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.

Start Date01 Oct 2022

Sponsor / Collaborator

Fudan University Affiliated Eye & Ent Hospital

TCTR20210129003 / Not yet recruitingPhase 1

Adjunctive vitamin A and vitamin D3 (Cholecalciferol) for enhancing efficacy of allergen-specific immunotherapy in allergic rhinitis, A randomized, double-blind, placebo-controlled trial

Start Date03 Feb 2021

Sponsor / Collaborator

Phramongkutklao College of Medicine

100 Clinical Results associated with allergic rhinitis due to dust mite

100 Translational Medicine associated with allergic rhinitis due to dust mite

0 Patents (Medical) associated with allergic rhinitis due to dust mite

Literatures (Medical) associated with allergic rhinitis due to dust mite

24 Nov 2023·American journal of otolaryngology

Short-term and long-term efficacy of sublingual immunotherapy in different courses for house dust mite-induced allergic rhinitis.

Article

Author: Jie Yang ; Jing Zheng ; Yu Zhou ; Quan Qiu ; Jiabin Zhan ; Xin Wei

PURPOSE:

Sublingual immunotherapy (SLIT) has been proven to be an effective and safe treatment for patients with house dust mite (HDM)-induced allergic rhinitis (AR) to achieve short-term and long-term efficacy. This study aimed to investigate the relationship between SLIT duration and long-term efficacy.

MATERIALS AND METHODS:

This study involved 134 patients who underwent SLIT between 2019 and 2021 (in the 2-year group), between 2018 and 2021(in the 3-year group), or between 2017 and 2021 (in the 4-year group). The total nasal symptoms score (TNSS), total medication score (TMS), visual analogue scale (VAS), the Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) and adverse events (AEs) were assessed at baseline, after treatment (2021) and one year after the treatment completion (2022). The correlation between MiniRQLQ and other indicators was also analyzed.

RESULTS:

After SLIT, patients in all three groups showed significant improvements in TNSS, TMS, VAS and MiniRQLQ scores (all p < 0.001). These improvements were sustained even one year after SLIT. Patients who received 3-4 years of SLIT showed significant improvement compared with those who received 2 years of SLIT in all clinical outcomes (all p < 0.01). The analysis showed positive correlations between the MiniRQLQ and TNSS, TMS, and VAS (all p < 0.001). No significant difference was observed in the AE rate in all three groups (p > 0.05).

CONCLUSION:

Different duration of HDM SLIT could generate various short-term and long-term clinical efficacy. The MiniRQLQ could be applied to evaluate SLIT efficacy in clinical practice.

01 Jun 2023·Lin chuang er bi yan hou tou jing wai ke za zhi = Journal of clinical otorhinolaryngology, head, and neck surgery

[Characteristics of allergen component in dust mite-induced allergic rhinitis patients].

Article

Author: Hao Chen ; Ping Ji ; Lin Yang ; Nan Huang ; Qing Jiang ; Yaqi Yang ; Rongfei Zhu

