The Efficacy Of Elonide Nasal Corticosteroids In Managing Allergic Rhinitis

NCT05912192 | Completed

• 1 other identifier: FF-2021-421
• Study Type: interventional
• Target: 163
• Locations: 1 country
• Sites: 1

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

Conditions

Allergic Rhinitis

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Adverse effect of Nasal Spray

  Baseline to week 4

Study Arms (3)

Elonide Nasal Spray

EXPERIMENTAL

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

Nasonex Nasal Spray

ACTIVE COMPARATOR

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

Normal Saline

PLACEBO COMPARATOR

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

Interventions

Elonide Nasal Spray DRUG

50mcg/dose One puff for each nostrils twice daily

Also known as: Elonide

Elonide Nasal Spray

Nasonex Nasal Spray DRUG

50mcg/dose One puff for each nostrils twice daily

Nasonex Nasal Spray

Normal saline DRUG

50mcg/dose of 0.9% sodium chloride One puff for each nostrils twice daily

Also known as: Placebo

Normal Saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National University of Malaysia: lead
• HOE pharmaceuticals Sdn. Bhd.: collaborator

Study Sites (1)

Department of Otorhinolaryngology, Head and Neck Surgery, Faculty of Medicine, Universiti Kebangsaan Malaysia

Cheras, Kuala Lumpur, 56000, Malaysia

Location

MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

Mometasone Furoate; Saline Solution

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Hardip Singh Gendeh

  Department of Otorhinolaryngology, Faculty of Medicine, Universiti Kebangsaan Malaysia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2023
• First Posted: June 22, 2023
• Study Start: February 24, 2022
• Primary Completion: April 14, 2023
• Study Completion: April 14, 2023
• Last Updated: June 22, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data can be assess 6 months after publication
• Access Criteria: Access to trial IPD can be access by qualified researchers engaging in independent scientific research.

Locations

MY (1)