Comparison of the Effects of Nasal Steroids and Montelukast on Olfactory Functions in Patients With Allergic Rhinitis

Allergic Rhinitis Clinical Trial

Official title:

Istanbul Gaziosmanpasa Taksim Research and Training Hospital,

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02565212
• Other study ID #: 55
• Status: Completed
• Phase: Phase 4
• First received: June 15, 2015
• Last updated: September 29, 2015
• Start date: May 2014
• Est. completion date: October 2014

Study information

• Verified date: September 2015
• Source: Istanbul Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The investigators aimed to evaluate by the Sniffin' Sticks test the effects on olfactory functions of nasal steroids and leukotriene antagonists used for allergic rhinitis.Thirty patients with seasonal were included in this study. Patients were randomly divided into three groups of 10 patients; group 1 received montelukast sodium and mometasone furoate therapy, group 2 received only montelukast, and group 3 only mometasone furoate. Patients' olfactory functions were determined using the Sniffin' Sticks olfactory test before and after a month treatments.

Threshold, discrimination, identification, and TDI values were not significantly different among the groups before treatment. For Group 1 and Group 3 patients, there were statistically significant differences in threshold, discrimination, identification, and TDI values before and after treatment (p < 0.05) (Wilcoxon signed ranks analysis) For Group 2 patients, the before and after treatment values of threshold, discrimination, identification, and TDI showed no significant differences (p > 0.05). According to the findings of our study, MF is superior to montelukast in improving olfactory function. Although montelukast has been shown to be effective against AR symptoms, its effect on olfactory function was not demonstrated in this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Positive skin test to grass and/or tree pollens in patients with clinical history of seasonal AR for at least 1 year

Exclusion Criteria:

• Patients who had received drug treatment or immunotherapy before the study were excluded.

• Patients with asthma, deviated nasal septum, history of nasal operation, turbinate hypertrophy, nasal polyposis or chronic nasal disorders, pregnancy, or upper airway infections were also excluded.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergic Rhinitis
• Rhinitis

Intervention

Drug:
• Montelukast,mometazon froat

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Training and Research Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of the effects of nasal steroids and montelukast on olfactory functions in patients with allergic rhinitis	Sniff'in and Snick test (olfactory Test)	1 month	Yes