Study design: A randomized, double-blind, prospective and multicentric clinical study
Setting: Tertiary university hospitals
Methods: Patients 20 years of age and older with PAR were assessed over 3 months of treatment with fix combination of montelukast 10 mg plus desloratidine 5 mg once daily (n=40). Comparative acoustic rhinometric evaluation was used to compare nasal changes in before and after treatments. For evaluation of HRQL between before and after treatments at the first and third months, the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) was used.
Results: Nasal symptoms and findings including itching, sneezing, discharge, congestion and edema and color change of turbinates have been decreased after treatment. In acoustic rhinometry, minimum cross-sectional area (MCA) measurements and volume results were statistically higher than in before treatment (p<0.001). Correlation was found that between the volume results and nasal discharged and/or congestion in right nasal passages. In left nasal passages, statistical relation was described between the MCA measurements and itching and/or change of turbinate color (p<0.05). There was a larger decrease in the overall RQLQ score for the group using montelukast plus desloratidine compared with the pre-treatment scores (p<0.001). The difference between scores at baseline versus the end of the first and third months for all domains was statically significant (p<0.001). The treatment difference in change from first month to the end of the third month was statically significant, in favor of the third month, for eye, nose, and non- nose/eye symptoms, sleep, practical problems, emotions and activities that have been limited by nose or eye symptoms, and for overall score.
Conclusion: Significant reductions in signs and symptoms of PAR with montelukast plus desloratadine treatment were accompanied by improved disease-specific QOL measures. Montelukast in combination with desloratidine provides improvements in acoustic rhinometric values including volume and MCA in patients with PAR. Acoustic rhinometry should be use in diagnostic and prognostic process in patients with PAR.