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

Allergic Rhinitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05919316
• Other study ID #: GGPM-2022-028
• Status: Recruiting
• Phase: N/A
• Start date: July 4, 2023
• Est. completion date: April 30, 2024

Study information

• Verified date: March 2024
• Source: National University of Malaysia
• Contact: Hardip Singh Gendeh
• Phone: 0391456576
• Email: hardip.gendeh[@]ppukm.ukm.edu.my
• Is FDA regulated: No
• Study type: Interventional

Clinical 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?

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Allergic Rhinitis
• Rhinitis
• Rhinitis, Allergic

Intervention

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

Locations

Country	Name	City	State
Malaysia	Otorhinolaryngology Department, Head and Neck Surgery, Faculty of Medicine, UKM Medical Centre, Jalan Yaacob Latif, Bandar Tun Razak, Cheras	Kuala Lumpur	Cheras

Sponsors (1)

Lead Sponsor	Collaborator
National University of Malaysia

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Baseline and Week 2
Primary	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.	Baseline and Week 2
Primary	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)	Baseline and Week 2
Primary	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.	Week 2
Primary	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)	Week 2