presented here.
Main inclusion criteria
- ≥ 12 years old
- ≥ 2 year history of seasonal allergic rhinitis (SAR)
- Significant current clinical rhinitis symptomatology
- Positive skin test to relevant pollen
- Moderate-to-severe symptom score
- Average age about 37 years
- Average length of seasonal allergic rhinitis about 20 years
- Average total nasal symptom score - 19
Randomized treatment groups
- Group 1 (848 patients): Combination nasal spray containing fluticasone and azelastine (Dymista®, MP29-02)
- Group 2 (846 patients): Fluticasone spray
- Group 3 (847 patients): Azelastine spray
- Group 4 (857 patients): Placebo spray
- All sprays were given as 1 spray in each nostril twice daily
- There was a 7-day placebo spray lead-in period
Primary outcome: The sum of the morning and evening change from baseline in reflective total nasal symptom score
(range 0 - 24, 0 = no symptoms, 24 = severe symptoms) over the treatment period
|Duration: 2 weeks
||Dymista vs others p<0.001
- Patients using the combination spray had quicker symptom relief (defined as ≥ 50% reduction in symptoms) than patients using fluticasone
(up to 3 days earlier) or azelastine (up to 5 days earlier) alone
- Eye symptoms were significantly improved with all 3 treatment when compared to placebo
- The most common side effect was bad taste in mouth from the azelastine-containing products (up to 7.2% of subjects)
Findings: MP29-02 represents a novel therapy that demonstrated superiority to 2 first-line therapies for AR. Patients with moderate-to-severe SAR achieved better control,
and their symptoms were controlled earlier with MP29-02 than with recommended medications according to guidelines.
Allergic rhinitis is a common
condition that makes millions of people miserable each year. This study showed that the combination of a nasal steroid and a nasal antihistamine was superior to a nasal steroid alone.
Perhaps the most significant finding was that the combination spray led to quicker symptom relief (3 - 5 days sooner) than either drug alone. Overall,
the absolute difference in symptom relief between the combination spray and the nasal steroid was small (about a 3% difference on the total nasal symptom score). Azelastine may cause a bad taste
in up to 20% of patients which can lead to discontinuation.
In conclusion, patients who suffer from seasonal allergic rhinitis may want to try a combination of azelastine and a nasal steroid for quicker, slightly better relief than a nasal steroid
alone. The combination product in the study is marketed as Dymista®, and it has a generic. Azelastine and fluticasone are also sold individually and may be cheaper when prescribed separately.