Radiofrequency Ablation of Bilateral Inferior Turbinate Followed by Subcutaneous Immunotherapy Trial — RABIT  

Allergic Rhinitis Due to House Dust Mite Clinical Trial

Official title: Radiofrequency Ablation of Bilateral Inferior Turbinate Followed by Subcutaneous Immunotherapy Trial for Severe House Dust Mite-sensitized Allergic Rhinitis

Status Not yet recruiting

Clinical Trial Summary

Allergic rhinitis (AR) is a global health issue adversely impacting the quality of life (QoL) of affected individuals and exerting a huge public health burden. Allergen immunotherapy (AIT) has been shown to be effective in the treatment of not only the symptoms, but also the underlying causes of the disease. Moreover, AIT has a preventative role against new sensitizations and development of asthma in AR patients. Hence AIT is recommended as an integrated part of an allergy management strategy in the treatment of AR. Over the development of one century, AIT has been delivered by various routes. Among them, subcutaneous immunotherapy (SCIT) has been currently widely used in clinical practice.

House dust mite (HDM) has been reported to be the most common sensitizing allergen in China. Nasal obstruction is the common complaint in HDM-sensitized AR and prompts patients to seek medical help. It has been proved that HDM-SCIT showed favourable efficacy in treating persistent AR. However, HDM-SCIT recommends 3 years of subcutaneous injection and requires good adherence to guarantee the efficacy. Later onset of nasal obstruction alleviation might reduce the adherence of HDM-SCIT.

Radiofrequency ablation of bilateral inferior turbinate can relieve nasal obstruction within a short time after operation. It is hypothesized that, in HDM-AR patients with severe nasal obstruction, bilateral inferior turbinate surgery followed by HDM-SCIT will obtain quick-onset of good nasal ventilation and improve AIT adherence.

The overall objective of the proposed randomized controlled trial is to test whether radiofrequency ablation of bilateral inferior turbinate followed by subcutaneous immunotherapy will improve nasal obstruction among patients with house dust mite sensitized allergic rhinitis (HDM-AR) compared to subcutaneous immunotherapy (SCIT) only during the 4-month build-up phase as well as the 36-month full phase of SCIT.

Clinical Trial Description

The overall objective of the proposed randomized controlled trial is to test whether radiofrequency ablation of bilateral inferior turbinate followed by subcutaneous immunotherapy will improve nasal obstruction among patients with house dust mite sensitized allergic rhinitis (HDM-AR) compared to subcutaneous immunotherapy (SCIT) only during the 4-month build-up phase as well as the 36-month full phase of SCIT.

Specifically, the investigator propose to conduct a multicentre randomized trial to achieve the following specific aims:

1. To test whether radiofrequency ablation of bilateral inferior turbinate plus subcutaneous immunotherapy (RABIT) will improve nasal obstruction over a 4-month build-up phase of SCIT compared to subcutaneous immunotherapy (SCIT) only among patients with HDM-AR in China;

2. To test whether RABIT will improve each nasal symptom of AR, including sneezing, nasal itching, rhinorrhea and nasal congestion over the 36-month full phase of SCIT compared to SCIT only among patients with HDM-AR in China;

3. To evaluate whether RABIT will improve health-related quality of life (HRQoL) compared to SCIT only among patients with HDM-AR in China;

4. To estimate the cost-effectiveness of RABIT compared to SCIT only in China.

5. To test whether RABIT will decrease the risk of incidence of asthma and reduce new sensitizations compared to SCIT only in China. ;

Related Conditions & MeSH terms

• Allergic Rhinitis Due to House Dust Mite
• Rhinitis
• Rhinitis, Allergic

• NCT number: NCT05510024
• Study type: Interventional
• Source: Eye & ENT Hospital of Fudan University
• Contact: Huabin Li
• Phone: 18816993402
• Email: noseli@163.com
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2022
• Completion date: December 31, 2026