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

NCT02565212 | Completed Phase 4

• 1 other identifier: 55
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Allergic Rhinitis

Keywords

Montelukast; Sniffin' Sticks test; allergic rhinitis; mometasone furoate

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

GROUP 1

EXPERIMENTAL

montelukast sodium and mometasone

Drug: Montelukast,mometazon froat

Group 2

ACTIVE COMPARATOR

montelukast

Drug: Montelukast,mometazon froat

Group 3

ACTIVE COMPARATOR

mometasone furoate

Drug: Montelukast,mometazon froat

Interventions

Montelukast,mometazon froat DRUG

GROUP 1; Group 2; Group 3

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul Training and Research Hospital: lead

MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

montelukast

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Istanbul Gaziosmanpasa Taksim Research and Training Hospital,

Study Record Dates

• First Submitted: June 15, 2015
• First Posted: October 1, 2015
• Study Start: May 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: October 1, 2015

Record last verified: 2015-09