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

NCT05919316 | Recruiting

• 1 other identifier: GGPM-2022-028
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Allergic Rhinitis

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

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.

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.

Drug: Nasonex Nasal Spray

Interventions

Rhinophototherapy DEVICE

Intranasal rhinophotometer to be used at home for 4.5 minutes three times daily for 14 days

Also known as: Intranasal rhinophototherapy Bionette

Rhinophototherapy

Nasonex Nasal Spray DRUG

50mcg/dose, 2 sprays each nostril (morning or evening) once daily for 14 days

Also known as: Mometasone furoate nasal spray

Intranasal Corticosteroids

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• National University of Malaysia: lead

Study Sites (1)

Otorhinolaryngology Department, Head and Neck Surgery, Faculty of Medicine, UKM Medical Centre, Jalan Yaacob Latif, Bandar Tun Razak, Cheras

Kuala Lumpur, Cheras, 56000, Malaysia

RECRUITING

Related Publications (1)

• 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 Jan 7:34894251401132. doi: 10.1177/00034894251401132. Online ahead of print.

  PMID: 41501617 DERIVED

MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

Mometasone Furoate

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Hardip Singh Gendeh

  Otorhinolaryngology Department, Head and Neck Surgery, Faculty of Medicine, UKM Medical Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hardip Singh Gendeh

CONTACT

0391456576; hardip.gendeh@ppukm.ukm.edu.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2023
• First Posted: June 26, 2023
• Study Start: July 4, 2023
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: March 21, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 6 months after publication
• Access Criteria: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research.

Locations

MY (1)