The Efficacy Of Elonide Nasal Corticosteroids In Managing Allergic Rhinitis
NCT ID: NCT05912192
Last Updated: 2023-06-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
163 participants
INTERVENTIONAL
2022-02-24
2023-04-14
Brief Summary
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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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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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
Elonide Nasal Spray
50mcg/dose One puff for each nostrils twice daily
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
Nasonex Nasal Spray
50mcg/dose One puff for each nostrils twice daily
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
Normal saline
50mcg/dose of 0.9% sodium chloride One puff for each nostrils twice daily
Interventions
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Elonide Nasal Spray
50mcg/dose One puff for each nostrils twice daily
Nasonex Nasal Spray
50mcg/dose One puff for each nostrils twice daily
Normal saline
50mcg/dose of 0.9% sodium chloride One puff for each nostrils twice daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Newly diagnosed mild, moderate to severe, intermittent and persistent allergic rhinitis
* Positive skin prick test or serum Immunoglobulin E
Exclusion Criteria
* Below 18 years old
* Patients diagnosed with asthma or immunodeficiency diseases
* Pregnancy
* Other concomitant rhinology disease
* Smokers
* Severe deviated nasal septum
18 Years
ALL
Yes
Sponsors
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HOE pharmaceuticals Sdn. Bhd.
UNKNOWN
National University of Malaysia
OTHER
Responsible Party
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Principal Investigators
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Hardip Singh Gendeh
Role: PRINCIPAL_INVESTIGATOR
Department of Otorhinolaryngology, Faculty of Medicine, Universiti Kebangsaan Malaysia
Locations
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Department of Otorhinolaryngology, Head and Neck Surgery, Faculty of Medicine, Universiti Kebangsaan Malaysia
Cheras, Kuala Lumpur, Malaysia
Countries
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Other Identifiers
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FF-2021-421
Identifier Type: -
Identifier Source: org_study_id
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