The Efficacy Of Elonide Nasal Corticosteroids In Managing Allergic Rhinitis

National University of Malaysia

Status: Completed

Conditions: Allergic Rhinitis

Treatments: Drug: Elonide Nasal Spray; Drug: Nasonex Nasal Spray; Drug: Normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT05912192

FF-2021-421

Details and patient eligibility

About

The aim of this clinical study is to compare the efficacy of Elonide Nasal Spray to Nasonex Nasal Spray and Placebo (non-active ingredient) in the management of allergic rhinitis.

There are two hypotheses of this study:

1. Elonide nasal spray is same efficacy to Nasonex nasal spray.
2. Elonide nasal spray is more efficient to placebo.

Full description

There are several objectives of the study:

1. To compare the efficacy of Elonide to Nasonex and Placebo in treating allergic rhinitis via Quality of life assessments and nasal airflow improvements.
2. To compare the efficacy of Elonide to Nasonex and Placebo in treating allergic rhinitis via symptomatics improvement.
3. To assess the side effect of Nasal spray given.

Patients who meet the criteria to join the study will be randomized in a double-blind manner (patients and investigators). Patients will be given information about the study and consent form, patients will be randomized to 3 treatment group(Elonide, Nasonex, Placebo). Patients will be evaluated before and after treatment in one month time. Patients will be advised to use the nasal spray twice daily.

Enrollment: 163 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• All adults patients 18 years and above
• Newly diagnosed mild, moderate to severe, intermittent and persistent allergic rhinitis
• Positive skin prick test or serum Immunoglobulin E

Exclusion criteria

• Patients who have been on allergic rhinitis treatment
• Below 18 years old
• Patients diagnosed with asthma or immunodeficiency diseases
• Pregnancy
• Other concomitant rhinology disease
• Smokers
• Severe deviated nasal septum

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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163 participants in 3 patient groups, including a placebo group

Elonide Nasal Spray

Experimental group

Description:

Elonide is generic nasal spray Dose: 50 mcg/dose mometasone furoate 140 sprays per nasal spray One pump for both nostrils twice daily

Treatment:

Drug: Elonide Nasal Spray

Nasonex Nasal Spray

Active Comparator group

Description:

Nasonex Aqueous Nasal Spray Dose: 50 mcg/dose mometasone furoate 140 sprays per nasal spray The usual recommended dose for prophylaxis and treatment is two sprays (50 micrograms/spray) in each nostril once daily (total dose 200 micrograms) One pump for both nostrils twice daily

Treatment:

Drug: Nasonex Nasal Spray

Normal Saline

Placebo Comparator group

Description:

Placebo used is 0.9% sodium chloride Dose: 50 mcg/dose of 0.9% sodium chloride One pump for both nostrils twice daily

Treatment:

Drug: Normal saline