May 20th, 2022 - This study is a phase IIb, multicenter, multi-national, double-blind, randomized, parallel-arm, placebo-controlled study to evaluate the effect of 5 dose levels of CSJ117 (0.5; 1; 2; 4 and 8 mg) inhaled once daily compared with placebo, when added to standard of care asthma therapy in adult subjects with inadequately controlled asthma despite medium to high dose ICS plus LABA. Approximately 625...

May 20th, 2022 - Allergic inflammation is central to the pathogenesis of allergic diseases, including atopic dermatitis, asthma, allergic rhinitis, and food allergy. These disorders are common, affecting up to 50 million Americans, and their pathophysiology remains poorly understood. Among allergic diseases, atopic dermatitis is common, with a prevalence of up to 20% in children. It is associated with the most ...

May 20th, 2022 - Systemic mastocytosis is a disorder caused by clonal mast cell proliferation and release of mast cell mediators including tryptase. As a result, mast cell numbers may increase and affect target organs including the dermis (maculopapular cutaneous mastocytosis/urticaria pigmentosa, flushing), gastrointestinal tract (abdominal pain, diarrhea), skeletal system (osteoporosis), hematological system ...

May 20th, 2022 - Part 1 of the study will be randomised, double blind, placebo-controlled, and conducted in parallel for the 2 lower dose levels (Part 1a) followed by an unblinded safety review and escalation to the highest dose (Part 1b) dependent on the outcome of the safety review. Part 1a will consist of 30 participants who will be randomised 1:1:1 to receive 1 of the 2 lower AZD1402 dry power inhaler (DPI)...

May 20th, 2022 - Asthma is a complex disease where the interplay between genetic factors and environmental exposures controls susceptibility and disease progression. In the U.S., there remains an epidemic of asthma that disproportionately affects underrepresented minorities and creates a major public health burden, especially among children. Asthmatics of African ancestry continue to have more severe asthma and...

May 20th, 2022 - Allergy skin prick tests and measurement of food-specific immunoglobulin E (IgE) levels are common but not robust means to diagnose food allergy, so patients may be placed on overly restrictive food elimination diets as a result of false positive results. Such restrictions can lead to poor weight gain, malnutrition, and negative impact on quality of life. More than half of patients who are sens...

May 20th, 2022 - Asthma is a common disease and a significant public health problem, affecting one in every 10 individuals, nearly 30 million people in the US alone. About 5-10% of asthmatics have severe disease that is difficult to control with standard therapies. Severe asthmatics are considered to be relatively resistant to corticosteroids, a mainstay of therapy in asthma. Furthermore, chronic corticosteroid...

May 20th, 2022 - The primary objective of this research is to perform in vivo assessment of the metabolic signatures associated with immunity, with particular focus on the immune modulators of wound healing and tissue repair. Perhaps the most demonstrative example of immune dysfunction resulting from metabolic disorder is that of adenosine deaminase (ADA) severe combined immune deficiency (SCID). While several ...

May 20th, 2022 - Urticaria is a common skin disorder that is classified according to its chronicity into acute and chronic forms. It may occur spontaneously or on exposure to a physical factor. In the latter case, the urticaria is classified as a physical urticaria . Physical urticaria may be induced by mechanical and applied pressure, exercise, or exposure to cold, heat, sun, water, or vibration. The urticaria...

May 20th, 2022 - This protocol is designed to screen subjects (and some family members) with suspected or identified genetic diseases of allergic inflammation or mast cell homeostasis and activation. Patients determined by clinical history and initial outside evaluation by their referring physician to be of interest will be consented and enrolled into this study. Blood specimens, stored blood products and deriv...

May 20th, 2022 - This protocol is designed to provide blood, skin, stool/rectal swabs, buccal mucosa and bone marrow aspirate samples from approximately 250 healthy volunteer donors for use in in vitro studies such as studies of cells of the immune system, mastocytosis, and allergic diseases. Participants will donate samples using conventional techniques. The investigational nature of the studies in which sampl...

May 20th, 2022 - BACKGROUND: The use of antibiotics has revolutionized medicine, yet the impact of antimicrobials on the human microbiome is incompletely understood. Antimicrobial treatments, including topical and systemic antibiotics, are highly effective and are frequently used to manage disease flares of AD. Concomitant use of dilute bleach baths reduces the clinical severity of AD in patients with clinical ...

May 20th, 2022 - The main aim of this study is to investigate the change in asthma control after 6 months of therapy in patients treated with benralizumab biologic therapy for severe eosinophilic asthma under real-life conditions in a pulmonary care setting in Germany. The study also aims to investigate Quality-of-Life (QoL), the early treatment response, treatment effectiveness and the change in asthma control...

May 20th, 2022 - This protocol is designed to examine those growth potentiating and inhibiting factors which regulate mast cell number and survival in patients with mastocytosis, and to explore the molecular basis of the disease process in hopes of improving therapy. Patients will carry the diagnosis of mastocytosis based on abnormal bone marrow biopsy and aspirate, abnormal skin biopsy, presence of urticaria p...

May 20th, 2022 - There are approximately 15 million Americans, including 6 million children, who have a potentially life-threatening food allergy. The prevalence of this disease has increased over the last three decades, in both the United States and other developed countries. There are no cures or effective prevention or treatment strategies for food allergy. Moreover, little is known about the factors that ac...

May 20th, 2022 - Skin microbiota (bacteria, fungi, viruses, phage, archae) play a significant role in common dermatological conditions, such as atopic dermatitis/AD (eczema). Since culture-dependent methods are often biased assessments of microbial diversity, genomic methods can expand our understanding of the human microbiome and skin diseases. Chronic dermatitis is typical among rare primary immunodeficiencie...

May 20th, 2022 - Episodic angioedema with eosinophilia (EAE), also known as Gleich s Syndrome,is a rare disorder characterized by recurrent episodes of urticaria, fever, angioedema, weight gain and dramatic eosinophilia that occur at 3- to 6-week intervals and resolve with spontaneous diuresis in the absence of therapy. Although the syndrome is often classified in the broad category of idiopathic hypereosinophi...

May 20th, 2022 - Study Description: This is a single-site study to determine the safety of administering a dose of the Pfizer-BioNTech mRNA coronavirus disease 2019 (COVID-19) vaccine (Comirnaty) to individuals who experienced a systemic allergic reaction to their first full dose of the same vaccine or the Moderna mRNA vaccine, and to investigate possible mechanisms underlying allergic reactions. Objectives: Pr...

May 20th, 2022 - Study Description: This study is designed to collect data and clinical samples from participants with elevated eosinophil counts in the peripheral blood or tissues or their relatives to enhance our understanding of the mechanisms driving eosinophilia and eosinophil activation in patients with a wide range of eosinophilic disorders with the ultimate goal of improving diagnostics and identifying ...

May 20th, 2022 - This tissue procurement protocol proposes to perform bronchoscopy with bronchoalveolar lavage, bronchial brushings, and bronchial wall biopsies as well as to collect samples of sputum, exhaled breath condensates and blood, in order to evaluate the molecular mechanisms underlying the pathogenesis of airway inflammation, airway hyperresponsiveness, and airway remodeling in asthmatic subjects.