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Rhinitis, Allergic clinical trials

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NCT ID: NCT06104332 Recruiting - Allergic Rhinitis Clinical Trials

PMCF to Assess Real-life Usage Effectiveness, Safety and Patient Satisfaction of a Range of Hypertonic Seawater-based Decongestant Nasal Sprays

Start date: November 4, 2023
Phase:
Study type: Observational

The brief of this observational study is to evaluate usage, efficacy, safety and patient satisfaction of a range of hypertonic seawater-based decongestant nasal sprays in general population. The main questions it aims to answer are: - Usage, - Efficacy, - Safety, - Satisfaction, in real-life usage with children, adults and pregnant or breastfeeding women. Participants will use the nasal spray as usual habits and complete daily questionnaires.

NCT ID: NCT06085963 Recruiting - Clinical trials for Allergic Rhinitis Due to Pollen

Nasal Allergen Challenge Test as a Method to Detect Clinical Reactivity Against Birch Pollen

NAC
Start date: February 1, 2023
Phase: N/A
Study type: Interventional

Clinical efficacy and tolerability for allergen specific immunotherapy (AIT) with Itulazax (birch pollen extract tablet) is well established. Allergen challenges are used by clinicians to confirm correct diagnosis and by researchers to evaluate the efficacy of different interventions, eg. AIT. The challenge is performed by using a specific controlled administration schedule of an allergen product in the shock organ (nose, eye, or airway) and then monitor the result. Nasal Allergen Challenge (NAC) is the most common allergen challenge used. Aquagen SQ (birch pollen extract) has since decades been golden standard for this purpose, but production of this product ended 2019. Clinicians as well as researchers are now in need for an alternative product. To evaluate a new method for NAC would be of value from a clinical- and research perspective. From a Nordic perspective a NAC study with dissolved Itulazax would be of special interest since birch allergy is a dominant allergen in the region. In a recently published article it was shown that dissolved Grazax and Aquagen Phleum pratense gave comparable result used in grass allergic patients. Therefore, it seems reasonable to assume that the same method could be used with dissolved Itulazax. The aim of this clinical trial is to evaluate the feasibility of nasal allergen challenge tests with dissolved Itulazax tablets. The main benefit of this proposal is that the allergen composition of the provocation test product is the same as the final product to be treated with. This is likely to increase the treatment motivation of the patient. In addition, the dissolving process is easier for the physician compared to the dissolving of the previously used Aquagen.

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: 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