Objective:To investigate the characteristics of allergen component in dust mite（DM） -induced allergic rhinitis（AR） patients, and provide reference for the diagnosis and treatment of AR. Methods:DM-induced AR patients with or without allergic asthma（AA） who visited the Allergy Department of Tongji Hospital, Huazhong University of Science and Technology between 2021 and 2022 were enrolled. Patients'age, gender, and visual analog scale（VAS） for symptoms were recorded. sIgE and sIgG4 levels of allergen components such as Der f1, Der f2, Der p1, Der p2, Der p7, Der p10, Der p21, and Der p23 were detected using a protein chip method. The sensitization characteristics of the allergen components in the patients were observed, and the correlation between sIgE, sIgG of each component and VAS as well as the component differences between AR and AR with AA（AR&AA） were evaluated. Results:A total of 87 DM-induced AR patients were enrolled, with 42.5% of them were AR&AA, their VAS scores were significantly higher than those of AR patients（6.38±1.95 vs 5.25±1.85, P=0.009 8）. The order of sensitization rates for DM components was as follows: Der p2（82.8%）, Der f2（81.6%）, Der p1（74.7%）, Der f1（70.1%）, and Der p23（35.6%）. The order of positive rates for sIgG4 was: Der p2（21.8%）, Der f2（13.8%）, Der p21（8.0%）, and Der p7（6.9%）. There were no correlation between the sIgE, sIgG4 levels or positive numbers of components and VAS scores, but there were positive correlations between sIgE, sIgG4 concentrations of components. Compared with AR patients, AR&AA patients had higher levels of sIgE for Der p（60.5[7.2-91.1]vs 14.0[4.8-45.1], P=0.02）, Der f（49.8[15.7-81.6]vs 21.3[7.0-50.2], P=0.04）, Der p1（27.2[0.7-51.5]vs 2.6[0.2-24.9], P=0.02）, Der p2（20.0[1.4-60.6]vs 5.5[0.6-19.1], P=0.004）, and Der f2（58.9[16.0-89.2]vs 23.4[0.9-56.8], P=0.009）, and a higher proportion of AR with AA patients had sIgE levels of Der p1（70.3% vs 48.0%, P=0.038） and Der p23（27.0% vs 14.0%, P=0.039） that were ≥3 grades. Conclusion:Der p1/f1, Der p2/f3, and Der p23 are the major components of DM sensitized AR patients. Multiple component sensitization and sIgE, sIgG4 levels of each component are not correlated with the severity of AR. The sIgE levels of the Der p1/f1, Der p2/f3, and Der p23 components in AR&AA patients are higher than AR.

11 Feb 2023·Asian Pacific journal of allergy and immunology

Skin prick test and serum specific IgE in predicting dust mite-induced allergic rhinitis diagnosed from nasal provocation test in chronic rhinitis children.

Article

Author: Natchanun Klangkalya ; Watcharoot Kanchongkittiphon ; Adithep Sawatchai ; Potjanee Kiewngam ; Wanlapa Jotikasthira ; Wiparat Manuyakorn

BACKGROUND:

Allergen skin prick test (SPT) and serum specific immunoglobulin E (sIgE) are effective diagnostic tests in allergic rhinitis (AR), however, positive results may not always correlate with clinical allergies. A nasal provocation test (NPT) can identify the causative allergen for immunotherapy, but it's not routinely performed.

OBJECTIVE:

To establish the cutoff value for the house dust mite (HDM) SPT mean wheal diameter (MWD) and HDM sIgE level for identifying children with HDM-induced AR diagnosed from NPT.

METHODS:

Children aged 5 to 18 years old with chronic rhinitis were evaluated by HDM SPT, sIgE, and NPT. Children with positive NPT results indicated HDM-induced AR. The cutoff values of the HDM SPT and sIgE level for predicting positive NPT were determined using a receiver operating characteristic curve.

RESULTS:

A total of 245 children with a mean age of 9.53 ± 3 years were enrolled. HDM SPT results were positive (≥ 3 mm) in 160 (65.3%) children. HDM NPT results were positive in 176 (71.8%) children. Among children with positive HDM SPT (n = 160), 153 children (95.6%) were confirmed as having AR on NPT findings. The cutoff values for positive NPT responses were 6.6 mm for HDM SPT (yielding 100% specificity and 100% positive predictive value) and 17.0 kUA/L for sIgE (98.6% specificity and 99.2% positive predictive value).

CONCLUSIONS:

This study proposes HDM SPT and sIgE cutoff values for use in the diagnosis of HDM-induced AR based on NPT. These cutoff values can be used to identify HDM-induced AR children who might benefit from immunotherapy.

