Radiofrequency Ablation of Bilateral Inferior Turbinate Followed by Subcutaneous Immunotherapy Trial

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorEye & ENT Hospital of Fudan University

About this trial

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.

Eligibility criteria

Qualifiers

aged 18 to 60 years

at least 2-year history of physician-diagnosed HDM-AR, with positive skin prick test to house dust mite and/or positive serum antigen-specific IgE

nasal congestion score ≥7, severe inferior turbinate hypertrophy (no visible of middle turbinate)

no oral steroids for 4 weeks prior to treatment

Disqualifiers

symptomatic seasonal AR

any respiratory infection within the previous 4 weeks prior to recruitment

chronic rhinosinusitis with or without nasal polyps, nasal septum deviation, cleft lip and/or palate, autoimmune disorders, malignant tumor, immune deficiency disease, tuberculosis, cardiac dysfunction, uncontrolled asthma, beta blocker in taker, other severe systemic disease

pregnancy or breastfeeding females

Trial design

Treatments tested in this trial

  • Radiofrequency ablation of bilateral inferior turbinate followed by subcutaneous immunotherapy
  • SCIT

Treatment groups

392 Participants
are divided into 2 treatment groups

Locations

This trial has no locations