Comparison of the clinical efficacy of standard and mucoadhesive-based nasal decongestants.
OBJECTIVE
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.
Tzachev
Christo T
CT
Department of Industrial Pharmacy, Faculty of Pharmacy, Medical University, Sofia, Bulgaria.
Mandajieva
Mariana
M
Minkov
Evgeniy H
EH
Popov
Todor A
TA
D000328:Adult; D000368:Aged; D019540:Area Under Curve; D002626:Chemistry, Pharmaceutical; D016001:Confidence Intervals; D018592:Cross-Over Studies; D004311:Double-Blind Method; D004337:Drug Carriers / Q000627:therapeutic use; D005260:Female; D006801:Humans; D007093:Imidazoles / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D014663:Nasal Decongestants / Q000627:therapeutic use*; D012221:Rhinitis, Allergic, Perennial / Q000188:drug therapy*; D018709:Statistics, Nonparametric; D016896:Treatment Outcome
D004337:Drug Carriers; D007093:Imidazoles; D014663:Nasal Decongestants; C009695:xylometazoline