Allergic RhinitisNCT05919316
The Efficacy Of Rhinophototherapy Compared To Intranasal Corticosteroids On The Nasal Mucosa
A study testing Rhinophototherapy and Nasonex Nasal Spray in people with Allergic Rhinitis, run by National University of Malaysia at 1 site in Malaysia.
Trial summary
The aim of this study to compare the efficacy of Rhinophototherapy to Intranasal Corticosteroids on the the nasal mucosa of allergic rhinitis patients. The main question to answer is: Does intranasal phototherapy reduce inflammation in the tissue biopsy of the inferior turbinate mucosa compared to intranasal steroids?… 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?
- Rhinophototherapy and Nasonex Nasal Spray
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteMalaysia
- Study dates
- 4 Jul 2023to 10 Nov 2024
- 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
- Adult patients 18 years and above
- Newly diagnosed allergic rhinitis
- Allergic rhinitis is confirmed via positive skin prick test or serum Immunoglobulin E
Who cannot join
- Anaphylaxis /poorly controlled bronchial asthma
- Refused nasal biopsy
- Usage of intranasal corticosteroids and/or antihistamine sprays for the past 1 month
- Consumption of oral leukotriene receptor antagonist or oral steroids for the past 1 month
- Concomitant nasal pathology (malignancy, chronic rhinosinusitis with nasal polyposis, severe deviated nasal septum)
- Bleeding disorder or on anticoagulant/antiplatelet therapy
- Recent URTI/Covid-19 within past 14 days
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
Otorhinolaryngology Department, Head and Neck Surgery, Faculty of Medicine, UKM Medical Centre, Jalan Yaacob Latif, Bandar Tun Razak, Cheras
Kuala Lumpur, Cheras, 56000
About this study
Official title: The Efficacy Of Rhinophototherapy Compared To Intranasal Corticosteroids On The Nasal Mucosa Of Allergic Rhinitis Patients
The aim of this study to compare the efficacy of Rhinophototherapy to Intranasal Corticosteroids on the the nasal mucosa of allergic rhinitis patients. The main question to answer is: Does intranasal phototherapy reduce inflammation in the tissue biopsy of the inferior turbinate mucosa compared to intranasal steroids?
The hypothesis for this study is Intranasal phototherapy will reduce mucosal inflammation without mucosal damage and is comparable to intranasal steroids in allergic rhinitis patients
Read the detailed description
There are several specific objectives for this study:
- To subjectively and objectively compare the efficacy of intranasal phototherapy and intranasal corticosteroids in treating allergic rhinitis via assessment of rhinomanometry, peak nasal inspiratory flow (PNIF) and visual analogue scale(VAS) score.
- To determine mucosal inflammatory cells changes (eosinophils, neutrophils, mast cells) between patients treated with intranasal rhinophototherapy and intranasal corticosteroids.
- To determine mucosal damage (fibrosis, mucosal ulceration , squamous metaplasia) between patients treated with intranasal rhinophototherapy and intranasal corticosteroids.
Patients who meet the criteria to join the study will be randomized in a single-blinded manner(investigator). Patients will be given information about the study and consent form, patients will be randomized to 2 treatment group (rhinophototherapy and Nasonex nasal spray). Patients will be evaluated before and after treatment in two weeks time.
- Conditions
- Allergic Rhinitis
- Being tested
- Rhinophototherapy, Nasonex Nasal Spray
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RhinophototherapyDevice
Also called Intranasal rhinophototherapy Bionette
Intranasal rhinophotometer to be used at home for 4.5 minutes three times daily for 14 days
Nasonex Nasal SprayDrug
Also called Mometasone furoate nasal spray
50mcg/dose, 2 sprays each nostril (morning or evening) once daily for 14 days
| Study group | Role | What they receive |
|---|---|---|
| Rhinophototherapy | Experimental | Intranasal Rhinophototherapy is an electronic allergic rhinitis treatment device (brand Bionette) also a medical device that producing low level narrow band red light at a wavelength of 630nm. It is a Class B medical device (registration of Malaysia number GB67793908818). It is powered by two alkaline button batteries with a dimension of 52mm x 40mm and weighing less than 20g . Light is produced via nasal prongs which are to be inserted into both nostrils. Plastic nasal cannula are available and can be replaced to ensure sterility and prevent transmission of infection. Receives: Device: Rhinophototherapy |
| Intranasal Corticosteroids | Active comparator | Mometasone furoate will be available in the form of Nasonex Nasal Spray. It has a dose of 50 mcg/dose mometasone furoate per spray, registration no: MAL20001010AZ, distributed by: Merck Sharp \& Dohme (Malaysia) Sdn. Bhd. Receives: Drug: Nasonex Nasal Spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Symptoms Score of Allergic Rhinitis at week 2
The Visual Analogue Score (VAS) is a validated, self-reported instrument assessing average scoring of overall allergic rhinitis symptoms and details of allergic symptoms (runny nose, sneezing, nasal blockage, nasal itchiness) in the last 14 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 2 score)
Measured: Baseline and Week 2
Peak nasal inspiratory flow meter (PNIF)
PNIF is an easy to use object which measures airflow through the nose during maximal inspiration. Air flow is measured via a variable diameter in litre/minute. Inertia of inspiratory air will move the marker to indicate the maximum flow achieved. The best of 3 attempts of inspiration will be taken. The maximum value indicates better result of inspiration.
