Nasal spray improves seasonal allergic rhinitis symptoms in children aged 6 to 11 years

Key takeaways:

• The researchers found significant and meaningful improvements in reflective and instantaneous Total Nasal Symptom Scores with GSP301 treatment.
• There also were statistically significant improvements in overall Pediatric Rhinoconjunctivitis Quality of Life Questionnaire scores.
• Most treatment-emergent adverse events were unrelated to the study treatment, and all except one in the placebo group were mild or moderate.

The nasal spray GSP301 effectively treated symptoms of seasonal allergic rhinitis in children aged 6 to 11 years with a positive impact on their quality of life, according to a study published in Annals of Allergy, Asthma & Immunology.

The medication also had a favorable safety and tolerability profile, Bruce M. Prenner, MD, lead physician and president of Allergy Associates Medical Group in San Diego, and colleagues wrote in the study.

GSP301 (Ryaltris, Glenmark Pharmaceuticals) — which includes a fixed-dose combination of 665 µg of the antihistamine olopatadine hydrochloride and 25 µg of the corticosteroid mometasone furoate — is FDA approved for children aged at least 12 years. The current analysis sought to evaluate its safety and efficacy among younger children with season allergic rhinitis during the spring or fall allergy season.

The cohort included 446 patients ( 75% white), with nearly 45% aged 6 to younger than 9 years, assigned to placebo (n = 221; mean age, 8.7 years) or GSP301 (n = 225, mean age, 8.6 years). Patients received one spray in each nostril twice a day for 14 days.

The researchers found statistically significant and clinically meaningful improvements in average morning and evening 12-hour reflective Total Nasal Symptom Scores (rTNSS) over the treatment period compared with placebo (P = .001), meeting the study’s primary endpoint. These improvements occurred from day 3 to day 14 (P < .05).

There also were statistically significant differences favoring GSP301 in all individual average morning and evening reflective nasal symptoms over the treatment period (P < .05).

Similarly, the researchers found statistically significant and clinically meaningful improvements in average instantaneous morning and evening TNSS throughout the treatment period compared with placebo (P < .001), with significant improvements in all symptoms except for nasal itching and on each treatment day (P < .05).

Average morning and evening reflective and instantaneous total ocular symptom scores showed numerical improvements (least mean squares difference, –0.2 to –0.1) with GSP301 during the treatment period, except for instantaneous redness of eyes. However, only the difference in reflective scores for tearing/watering eyes achieved statistical significance (P = .038).

GSP301 led to statistically significant improvements in Physician-assisted Nasal Symptom Scores on day 15 (P = .01) and in scores for all physician-assessed individual nasal symptoms compared with placebo (P < .05) as well.

Further, there were statistically significant improvements in overall Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) scores on day 15 with GSP301 compared with placebo (P < .001). Improvements specifically were seen in activity limitations, practical problems, nose symptoms and other symptoms based on the PRQLQ (P < .05), with the largest effect size and highest level of significance for nose symptoms (least squares mean difference, –0.6; P < .001).

Finally, 12% of the GSP301 group and 10.4% of the placebo group experienced one or more treatment-emergent adverse events, including dysgeusia, headache, epistaxis and abnormal ENT examination, although only the GSP301 group experienced dysgeusia.

Most treatment-emergent adverse events were unrelated to the study treatment, the researchers wrote, and all except for one event in the placebo group were mild or moderate. Five of the placebo patients and four of the GSP301 patients discontinued participation in the study due to treatment-emergent adverse events, and these events were resolving or had resolved when the study was written.

Noting that GSP301 treatment for seasonal allergic rhinitis only is approved for patients aged 12 years and older in the United States, the researchers said that their findings support its safe and effective use in patients aged 6 years and older.