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Rhinitis, Allergic clinical trials

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NCT ID: NCT06061848 Recruiting - Clinical trials for Allergic Rhinitis Due to Grass Pollen

Intralymphatic Immunotherapy Enhanced by Vitamin-D, a Randomized Placebo-controlled Trial and Comparison With SLIT

ILIT vs SLIT
Start date: February 1, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

A national, multicenter, randmised double blind study with parallell arms. 360 patients with grass induced allergic rhinitis will be open randomised 1:2 to 3 years Grazax sublingual immunotherapy or 3 intralymphatic injections with ALK Alutard Timothy. In a second step, the ILIT group will be double blind randomised 1:1 to an intramuscular injection of Vitamin D Vicotrat or placebo, 4 week before the start of the intralymphatic treatment. The primary outcome measure is daily combined symptoms and medication scores during grass pollen season.

NCT ID: NCT06046391 Recruiting - Clinical trials for Seasonal Allergic Rhinitis

Efficacy and Safety of LP-003 in Moderate-to-severe Seasonal Allergic Rhinitis Adult

Start date: July 6, 2023
Phase: Phase 2
Study type: Interventional

Allergic rhinitis (AR) affects large population worldwide, the most commonly used medication include anti-histamine, nasal spray and anti-LTRAs inhibitors (leukotriene receptor antagonists), Even after those first-line treatment, there is still a large number of patient (~20%) are not well/adequately controlled. Anti-IgE antibody has been approved to treat moderate to severe AR by PMDA/Japan in 2020, demonstrating the efficacy of IgE blockade in the treatment of allergic rhinitis. The current study presents a novel anti-IgE antibody (LP-003) with higher affinity to IgE, stronger efficacy and longer half-life.

NCT ID: NCT06038279 Recruiting - Allergic Rhinitis Clinical Trials

Trial of INI-2004 in Healthy Volunteers and Participants With Allergic Rhinitis.

Start date: July 4, 2023
Phase: Phase 1
Study type: Interventional

This is a Phase I/Ib, randomised, double-blind, placebo-controlled study of INI-2004, administered as single or multiple doses. This study will be conducted in two parts: Phase I single ascending dose (SAD) and Phase Ib multiple ascending dose (MAD).

NCT ID: NCT06028490 Recruiting - Allergic Rhinitis Clinical Trials

A Study of IL4Rα Monoclonal Antibody in Patients With Uncontrolled Seasonal Allergic Rhinitis.

Start date: September 7, 2023
Phase: Phase 2
Study type: Interventional

Allergic rhinitis (AR) is a non-infectious chronic inflammatory disease of the nasal mucosa mainly mediated by immunoglobulin E after exposure to allergens in atopic individuals. The typical symptoms of AR are paroxysmal sneezing, watery rhinorrhea, itching, and nasal congestion, which may be accompanied by ocular symptoms, including eye itching, tearing, redness, and burning sensation, which are more common in patients with hay fever allergies. Bronchial asthma is associated with bronchial asthma in 40% of patients with AR, suggesting a comorbid feature of allergic disease.

NCT ID: NCT06027736 Recruiting - Allergic Rhinitis Clinical Trials

The Effectiveness of Pharmacist-led Educational Model in Patients With Allergic Rhinitis

AR-PRISE
Start date: June 1, 2023
Phase: N/A
Study type: Interventional

Allergic rhinitis is a chronic respiratory disorder affecting patients' quality of life and work performance. Pharmacists are identified as suitable professionals to deliver patient education and pharmaceutical care in managing allergic rhinitis (AR) patients. Local clinical practice guidelines in Malaysia are lacking, especially in pharmaceutical care in public healthcare institutions. This study protocol describes a randomised control trial (RCT) that aims to determine the effectiveness of a pharmacist-led educational model in managing AR (AR-PRISE Model) compared to standard pharmaceutical care. The AR-PRISE model delivers patient educational material (video) and an algorithm for pharmaceutical care.

NCT ID: NCT06021912 Recruiting - Clinical trials for Study the Efficacy of ITA in Patients With Allergic Asthma or Allergic Rhinitis or Allergic Rhinitis Compared With Conventional Treatment

e-ITAG Allergen Immunotherapy in the Management of Allergic Asthma

EITAG
Start date: March 1, 2023
Phase:
Study type: Observational

Allergy is defined as a specific abnormal and excessive reaction of the immune system to exposed allergen . This reaction is reproducible with each new exposure allergen . A recent study by The European Academy of Allergy and Clinical Immunology" (EAACI) estimates that 30% of the population suffers from allergic rhinitis and/or conjunctivitis, 20% of children suffer from asthma, and 8% of the population suffers from food allergies in Europe, with a clear increase in prevalence. Allergenic immunotherapy (AIT) remains a corner stone in the treatment of allergic diseases. It involves administering an increasing dose of allergens to induce immunological tolerance. The efficacy and safety of ITA have already been demonstrated. However, patient response is highly heterogeneous. This findinf illustrates the value of biomarkers in the selection of patients, enabling prediction of response to ITA and follow-up.

