Allergic Rhinitis
Conditions
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. Elonide nasal spray is same efficacy to Nasonex nasal spray. 2. Elonide nasal spray is more efficient to placebo.
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.
Interventions
DRUGElonide Nasal Spray
50mcg/dose One puff for each nostrils twice daily
50mcg/dose One puff for each nostrils twice daily
DRUGNormal saline
50mcg/dose of 0.9% sodium chloride One puff for each nostrils twice daily
Sponsors
HOE pharmaceuticals Sdn. Bhd.
National University of Malaysia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Symptoms Score on Allergic Rhinitis at Week 4 | 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) |
| Mean difference from Baseline in Quality of Life Questionnaire on several domains at Week 4 | 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) |
| Change from Baseline in Total Nasal Resistance while normal breathing at Week 4 | 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
| Measure | Time frame | Description |
|---|---|---|
| Adverse effect of Nasal Spray | Baseline to week 4 | Any kind of side effect experience by patients in the period of using nasal spray |
Countries
Malaysia
Outcome results
None listed