Clinical trial NCT05919316: The Efficacy Of Rhinophototherapy Compared To Intranasal Corticosteroids On The Nasal Mucosa
Official title: The Efficacy Of Rhinophototherapy Compared To Intranasal Corticosteroids On The Nasal Mucosa Of Allergic Rhinitis Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Allergic Rhinitis
Lead sponsor: National University of Malaysia
Sponsor class: OTHER
First posted: 2023-06-26
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline in Symptoms Score of Allergic Rhinitis at week 2
timeFrame: Baseline and Week 2
measure: Peak nasal inspiratory flow meter (PNIF)
timeFrame: Baseline and Week 2
measure: Total nasal resistance by Rhinomanometry
timeFrame: Baseline and Week 2
measure: Determination of mucosal inflammatory cells changes (eosinophils, neutrophils, mast cells) between patients treated with intranasal rhinophototherapy and intranasal corticosteroids.
timeFrame: Week 2
measure: Determination of mucosal damage (fibrosis, mucosal ulceration , squamous metaplasia) between patients treated with intranasal rhinophototherapy and intranasal corticosteroids.
timeFrame: Week 2
Secondary outcomes:
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: Otorhinolaryngology Department, Head and Neck Surgery, Faculty of Medicine, UKM Medical Centre, Jalan Yaacob Latif, Bandar Tun Razak, Cheras
state: Cheras
Study officials:
affiliation: Otorhinolaryngology Department, Head and Neck Surgery, Faculty of Medicine, UKM Medical Centre
name: Hardip Singh Gendeh
role: PRINCIPAL_INVESTIGATOR
References: