Budesonide Irrigation in Allergic Rhinitis

NCT06785662 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: Si044/2022
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Allergic Rhinitis

Keywords

intranasal corticosteroid; budesonide nasal irrigation; Budesonide nasal spray; Allergic rhinitis

Outcome Measures

Primary Outcomes (1)

• 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 1. Mild symptoms (present but not bothersome) 2. Moderate symptoms (noticeable and somewhat bothersome) 3. Severe symptoms (very bothersome and interfering with daily activities)

  Follow-up visits were scheduled at 2 and 4 weeks after starting treatment.

Secondary Outcomes (4)

• Postnasal Drip Symptom Score (PND)

  Follow-up visits were scheduled at 2 and 4 weeks after starting treatment.

• Rhinoconjunctivitis Quality of Life Questionnaire (RCQ-36)

  Follow-up visits were scheduled at 2 and 4 weeks after starting treatment.

• Peak Nasal Inspiratory Flow (PNIF)

  Follow-up visits were scheduled at 2 and 4 weeks after starting treatment.

• Adverse events

  Follow-up visits were scheduled at 2 and 4 weeks after starting treatment.

Study Arms (2)

The budesonide nasal irrigation group

EXPERIMENTAL

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 budesonide nasal spray group

ACTIVE COMPARATOR

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

Interventions

The budesonide nasal irrigation DRUG

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.

The budesonide nasal irrigation group

The budesonide nasal spray DRUG

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).

The budesonide nasal spray group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Siriraj Hospital: lead

Study Sites (1)

Siriraj Hospital, Mahidol University

Bangkok, 10700, Thailand

Location

MeSH Terms

Conditions

Rhinitis, Allergic

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Navarat Kasemsuk, M.D.

CONTACT

+66870890444; mintkus32@hotmail.com

Pongsakorn Tantilipikorn, M.D., PhD.

CONTACT

+66818363074; pongsakorn.tan@mahidol.ac.th

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Model Details: This trial will be reported according to CONSORT 2010 statement for randomized controlled trials. The enrolled participants were assigned a study code that was enclosed in a sealed envelope, prepared by personnel not involved in the research, and then randomly allocated into one of two groups using a computer-generated random permuted blocks design. The outcomes assessors were blinded to the randomization.

Study Record Dates

• First Submitted: January 13, 2025
• First Posted: January 21, 2025
• Study Start: February 12, 2025
• Primary Completion: January 1, 2026
• Study Completion: June 1, 2026
• Last Updated: January 21, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)