Clinical trial NCT05510024: Radiofrequency Ablation of Bilateral Inferior Turbinate Followed by Subcutaneous Immunotherapy Trial
Official title: Radiofrequency Ablation of Bilateral Inferior Turbinate Followed by Subcutaneous Immunotherapy Trial for Severe House Dust Mite-sensitized Allergic Rhinitis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Allergic Rhinitis Due to House Dust Mite
Lead sponsor: Eye & ENT Hospital of Fudan University
Sponsor class: OTHER
First posted: 2022-08-22
Enrollment: 392
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in nasal congestion score (NCS)
timeFrame: 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:
measure: TNSS
timeFrame: 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)
measure: total combined score (TCS)
timeFrame: 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)
measure: Rescue medication score
timeFrame: 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)
measure: Health-related quality of life
timeFrame: 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)
measure: Number of patients who achieve target maintenance dose
timeFrame: end of build up phase (Visit2, up to four months after first injection)
measure: Incidence rate of asthma and new sensitizations
timeFrame: baseline (Visit 0), up to 12 months (Visit 3), up to 24 months (Visit 4), up to 36 months (Visit5)
measure: cost effectiveness ratio
timeFrame: baseline (Visit 0), up to 36 months (Visit5)
measure: adverse events
timeFrame: 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)
Other outcomes:
Locations:
Study officials:
affiliation: Eye & ENT Hospital of Fudan University
name: Huabin Li
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.