Budesonide Irrigation in Allergic Rhinitis

The Efficacy of Budesonide Nasal Irrigation in Allergic Rhinitis Patients: A Randomized, Controlled Trial.

Topical nasal steroids are significant therapeutic options for allergic rhinitis (AR). The distribution of intranasal steroid spray (INS) administration is less than that of irrigation. However, the available data on steroid nasal irrigation is limited. This article aims to evaluate the efficacy and adverse effects (AEs) of steroid irrigation in AR patients.

Study Overview

• Status: Not yet recruiting
• Conditions: Allergic Rhinitis
• Intervention / Treatment: Drug: The budesonide nasal irrigation; Drug: The budesonide nasal spray

Detailed Description

Allergic rhinitis is a prevalent health problem found in Thai population, with various treatment approaches available, such as avoiding triggering allergens, using pharmacological treatments, receiving allergy immunotherapy, and going on a surgery.[1] Nowadays, the use of topical medications, particularly steroids, plays a crucial role in treating nasal and sinus conditions due to their anti-inflammatory properties. Normally, steroids can be administered through diverse methods including nasal sprays, drops, and irrigation. The general guidelines for treating allergic rhinitis or chronic sinusitis typically emphasized the use of topical nasal steroids, particularly in spray form.[2, 3] Other forms of drug administration are generally considered alternative options. However, studies have shown that the distribution of medication via nasal spray is inferior to that of other delivery methods, including nasal irrigation. Most of the medication is concentrated in the anterior portion of the nasal cavity, particularly the nasal vestibule, with limited distribution to the inferior turbinate, superior turbinate, sphenoethmoidal recess, and superior olfactory cleft, compared to nasal irrigation. Therefore, the administration of topical steroids by nasal irrigation may serve as an alternative topical steroid delivery method.[4] Previous studies have mentioned the use of steroid nasal irrigation, primarily in patients with post-endoscopic sinus surgery for chronic sinusitis.[5-17] Additionally, there have been studies addressing its application in conditions such as allergic fungal rhinitis, acute sinusitis in children, and post-operative patients following septoplasty.[18, 19] The use of steroid nasal irrigation for treating allergic rhinitis has been scarcely discussed, and there is limited data available. One study investigated the use of budesonide nasal irrigation compared to normal saline nasal irrigation in patients with allergic rhinitis. The results showed that the Sinonasal Outcome Test-22 (SNOT-22) score and Visual Analog Scale (VAS) scores in the budesonide nasal irrigation group were significantly superior than those in the saline irrigation group.[20] However, there have been no studies conducted on patients with allergic rhinitis where nasal spray treatment was insufficient to control the symptoms of nasal inflammation. Additionally, no comparative studies between different drug administration techniques have been carried out.

This study aims to evaluate the efficacy of budesonide nasal irrigation in patients with allergic rhinitis, where the use of nasal steroid spray alone was insufficient to control nasal inflammation and required dosage adjustment. We hypothesized that administering steroids via nasal irrigation would improve drug distribution, leading to better outcomes.

• Study Type: Interventional
• Enrollment (Estimated): 78
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Navarat Kasemsuk, M.D.; Phone Number: +66870890444; Email: mintkus32@hotmail.com
• Study Contact Backup: Name: Pongsakorn Tantilipikorn, M.D., PhD.; Phone Number: +66818363074; Email: pongsakorn.tan@mahidol.ac.th

Study Locations

• Thailand
  • Bangkok, Thailand, 10700
    • Siriraj Hospital, Mahidol University
    • Contact: Navarat Kasemsuk; Phone Number: 0870890444; Email: mintkus32@hotmail.com
    • Contact: Pomgsakorn Tantilipikorn, M.D., PhD.; Phone Number: +66818363074; Email: pongsakorn.tan@mahidol.ac.th
    • Principal Investigator: Navarat Kasemsuk, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Participants aged 18-60 years diagnosed with perennial allergic rhinitis based on ARIA guidelines, who have previously consistently used intranasal corticosteroids for at least 2 weeks with inadequate control of nasal inflammation defined by a VAS score of ≥5 out of 10 and requiring dosage adjustment. Noted that proper technique should have been confirmed through retrospective questioning.

