Fluticasone + Azelastine Nasal Spray Provides Significant Symptom Relief in Allergic Rhinitis
Introduction
Allergic rhinitis (AR) is characterized by sneezing, nasal congestion, itchy nose and rhinorrhea. The patients also experience physiological symptoms such as itching, runny eyes, stuffy nose and headaches, negatively affecting the daily activities. The symptoms not only manifest in the upper respiratory tract but also affect the lower respiratory tract. There is a need of an accurate medical therapy which can provide adequate symptomatic relief, is clinically effective and reduces the AR complications.
Aim
This study evaluated the efficacy of topical therapy with fluticasone propionate and antihistamine (azelastine hydrochloride) and fluticasone propionate alone in patients with AR. The efficacy of these drugs in suppressing the AR symptoms was also compared.
Methods
Study Design
- Triple-blind retrospective analysis conducted at a single center
Treatment Strategy
- A total of 220 patients of perennial or seasonal AR were enrolled
- Clinical and laboratory investigations were performed to assess the AR symptoms
- Baseline symptoms were recorded in the symptom diary
Endpoints
- Sneezing symptom score
- Nasal obstruction symptom score
- Watering of eyes symptom score
- Adverse events
Results
- The patients were randomized to group 1 and group 2 of 110 patients each; who received 2 puffs /nostril of fluticasone propionate alone and fluticasone propionate + azelastine for 4 weeks
- The mean total symptom scores were comparable in both the treatment groups at baseline
- Post-treatment scores were reduced in both the groups
- Comparison of symptom scores is shown in Table 1.
- Fluticasone + Azelastine nasal spray demonstrated better reduction in sneezing, nasal obstruction and eye watering symptom scores post-treatment
|
|
Pre-treatment |
Post-treatment |
% reduction in score |
P value |
|
Sneezing symptom score (Mean + Standard deviation) | ||||
|
Group 1 |
2.44+0.71 |
0.21+0.36 |
91.35% |
<0.05 |
|
Group 2 |
2.61+0.79 |
0.11+0.41 |
95.8% |
|
|
Nasal obstruction symptom score (Mean + Standard deviation) | ||||
|
Group 1 |
2.36+0.66 |
0.61+0.21 |
74.15% |
<0.05 |
|
Group 2 |
2.41+0.61 |
0.27+0.13 |
88.79% |
|
|
Watering of eyes symptom score (Mean + Standard deviation) | ||||
|
Group 1 |
0.45+0.51 |
0.04+0.11 |
88.89% |
<0.05 |
|
Group 2 |
0.63+0.23 |
0.04+0.13 |
96.29% |
|
- None of the patients reported any significant side effect
- Moderate side effect was reported by only 12/220 patients, 5 from group 1 and 7 from group 2
- The most common side effect was nasal bleeding followed by nasal discomfort, throat irritation and headache
Conclusion
- The fluticasone propionate and azelastine hydrochloride combination nasal spray was clinically more effective in suppressing allergic rhinitis (AR) symptoms as compared to fluticasone alone.
Int J Res Pharm Sci.2020; 11(3):4636-43.
