Efficacy and Safety of Fixed Combination of Olopatadine and Mometasone in Nasal Spray for Treatment of Seasonal Allergic Rhinitis

Methodology and Study Progress 

A total of 1,180 patients (average age 39.3 years) aged ≥ 12 years with seasonal allergic rhinitis were enrolled in a multicenter, double-blind, randomized phase III clinical study. They were randomized into 4 groups:

• fixed combination of 665 μg olopatadine hydrochloride + 25 μg mometasone furoate (GSP301)
• 665 μg olopatadine
• 25 μg mometasone
• placebo

The treatment was administered intranasally in the form of a nasal spray (2 sprays into each nostril 2× daily) during the spring pollen season. After an initial placebo phase lasting 7–10 days, a 15–17-day treatment phase followed. All patients had been treated for allergic rhinitis for ≥ 2 years, with a reaction to the allergen confirmed by a skin prick test.

Exclusion criteria were as follows:

• nasal polyps or clinically significant malformation, respiratory disease, or infection
• recent nasal biopsy, trauma, or surgery
• significant atopic dermatitis
• acute or significant chronic sinusitis
• chronic purulent postnasal drip
• medication-induced rhinitis
• acute respiratory illness or infection (e.g., bronchitis, pneumonia, or flu)
• respiratory infection during the initial phase of the study

Monitored parameters included changes in reflective (i.e., over the past 12 hours) nasal and ocular symptom scores (rTNSS – reflective Total Nasal Symptom Score and rTOSS – reflective Total Ocular Symptom Score), instantaneous (i.e., over the last 10 minutes before the next dose) nasal and ocular symptom scores (iTNSS – instantaneous Total Nasal Symptom Score and iTOSS – instantaneous Total Ocular Symptom Score) in the morning and afternoon. Additionally, the time to onset of effect, physician-assessed nasal symptom score (PNSS), specific quality of life, and the incidence of adverse events were monitored.

Results

A total of 1,126 patients completed the study. Most had moderate nasal and ocular symptoms of allergic rhinitis at entry.

During 14 days of GSP301 use, both morning and afternoon rTNSS improved compared to placebo (least squares mean difference −0.98; 95% confidence interval [CI] −1.38 to −0.57; p < 0.001) and olopatadine (p = 0.003). Statistically significant improvement was also seen compared to mometasone (p = 0.059). Significant improvement during GSP301 treatment was also achieved regarding morning and afternoon iTNSS compared to placebo and each monotherapy (all p < 0.05). Compared to placebo, GSP301 also reduced individual nasal symptoms, total ocular symptoms (rTOSS and iTOSS), and quality of life (all p < 0.01) and PNSS (p < 0.001).

GSP301's onset of effect was seen after 15 minutes, significantly earlier than after placebo or monotherapy, and this difference persisted at each subsequent measurement.

Adverse events (mostly mild or moderate) were observed in 12.9% of patients with GSP301, 12.5% with olopatadine, 7.1% with mometasone, and 9.4% with placebo.

Conclusion

The fixed combination of the antihistamine olopatadine hydrochloride (with rapid onset of action) and the corticosteroid mometasone furoate (providing long-term relief) administered 2× daily in the form of a nasal spray was found to be an effective and safe treatment modality for seasonal allergic rhinitis in adolescents (aged 12 and older) and adults.

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Source: Hampel F. C., Pedinoff A. J., Jacobs R. L. et al. Olopatadine-mometasone combination nasal spray: evaluation of efficacy and safety in patients with seasonal allergic rhinitis. Allergy Asthma Proc 2019; 40 (4): 261–272, doi: 10.2500/aap.2019.40.4223.