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

Shiraz University of Medical Sciences

Status: Unknown

Conditions: Allergic Rhinitis

Treatments: Drug: Budesonide; Drug: Montelukast; Drug: Placebo; Drug: Azelastine

Study type: Interventional

Funder types: Other

Identifiers

NCT04561687

98-01-49-21547

Details and patient eligibility

About

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.

Enrollment: 66 estimated patients

Sex: All

Ages: 6 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Under any treatment

  • Drug sensitivity

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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66 participants in 3 patient groups, including a placebo group

Azelastine and Nasal Budesonide

Active Comparator group

Description:

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

Treatment:

Drug: Budesonide

Drug: Azelastine

Montelukast and Nasal budesonide

Active Comparator group

Description:

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

Treatment:

Drug: Montelukast

Drug: Budesonide

Nasal Budesonide and Placebo

Placebo Comparator group

Description:

Placebo once daily

Treatment:

Drug: Placebo

Drug: Budesonide