NCT ID: NCT05960266 Recruiting - Clinical trials for Rhinitis, Allergic, Seasonal

Immunological Analysis of Lymph Node Tissue After Intralymphatic Immunotherapy: A Prospective Case Control Study

ILIT-FNA
Start date: October 23, 2023
Phase: Early Phase 1
Study type: Interventional

Allergy is a public health problem as more than 20% of western society is affected by it. Symptomatic treatment of allergy suffices with less severe allergy. Patients with more severe allergy should be treated with allergen immunotherapy (AIT). Present options of AIT are efficient but of long duration, associated with side effects and require much time from the patient. With Intralymphatic immunotherapy (ILIT), allergen is injected into the lymph node under ultrasound guidance. ILIT is complete after 3 treatment visits, may be more effective than and may have markedly fewer side effects than presently available methods of AIT. The investigators plan a randomized, parallel group, open-label, prospective case-control study to assess immunological changes in lymph node and peripheral blood after intralymphatic (ILIT) or subcutaneous (SCIT) immunotherapy with POLVAC. The intervention consists of one ultrasound-guided injection of allergen into inguinal lymph node or subcutaneous injection 1 cm next to the lymph node. Intervention quality (accuracy of injection) will be assessed by the administering physician during treatment and via video recording on the ultrasound device. Side effects associated with treatment will be recorded by the patients for 3 days after the injection. The effect of intralymphatic or subcutaneous injection on lymph node tissue and immunoglobulins E and G4 in serum as well as cellular analyses of lymph node tissue and peripheral blood will be determined in samples taken during the trial. The primary effect parameter is the effect of a single intralymphatic allergen injection on immunological parameters as well as allergen delivery to the lymph node as compared with a single subcutaneous injection.

NCT ID: NCT05922176 Recruiting - Rhinitis, Allergic Clinical Trials

Biomarker Screening for Immunotherapy Response Evaluation Using Microneedle Patch in Patients With Allergic Rhinitis

MIST
Start date: May 22, 2023
Phase:
Study type: Observational

Allergic rhinitis is a disease in which the nasal mucous membrane overreacts to allergens, resulting in symptoms such as spasmodic and repetitive sneezing, rhinorrhea, and stuffy nose, and can be treated with immunotherapy for radical treatment. Immunotherapy treatments include subcutaneous injections, sublingual tablets, and sublingual fluids, and subcutaneous injections have the risk of anaphylaxis, the hassle of daily administration at home, and local allergic reactions. Transdermal absorption immunotherapy (DF19001) that can compensate for the shortcomings of these existing immunotherapy drugs is currently under clinical research in Korea (Severance Hospital IRB No. 4-2021-1345). Immunotherapy requires periodic monitoring, such as analyzing immunological changes through sample collection and determining the dose and cycle of administration, because the treatment period is long and individual immune responses are different. Existing methods for confirming immune responses in samples used invasive skin biopsy and blood collection methods, but in-blood evaluation indicators have the disadvantage of being ineffective as initial efficacy evaluations or predictive evaluations before treatment. In addition, skin biopsy should be performed by a specialist, and there is a disadvantage that resistance occurs because the patient's pain is accompanied, and scars or bruises may remain. Therefore, since it is a biopsy through minimal invasion compared to a tissue biopsy, the investigators would like to use a method of collecting skin samples through a microstructure (micro needle patch), a method that has little pain and no scars. Through this study, RNA is obtained from patients with house dust mite allergic rhinitis through minimally invasive skin samples, and immunotherapy response evaluation biomarkers are screened according to immunotherapy implementation, and its use as an indicator of immunotherapy prognosis in allergic diseases.

NCT ID: NCT05919316 Recruiting - Allergic Rhinitis Clinical Trials

The Efficacy Of Rhinophototherapy Compared To Intranasal Corticosteroids On The Nasal Mucosa

Start date: July 4, 2023
Phase: N/A
Study type: Interventional

The aim of this study to compare the efficacy of Rhinophototherapy to Intranasal Corticosteroids on the the nasal mucosa of allergic rhinitis patients. The main question to answer is: Does intranasal phototherapy reduce inflammation in the tissue biopsy of the inferior turbinate mucosa compared to intranasal steroids? The hypothesis for this study is Intranasal phototherapy will reduce mucosal inflammation without mucosal damage and is comparable to intranasal steroids in allergic rhinitis patients

NCT ID: NCT05915507 Recruiting - Allergic Rhinitis Clinical Trials

Effect of Laser Acupuncture Alone or Combined With Pranayama Exercise on Inflammation in Allergic Rhinitis in Geriatrics

Start date: July 5, 2023
Phase: N/A
Study type: Interventional

Allergic rhinitis (AR) represents one of the most common global health problems with seriously increasing incidence over the last decades.The goal of the treatment of rhinitis is to prevent or reduce the symptoms through reduction of the inflammation of affected tissues. Acupuncture and pranayama yoga exercises had reported a significant improvement in daily symptoms and an increase of symptom-free days in many studies enrolling geriatric patients.