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| Name | Class |
|---|---|
| HOE pharmaceuticals Sdn. Bhd. | UNKNOWN |
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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:
There are several objectives of the study:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Elonide Nasal Spray | Drug | 50mcg/dose One puff for each nostrils twice daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse effect of Nasal Spray | Any kind of side effect experience by patients in the period of using nasal spray | Baseline to week 4 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hardip Singh Gendeh | Department of Otorhinolaryngology, Faculty of Medicine, Universiti Kebangsaan Malaysia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Otorhinolaryngology, Head and Neck Surgery, Faculty of Medicine, Universiti Kebangsaan Malaysia | Cheras | Kuala Lumpur | 56000 | Malaysia |
Data obtained through this study may be provided to qualified researchers with academic interest in allergic rhinitis.
Data can be assess 6 months after publication
Access to trial IPD can be access by qualified researchers engaging in independent scientific research.
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| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
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| ID | Term |
|---|---|
| D000068656 | Mometasone Furoate |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| 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 |
|
|
| D010038 |
| Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |