Efficacy and long-term safety of mometasone furoate nasal spray in children with perennial allergic rhinitis

Abstract

Background:

Allergic rhinitis (AR) affects up to 40% of children by age 6 years. Perennial AR (PAR) causes sleep disturbance, diminishes concentration in school, impairs psychosocial functioning, and reduces quality of life. This study evaluated efficacy and long-term safety of the intranasal corticosteroid mometasone furoate nasal spray (MFNS) in children with PAR.

Methods:

This study comprised a double-blind, 4-week efficacy and safety period followed by a 6-month, open-label safety period. Primary efficacy variable during the double-blind period was mean change in physician-evaluated total nasal symptom score (TNSS) from baseline to day 15. Other efficacy variables during this phase included subject-evaluated TNSS, individual nasal symptoms, and total symptom score (TSS, nasal and non-nasal symptoms, summed). Physician-evaluated improvement in overall condition of PAR was assessed during the open-label period. Adverse events (AEs) were monitored throughout.

Results:

Subjects aged 3–11 years with PAR (n = 381) were randomized to MFNS 100 µg (n = 190) or placebo (n = 191) daily for 4 weeks; 357 subjects continued into the open-label period, receiving MFNS only. Between baseline and day 15, significantly greater mean changes were seen with MFNS-treated patients than placebo in physician-evaluated TNSS (−2.8, −39%, vs. −2.2, −32%; p = 0.02). Statistically significant improvements in MFNS versus placebo were reported for subject-evaluated TNSS, TSS, and individual nasal symptom scores (p ≤ 0.03 for all).

Improvement continued through the open-label period. Subjects treated with MFNS in both periods experienced a 45% further reduction in TSS in this study phase, while those who switched from placebo to MFNS saw a further 49% decrease. MFNS was well-tolerated in both periods. The most frequently reported treatment-related AEs during the double-blind period for MFNS and placebo, respectively, were epistaxis, seven (4%) and nine (5%); sneezing, five (3%) and seven (4%); headache, six (3%) and five (3%). During the open-label period, the AEs reported most often were epistaxis 37 (10%), headache nine (3%), and rhinitis 12 (3%).

Limitations:

Studies in children present unique challenges because subjects are too young to grasp subjective concepts such as symptom severity, especially as rated on a numbered scale. In addition, the 6-month extension of the placebo-controlled phase used a single agent. It is also possible that subjects’ symptoms could have abated independent of mometasone furoate treatment.

Conclusion:

MFNS 100 µg/day effectively reduces TNSS, TSS (including ocular symptoms), and individual symptoms associated with PAR and is well-tolerated for up to 6 months in children aged 3–11 years with a safety profile similar to placebo.

Key words::

• Adverse events
• Children
• Intranasal corticosteroids
• Persistent allergic rhinitis

Transparency

Declaration of funding

Financial support for this study was provided by Schering-Plough Corporation, now Merck & Co., Inc., Whitehouse Station, New Jersey, USA. The authors have made substantial contributions to the conception and design of the study, have revised the article critically for important intellectual content, and have approved the version that was submitted.

Declaration of financial/other relationships

C.B-C. has been involved in the speaker’s bureaus for GlaxoSmithKline and sanofi-aventis and has received speaker’s honoraria from Altana, sanofi-aventis, Novartis, Schering-Plough, Lofarma (Italy), MSD, Boehringer-Ingelheim, AstraZeneca, Grünenthal, Lofarma, Merck Serono Argentina, Phoenix Argentina, FAES Spain, ALK-Abello, Uriach Spain, UCB, and BioAllergy (Italy). He has also received clinical research support from sanofi-aventis, GlaxoSmithKline, Schering-Plough, MSD, and Novartis. P.P. has received clinical research support from Schering-Plough Corporation. Peer reviewers may receive honoraria from CMRO for their review work. The peer reviewers have disclosed no relevant financial relationships.

Acknowledgments

Editorial assistance was provided by Patricia C. Abramo. This assistance was funded by Schering-Plough.