scholarly journals Intralymphatic immunotherapy with tyrosine-adsorbed allergens: a double-blind, placebo-controlled trial

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Hye Jung Park ◽  
Sae-Hoon Kim ◽  
Yoo Seob Shin ◽  
Chul Hwan Park ◽  
Eun-Suk Cho ◽  
...  
Keyword(s):  
Allergic Rhinitis ◽  
Injection Site ◽  
Symptom Score ◽  
Therapeutic Efficacy ◽  
Controlled Trial ◽  
Life Questionnaire ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Medication Score ◽  
Allergen Extracts

Abstract Background Most previous studies used aluminum hydroxide-absorbed allergen extracts in evaluating the potential therapeutic roles of intralymphatic allergen-specific immunotherapy (ILAIT). In this study, we evaluated the therapeutic efficacy and safety of ILAIT with L-tyrosine-adsorbed allergen extracts of Dermatophagoides farinae, D. pteronyssinus, cat, dog, or mixtures thereof, in patients with allergic rhinitis induced by these allergens. Methods In this randomized, double-blind, placebo-controlled trial, study subjects received three intralymphatic injections of L-tyrosine-adsorbed allergen extracts (active group) or saline (placebo group) at 4-week intervals. Results Although ILAIT reduced daily medication use and skin reactivity to HDM and cat allergens at 4 months after treatment, overall symptom score on a visual analog scale (VAS), sinonasal outcome test-20 (SNOT-20), rhinoconjunctivitis quality of life questionnaire (RQLQ), daily symptom score (dSS), daily medication score (dMS), daily symptom medication score (dSMS), nasal reactivity to HDM allergen, and basophil activity to HDM, cat, and dog allergens at 4 months and 1 year after treatment were similar between the treatment and control groups. Intralymphatic injection was more painful than a venous puncture, and pain at the injection site was the most frequent local adverse event (12.8%); dyspnea and wheezing were the most common systemic adverse events (5.3%). Conclusions ILAIT with L-tyrosine-adsorbed allergen extracts does not exhibit profound therapeutic efficacy in allergic rhinitis and can provoke moderate-to-severe systemic reactions and cause pain at the injection site. Trial registration: clinicaltrials.gov: NCT02665754; date of registration: 28 January 2016

A Randomized, Double-Blind, Placebo Controlled Trial of Sublingual Immunotherapy with House-Dust Mite Extract for Allergic Rhinitis

2017 ◽  
Vol 31 (4) ◽  
pp. e42-e47 ◽  
Author(s):  
Yu Guo ◽  
Yanqing Li ◽  
Dehui Wang ◽  
Quan Liu ◽  
Zhuofu Liu ◽  
...  
Keyword(s):  
Allergic Rhinitis ◽  
Symptom Score ◽  
Active Treatment ◽  
Sublingual Immunotherapy ◽  
Controlled Trial ◽  
Active Treatment Group ◽  
Nasal Symptom ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Dust Mite

Objective This study was designed to evaluate the efficacy and safety of sublingual immunotherapy (SLIT) with house-dust mite (HDM) extract in Chinese patients with HDM-induced allergic rhinitis (AR). Methods A randomized, double-blind, placebo controlled trial was conducted with the outpatients of the Eye, Ear, Nose, and Throat Hospital, Fudan University. Forty-eight patients were eligible for randomization to SLIT with a mixture of Dermatophagoides pteronyssinus and Dermatophagoides farinae extract or placebo for 1 year. The primary outcome measures for efficacy were the total nasal symptom score (TNSS) and the individual nasal symptom score. Secondary end points were allergic conjunctivitis scores (ACS) and medication scores (MS). Adverse events (AE) also were monitored. Results Intragroup analysis demonstrated a significant improvement in the active treatment group for individual nasal symptom score and TNSS (p < 0.05), although no improvement was observed in the placebo group of congestion, sneezing, and itching (p > 0.05). Furthermore, the ACS and MS in the active treatment group also statistically decreased (p < 0.05). In addition, the active treatment had significant effects on relieving nasal symptoms both in adults and children (p < 0.05), and no statistical difference was observed between these two subgroups (p > 0.05). AEs that occurred ranged from mild to moderate, and no severe systematic reactions were observed. Conclusion SLIT with a mixture of HDM extract significantly relieved allergy symptoms and reduced the need for antiallergic drugs, which indicated the superiority of active treatment over placebo for patients with HDM-induced AR. However, due to the limited sample size, the findings need to be further confirmed.

