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

Primary Purpose

Allergic Rhinitis

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Montelukast,mometazon froat
Sponsored by
Istanbul Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Allergic Rhinitis focused on measuring Montelukast, Sniffin' Sticks test, allergic rhinitis, mometasone furoate

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    Active Comparator

    Arm Label

    GROUP 1

    Group 2

    Group 3

    Arm Description

    montelukast sodium and mometasone

    montelukast

    mometasone furoate

    Outcomes

    Primary Outcome Measures

    Comparison of the effects of nasal steroids and montelukast on olfactory functions in patients with allergic rhinitis
    Sniff'in and Snick test (olfactory Test)

    Secondary Outcome Measures

    Full Information

    First Posted
    June 15, 2015
    Last Updated
    September 29, 2015
    Sponsor
    Istanbul Training and Research Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02565212
    Brief Title
    Comparison of the Effects of Nasal Steroids and Montelukast on Olfactory Functions in Patients With Allergic Rhinitis
    Official Title
    Istanbul Gaziosmanpasa Taksim Research and Training Hospital,
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2014 (undefined)
    Primary Completion Date
    October 2014 (Actual)
    Study Completion Date
    October 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Istanbul Training and Research Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Allergic Rhinitis
    Keywords
    Montelukast, Sniffin' Sticks test, allergic rhinitis, mometasone furoate

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    30 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    GROUP 1
    Arm Type
    Experimental
    Arm Description
    montelukast sodium and mometasone
    Arm Title
    Group 2
    Arm Type
    Active Comparator
    Arm Description
    montelukast
    Arm Title
    Group 3
    Arm Type
    Active Comparator
    Arm Description
    mometasone furoate
    Intervention Type
    Drug
    Intervention Name(s)
    Montelukast,mometazon froat
    Primary Outcome Measure Information:
    Title
    Comparison of the effects of nasal steroids and montelukast on olfactory functions in patients with allergic rhinitis
    Description
    Sniff'in and Snick test (olfactory Test)
    Time Frame
    1 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Learn more about this trial

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

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