Radiofrequency Ablation of Bilateral Inferior Turbinate Followed by Subcutaneous Immunotherapy Trial
- Conditions
- Allergic Rhinitis Due to House Dust Mite
- Interventions
- Procedure: Radiofrequency ablation of bilateral inferior turbinate followed by subcutaneous immunotherapyProcedure: SCIT
- Registration Number
- NCT05510024
- Lead Sponsor
- Eye & ENT Hospital of Fudan University
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 392
- 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
- no intranasal steroids and/or antihistamines for 2 weeks prior to recruitment
- 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
- those who had previously received AIT or nasal surgery within one month or those who participated other clinical trials within 3 months prior to recruitment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Radiofrequency ablation of bilateral inferior turbinate followed by subcutaneous Immunotherapy Radiofrequency ablation of bilateral inferior turbinate followed by subcutaneous immunotherapy Radiofrequency ablation of bilateral inferior turbinate followed by subcutaneous Immunotherapy will be conducted in participants with severe house dust mite-sensitized allergic rhinitis. Subcutaneous Immunotherapy (SCIT) SCIT Allergen-specific subcutaneous Immunotherapy will be conducted in participants with severe house dust mite-sensitized allergic rhinitis.
- Primary Outcome Measures
Name Time Method Change in nasal congestion score (NCS) baseline (Visit 0), one month after surgery (Visit 1, before first injection in SCIT), end of build up phase (Visit2, up to four months after first injection), up to 12 months (Visit 3), up to 24 months (Visit 4), up to 36 months (Visit5) Nasal congestion is graded on a visual analog scale score (0, none; 10, severe). (1) Phase I: change in NCS during the 4-month build-up phase of SCIT between the intervention and control groups (2) Phase II: differences in NCS over the 36-month full phase of subcutaneous immunotherapy (SCIT) between the intervention and control groups.
- Secondary Outcome Measures
Name Time Method Rescue medication score baseline (Visit 0), one month after surgery (Visit 1, before first injection in SCIT), end of build up phase (Visit2, up to four months after first injection), up to 12 months (Visit 3), up to 24 months (Visit 4), up to 36 months (Visit5) The need for rescue medication was assessed throughout the treatment as rescue medication score (RMS), ranging from 0 to 3 as follows: 0 = no use of rescue medication, 1 = use of oral and/or topical non-sedative H1 antihistamines, 2 = use of intranasal corticosteroids with/without H1 antihistamines, and 3 = use of oral corticosteroids with/without intranasal corticosteroids, with/without H1 antihistamines.
Incidence rate of asthma and new sensitizations baseline (Visit 0), up to 12 months (Visit 3), up to 24 months (Visit 4), up to 36 months (Visit5) Incidence rate of asthma on those who did not have asthma at baseline
TNSS baseline (Visit 0), one month after surgery (Visit 1, before first injection in SCIT), end of build up phase (Visit2, up to four months after first injection), up to 12 months (Visit 3), up to 24 months (Visit 4), up to 36 months (Visit5) total nasal symptoms score including nasal congestion, rhinorrhea, itching and sneezing
total combined score (TCS) baseline (Visit 0), one month after surgery (Visit 1, before first injection in SCIT), end of build up phase (Visit2, up to four months after first injection), up to 12 months (Visit 3), up to 24 months (Visit 4), up to 36 months (Visit5) Total combined score (TCS) is calculated as the combined score of average scores of six nasal/conjunctivitis symptoms (rhinorrhea, nasal congestion, nasal itching, sneezing, gritty eyes, and watery eyes) and the rescue medication score (RMS), ranging from 0 to 6 (0, none; 6, severe).
Health-related quality of life baseline (Visit 0), one month after surgery (Visit 1, before first injection in SCIT), end of build up phase (Visit2, up to four months after first injection), up to 12 months (Visit 3), up to 24 months (Visit 4), up to 36 months (Visit5) The rhinoconjunctivitis quality of life questionnaire (RQLQ) consisted of seven domains with a total of 28 questions. And the score was recorded at each visit to evaluate the quality of life.
adverse events baseline (Visit 0), one month after surgery (Visit 1, before first injection in SCIT), end of build up phase (Visit2, up to four months after first injection), up to 12 months (Visit 3), up to 24 months (Visit 4), up to 36 months (Visit5) Safety was evaluated by the occurrence and severity of adverse events (AEs) and the casual relationship between AEs and the experimental drug. All AEs will be categorized as mild (no impact on the activities of daily living), moderate (decreased or affected performance of the activities of daily living) or severe (an inability to perform the activities of daily living or death).
Number of patients who achieve target maintenance dose end of build up phase (Visit2, up to four months after first injection) Number of patients who achieve target maintenance dose
cost effectiveness ratio baseline (Visit 0), up to 36 months (Visit5) Primary incremental cost effectiveness ratio (ICER) measures will be cost per % change in nasal congestion score