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

Not Applicable

• Conditions: Allergic Rhinitis
• Interventions: Drug: Budesonide; Drug: Montelukast; Drug: Azelastine; Drug: Placebo

• Registration Number: NCT04561687
• Lead Sponsor: Shiraz University of Medical Sciences

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-16
• Status Verified: 2020-09
• Study First Submitted: 2020-09-11
• Study First Submitted QC: 2020-09-19
• Last Update Submitted: 2020-09-23
• Study First Posted: 2020-09-24
• Last Update Posted: 2020-09-25
• Primary Completion: 2021-09-01
• Study Completion: 2021-12-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

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

Exclusion Criteria

• Under any treatment

  • Drug sensitivity

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nasal Budesonide and Placebo	Budesonide	Placebo once daily
Nasal Budesonide and Placebo	Placebo	Placebo once daily
Montelukast and Nasal budesonide	Montelukast	Montelukast 5mg 6-14years old and 10mg for older
Azelastine and Nasal Budesonide	Budesonide	Spray nasal Azelastine 1puff daily for 6-12years old patients and 2puff for older
Azelastine and Nasal Budesonide	Azelastine	Spray nasal Azelastine 1puff daily for 6-12years old patients and 2puff for older
Montelukast and Nasal budesonide	Budesonide	Montelukast 5mg 6-14years old and 10mg for older

Primary Outcome Measures

Name	Time	Method
Change in Sino-Nasal Outcome Test scores (SNOT-22)	Baseline,month1,month3	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.

Trial Locations

Locations (1)

Shiraz University of Medical Science; 🇮🇷 Shiraz, Iran, Islamic Republic of