The Efficacy Of Rhinophototherapy Compared To Intranasal Corticosteroids On The Nasal Mucosa

National University of Malaysia

Status: Enrolling

Conditions: Allergic Rhinitis

Treatments: Drug: Nasonex Nasal Spray; Device: Rhinophototherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05919316

GGPM-2022-028

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adult patients 18 years and above
• Newly diagnosed allergic rhinitis
• Allergic rhinitis is confirmed via positive skin prick test or serum Immunoglobulin E

Exclusion criteria

• 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Rhinophototherapy

Experimental group

Description:

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.

Treatment:

Device: Rhinophototherapy

Intranasal Corticosteroids

Active Comparator group

Description:

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.

Treatment:

Drug: Nasonex Nasal Spray