Clinical trial

The Efficacy Of Elonide Nasal Corticosteroids In Managing Allergic Rhinitis

Name

FF-2021-421

Description

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.

Trial arms

Trial start

2022-02-24

Estimated PCD

2023-04-14

Trial end

2023-04-14

Status

Completed

Treatment

Elonide Nasal Spray

50mcg/dose One puff for each nostrils twice daily

Arms:

Elonide Nasal Spray

Other names:

Elonide

Nasonex Nasal Spray

50mcg/dose One puff for each nostrils twice daily

Arms:

Nasonex Nasal Spray

Normal saline

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

Arms:

Normal Saline

Other names:

Placebo

Size

163

Primary endpoint

Change from Baseline in Symptoms Score on Allergic Rhinitis at Week 4

Baseline and week 4

Mean difference from Baseline in Quality of Life Questionnaire on several domains at Week 4

Baseline and week 4

Change from Baseline in Total Nasal Resistance while normal breathing at Week 4

Baseline and week 4

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 163, 'type': 'ACTUAL'}}

Updated at

2023-06-22

1 organization

2 products

1 drug

1 indication

Organization

National University of Malaysia

Product

Indication

Product

Drug