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NCT05510024: RABIT

Radiofrequency Ablation of Bilateral Inferior Turbinate Followed by Subcutaneous Immunotherapy Trial

Not yet recruiting NA Last updated 22 August 2022
What this trial tests

NA trial testing Radiofrequency ablation of bilateral inferior turbinate followed by subcutaneous immunotherapy in Allergic Rhinitis Due to House Dust Mite in 392 participants. Not yet recruiting.

Timeline
1 October 2022
Primary endpoint
30 June 2026
31 December 2026

Quick facts

Lead sponsorEye & ENT Hospital of Fudan University
PhaseNA
StatusNot yet recruiting
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment392
Start date1 October 2022
Primary completion30 June 2026
Estimated completion31 December 2026

Drugs / interventions tested

Conditions studied

Sponsor

Eye & ENT Hospital of Fudan University

Who can join

Adults 18 to 60, any sex, with Allergic Rhinitis Due to House Dust Mite. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Allergic Rhinitis Due to House Dust Mite

Currently open trials in the same condition.

Other Eye & ENT Hospital of Fudan University trials

Trials by the same sponsor.

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Data sources for this page

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