Comparison of Montelukast and Azelastine in Treatment of Moderate to Severe Allergic Rhinitis

NCT ID: NCT04561687

Last Updated: 2020-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-16

Study Completion Date

2021-12-15

Brief Summary

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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.

Detailed Description

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Conditions

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Allergic Rhinitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Azelastine and Nasal Budesonide

Spray nasal Azelastine 1puff daily for 6-12years old patients and 2puff for older

Group Type ACTIVE_COMPARATOR

Azelastine

Intervention Type DRUG

Azelastine and nasal budesonide

Budesonide

Intervention Type DRUG

To all groups

Montelukast and Nasal budesonide

Montelukast 5mg 6-14years old and 10mg for older

Group Type ACTIVE_COMPARATOR

Montelukast

Intervention Type DRUG

Montelukast and nasal budesonide

Budesonide

Intervention Type DRUG

To all groups

Nasal Budesonide and Placebo

Placebo once daily

Group Type PLACEBO_COMPARATOR

Budesonide

Intervention Type DRUG

To all groups

Placebo

Intervention Type DRUG

Placebo and nasal budesonide

Interventions

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Montelukast

Montelukast and nasal budesonide

Intervention Type DRUG

Azelastine

Azelastine and nasal budesonide

Intervention Type DRUG

Budesonide

To all groups

Intervention Type DRUG

Placebo

Placebo and nasal budesonide

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age 6-50years
* Moderate to severe allergic rhinitis

Exclusion Criteria

* Under any treatment

* Drug sensitivity
Minimum Eligible Age

6 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shiraz University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Nasrin Mortazavi Far

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nasrin Mortazavi

Role: PRINCIPAL_INVESTIGATOR

Shiraz University of Medical Science

Locations

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Shiraz University of Medical Science

Shiraz, , Iran

Site Status RECRUITING

Countries

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Iran

Central Contacts

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Nasrin Mortazavi Far

Role: CONTACT

989195774656

Other Identifiers

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98-01-49-21547

Identifier Type: -

Identifier Source: org_study_id

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