News (Medical) associated with allergic rhinitis due to dust mite

25 Jan 2024

·www.globenewswire.com

ALK’s European registration application for house dust mite SLIT-tablet in young children accepted for review

ALK (ALKB:DC / OMX: ALK B / AKBLF) today announced that the European regulatory filing for ACARIZAX® (house dust mite sublingual immunotherapy tablet) in young children has been accepted for review by the relevant health authorities via a type II variation. The European regulatory review process is anticipated to take up to nine months so that, subject to approval, the first market introductions in Europe could take place from late 2024/beginning of 2025. The data used in the filing include results from a recently completed Phase 3 clinical trial involving 1,458 children in North America and Europe. The MT-12 trial was a randomised, placebo-controlled trial to study the efficacy and safety of ACARIZAX® in children aged five to 11 with a clinical history of house dust mite-induced allergic rhinitis with or without conjunctivitis (and with or without asthma). The trial was designed to demonstrate the effect of treatment of ACARIZAX® as measured by improvement in the total combined rhinitis score (TCRS) during the last eight weeks of the 12-month-treatment. The trial achieved its primary endpoint confirming an improvement of 22% compared to placebo. ALK’s Executive Vice President of Research and Development, Henriette Mersebach, says: “I’m pleased that our registration application for ACARIZAX® for young children has been accepted for review, and we are looking very much forward to the dialogue with the European authorities over the coming months. The results in children are robust and consistent with previous trial results and this filing represents an important step forward for our ability to transform the medical treatment of children with house dust mite allergy as well as for ALK’s long-term growth ambitions.” Globally, it is estimated that more than 10 million children, aged five to 11, have uncontrolled respiratory allergies and the number is growing. House dust mites are a common cause of allergy and closely linked to asthma. Japan is currently the only country where the house dust mite tablet (MITICURE™) is approved for young children, while in other markets it is approved for the treatment of persistent moderate-to-severe house dust mite-induced allergic rhinitis for patients aged 12-65. In addition, in Europe, the tablet is also approved for house dust mite-induced allergic asthma in patients aged 18-65. ALK expects to submit a corresponding application to the FDA in USA in the first half of 2024. ALK-Abelló A/S For further information, please contact: Investor Relations: Per Plotnikof, tel. +45 2261 2525 Media: Maiken Riise Andersen, tel. +45 5054 1434 About ALKALK is a global specialty pharmaceutical company focused on allergy and allergic asthma. It markets allergy immunotherapy treatments and other products and services for people with allergy and allergy doctors. Headquartered in Hørsholm, Denmark, ALK employs around 2,800 people worldwide and is listed on Nasdaq Copenhagen. Find more information at www.alk.net. Attachment InvestorNews_25Jan2024

Clinical ResultPhase 3ImmunotherapyDrug Approval

14 Feb 2023

·www.biospace.com

Altamira Therapeutics to Report Bentrio Clinical Data, in House Dust Mite and Grass Pollen Allergic Rhinitis, at Feb. 25 AAAAI Annual Meet-ing

