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Birch Pollen Allergy clinical trials

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NCT ID: NCT06037148 Completed - Clinical trials for Birch Pollen Allergy

Study to Evaluate Safety, Tolerability and Explorative Efficacy of DM-101PX in Birch Pollen Allergic Participants

Start date: September 7, 2023
Phase: Phase 1
Study type: Interventional

Randomized, double-blind placebo-controlled phase I trial with the primary aim to investigate safety and tolerability of three ascending dosing schemes of DM-101-PX in birch pollen allergic adults. As an explorative objective, the trial will also investigate the effect of DM-101PX on the allergic symptoms following birch pollen allergen exposure in a chamber. Expanded access to the study treatment is not available.

NCT ID: NCT05668390 Active, not recruiting - Clinical trials for Allergic Rhinoconjunctivitis

Safety and Efficacy of STALORAL® Birch 300 IR in a Paediatric Population With Birch Pollen-induced ARC w/o Asthma

YOBI
Start date: November 14, 2023
Phase: Phase 3
Study type: Interventional

Allergic rhinoconjunctivitis due to birch pollen is a seasonal problem which manifests as a combination of nasal symptoms (such as congestion, runny nose, sneezing, itching of the nose) and ocular symptoms (such as red, itchy and watery eyes). For several birch-allergic patients, allergic rhinoconjunctivitis occurs with an oral allergy syndrome. The purpose of this study is to demonstrate the safety and efficacy of the study drug (STALORAL Birch 300 IR) in children and adolescents with birch pollen-induced allergic rhinoconjunctivitis, with or without asthma, when treated before and during the pollen season. Approximately 699 children will participate in this study. The study will be conducted worldwide in approximately 100 medical sites in about 14 countries. The total duration of the study will be approximately 20 months.

NCT ID: NCT05346718 Recruiting - Allergic Rhinitis Clinical Trials

Threshold Concentrations for Ragweed and Birch Pollen in Seasonal Allergic Rhinitis

UBAMBI
Start date: September 1, 2022
Phase: N/A
Study type: Interventional

The ragweed Ambrosia artemisiifolia is spreading in northern Europe due to climate change. The pollen are considered highly allergenic and might trigger allergy symptoms at much lower concentrations than e.g. grass or birch pollen. This study aims to determine threshold concentrations for ragweed and birch pollen in patients with seasonal allergic rhinitis. Participants will be exposed in an allergen challenge chamber that was technically modified to maintain very low and stable pollen concentrations for several hours. The study design is adaptive, where the pollen concentrations are escalated or de-escalated based on interim analysis of resulting allergic symptoms.

NCT ID: NCT04912076 Completed - Clinical trials for Allergic Rhinoconjunctivitis

S.C. Immunotherapy With BM41 in Patients With Allergic Rhino-conjunctivitis Caused by Birch Pollen

BM41
Start date: September 17, 2018
Phase: Phase 1
Study type: Interventional

The aim of this clinical phase I single centre, randomized, double-blind, placebo-controlled study with open comparator is to investigate tolerability and safety as well as the immunological effects of BM41 in comparison to placebo (double blind) and to a standard subcutaneous immunotherapy Alutard SQ (open) in birch allergic patients.

NCT ID: NCT04435678 Completed - Clinical trials for House Dust Mite Allergy

Diagnostic Accuracy of the MADx Multi Array Xplorer (MAX 45k) Automated Laboratory System and the MADx Allergy Explorer Version 2 (ALEX²) - IgE Multiplex Test for the Diagnosis of Pre-defined Groups of Specific High-priority Allergens

