Safe Long-term Treatment of Nasal Symptoms in Patients with Perennial Allergic Rhinitis
In persistent allergic rhinitis, achieving symptom control is often difficult despite pharmacological treatment and minimizing contact with the allergen. Good efficacy in clinical studies has been shown with combined therapy of intranasal antihistamines with locally acting corticosteroids. The presented study evaluated the long-term safety profile and efficacy of a fixed combination of olopatadine with mometasone.
Local Treatment of Allergic Rhinitis
In patients with persistent allergic rhinitis, long-term treatment may lead to a reduction in therapy efficacy. In short-term clinical studies, a fixed combination of the intranasal antihistamine olopatadine with the corticosteroid mometasone furoate showed significant and sustainable improvement of seasonal allergic rhinitis symptoms compared to placebo and individual components administered as monotherapy. The treatment was well tolerated in these studies and had a rapid onset of effect – within 15 minutes.
Based on the study results, further clinical evaluation was conducted to assess the long-term efficacy and safety of this combination over 52 weeks.
Methodology and Study Objectives
601 patients with perennial allergic rhinitis participated in a randomized double-blind study. Patients aged 12 years and older were randomized in a ratio of 4:1:1 into an active treatment group (2 times daily 665 μg olopatadine + 25 μg mometasone as a fixed combination in a nasal spray, solution pH 3.7) and two control groups (placebo with pH 3.7 and placebo with neutral pH 7.0).
The primary objective of the study was to assess the safety profile. Efficacy was evaluated for the fixed combination compared to placebo of the same pH, using parameters of change in mean morning total nasal symptom score (rTNSS – reflective Total Nasal Symptom Score), instantaneous nasal symptom score (iTNSS – instantaneous Total Nasal Symptom Score), physician-assessed nasal symptom score (PNSS – Physician-assessed Nasal Symptom Score), and quality of life.
Results
After 52 weeks, adverse events during treatment occurred in 51.7% of patients with active treatment (n = 393), 41.4% with placebo pH 3.7 (n = 99), and 53.5% with placebo pH 7.0 (n = 101). No clinically significant differences in incidence of adverse events during treatment or other assessed safety parameters were observed between groups.
The fixed olopatadine/mometasone combination compared to placebo provided significant and clinically meaningful improvement in mean rTNSS and iTNSS scores at week 6 and 30. At week 52, the average least squares mean difference (LSMD) compared to placebo for rTNSS was -0.91 (95% confidence interval [CI] -1.35 to -0.47; p < 0.001) and for iTNSS -0.75 (95% CI -1.17 to -0.33; p < 0.001), with significant improvement for each evaluated symptom (p < 0.05 for all comparisons).
PNSS and quality of life were significantly improved compared to placebo at weeks 6 and 30 (p < 0.05), but this improvement did not reach statistical significance at week 52.
Conclusion
The fixed combination of olopatadine with mometasone administered 2 times daily as a nasal spray was well tolerated by patients and provided statistically significant and clinically meaningful improvement in nasal symptoms of persistent allergic rhinitis. This treatment demonstrated a favorable long-term safety profile and good efficacy without loss of effectiveness over a one-year follow-up in patients older than 12 years.
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Source: Segall N., Prenner B., Lumry W. et al. Long-term safety and efficacy of olopatadine-mometasone combination nasal spray in patients with perennial allergic rhinitis. Allergy Asthma Proc 2019; 40 (5): 301–310, doi: 10.2500/aap.2019.40.4233.
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