Allergic RhinitisNCT05912192
The Efficacy Of Elonide Nasal Corticosteroids In Managing Allergic Rhinitis
A study testing Elonide Nasal Spray, Nasonex Nasal Spray and Normal saline in people with Allergic Rhinitis, run by National University of Malaysia at 1 site in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- Elonide Nasal Spray, Nasonex Nasal Spray and Normal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 163 participants
- Where
- 1 siteMalaysia
- Study dates
- 24 Feb 2022to 14 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
Department of Otorhinolaryngology, Head and Neck Surgery, Faculty of Medicine, Universiti Kebangsaan Malaysia
Cheras, Kuala Lumpur, 56000
About this study
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:
- Elonide nasal spray is same efficacy to Nasonex nasal spray.
- Elonide nasal spray is more efficient to placebo.
Read the detailed description
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.
- Conditions
- Allergic Rhinitis
- Being tested
- Elonide Nasal Spray, Nasonex Nasal Spray, Normal saline
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elonide Nasal SprayDrug
Also called Elonide
50mcg/dose One puff for each nostrils twice daily
Nasonex Nasal SprayDrug
50mcg/dose One puff for each nostrils twice daily
Normal salineDrug
Also called Placebo
50mcg/dose of 0.9% sodium chloride One puff for each nostrils twice daily
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Elonide Nasal Spray |
| 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 Receives: Drug: Nasonex Nasal Spray |
| 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 Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: Baseline and week 4
Secondary outcomes (1)
Adverse effect of Nasal Spray
Any kind of side effect experience by patients in the period of using nasal spray
Measured: Baseline to week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start24 Feb 2022
- Primary completion14 Apr 2023
- Study completion14 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic RhinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Malaysia
- Sponsor type
- University, hospital or other
- Collaborators
- HOE pharmaceuticals Sdn. Bhd.
- Responsible party
- Sponsor
- Investigators
- Hardip Singh Gendeh, Principal investigator, Department of Otorhinolaryngology, Faculty of Medicine, Universiti Kebangsaan Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05912192
- Sponsor's protocol ID
- FF-2021-421
- Status last verified
- Jun 2023
- First submitted
- 12 Jun 2023
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data obtained through this study may be provided to qualified researchers with academic interest in allergic rhinitis.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy Of Elonide Nasal Corticosteroids In Managing Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT05912192
- Acronym / sponsor ID
- FF-2021-421
- Conditions
- Allergic Rhinitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- National University of MalaysiaUniversity, hospital or other
- Collaborators
- HOE pharmaceuticals Sdn. Bhd.
- Study start
- 24 Feb 2022 (actual)
- Primary completion
- 14 Apr 2023 (actual)
- Study completion
- 14 Apr 2023 (actual)
- First posted
- 22 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Elonide nasal spray is same efficacy to Nasonex nasal spray.
- Elonide nasal spray is more efficient to placebo.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Elonide Nasal Spray | Experimental | Drug: Elonide Nasal SprayElonide 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 | Drug: Nasonex Nasal SprayNasonex 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 | Drug: Normal salinePlacebo used is 0.9% sodium chloride Dose: 50 mcg/dose of 0.9% sodium chloride One pump for both nostrils twice daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- Patients who have been on allergic rhinitis treatment
- Below 18 years old
- Patients diagnosed with asthma or immunodeficiency diseases
- Pregnancy
- Other concomitant rhinology disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Elonide Nasal SprayAlso: Elonide50mcg/dose One puff for each nostrils twice daily | Drug | Elonide Nasal Spray |
| Nasonex Nasal Spray50mcg/dose One puff for each nostrils twice daily | Drug | Nasonex Nasal Spray |
| Normal salineAlso: Placebo50mcg/dose of 0.9% sodium chloride One puff for each nostrils twice daily | Drug | Normal Saline |
Primary outcome
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)
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)
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)
1 secondary outcome
Adverse effect of Nasal Spray
Time frame: Baseline to week 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Individual participant dataSharing planned: Yes. Data obtained through this study may be provided to qualified researchers with academic interest in allergic rhinitis.
Related trials for Allergic Rhinitis
Not yet recruitingPhase 1
Safety and Tolerability of Fluticasone Propionate 10% Nasal Insert in Participants With Chronic Allergic Rhinitis
Chronic Allergic Rhinitis
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis_MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis. MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
Enrolling by invitationObservational study
Allergy, Asthma, and Atopic Eczema in Finland
Asthma, Asthma in Children
Not yet recruitingObservational study
Prevelance of Bronchial Asthma and Allergic Rhinitis Among Children With Nephrotic Syndrom at Sohag University Hospital
Allergic Diseases in Nephrotic Children, Nephrotic Syndrom
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hardip Singh Gendeh principal investigator
Department of Otorhinolaryngology, Faculty of Medicine, Universiti Kebangsaan Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Elonide Nasal Spray, Nasonex Nasal Spray and Normal saline in people with Allergic Rhinitis, run by National University of Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Symptoms Score on Allergic Rhinitis at Week 4 (time frame: Baseline and week 4). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.