A phase IV, single-center, crossover evaluation of the efficacy of an external nasal dilator strip in children with nasal congestion.

BACKGROUND

In the United States and other countries, external nasal dilator strips have been marketed for use by adults and by children ages 5-12 years to improve nasal airflow and provide temporary relief from nasal congestion and stuffiness.

OBJECTIVE

The objectives of this exploratory analysis were to assess and correlate objective and subjective measures of efficacy of two nasal strips variants, Kids and adult small/medium (Regular), in children with nasal congestion. The correlation of efficacy for each variant to nose dimensions and age was also explored.

METHODS

In a single-center, crossover study, peak nasal inspiratory flow (PNIF) was measured in 40 children with nasal congestion ages 5-12 years before and after application of the nasal strips. Spearman correlations were calculated between objective and subjective measures of efficacy and between efficacy measures, nose dimensions, and age.

RESULTS

In the 40 patients who completed the study, both the Kids and the Regular nasal strips worked well and improved the PNIF by 15% (supine position) to 22% (seated position) over baseline. No statistically significant differences in efficacy were found between the two variants of nasal dilator strips.

CONCLUSIONS

Use of both the Kids and Regular nasal strips significantly improved the PNIF from baseline in children with nasal congestion, and no new safety signals were observed. There was a slight subjective preference for the Kids nasal strips by the younger children, which indicated that children with smaller noses preferred the Kids nasal strips instead of the larger Regular nasal strips. Clinical trial NCT02113449, www.clinicaltrials.gov.