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

September 29, 2015 updated by: dalgic abdullah, Istanbul Training and Research Hospital

Istanbul Gaziosmanpasa Taksim Research and Training Hospital,

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GROUP 1
montelukast sodium and mometasone
Drug: Montelukast,mometazon froat
Active Comparator: Group 2
montelukast
Drug: Montelukast,mometazon froat
Active Comparator: Group 3
mometasone furoate
Drug: Montelukast,mometazon froat

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of the effects of nasal steroids and montelukast on olfactory functions in patients with allergic rhinitis
Time Frame: 1 month
Sniff'in and Snick test (olfactory Test)
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

June 15, 2015

First Submitted That Met QC Criteria

September 29, 2015

First Posted (Estimate)

October 1, 2015

Study Record Updates

Last Update Posted (Estimate)

October 1, 2015

Last Update Submitted That Met QC Criteria

September 29, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 55

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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