Comparison of the clinical efficacy of standard and mucoadhesive-based nasal decongestants

Abstract

Aims: To compare two xylometazoline 0.1% preparations: reference commercial solution (RS) and test mucoadhesive solution (TS).

Methods: Twenty subjects with perennial allergic rhinitis (age range 18-69 years, 5 atopic, 7 men) applied randomly in turn TS and RS for 5 days in a double-blind crossover clinical trial. Nasal airflow resistance (NAR), nasal symptoms (6 grade scoring), frequency of application (times/day), and side-effects were recorded.

Results: Mean ratio TS/RS of areas under the resistance/time curves for NAR +/- 90% CI: 3.56 +/- 0.92; mean TS-RS differences +/- 95% CI: for congestion: -1.12 +/- 0.59, for frequency of application: -1.10 +/- 0.20. Subjects experienced fewer side-effects with TS.

Conclusions: A mucoadhesive solution with a decongestant had a greater and longer lasting effect on nasal congestion in subjects with perennial allergic rhinitis than the commercially available decongestant solution. It also caused fewer side effects.

Figures

Figure 1

NAR change (NAR0−NARi) over time (6 h) on day 1 after application of TS (•) and RS (○), both containing xylometazoline 0.1% as an active agent.

Figure 2

Patients assessment of their ‘nose stuffiness’ over a 5 day treatment period with the TS (•) and RS (○) (minimal discomfort=1; maximal discomfort=6).