Introduction

Nasal polyposis is a rare condition in children. Nevertheless, children suffering with nasal polyposis require an effective therapy to treat the condition. Studies have demonstrated that mometasone furoate nasal spray (MFNS) improves nasal symptoms and reduces polyp size in adults with nasal polyposis. Studies have also demonstrated the safety and efficacy of intranasal corticosteroids, including MFNS, in pediatric populations at dosages used to treat allergic rhinitis. The current data on the safety of intranasal corticosteroid use in children at the higher dosages necessary to treat nasal polyposis is very scarce.

Aim

To ascertain the safety of MFNS to treat nasal polyposis in pediatric subjects aged 6–17 years.

Patient Profile

• Children affected with bilateral nasal polyposis (age; 6-17 years).
• The study subjects had a nasal congestion/obstruction score ≥ 1 on a scale of 0 (none) to 3 (severe), rated in the morning according to prior (reflective over the previous 12 h) symptom assessment on each of the last 2 days prior to and on the morning of the baseline visit.

Methods

Study Design

Treatment Strategy

• The study subjects were randomized 4:4:1:1 to receive MFNS once daily, MFNS twice daily, placebo once daily, or placebo twice daily.
• Patients aged 6-11 years were treated with MFNS 100 µg (once or twice daily as per randomization). Patients aged 12-17 years were treated with MFSN 200 µg (once or twice daily as per randomization).
• The study subjects were treated for 4 months and evaluations were conducted at day 8 and months 1, 2, 3, and 4.

Outcome

Primary Outcome

adrenal (HPA) axis function].

Secondary Safety Outcome

• 24-h urinary free cortisol corrected for creatinine.
• Incidence of adverse events. 

Efficacy Outcomes

• Subject-rated signs/symptoms
• Investigator-evaluated therapeutic response, and polyp size

Results

• The study population comprised of 127 subjects (46 in age group 6–11 yr and 81 in age group 12–17 yr). 
• The least squares mean (LSM) changes from baseline in 24-h urinary free cortisol levels did not differ significantly amongst the patients treated with MFNS once daily/twice daily or placebo, or in the subgroups 6-11 years and 12-17 years (Fig. 1).

Fig. 1: Urinary free cortisol at baseline and study end

• The LSM change in 24-h urinary free cortisol corrected for creatinine did not differ significantly between MFNS-treated and placebo-treated groups. 
• No safety issues were evident during the study period.
• The study was not powered to evaluate the efficacy. MFNS twice daily produced the greatest improvement in polyp size, congestion, and rhinorrhea/postnasal drip. Both once‑ and twice‑daily groups showed superior congestion relief, as compared to placebo, with twice‑daily dosing yielding better investigator‑assessed therapeutic response.

Conclusion

• Findings from the study confirm the safety profile of MFNS in children affected with bilateral nasal polyps over 4 months, even at double the recommended pediatric dosage for allergic rhinitis.
• No clinically meaningful changes were observed in the HPA axis of the treated children as measured by 24-h urinary free cortisol level. 

Pediatr Allergy Immunol. 2013: 24: 33–38.