Clinical Research Directory

A Histamine Pharmacodynamic Biomarker to Guide Treatment in Pediatric Asthma (HAS3)

This is a randomized, double-blind, placebo-controlled, crossover study comparing asthma control post treatment in African American/Black and Caucasian/White children in both hyper and hypo responsive HILD (Histamine Lontophoresis with Laser Doppler monitoring) phenotypes with uncontrolled persistent allergic asthma using Levocetirizine (LTZ) vs placebo.

Safety and Immunogenicity of Cat-allergen Intralymphatic Immunotherapy in Patients With Cat Allergy With and Without Asthma

The goal of this clinical trial is to evaluate the safety and tolerability of intralymphatic immunotherapy (ILIT) with ALUTARD SQ Felis domesticus in patients with cat allergy-induced allergic rhinitis and asthma. The main questions it aims to answer are: Is ILIT with ALUTARD SQ Felis domesticus safe and well tolerated? What immunological responses play a role in ILIT? Researchers will compare the effects of ILIT to existing subcutaneous immunotherapy (SCIT) approaches to assess safety, tolerability, immunogenicity, and efficacy. Participants will: Receive 3-4 ILIT injections of ALUTARD SQ Felis domesticus into an inguinal lymph node, guided by ultrasound. Undergo safety monitoring, including WAO guidelines for systemic allergic reactions and tryptase measurement. Complete lung function tests, questionnaires, and a modified nasal provocation test to evaluate asthma effects and treatment efficacy. Provide blood samples for ImmunoCAP and basophil activation testing using CAST ELISA. Inclusion criteria: Adults aged 18-65 with cat-dander-induced allergic rhinitis and asthma. Exclusion criteria: Hypersensitivity to treatment components, systemic steroid use, uncontrolled asthma (FEV1 \< 70%), recent severe asthma exacerbations, or serious comorbidities. The study aims to generate data to inform future efficacy trials.

ROLL'YN-OMA: an Observational Study in Patients Treated by Omlyclo®, an Omalizumab Biosimilar

ROLL'YN-OMA is a real-world study in patients receiving standard biologic therapies who have been in control and/or remission of their disease for at least 3 months and whose physician has independently decided, within the framework of a shared medical decision, to switch them to OMLYCLO®. The primary objective of this study is to evaluate the maintenance of this control and/or clinical remission 12 months after initiation of the biosimilar, and subsequently, patient satisfaction at 6 and 12 months.

Tyrosine Allergoid Paediatric and Adult Study

The primary objective of this 5-year study is to demonstrate non-inferiority of children compared to adults by exploring long-term effectiveness after treatment with TA Bäume (trees) and TA Gräser (grass) following a perennial posology.

Modified Shenling Baizhu Powder for Allergic Asthma With Spleen Deficiency and Dampness Accumulation Syndrome

Allergic asthma is a common allergic disease characterized by a protracted disease course and recurrent episodes, which severely impairs patients' physical and mental health. There is a paucity of high-quality clinical evidence in the treatment of allergic asthma with traditional Chinese medicine (TCM). This study will enroll patients who are persistent allergic asthma with spleen deficiency and dampness accumulation syndrome. A multicenter, randomized, double-blind, placebo-controlled trial design is adopted. The experimental group will receive Modified Shenling Baizhu Powder in addition to Budesonide and Formoterol Fumarate Powder for Inhalation, while the control group will receive a placebo in addition to the same inhalation therapy. Both groups will undergo an 8 week of treatment followed by a 12 week of follow-up. The primary outcome is Asthma Control Test scores, and the secondary outcomes include acute exacerbations, Asthma Control Questionnaire scores, Asthma Quality of Life Questionnaire scores, pulmonary function, airway inflammatory markers, clinical symptom scores, serum inflammatory markers, immune markers, and use of controller medications.

Efficacy, Safety, and Pharmacokinetics of LP-003 Injection in Allergic Asthma Patients

This is a multicenter, randomized, masked, active and placebo controlled, Phase II clinical study to evaluate the efficacy, safety, and pharmacokinetics of LP-003 injection in adult patients with moderate to severe persistent allergic asthma.

