The Efficacy Of Elonide Nasal Corticosteroids In Managing Allergic Rhinitis

Allergic Rhinitis Clinical Trial

Official title:

The Efficacy Of Elonide Nasal Corticosteroids In Managing Allergic Rhinitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05912192
• Other study ID #: FF-2021-421
• Status: Completed
• Phase: N/A
• Start date: February 24, 2022
• Est. completion date: April 14, 2023

Study information

• Verified date: June 2023
• Source: National University of Malaysia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 163
• Est. completion date: April 14, 2023
• Est. primary completion date: April 14, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Allergic Rhinitis
• Rhinitis
• Rhinitis, Allergic

Intervention

Drug:
• Elonide Nasal Spray
50mcg/dose One puff for each nostrils twice daily
• Nasonex Nasal Spray
50mcg/dose One puff for each nostrils twice daily
• Normal saline
50mcg/dose of 0.9% sodium chloride One puff for each nostrils twice daily

Locations

Country	Name	City	State
Malaysia	Department of Otorhinolaryngology, Head and Neck Surgery, Faculty of Medicine, Universiti Kebangsaan Malaysia	Cheras	Kuala Lumpur

Sponsors (2)

Lead Sponsor	Collaborator
National University of Malaysia	HOE pharmaceuticals Sdn. Bhd.

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in Symptoms Score on Allergic Rhinitis at Week 4	The Visual Analogue Score (VAS) is a validated, self-reported instrument assessing average scoring of overall allergic rhinitis symptoms in the last 7 days period from treatment date. Possible score range from 0 (no symptoms) to 100 (worst possible symptoms). Maximum number of change from baseline indicate improvement of symptoms.; Change= (Baseline score - Week 4 score)	Baseline and week 4
Primary	Mean difference from Baseline in Quality of Life Questionnaire on several domains at Week 4	Rhinoconjunctivitis Quality of Life Questionnaire (RQOLQ) contains several domains score to access patient quality of life for a 7 days period from treatment date. The domains include activities, sleep, non-hay symptoms, practical problems, nasal symptoms, eye symptoms and emotional. Possible scoring from 0 (not trouble) to 6 (extremely troubled).; Change= (Baseline score - Week 4 score)	Baseline and week 4
Primary	Change from Baseline in Total Nasal Resistance while normal breathing at Week 4	Total Nasal Resistance is performed using Rhinomanometry device that provides a functional measure if pressure during a breathing cycle. Normal values for total nasal resistance is below 0.2 and to 0.3 Pa cm3/s. Worst case will be higher than 0.3 Pa cm3/s indicate nasal obstruction.; Change= (Baseline score - Week 4 score)	Baseline and week 4
Secondary	Adverse effect of Nasal Spray	Any kind of side effect experience by patients in the period of using nasal spray	Baseline to week 4