MADMAX
Start date: July 22, 2020
Phase: N/A
Study type: Interventional

About 20% of the general population are affected by an allergy - with an upward trend. Quite often, allergic people do not consider their disease as serious and suffer from subsequent complications, like allergic asthma, later in their life. The sooner the allergen source is identified, the sooner the therapeutic intervention (e.g. dietary recommendations, allergen avoidance, anti-inflammatory treatment or allergen immunotherapy) can be started. Cross-reactivity may also play an important role. Therefore, a comprehensive allergy test is essential for an optimal treatment of patients. Modern multiplex testing is an individualized diagnostic approach, which may help to identify eligible patients for allergen immunotherapy and may identify risk groups by analyzing the sIgE profile. Until now, published data on the clinical usability of multiplex allergy diagnostic test systems are often limited. Even though, available studies show a good correlation between conventionally used multiplex or singleplex assays (ISAC or ImmunoCAP) and the new multiplex assay (ALEX and ALEX²), the results are often based on small sample sizes investigating many different allergens. Therefore, this clinical performance study is conducted to evaluate the diagnostic accuracy of the ALEX² IgE multiplex test using the Multi Array Explorer (MAX 45k, MacroArray Diagnostics) automated laboratory system in comparison to a conventional IgE singleplex test system as well as clinical symptoms and skin prick test results in a total of 826 patients. Patients with the most common inhalant allergies (e.g. grass pollen, house dust mite or cat allergy) will be included as well as patients suffering from Hymenoptera venom allergy, which is the major cause of anaphylaxis.

NCT ID: NCT04266028 Completed - Clinical trials for Birch Pollen Allergy

Study to Evaluate Safety and Tolerability of sc Immunotherapy With DM-101 in Adults With Birch Pollen Allergy

Start date: February 11, 2020
Phase: Phase 1
Study type: Interventional

Randomized, double-blind placebo-controlled phase I study to investigate the safety and tolerability of ascending doses of DM-101 in adult subjects with birch pollen allergy.

NCT ID: NCT03969849 Completed - Healthy Volunteers Clinical Trials

Study to Assess the Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Effects of a Single Dose of REGN5713-5714-5715 in Healthy Adult Participants

Start date: June 3, 2019
Phase: Phase 1
Study type: Interventional

The primary objective of the study is to evaluate the safety and tolerability of REGN5713-5714-5715 in healthy adult participants. The secondary objectives of the study are: In Part A and Part B: - To characterize the concentration time profile of single doses of REGN5713-5714-5715 in healthy adults - To assess the immunogenicity of single dose of REGN5713-5714-5715. In Part B: - To assess the inhibition of allergic symptoms as measured by total nasal symptom score (TNSS) provoked by a birch allergen nasal allergen challenge (NAC) in birch-sensitized allergic subjects after a single subcutaneous (SC) dose of REGN5713-5714-5715 - To assess the skin test reactivity provoked by a skin prick test (SPT) with serial birch allergen titration after a single SC dose of REGN5713-5714-5715.

NCT ID: NCT02146300 Not yet recruiting - Clinical trials for Birch Pollen Allergy

Effect of the Nasal Provocation on the Breathing Style

Start date: March 2014
Phase: N/A
Study type: Interventional

The purpose of this study is to find out how the provocation of the nose changes breathing style (specifically, frequency and tidal volume changes)

NCT ID: NCT02143583 Completed - Clinical trials for Birch Pollen Allergy

Follow-up of Study AN004T to Assess the Persistence of AllerT Efficacy During the 2nd to 4th Season After Treatment

Start date: February 2014
Phase: Phase 2
Study type: Observational

Study aiming to evaluate the efficacy of a 2-month pre-seasonal treatment with an AllerT 50 µg or 100 µg maintenance dose administered in previous study AN004T in reducing symptoms of allergic rhinoconjunctivitis during the 2nd following birch pollen season.

NCT ID: NCT02074930 Completed - Clinical trials for Birch Pollen Allergy

Comparison of the Influence of Different Skin Conditions on the Allergic Skin Reactivity to Epicutanous Allergen Exposure

Start date: February 2014
Phase: N/A
Study type: Interventional

It is an open-label physiological investigation of the allergic skin reactivity to epicutaneous allergen exposition in 20 allergic patients in two different skin conditions. The focus of the study is on the skin preparation/condition and not on the specific allergen or allergy, but for reasons of homogeneity a single allergic disease, birch pollen allergy was chosen as the basis for the testing. In order to evaluate the effects of the two different skin preparation techniques an intraindividual comparison of the skin reactivity in terms of the immediate phase I reaction to serial dilutions of birch pollen extracts was chosen. The serial dilution approach allows a dose dependent effect evaluation and comparison of the sensitivity. The differences will be explained mainly by the two different skin preparations allowing a quantitative comparison of these techniques.