Radiofrequency Ablation of Bilateral Inferior Turbinate Followed by Subcutaneous Immunotherapy Trial

NCT05510024 | Not Yet Recruiting DMC

• 1 other identifier: RABIT-2022
• Study Type: interventional
• Target: 392
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Allergic Rhinitis Due to House Dust Mite

Outcome Measures

Primary Outcomes (1)

• Change in nasal congestion score (NCS)

  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 Outcomes (8)

• 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 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)

• 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)

• 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)

• Number of patients who achieve target maintenance dose

  end of build up phase (Visit2, up to four months after first injection)

Study Arms (2)

Radiofrequency ablation of bilateral inferior turbinate followed by subcutaneous Immunotherapy

EXPERIMENTAL

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

Subcutaneous Immunotherapy (SCIT)

ACTIVE COMPARATOR

Allergen-specific subcutaneous Immunotherapy will be conducted in participants with severe house dust mite-sensitized allergic rhinitis.

Procedure: SCIT

Interventions

Radiofrequency ablation of bilateral inferior turbinate followed by subcutaneous immunotherapy PROCEDURE

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.

Radiofrequency ablation of bilateral inferior turbinate followed by subcutaneous Immunotherapy

SCIT PROCEDURE

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.

Subcutaneous Immunotherapy (SCIT)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eye & ENT Hospital of Fudan University: lead

Related Publications (8)

• Brozek JL, Bousquet J, Agache I, Agarwal A, Bachert C, Bosnic-Anticevich S, Brignardello-Petersen R, Canonica GW, Casale T, Chavannes NH, Correia de Sousa J, Cruz AA, Cuello-Garcia CA, Demoly P, Dykewicz M, Etxeandia-Ikobaltzeta I, Florez ID, Fokkens W, Fonseca J, Hellings PW, Klimek L, Kowalski S, Kuna P, Laisaar KT, Larenas-Linnemann DE, Lodrup Carlsen KC, Manning PJ, Meltzer E, Mullol J, Muraro A, O'Hehir R, Ohta K, Panzner P, Papadopoulos N, Park HS, Passalacqua G, Pawankar R, Price D, Riva JJ, Roldan Y, Ryan D, Sadeghirad B, Samolinski B, Schmid-Grendelmeier P, Sheikh A, Togias A, Valero A, Valiulis A, Valovirta E, Ventresca M, Wallace D, Waserman S, Wickman M, Wiercioch W, Yepes-Nunez JJ, Zhang L, Zhang Y, Zidarn M, Zuberbier T, Schunemann HJ. Allergic Rhinitis and its Impact on Asthma (ARIA) guidelines-2016 revision. J Allergy Clin Immunol. 2017 Oct;140(4):950-958. doi: 10.1016/j.jaci.2017.03.050. Epub 2017 Jun 8.

  PMID: 28602936 BACKGROUND

• Durham SR, Penagos M. Sublingual or subcutaneous immunotherapy for allergic rhinitis? J Allergy Clin Immunol. 2016 Feb;137(2):339-349.e10. doi: 10.1016/j.jaci.2015.12.1298.

  PMID: 26853126 BACKGROUND

• Lou H, Ma S, Zhao Y, Cao F, He F, Liu Z, Bousquet J, Wang C, Zhang L, Bachert C. Sensitization patterns and minimum screening panels for aeroallergens in self-reported allergic rhinitis in China. Sci Rep. 2017 Aug 24;7(1):9286. doi: 10.1038/s41598-017-10111-9.

  PMID: 28839248 BACKGROUND

• Ciprandi G, Cirillo I, Vizzaccaro A, Tosca M, Passalacqua G, Pallestrini E, Canonica GW. Seasonal and perennial allergic rhinitis: is this classification adherent to real life? Allergy. 2005 Jul;60(7):882-7. doi: 10.1111/j.1398-9995.2005.00602.x.

  PMID: 15932377 BACKGROUND

• Karakoc-Aydiner E, Eifan AO, Baris S, Gunay E, Akturk E, Akkoc T, Bahceciler NN, Barlan IB. Long-Term Effect of Sublingual and Subcutaneous Immunotherapy in Dust Mite-Allergic Children With Asthma/Rhinitis: A 3-Year Prospective Randomized Controlled Trial. J Investig Allergol Clin Immunol. 2015;25(5):334-42.

  PMID: 26727762 BACKGROUND

• Sahin E, Dizdar D, Dinc ME, Cirik AA. Long-term effects of allergen-specific subcutaneous immunotherapy for house dust mite induced allergic rhinitis. J Laryngol Otol. 2017 Nov;131(11):997-1001. doi: 10.1017/S0022215117002110. Epub 2017 Oct 17.

  PMID: 29037263 BACKGROUND

• Tabar AI, Arroabarren E, Echechipia S, Garcia BE, Martin S, Alvarez-Puebla MJ. Three years of specific immunotherapy may be sufficient in house dust mite respiratory allergy. J Allergy Clin Immunol. 2011 Jan;127(1):57-63, 63.e1-3. doi: 10.1016/j.jaci.2010.10.025.

  PMID: 21211641 BACKGROUND

• Sohn MH. Efficacy and Safety of Subcutaneous Allergen Immunotherapy for Allergic Rhinitis. Allergy Asthma Immunol Res. 2018 Jan;10(1):1-3. doi: 10.4168/aair.2018.10.1.1. No abstract available.

  PMID: 29178670 BACKGROUND

Study Officials

• Huabin Li

  Eye & ENT Hospital of Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Huabin Li

CONTACT

18816993402; noseli@163.com

Hongfei Lou

CONTACT

15210295496; louhongfei@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessors who were involved in outcome measurements will be masked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Department of Allergy

Study Record Dates

• First Submitted: June 8, 2022
• First Posted: August 22, 2022
• Study Start: October 1, 2022
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 22, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share