House dust mite study shows statistically significant reduction in symptoms vs. no protection Grass pollen study shows faster onset of action and superior efficacy ratings by patients Bentrio® shows wider nasal cavity distribution, for 3.5 x more time, vs saline spray HAMILTON, BERMUDA / ACCESSWIRE / February 14, 2023 / Altamira Therapeutics Ltd. (Nasdaq:CYTO), a company dedicated to developing therapeutics that address important unmet medical needs, today announced that data from three clinical studies with the Company's Bentrio nasal spray in allergic rhinitis will be presented February 25, at the Annual Meeting of the American Academy of Allergy, Asthma & Immunology (AAAAI) in San Antonio, TX. Presentation Details Session Date & Time: Saturday, February 25, 2023, 10:45 am - 11:45 am ET Poster No. 337: Efficacy and Tolerability of the Barrier-Forming Drug-Free Nasal Spray AM-301 in Allergic Rhinitis Patients Exposed to Controlled Grass Pollen and House Dust Mite Challenge Presenting Author: Anne Marie Salapatek, Ph.D., Cliantha Research, Mississauga, Ontario, Canada The presentation will include data from the following clinical evaluations: House dust mite (HDM) allergic rhinitis. The randomized cross-over study in 37 patients undergoing controlled allergen exposure for 3 hours showed a statistically significant reduction in the change of the Total Nasal Symptom Score (TNSS) with application of Bentrio compared to no protection (publication submitted). The study was conducted by Cliantha Research, Canada. Grass pollen allergic rhinitis. The randomized cross-over study in 36 patients undergoing controlled allergen exposure for 4 hours showed: non-inferiority with regard to the change in the TNSS for Bentrio compared to a hydroxypropyl methylcellulose nasal spray, faster onset of protection, and better subjective ratings of efficacy[1]. The study was conducted by the Fraunhofer Institute for Toxicology and Experimental Medicine, Germany. Nasal residence time. The randomized study in 8 healthy volunteers showed wide distribution of fluorescence-labelled Bentrio for 3.5 hours within relevant parts of the nasal cavity compared to smaller coverage and presence for only one hour with labelled saline nasal spray (publication submitted). The study was conducted by the University of Tubingen, Germany. All three studies of Bentrio nasal spray demonstrated good safety and tolerability. About The 2023 AAAAI Annual Meeting The 2023 AAAAI Annual Meeting will take place February 24-27 in San Antonio, TX. The conference draws academic and clinical leaders from around the world to showcase new research and discuss other developments in allergy, asthma and immunologic diseases. For more info, visit: About Altamira Therapeutics Altamira Therapeutics (NASDAQ:CYTO) is dedicated to developing RNA-based therapeutics for extrahepatic targets (OligoPhore™ / SemaPhore™ delivery platforms). The Company currently has two flagship siRNA programs in preclinical development beyond in vivo proof of concept: AM-401 for KRAS driven cancer and AM-411 for rheumatoid arthritis. The versatile delivery platform is also suited for mRNA and other types of RNA therapeutics and shall be leveraged via out-licensing to pharma or biotech companies. In addition, Altamira is in the process of divesting and/or licensing-out its legacy assets in allergology and viral infection (Bentrio® OTC nasal spray; commercial) and inner ear therapeutics (AM-125 nasal spray for vertigo; post Phase 2; Keyzilen® and Sonsuvi® for tinnitus and hearing loss; Phase 3). Founded in 2003, Altamira is headquartered in Hamilton, Bermuda, with its main operations in Basel, Switzerland. For more information, visit: Forward-Looking Statements This press release may contain statements that constitute "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements are statements other than historical facts and may include statements that address future operating, financial or business performance or Altamira Therapeutics' strategies or expectations. In some cases, you can identify these statements by forward-looking words such as "may", "might", "will", "should", "expects", "plans", "anticipates", "believes", "estimates", "predicts", "projects", "potential", "outlook" or "continue", or the negative of these terms or other comparable terminology. Forward-looking statements are based on management's current expectations and beliefs and involve significant risks and uncertainties that could cause actual results, developments and business decisions to differ materially from those contemplated by these statements. These risks and uncertainties include, but are not limited to, the success of the continued commercialization of Bentrio and success of strategic transactions, including licensing or partnering, with respect to Bentrio or any other legacy assets, Altamira Therapeutics' need for and ability to raise substantial additional funding to continue the development of its product candidates, the timing and conduct of clinical trials of Altamira Therapeutics' product candidates, the clinical utility of Altamira Therapeutics' product candidates, the timing or likelihood of regulatory filings and approvals, Altamira Therapeutics' intellectual property position and Altamira Therapeutics' financial position, including the impact of any future acquisitions, dispositions, partnerships, license transactions or changes to Altamira Therapeutics' capital structure, including future securities offerings. These risks and uncertainties also include, but are not limited to, those described under the caption "Risk Factors" in Altamira Therapeutics' Annual Report on Form 20-F for the year ended December 31, 2021, and in Altamira Therapeutics' other filings with the SEC, which are available free of charge on the Securities Exchange Commission's website at: . Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those indicated. All forward-looking statements and all subsequent written and oral forward-looking statements attributable to Altamira Therapeutics or to persons acting on behalf of Altamira Therapeutics are expressly qualified in their entirety by reference to these risks and uncertainties. You should not place undue reliance on forward-looking statements. Forward-looking statements speak only as of the date they are made, and Altamira Therapeutics does not undertake any obligation to update them in light of new information, future developments or otherwise, except as may be required under applicable law. CONTACT Hear@altamiratherapeutics.com 800-460-0183 SOURCE: Altamira Therapeutics View source version on accesswire.com:

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