Budesonide Irrigation in Allergic Rhinitis

Siriraj Hospital

Status and phase: Not yet enrolling; Phase 4

Conditions: Allergic Rhinitis

Treatments: Drug: The budesonide nasal spray; Drug: The budesonide nasal irrigation

Study type: Interventional

Funder types: Other

Identifiers

NCT06785662

Si044/2022

Details and patient eligibility

About

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.

Full 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.

Enrollment: 78 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

78 participants in 2 patient groups

The budesonide nasal irrigation group

Experimental group

Description:

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.

Treatment:

Drug: The budesonide nasal irrigation

The budesonide nasal spray group

Active Comparator group

Description:

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).

Treatment:

Drug: The budesonide nasal spray