The Efficacy Of Elonide Nasal Corticosteroids In Managing Allergic Rhinitis

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.

Study Overview

• Status: Completed
• Conditions: Allergic Rhinitis
• Intervention / Treatment: Drug: Elonide Nasal Spray; Drug: Nasonex Nasal Spray; Drug: Normal saline

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 163
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malaysia
  • Kuala Lumpur
    • Cheras, Kuala Lumpur, Malaysia, 56000
      • Department of Otorhinolaryngology, Head and Neck Surgery, Faculty of Medicine, Universiti Kebangsaan Malaysia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Elonide Nasal Spray; Elonide is generic nasal spray Dose: 50 mcg/dose mometasone furoate 140 sprays per nasal spray One pump for both nostrils twice daily	Drug: Elonide Nasal Spray; 50mcg/dose One puff for each nostrils twice daily; Other Names: Elonide
Active Comparator: Nasonex Nasal Spray; 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	Drug: Nasonex Nasal Spray; 50mcg/dose One puff for each nostrils twice daily
Placebo Comparator: Normal Saline; Placebo used is 0.9% sodium chloride Dose: 50 mcg/dose of 0.9% sodium chloride One pump for both nostrils twice daily	Drug: Normal saline; 50mcg/dose of 0.9% sodium chloride One puff for each nostrils twice daily; Other Names: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse effect of Nasal Spray	Any kind of side effect experience by patients in the period of using nasal spray	Baseline to week 4

Collaborators and Investigators

• Sponsor: National University of Malaysia
• Collaborators: HOE pharmaceuticals Sdn. Bhd.
• Investigators: Principal Investigator: Hardip Singh Gendeh, Department of Otorhinolaryngology, Faculty of Medicine, Universiti Kebangsaan Malaysia

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2022
• Primary Completion (Actual): April 14, 2023
• Study Completion (Actual): April 14, 2023

Study Registration Dates

• First Submitted: June 12, 2023
• First Submitted That Met QC Criteria: June 12, 2023
• First Posted (Actual): June 22, 2023

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 12, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic; Anti-Inflammatory Agents; Dermatologic Agents; Anti-Allergic Agents; Mometasone Furoate
• Other Study ID Numbers: FF-2021-421

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data obtained through this study may be provided to qualified researchers with academic interest in allergic rhinitis.
• IPD Sharing Time Frame: Data can be assess 6 months after publication
• IPD Sharing Access Criteria: Access to trial IPD can be access by qualified researchers engaging in independent scientific research.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No