Measured: Baseline and Week 2
Total nasal resistance by Rhinomanometry
Rhinomanometry provides a functional measure of pressure/flow during a breathing cycle. It is to be performed at week 0, prior to commencement of nasal spray and week 2 of treatment for comparisons. 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 2 score)
Measured: Baseline and Week 2
Determination of mucosal inflammatory cells changes (eosinophils, neutrophils, mast cells) between patients treated with intranasal rhinophototherapy and intranasal corticosteroids.
Nasal mucosa biopsy will be performed after 2 weeks of usage of intranasal phototherapy/corticosteroids under local anesthesia. Biopsy samples will be kept in glass bottles filled with paraformaldehyde. It will be labelled, packaged with a biohazard wrap and be transported within an hour to the histopathology lab.
Quantification of eosinophil, neutrophil and mast cell numbers in inferior turbinate tissue biopsy will be performed by counting numbers of stained cells. Results are expressed as the number of cells per one hpf of tissue.
Measured: Week 2
Determination of mucosal damage (fibrosis, mucosal ulceration , squamous metaplasia) between patients treated with intranasal rhinophototherapy and intranasal corticosteroids.
Nasal mucosa biopsy will be performed after 2 weeks of usage of intranasal phototherapy/corticosteroids under local anesthesia. Biopsy samples will be kept in glass bottles filled with paraformaldehyde. It will be labelled, packaged with a biohazard wrap and be transported within an hour to the histopathology lab.
Tissue will be assessed histologically based on a modified grading system.
Mucosal damage:
- mucosal ulceration (absent or present)
- squamous metaplasia (absent or present)
- Presence of fibrosis (absent or present)
Measured: Week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2023
- Study start4 Jul 2023
- Primary completion10 Oct 2024
- Study completion10 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Care provider, Investigator
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hardip Singh Gendeh, Principal investigator, Otorhinolaryngology Department, Head and Neck Surgery, Faculty of Medicine, UKM Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05919316
- Sponsor's protocol ID
- GGPM-2022-028
- Status last verified
- May 2026
- First submitted
- 16 Jun 2023
- Last updated
- 22 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication plan to be shared to researchers.
Publications
Ramasamy K, Gendeh HS, Wan Hamizan AK, Md Pauzi SH, Zahedi FD, Megat Ismail NF, Alfian N, Abdul Razak NN, Chinna K, Husain S. Histological Impact of Rhinophototherapy Compared to Intranasal Corticosteroids on Inflammatory Cells and Nasal Mucosa in Allergic Rhinitis. Ann Otol Rhinol Laryngol. 2026 Jun;135(6):458-463. doi: 10.1177/00034894251401132. Epub 2026 Jan 7.
PubMed 41501617
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy Of Rhinophototherapy Compared To Intranasal Corticosteroids On The Nasal Mucosa Of Allergic Rhinitis Patients
- ClinicalTrials.gov ID
- NCT05919316
- Acronym / sponsor ID
- GGPM-2022-028
- Conditions
- Allergic Rhinitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- National University of MalaysiaUniversity, hospital or other
- Study start
- 4 Jul 2023 (actual)
- Primary completion
- 10 Oct 2024 (actual)
- Study completion
- 10 Nov 2024 (actual)
- First posted
- 26 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 study to compare the efficacy of Rhinophototherapy to Intranasal Corticosteroids on the the nasal mucosa of allergic rhinitis patients. The main question to answer is: Does intranasal phototherapy reduce inflammation in the tissue biopsy of the inferior turbinate mucosa compared to intranasal steroids?
The hypothesis for this study is Intranasal phototherapy will reduce mucosal inflammation without mucosal damage and is comparable to intranasal steroids in allergic rhinitis patients
Detailed description
There are several specific objectives for this study:
- To subjectively and objectively compare the efficacy of intranasal phototherapy and intranasal corticosteroids in treating allergic rhinitis via assessment of rhinomanometry, peak nasal inspiratory flow (PNIF) and visual analogue scale(VAS) score.
- To determine mucosal inflammatory cells changes (eosinophils, neutrophils, mast cells) between patients treated with intranasal rhinophototherapy and intranasal corticosteroids.
- To determine mucosal damage (fibrosis, mucosal ulceration , squamous metaplasia) between patients treated with intranasal rhinophototherapy and intranasal corticosteroids.
