NCT05919316

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

The Efficacy Of Rhinophototherapy Compared To Intranasal Corticosteroids On The Nasal Mucosa Of Allergic Rhinitis Patients

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: National University of Malaysia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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? 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: 1. 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. 2. To determine mucosal inflammatory cells changes (eosinophils, neutrophils, mast cells) between patients treated with intranasal rhinophototherapy and intranasal corticosteroids. 3. 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

Interventions

Type	Name	Description
DEVICE	Rhinophototherapy	Intranasal rhinophotometer to be used at home for 4.5 minutes three times daily for 14 days
DRUG	Nasonex Nasal Spray	50mcg/dose, 2 sprays each nostril (morning or evening) once daily for 14 days

Timeline

• Start date: 2023-07-04
• Primary completion: 2024-04-30
• Completion: 2024-04-30
• First posted: 2023-06-26
• Last updated: 2024-03-21

Locations

1 site across 1 country: Malaysia