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

NCT04561687 | Unknown

• 1 other identifier: 98-01-49-21547
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline,month1,month3

Study Arms (3)

Azelastine and Nasal Budesonide

ACTIVE COMPARATOR

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

Drug: Azelastine; Drug: Budesonide

Montelukast and Nasal budesonide

ACTIVE COMPARATOR

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

Drug: Montelukast; Drug: Budesonide

Nasal Budesonide and Placebo

PLACEBO COMPARATOR

Placebo once daily

Drug: Budesonide; Drug: Placebo

Interventions

Montelukast DRUG

Montelukast and nasal budesonide

Montelukast and Nasal budesonide

Azelastine DRUG

Azelastine and nasal budesonide

Azelastine and Nasal Budesonide

Budesonide DRUG

To all groups

Azelastine and Nasal Budesonide; Montelukast and Nasal budesonide; Nasal Budesonide and Placebo

Placebo DRUG

Placebo and nasal budesonide

Nasal Budesonide and Placebo

Eligibility Criteria

• Age: 6 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Under any treatment
• Drug sensitivity

Sponsors & Collaborators

• Shiraz University of Medical Sciences: lead

Study Sites (1)

Shiraz University of Medical Science

Shiraz, Iran

RECRUITING

MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

montelukast; azelastine; Budesonide

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Nasrin Mortazavi

  Shiraz University of Medical Science

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nasrin Mortazavi Far

CONTACT

989195774656; nasrinmortazavi@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: September 11, 2020
• First Posted: September 24, 2020
• Study Start: January 16, 2020
• Primary Completion: September 1, 2021
• Study Completion: December 15, 2021
• Last Updated: September 25, 2020

Record last verified: 2020-09

Locations

IR (1)