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Allergic Rhinitis Due to House Dust MiteRABITNCT05510024

Radiofrequency Ablation of Bilateral Inferior Turbinate Followed by Subcutaneous Immunotherapy Trial

A study testing Radiofrequency ablation of bilateral inferior turbinate followed by subcutaneous immunotherapy and SCIT in people with Allergic Rhinitis Due to House Dust Mite, run by Eye & ENT Hospital of Fudan University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Allergic Rhinitis Due to House Dust Mite
What is being tested?
Radiofrequency ablation of bilateral inferior turbinate followed by subcutaneous immunotherapy and SCIT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
392 participants
Where
No sites listed yet
Study dates
1 Oct 2022to 31 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Huabin Li contact

18816993402

noseli@163.com

Hongfei Lou contact

15210295496

louhongfei@yahoo.com

About this study

Official title: 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.

Read more

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.

Read the 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.
Being tested
Radiofrequency ablation of bilateral inferior turbinate followed by subcutaneous immunotherapy, SCIT

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Radiofrequency ablation of bilateral inferior turbinate followed by subcutaneous immunotherapyProcedure or surgery

    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.

  • SCITProcedure or 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.

Study groups in NCT05510024
Study groupRoleWhat they receive
Radiofrequency ablation of bilateral inferior turbinate followed by subcutaneous ImmunotherapyExperimentalRadiofrequency ablation of bilateral inferior turbinate followed by subcutaneous Immunotherapy will be conducted in participants with severe house dust mite-sensitized allergic rhinitis.
Receives: Procedure: Radiofrequency ablation of bilateral inferior turbinate followed by subcutaneous immunotherapy
Subcutaneous Immunotherapy (SCIT)Active comparatorAllergen-specific subcutaneous Immunotherapy will be conducted in participants with severe house dust mite-sensitized allergic rhinitis.
Receives: Procedure: SCIT

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)

  1. TNSS

    total nasal symptoms score including nasal congestion, rhinorrhea, itching and sneezing

    Measured: 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)

  2. total combined score (TCS)

    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).

    Measured: 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)

  3. Rescue medication score

    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.

    Measured: 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)

  4. Health-related quality of life

    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.

    Measured: 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)

  5. Number of patients who achieve target maintenance dose

    Number of patients who achieve target maintenance dose

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

  6. Incidence rate of asthma and new sensitizations

    Incidence rate of asthma on those who did not have asthma at baseline

    Measured: baseline (Visit 0), up to 12 months (Visit 3), up to 24 months (Visit 4), up to 36 months (Visit5)

  7. cost effectiveness ratio

    Primary incremental cost effectiveness ratio (ICER) measures will be cost per % change in nasal congestion score

    Measured: baseline (Visit 0), up to 36 months (Visit5)

  8. adverse events

    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).

    Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Aug 2022
  2. Study start1 Oct 2022 (estimated)
  3. Primary completion30 Jun 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
392 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05510024
Sponsor's protocol ID
RABIT-2022
Acronym
RABIT
Status last verified
Aug 2022
First submitted
8 Jun 2022
Last updated
22 Aug 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 28602936

  • 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.

    PubMed 26853126

  • 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.

    PubMed 28839248

  • 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.

    PubMed 15932377

  • 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.

    PubMed 26727762

  • 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.

    PubMed 29037263

  • 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.

    PubMed 21211641

  • 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.

    PubMed 29178670

Questions about this trial

What is this clinical trial studying?

A study testing Radiofrequency ablation of bilateral inferior turbinate followed by subcutaneous immunotherapy and SCIT in people with Allergic Rhinitis Due to House Dust Mite, run by Eye & ENT Hospital of Fudan University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 22 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Huabin Li (18816993402, noseli@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05510024, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2022.

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