Evaluate the Efficacy and Safety of FB825 in Adult With Allergic Asthma

This is a randomized, placebo-controlled and double-blind study to evaluate the efficacy and safety of FB825 in adult patients with moderate-to-severe allergic asthma.

Creating A Risk Assessment Tool for Thunderstorm Asthma: the CARISTA Study

Thunderstorm asthma is a recurring public health emergency in South-Eastern Australia which occurs in springtime. The major identified risk factors for thunderstorm asthma is hay fever and allergy to ryegrass pollen. The goal of the CARISTA study is to identify the risk of springtime allergic and thunderstorm asthma in allergic adults living in South-Eastern Australia. To do this the investigators will recruit 530 people who have hay fever and test them for allergy to ryegrass pollen and undertake simple lung function testing. The investigators will ask study participants to complete a customised symptom tracker over the springtime pollen season for 2 consecutive years. The outcome the investigators are looking for is an asthma exacerbation or worsening asthma symptoms. This study will enable the investigators to identify indicators (biomarkers) of severe and moderate asthma exacerbations in order to identify those at risk of thunderstorm and seasonal asthma so protective treatments and strategies can be advised.

A Study on the Efficacy of Environmental Probiotics in Patients With Cat Hair Allergies

Objective of this clinical trial: The goal of this clinical study is to evaluate whether an environmental probiotic spray can improve symptoms in adults with cat allergy-induced allergic rhinitis (AR) and allergic asthma (AA). It will also assess the safety of the probiotic spray. The main questions it aims to answer are: Does the environmental probiotic spray reduce the severity of nasal and asthma symptoms in participants? Are there any adverse effects observed in participants using the probiotic spray? Researchers will compare the environmental probiotic spray group to a placebo group (a look-alike spray containing no active ingredients) to determine if the probiotic spray is effective in managing allergic rhinitis and asthma symptoms. Participants will: Receive the environmental probiotic spray or placebo daily for 3 months Attend monthly clinic visits for checkups and assessments Undergo a final evaluation at 3 months, including symptom scoring and safety checks Key Assessments: Total Nasal Symptom Score (TNSS) for allergic rhinitis Asthma Control Test (ACT) score for allergic asthma

Asthma Inflammation Research

The overall goal of the Asthma Inflammation Research \[AIR\] Translational Program is to create an integrated multidisciplinary team for the focused purpose of development of diagnostic and prognostic tests informative for airway inflammation, and for the design of innovative, targeted biologic therapeutics. The overarching aims of the AIR program are to conceptualize, develop, and test the next-generation therapeutics, and novel asthma diagnostic and prognostic tools that will allow us to improve the standard of asthma care.

Trial of JYB1904 in Patients With Allergic Asthma

This phase IIa trial is meant to evaluate the pharmacokinetics, pharmacodynamics and safety of JYB1904 in patients with allergic asthma.

Combination Therapy of Omalizumab and Allergen Immunotherapy for Moderate to Severe Asthma

The combined treatment of anti-IgE monoclonal antibody and standardized allergen immunotherapy has good efficacy and safety in allergic diseases. However, the efficacy and safety of the combined treatment for allergic asthma in the Chinese population have not been fully elucidated yet.This study is a prospective observational study designed to evaluate the efficacy and safety of omalizumab combined with allergen immunotherapy (AIT) in patients with moderate to severe asthma in the Chinese population.

Clinical Trial to Evaluate the Efficacy and Safety of Polymerized, Mannan-Conjugated Dermatophagoides Allergen Extract

Prospective, randomised, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of polymerized and mannan conjugated allergen extract of Dermatophagoides for the treatment of allergic rhinitis/rhinoconjunctivitis with or without asthma. The main objective of the clinical trial is to evaluate the clinical efficacy of the investigational medicinal product, administered sublingually, compared to placebo for the treatment of moderate-severe rhinitis/rhinoconjunctivitis with or without mild to moderate asthma and controlled using the Rhinitis/Rhinoconjunctivitis Combined Symptom and Medication Score (R-CSMS).