Comparison of Montelukast and Azelastine in Treatment of Moderate to Severe Allergic Rhinitis
Primary Purpose
Allergic Rhinitis
Status
Unknown status
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Montelukast
Azelastine
Budesonide
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Allergic Rhinitis
Eligibility Criteria
Inclusion Criteria:
- Age 6-50years
- Moderate to severe allergic rhinitis
Exclusion Criteria:
Under any treatment
- Drug sensitivity
Sites / Locations
- Shiraz University of Medical ScienceRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
Azelastine and Nasal Budesonide
Montelukast and Nasal budesonide
Nasal Budesonide and Placebo
Arm Description
Spray nasal Azelastine 1puff daily for 6-12years old patients and 2puff for older
Montelukast 5mg 6-14years old and 10mg for older
Placebo once daily
Outcomes
Primary Outcome Measures
Change in Sino-Nasal Outcome Test scores (SNOT-22)
Change in Sino-Nasal Outcome Test scores (SNOT-22) scores pre- and post-treatment. The Sino-Nasal Outcome Test asks subjects to rate how "bad" their rhinosinusitis by using a 0-5 point scale with 0=no problem, 1=very mild problem, 2=mild or slight problem, 3=moderate problem, 4=severe problem, 5=problem as bad as it can be.
Secondary Outcome Measures
Full Information
NCT ID
NCT04561687
First Posted
September 11, 2020
Last Updated
September 23, 2020
Sponsor
Shiraz University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT04561687
Brief Title
Comparison of Montelukast and Azelastine in Treatment of Moderate to Severe Allergic Rhinitis
Official Title
Comparison of Montelukast and Azelastine in Treatment of Moderate to Severe Allergic Rhinitis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 16, 2020 (Actual)
Primary Completion Date
September 1, 2021 (Anticipated)
Study Completion Date
December 15, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shiraz University of Medical Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Comparison of Montelukast and Azelastine In treatment of Allergic Rhinitis Allergic intent is one of the most common diseases of the respiratory system that has a devastating effect on the quality of life. The importance of studying this disease can be seen from the high prevalence of this diseas. In addition to the high prevalence, due to the reducing effect of this disease on the economy and academic performance of patients, a great burden is imposed by this disease on the country's health care system.Also finding the best treatment of allergic can help to control of Asthma if exists concurrently.
Inflammation of the nasal mucosa following the release of IgE can be shown as symptoms of runny nose, sneezing, nasal congestion.Many studies have been done in the field of allergic rhinitis to increase the cost-effectiveness of treatment of this complication. Among the treatments for this disease is the use of antihistamine nasal sprays such as Azelastine. Combination therapies such as combining Mometason furoate or fluticasone with Azelastine or Montelukast can also be mentioned. However, there is still a long way to go to find the best drug combination to reduce the economic and human costs to the global health system. Due to the high prevalence of allergic diseases such as allergic rhinitis, finding the best treatment or management of such diseases plays an important role in improving the quality of life and reducing the economic burden on society.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Rhinitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Azelastine and Nasal Budesonide
Arm Type
Active Comparator
Arm Description
Spray nasal Azelastine 1puff daily for 6-12years old patients and 2puff for older
Arm Title
Montelukast and Nasal budesonide
Arm Type
Active Comparator
Arm Description
Montelukast 5mg 6-14years old and 10mg for older
Arm Title
Nasal Budesonide and Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo once daily
Intervention Type
Drug
Intervention Name(s)
Montelukast
Intervention Description
Montelukast and nasal budesonide
Intervention Type
Drug
Intervention Name(s)
Azelastine
Intervention Description
Azelastine and nasal budesonide
Intervention Type
Drug
Intervention Name(s)
Budesonide
Intervention Description
To all groups
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo and nasal budesonide
Primary Outcome Measure Information:
Title
Change in Sino-Nasal Outcome Test scores (SNOT-22)
Description
Change in Sino-Nasal Outcome Test scores (SNOT-22) scores pre- and post-treatment. The Sino-Nasal Outcome Test asks subjects to rate how "bad" their rhinosinusitis by using a 0-5 point scale with 0=no problem, 1=very mild problem, 2=mild or slight problem, 3=moderate problem, 4=severe problem, 5=problem as bad as it can be.
Time Frame
Baseline,month1,month3
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age 6-50years
Moderate to severe allergic rhinitis
Exclusion Criteria:
Under any treatment
Drug sensitivity
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nasrin Mortazavi Far
Phone
989195774656
Email
nasrinmortazavi@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nasrin Mortazavi
Organizational Affiliation
Shiraz University of Medical Science
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shiraz University of Medical Science
City
Shiraz
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
12. IPD Sharing Statement
Learn more about this trial
Comparison of Montelukast and Azelastine in Treatment of Moderate to Severe Allergic Rhinitis
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