Late Phase Inflammation during Nasal Grass and Ragweed Challenge in a Double-Blind Placebo Controlled Trial with Astemizole

1995 ◽  
Vol 9 (3) ◽  
pp. 169-174 ◽  
Author(s):  
Marianne Frieri ◽  
James Madden ◽  
Myron Zitt ◽  
Nanjundaiah S. Kumar ◽  
Maria Knapik
Keyword(s):  
Allergic Rhinitis ◽  
Nasal Congestion ◽  
Controlled Trial ◽  
Statistical Significance ◽  
Interleukin 1 ◽  
Late Phase ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Nasal Provocation ◽  
Anti Inflammatory

Allergic rhinitis is an IgE-mediated inflammatory reaction characterized by an early “classic” immediate hypersensitivity response and/or a subsequent late phase response. Nasal provocation to antigen challenge is a useful method of evaluating this dual response. Several H1 antagonists may exhibit antiinflammatory properties by diminishing histamine release or inhibiting eosinophil chemotaxis. To determine whether astemizole has any anti-inflammatory characteristics, we studied 20 patients with allergic rhinitis in a double-blind placebo-controlled fashion after a 4-week course of treatment with this H1 antagonist. Nasal provocation over 30 minutes was performed out of season using increasing concentrations of grass or ragweed extract from 10–1000 PNU. Patients were evaluated for their clinical response, and nasal lavage secretions were analyzed over 6 hours by ELISA for alpha interleukin-1, interleukin-8, albumin, and histamine levels. Total sneezing and other symptom scores for rhinorrhea, nasal congestion, and pruritus were decreased in astemizole-treated compared to placebo-treated patients both at 30 minutes (early phase), and at 3 and 6 hours (late phase) after nasal provocation. However, these results did not reach statistical significance. Nasal α IL-1 levels diminished from diluent control lavage to a significantly greater degree in astemizole than in placebo-treated patients (P < 0.05). This diminution in late phase α IL-1 suggests that astemizole may possess anti-inflammatory properties.

Nasal Immunotherapy is Effective in the Treatment of Rhinitis Due to Mite Allergy. A Double Blind Placebo-Controlled Study with Rhinological Evaluations

2002 ◽  
Vol 15 (2) ◽  
pp. 141-147 ◽  
Author(s):  
D. Passàli ◽  
L. Bellussi ◽  
G.C. Passàli ◽  
F. M. Passàli
Keyword(s):  
Allergic Rhinitis ◽  
Mucociliary Clearance ◽  
Controlled Trial ◽  
Controlled Study ◽  
Perennial Allergic Rhinitis ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Nasal Provocation ◽  
Mite Allergy ◽  
Perennial Rhinitis

The aim of this paper is to evaluate the efficacy of intranasal hyposensitizing therapy in perennial rhinitis. 36 patients suffering from perennial allergic rhinitis (Dermatophagoides-sensitive) underwent a double blind placebo-controlled trial for a period of 8 months. The efficacy of nasal immunotherapy was evaluated by collecting symptoms score and evaluating objective rhinological parameters (nasal resistance, cross areas and volumes, mucociliary clearance times, specific nasal provocation threshold). A significant improvement (p0,01) of symptom score of active against placebo group was observed after treatment. Also objective nasal parameters (total nasal resistances, mucociliary clearance, C-notch area, and provocative threshold) significantly (p0,01) improved after treatment. Adverse local reactions were rare and did not interfere with the protocol. The results underline the efficacy and quickness of local nasal immunotherapy in the treatment of perennial allergic rhinitis documented by the improvement of subjective and objective parameters.

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