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NCT Number: NCT05919316

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

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Kuala Lumpur, Cheras, 56000, Malaysia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rhinophototherapy

Device

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

Other names: Intranasal rhinophototherapy Bionette

Nasonex Nasal Spray

Drug

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

Other names: Mometasone furoate nasal spray

Primary outcomes

  1. Change from Baseline in Symptoms Score of Allergic Rhinitis at week 2

    Time frame: Baseline and 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)

  2. Peak nasal inspiratory flow meter (PNIF)

    Time frame: Baseline and Week 2

    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.

  3. Total nasal resistance by Rhinomanometry

    Time frame: Baseline and Week 2

    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)

  4. Determination of mucosal inflammatory cells changes (eosinophils, neutrophils, mast cells) between patients treated with intranasal rhinophototherapy and intranasal corticosteroids.

    Time frame: Week 2

    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.

  5. Determination of mucosal damage (fibrosis, mucosal ulceration , squamous metaplasia) between patients treated with intranasal rhinophototherapy and intranasal corticosteroids.

    Time frame: Week 2

    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)

Sponsors and collaborators

Lead sponsor

National University of Malaysia

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 26, 2023
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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