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

August 19, 2022 updated by: Huabin Li, Eye & ENT Hospital of Fudan University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

392

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
Procedure: Radiofrequency ablation of bilateral inferior turbinate followed by subcutaneous immunotherapy
The regulation and monitoring of the entire soft-coagulation process are conducted via the radiofrequency generator under endoscopic guidance. Lateral out-fracture of the inferior turbinate is performed if necessary. One month after surgery, allergen immunotherapy will be conducted. Standardized Dp allergen extracts (Alutard SQ, ALK-Abell'o) were used for SCIT. According to the manufacturer's instructions, the build up phase was carried out with weekly injections of volumes of 0.2, 0.4, and 0.8 mL in the first 3 vials (nos. 1 to 3) and 0.1, 0.2, 0.4, 0.8, and 1.0 mL in vial no. 4, reaching the maintenance dose, 100,000 standardized quality units. The specialist adjusted the dose according to the patient's therapeutic response, and the cumulative allergen dose for each patient was the maximal tolerable injected dose. Then, the maintenance dose was given with an injection interval of 6±2 weeks according to the manufacturer's recommendations.
ACTIVE_COMPARATOR: Subcutaneous Immunotherapy (SCIT)
Allergen-specific subcutaneous Immunotherapy will be conducted in participants with severe house dust mite-sensitized allergic rhinitis.
Procedure: SCIT
Allergen immunotherapy will be conducted. Standardized Dp allergen extracts (Alutard SQ, ALK-Abell'o) were used for SCIT. According to the manufacturer's instructions, the build up phase was carried out with weekly injections of volumes of 0.2, 0.4, and 0.8 mL in the first 3 vials (nos. 1 to 3) and 0.1, 0.2, 0.4, 0.8, and 1.0 mL in vial no. 4, reaching the maintenance dose, 100,000 standardized quality units. The specialist adjusted the dose according to the patient's therapeutic response, and the cumulative allergen dose for each patient was the maximal tolerable injected dose. Then, the maintenance dose was given with an injection interval of 6±2 weeks according to the manufacturer's recommendations.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in nasal congestion score (NCS)
Time Frame: 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.
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)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
TNSS
Time Frame: 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
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)
Time Frame: 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).
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)
Rescue medication score
Time Frame: 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.
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)
Health-related quality of life
Time Frame: 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.
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)
Number of patients who achieve target maintenance dose
Time Frame: end of build up phase (Visit2, up to four months after first injection)
Number of patients who achieve target maintenance dose
end of build up phase (Visit2, up to four months after first injection)
Incidence rate of asthma and new sensitizations
Time Frame: 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
baseline (Visit 0), up to 12 months (Visit 3), up to 24 months (Visit 4), up to 36 months (Visit5)
cost effectiveness ratio
Time Frame: baseline (Visit 0), up to 36 months (Visit5)
Primary incremental cost effectiveness ratio (ICER) measures will be cost per % change in nasal congestion score
baseline (Visit 0), up to 36 months (Visit5)
adverse events
Time Frame: 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).
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eye & ENT Hospital of Fudan University

Investigators

  • Principal Investigator: Huabin Li, Eye & ENT Hospital of Fudan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

October 1, 2022

Primary Completion (ANTICIPATED)

June 30, 2026

Study Completion (ANTICIPATED)

December 31, 2026

Study Registration Dates

First Submitted

June 8, 2022

First Submitted That Met QC Criteria

August 19, 2022

First Posted (ACTUAL)

August 22, 2022

Study Record Updates

Last Update Posted (ACTUAL)

August 22, 2022

Last Update Submitted That Met QC Criteria

August 19, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RABIT-2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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