Patients who meet the criteria to join the study will be randomized in a single-blinded manner(investigator). Patients will be given information about the study and consent form, patients will be randomized to 2 treatment group (rhinophototherapy and Nasonex nasal spray). Patients will be evaluated before and after treatment in two weeks time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rhinophototherapy | Experimental | Device: RhinophototherapyIntranasal Rhinophototherapy is an electronic allergic rhinitis treatment device (brand Bionette) also a medical device that producing low level narrow band red light at a wavelength of 630nm. It is a Class B medical device (registration of Malaysia number GB67793908818). It is powered by two alkaline button batteries with a dimension of 52mm x 40mm and weighing less than 20g . Light is produced via nasal prongs which are to be inserted into both nostrils. Plastic nasal cannula are available and can be replaced to ensure sterility and prevent transmission of infection. |
| Intranasal Corticosteroids | Active comparator | Drug: Nasonex Nasal SprayMometasone furoate will be available in the form of Nasonex Nasal Spray. It has a dose of 50 mcg/dose mometasone furoate per spray, registration no: MAL20001010AZ, distributed by: Merck Sharp \& Dohme (Malaysia) Sdn. Bhd. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients 18 years and above
- Newly diagnosed allergic rhinitis
- Allergic rhinitis is confirmed via positive skin prick test or serum Immunoglobulin E
Key exclusion criteria (8 listed)
- Anaphylaxis /poorly controlled bronchial asthma
- Refused nasal biopsy
- Usage of intranasal corticosteroids and/or antihistamine sprays for the past 1 month
- Consumption of oral leukotriene receptor antagonist or oral steroids for the past 1 month
- Concomitant nasal pathology (malignancy, chronic rhinosinusitis with nasal polyposis, severe deviated nasal septum)
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 |
|---|---|---|
| RhinophototherapyAlso: Intranasal rhinophototherapy BionetteIntranasal rhinophotometer to be used at home for 4.5 minutes three times daily for 14 days | Device | Rhinophototherapy |
| Nasonex Nasal SprayAlso: Mometasone furoate nasal spray50mcg/dose, 2 sprays each nostril (morning or evening) once daily for 14 days | Drug | Intranasal Corticosteroids |
Primary outcome
Change from Baseline in Symptoms Score of Allergic Rhinitis at week 2
Time frame: Baseline and Week 2
The Visual Analogue Score (VAS) is a validated, self-reported instrument assessing average scoring of overall allergic rhinitis symptoms and details of allergic symptoms (runny nose, sneezing, nasal blockage, nasal itchiness) in the last 14 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 2 score)
Peak nasal inspiratory flow meter (PNIF)
Time frame: Baseline and Week 2
PNIF is an easy to use object which measures airflow through the nose during maximal inspiration. Air flow is measured via a variable diameter in litre/minute. Inertia of inspiratory air will move the marker to indicate the maximum flow achieved. The best of 3 attempts of inspiration will be taken. The maximum value indicates better result of inspiration.
Total nasal resistance by Rhinomanometry
Time frame: Baseline and Week 2
Rhinomanometry provides a functional measure of pressure/flow during a breathing cycle. It is to be performed at week 0, prior to commencement of nasal spray and week 2 of treatment for comparisons. 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 2 score)
Determination of mucosal inflammatory cells changes (eosinophils, neutrophils, mast cells) between patients treated with intranasal rhinophototherapy and intranasal corticosteroids.
Time frame: Week 2
Nasal mucosa biopsy will be performed after 2 weeks of usage of intranasal phototherapy/corticosteroids under local anesthesia. Biopsy samples will be kept in glass bottles filled with paraformaldehyde. It will be labelled, packaged with a biohazard wrap and be transported within an hour to the histopathology lab. Quantification of eosinophil, neutrophil and mast cell numbers in inferior turbinate tissue biopsy will be performed by counting numbers of stained cells. Results are expressed as the number of cells per one hpf of tissue.
Determination of mucosal damage (fibrosis, mucosal ulceration , squamous metaplasia) between patients treated with intranasal rhinophototherapy and intranasal corticosteroids.
Time frame: Week 2
Nasal mucosa biopsy will be performed after 2 weeks of usage of intranasal phototherapy/corticosteroids under local anesthesia. Biopsy samples will be kept in glass bottles filled with paraformaldehyde. It will be labelled, packaged with a biohazard wrap and be transported within an hour to the histopathology lab. Tissue will be assessed histologically based on a modified grading system. Mucosal damage: * mucosal ulceration (absent or present) * squamous metaplasia (absent or present) * Presence of fibrosis (absent or present)
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 May 2026.
- Derived from this study: PubMed 41501617Ramasamy K, Gendeh HS, Wan Hamizan AK, Md Pauzi SH, Zahedi FD, Megat Ismail NF, Alfian N, Abdul Razak NN, Chinna K, Husain S. Histological Impact of Rhinophototherapy Compared to Intranasal Corticosteroids on Inflammatory Cells and Nasal Mucosa in Allergic Rhinitis. Ann Otol Rhinol Laryngol. 2026 Jun;135(6):458-463. doi: 10.1177/00034894251401132. Epub 2026 Jan 7.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication plan to be shared to researchers.
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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
Otorhinolaryngology Department, Head and Neck Surgery, Faculty of Medicine, UKM Medical Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rhinophototherapy and Nasonex Nasal Spray 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 8 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 May 2026. 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. 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 of Allergic Rhinitis at week 2 (time frame: Baseline and Week 2). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05919316, which also lists 1 linked publication.
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 May 2026.