Exclusion Criteria:

• Those with a history of sinus surgery, nasal or sinus tumors (including polyps), significant deviated nasal septum causing symptoms, oral corticosteroid uses for any indication, immunodeficiency, pregnancy, breastfeeding, or suspected fungal sinusitis indicated by ischemic nasal tissue, fungal masses, bone erosion, or calcifications on imaging were excluded. Participants would be withdrawn if severe complications arise from the use of topical budesonide.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: The budesonide nasal irrigation group; The participant in this group used a solution containing 1 milligram of budesonide mixed with 240 milliliters of normal saline in a squeeze bottle (Cleanoze®) for nasal irrigation. The procedure will be performed once daily while leaning slightly forward over a sink.	Drug: The budesonide nasal irrigation; The participant in this group used a solution containing 1 milligram of budesonide mixed with 240 milliliters of normal saline in a squeeze bottle (Cleanoze®) for nasal irrigation. The procedure will be performed once daily while leaning slightly forward over a sink.
Active Comparator: The budesonide nasal spray group; The participant in this group used a nasal spray containing 64 micrograms of budesonide per spray, with two sprays per nostril administered twice daily (morning and evening).	Drug: The budesonide nasal spray; The participants in this group used a nasal spray containing 64 micrograms of budesonide per spray, with two sprays per nostril administered twice daily (morning and evening).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Nasal Symptom Score (TNSS)	Full Name: Total Nasal Symptom Score Scale Range: 0 to 12 Scoring Interpretation: Higher scores indicate a worse outcome Each symptom is rated by the participant on a scale (0 to 3), based on severity: 0: No symptoms; Mild symptoms (present but not bothersome); Moderate symptoms (noticeable and somewhat bothersome); Severe symptoms (very bothersome and interfering with daily activities)	Follow-up visits were scheduled at 2 and 4 weeks after starting treatment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postnasal Drip Symptom Score (PND)	Postnasal Drip Symptom Score (PND) determines the severity of post nasal drip sensation Full Name: Postnasal Drip Symptom Score Scale Range: 0 to 3 Scoring Interpretation: Higher scores indicate a worse outcome. The PND focuses specifically on the severity of postnasal drip symptoms, with scores representing none (0), mild (1), moderate (2), or severe (3) symptoms.	Follow-up visits were scheduled at 2 and 4 weeks after starting treatment.
Rhinoconjunctivitis Quality of Life Questionnaire (RCQ-36)	Rhinoconjunctivitis Quality of Life Questionnaire (RCQ-36) determine disease-specific quality of life Full Name: Rhinoconjunctivitis Quality of Life Questionnaire - 36 Items Scale Range: 0 to 6 for each item, summing up to a total score. Scoring Interpretation: Higher scores indicate a worse outcome. This questionnaire assesses the impact of rhinoconjunctivitis symptoms on quality of life, covering domains such as sleep, activities, emotional well-being, and social functioning.	Follow-up visits were scheduled at 2 and 4 weeks after starting treatment.
Peak Nasal Inspiratory Flow (PNIF)	Peak Nasal Inspiratory Flow (PNIF) is an objective measurement to determine nasal patency Full Name: Peak Nasal Inspiratory Flow Scale Range: Measured in liters per minute (L/min); there is no fixed maximum value, as it depends on individual physiology. Scoring Interpretation: Higher values indicate a better outcome. PNIF measures the maximum airflow through the nasal passages during inspiration and is used as an objective measure of nasal patency (openness).	Follow-up visits were scheduled at 2 and 4 weeks after starting treatment.
Adverse events	All adverse events occurred during the usage of budesonide nasal irrigation were reported.	Follow-up visits were scheduled at 2 and 4 weeks after starting treatment.

Collaborators and Investigators

• Sponsor: Siriraj Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): February 12, 2025
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: January 13, 2025
• First Submitted That Met QC Criteria: January 20, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 20, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Allergic rhinitis; intranasal corticosteroid; budesonide nasal irrigation; Budesonide nasal spray
• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Nose Diseases; Otorhinolaryngologic Diseases; Rhinitis; Rhinitis, Allergic; Physiological Effects of Drugs; Anti-Inflammatory Agents; Autonomic Agents; Peripheral Nervous System Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Respiratory System Agents; Anti-Asthmatic Agents; Bronchodilator Agents; Budesonide
• Other Study ID Numbers: Si044/2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes