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Completed

NCT Number: NCT05912192

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Cheras, Kuala Lumpur, 56000, Malaysia

About this study

There are several objectives of the study:

  • To compare the efficacy of Elonide to Nasonex and Placebo in treating allergic rhinitis via Quality of life assessments and nasal airflow improvements.
  • To compare the efficacy of Elonide to Nasonex and Placebo in treating allergic rhinitis via symptomatics improvement.
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Elonide Nasal Spray

Drug

50mcg/dose One puff for each nostrils twice daily

Other names: Elonide

Nasonex Nasal Spray

Drug

50mcg/dose One puff for each nostrils twice daily

normal saline

Drug

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

Other names: Placebo

Primary outcomes

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

    Time frame: Baseline and 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)

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

    Time frame: Baseline and 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)

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

    Time frame: Baseline and 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)

Secondary outcomes

  1. Adverse effect of Nasal Spray

    Time frame: Baseline to week 4

    Any kind of side effect experience by patients in the period of using nasal spray

Sponsors and collaborators

Lead sponsor

National University of Malaysia

Other

Collaborators

  • HOE pharmaceuticals Sdn. Bhd.

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 22, 2023
Registry last updated
Jun 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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