Clinical trial NCT06785662: Budesonide Irrigation in Allergic Rhinitis
Official title: The Efficacy of Budesonide Nasal Irrigation in Allergic Rhinitis Patients: A Randomized, Controlled Trial.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Allergic Rhinitis
Keywords: intranasal corticosteroid
budesonide nasal irrigation
Budesonide nasal spray
Allergic rhinitis
Lead sponsor: Siriraj Hospital
Sponsor class: OTHER
First posted: 2025-01-21
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Total Nasal Symptom Score (TNSS)
timeFrame: Follow-up visits were scheduled at 2 and 4 weeks after starting treatment.
Secondary outcomes:
measure: Postnasal Drip Symptom Score (PND)
timeFrame: Follow-up visits were scheduled at 2 and 4 weeks after starting treatment.
measure: Rhinoconjunctivitis Quality of Life Questionnaire (RCQ-36)
timeFrame: Follow-up visits were scheduled at 2 and 4 weeks after starting treatment.
measure: Peak Nasal Inspiratory Flow (PNIF)
timeFrame: Follow-up visits were scheduled at 2 and 4 weeks after starting treatment.
measure: Adverse events
timeFrame: Follow-up visits were scheduled at 2 and 4 weeks after starting treatment.
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Siriraj Hospital, Mahidol University
Study officials:
References: