125 Clinical Trials for Various Conditions
This study will provide the clinicians guidance on the safest combination of inhaled and nasal corticosteroids for children with mild asthma and allergic rhinitis respectively; however, one safety concern is that these products are independently known to have dose-related effects on short term and intermediate term growth. Knemometry is a non invasive technique for measuring short-term lower leg growth in children and is currently the method of choice in growth studies of short duration. Subjects will be seen on a weekly basis for 18 weeks and at each visit, lower leg length will be measured using knemometry.
Background: Allergic or sinus diseases can affect the skin, sinuses, airways, and other parts of the body. Examples include pollen and environmental allergies, food allergies, asthma, and eczema. To learn more about how to prevent and treat these diseases, researchers need to study data, blood, fluid, and tissue samples from people affected by them. Objective: To collect data, blood, fluid, and tissue samples from people with allergic or sinus diseases. Eligibility: People aged 3 to 100 years with allergic or sinus diseases. Design: Participants will have at least one clinic visit, and most participants will have a baseline visit, annual visit, and an end of study visit. The duration of the study is 1 to 3 years. During the first clinic visit, the following procedures will be done to collect data, blood, fluid, and tissue samples: * Blood will be collected. * Cells and fluid may be collected from the inside of the nose using a long swab, and a small piece of skin may be scraped from inside the nose. * Skin cells will be collected by rubbing with a cotton swab. * A urine sample will be collected. * Allergy skin prick tests. Allergy-causing substances will be placed on the back or arm and the skin underneath gently scratched. If the participant is allergic to the substance, the skin may become red, itchy, and swollen locally ( at the site of the test). * Lung function test. Participants will breathe into a machine that measures the air moving in and out of their lungs. * If, as part of their routine care, participants are undergoing procedures such as having nasal polyps removed, skin tissue samples taken, or gastrointestinal biopsies, additional tissues may be collected for this study. * Participants will complete online questionnaires regarding their symptoms, health, and life. Participants may return for more visits for up to 3 years. ...
The trial involves two interventions: (i) exposure to HDM in the ACC and (ii) administration of dupilumab/placebo for dupilumab.
This study will investigate the role of dupilumab in the treatment of asthma with comorbid obesity. It is hypothesized that in airway epithelial cells, unique transcriptomic and proteomic expression patterns distinguish allergic and non-allergic patients with asthma and obesity and drive significant differential responses to dupilumab. It is further hypothesized that dupilumab will increase interleukin-13 receptor alpha 2 (IL-13Rα2) levels and/or signaling activity on airway epithelial cells isolated from allergic asthma patients with obesity. This is a pre-clinical research study of dupilumab-induced gene and protein expression analyses in nasal airway epithelial cells of adults with asthma and comorbid obesity. The study primarily seeks to: 1) assess the effect of dupilumab on transcriptomes, phosphoproteomes and secretomes of well-differentiated, primary airway epithelial cells as a function IL-13R subunit expression and IL-13Ra2 signaling, in allergic and non-allergic asthma patients with obesity; and 2) test whether dupilumab-induced gene and protein changes significantly correlate with parameters of airway inflammation in allergic and non-allergic asthma.
To determine if low levels of ozone (O3) encountered on a typical day in Chapel Hill will decrease spirometric values in mild asthmatics.
Determining how memory T helper type 2 (Th2) initiate recall responses to aeroallergens has the potential to change the therapeutic approach to allergic asthma, the most common asthma subtype. \~5-10% of effector Th2 cells recruited into the lung give rise to long-lived tissue resident memory cells that are poised to respond upon allergen re-exposure.Consequently, targeting memory Th2 cell activation is an attractive therapeutic strategy. However, it is not well understood how allergen inhalation initiates a memory Th2 cell response in the lung. The focus of this new study on the role of lung-resident memory Th2 cells in orchestrating the recall response to allergen in the lung, including the recruitment and activation of circulating Th2 cells, is a natural, timely and exciting extension of the investigators' ongoing Allergen Challenge Protocol.
To assess the effects of REGN3500, dupilumab, and REGN3500 plus dupilumab, compared with placebo, on changes in inflammatory gene expression signatures in sputum induced after a bronchial allergen challenge (BAC) in adults with mild allergic asthma, at week 4 after treatment initiation compared with those at screening.
The investigators will study the use of a home-based spirometer (Spirobank Smart spirometer) that connects to a smartphone app (VitalFlo) in teenagers with persistent asthma to determine if clinically significant changes in lung function detected by the spirometer are associated with patient-reported asthma symptoms.
The trial aims to demonstrate efficacy of the House Dust Mite SLIT-tablet versus placebo as add-on treatment in children and adolescents (5-17 years) with House Dust Mite allergic asthma based on clinically relevant asthma worsening.
This is a randomized, double-blind, placebo-controlled Phase 1 study of HA115 capsules administered orally to healthy adult volunteers.
An unmet medical need exists for patients with moderate and severe asthma who continue to demonstrate symptoms despite being on standard of care medications, and are not eligible for other biologic therapies developed or in development for T2-high(allergic/eosinophilic) asthma. The purpose of this study was to determine if CJM112, an anti-IL-17A antibody, displayed the clinical efficacy and safety profile to support further development in patients with inadequately controlled moderate to severe asthma with low IgE and low circulating eosinophil levels.
The purpose of this study is to determine whether a potential type 2 signature, obtained through stimulation of cell lines with various allergens in vitro, correlates with an allergic or asthmatic disease state ex vivo. This type 2 signature will be multi-hierarchical in nature and will be comprised cell surface receptor expression, pathway activation, and gene upregulation.
The study was the non-interventional, retrospective study aimed to assess the effectiveness and safety of omalizumab in children with allergic asthma in China, and described patient profiles and treatment patterns of omalizumab in real-world practice.
A retrospective database pre-post cohort study, identifying asthmatic patients, aged 6- 11, with omalizumab use over 24 months
The purpose of this study is to evaluate a previously FDA-approved medication that is known to help with allergy symptoms to see if it can decrease symptoms in patients with Meniere's Disease.
This study will assess the effect of omalizumab on exercise capacity, physical activity, and sleep quality after 24 weeks of treatment in participants with moderate to severe allergic asthma. Exercise capacity will be assessed using cardiopulmonary exercise testing (CPET). Physical activity and sleep quality will be assessed with a wearable physical activity and sleep monitor. The study will consist of a 4-week screening period, a 24-week treatment period, and a 4-week safety follow-up. Approximately 60 participants will be enrolled, and omalizumab will be dosed according to the approved United States Package Insert (USPI) dosing table.
This study is designed to identify Felis Catus, or cat hair, sensitive asthmatics who demonstrate a late phase asthmatic response after cat hair inhalation. These subjects may be invited to participate in a planned future study investigating novel asthma treatments.
Asthma is a heterogeneous disease, and although much is understood about mechanisms of inflammation in allergic asthma, less is known about mechanisms of irritant-induced asthma (IA). Understanding the underlying similarities and differences in mechanisms of these two types of asthma will help focus current treatments and lead to development of new therapies. There is a longstanding NYU/Bellevue Asthma registry (NYUBAR), with a large population (N = 900) of asthma cases and controls, a program that has been housed at the CTSI (formerly GCRC). The destruction of the World Trade Center (WTC) resulted in massive dust, gas and fume exposures to local residents, workers and cleanup workers and individuals involved in rescue and recovery and adverse respiratory health effects of this disaster are reported more than 7 years after 9/11. Many responders, as well as those exposed as residents or local workers, have developed IA, asthma that arises after a lag from an environmental exposure . The WTC Environmental Health Center (WTC EHC) is one of the three New York City (NYC) WTC Centers of Excellence and the only one that focuses on treatment and monitoring of local workers and residents. As such, it has a large population of individuals with irritant-induced asthma. It has been proposed to use participants from the NYUBAR and the WTC EHC to expand the knowledge of irritant and allergic asthma. Non-invasive studies allow for the assessment of airway inflammation, a non-specific response to environmental exposure and injury. Recent technologies also allow for assessment of microRNA (miRNA), small RNAs that regulate gene expression at the post-transcriptional level and thus serve as a pathway to regulation of inflammation. The hypothesis will be tested in that airway inflammation in irritant and allergic asthma may be similar, but result from divergent miRNA regulatory pathways expressed in sputum cells. These studies will provide preliminary data for future studies that will help identify biological pathways to categorize these asthma phenotypes and target future treatment interventions.
A phase IIb study in patients to evaluate CYT003- QbG10 versus placebo, in patients with mild to moderate allergic asthma not sufficiently controlled on inhaled steroid. Altogether 170 patients, randomized to two treatment groups will be included. Key outcome measures are patient reported parameters on their asthma
This study planned to assess long-term safety of QGE031 during 12 months treatment in asthma patients who completed study CQGE031B2201.
Despite advances in medications, allergic diseases, including allergic asthma continue to rise in prevalence. For this reason, there is a need for a better understanding of the mechanisms of allergic diseases and novel insights into modulating allergic inflammation. The investigators hypothesize that much remains to be learned about the behavior of T effector and T regulatory cells in allergic disease. Furthermore, the investigators hypothesize that novel mechanisms of allergic tolerance may exist, and elucidation of these mechanisms may provide insights into novel therapeutic strategies to control allergic diseases. The investigators will investigate the capacity for T cell tolerance induction in allergic subjects by a novel type of immune tolerizing dendritic cell (it-DC). The investigators will assess whether in vitro generated it-DCs have the capacity to induce antigen-specific T regulatory cells and suppress allergen-specific T effector cell function in vitro. Standardized Cat Allergen extract and Dust Mite Allergens will be used to generate changes in the airways that occur during exposure to allergen. For this investigation, the route of administration will be topical application of the titrated allergen to a bronchoscopically isolated subsegment of one lobe of one lung. The dose of biologic will be determined from prior skin-prick testing.
The purpose of this study is to assess the therapeutic potential and safety/tolerability of study drug (CYT003) at 3 dose levels versus placebo in patients with persistent moderate to severe allergic asthma not sufficiently controlled on current standard controller therapy. Altogether 360 patients randomized to 4 treatment groups will be included. The study compares three dose strength with placebo. Each patient receives 7 injections of study drug or undistinguishable placebo. Key outcome measures are patient reported parameters on their asthma.
This randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of 3 dosing regimens of MEMP1972A in patients with allergic asthma who remain inadequately controlled on chronic therapy with high dose inhaled corticosteroids and a second controller medication.Patients will be randomized to 4 Arms to receive subcutaneous repeating dose of either MEMP1972A 150 mg, 300 mg, or 450 mg, or placebo. Patients will continue their usual asthma medication throughout the study. Anticipated time on study treatment is 36 weeks, with a 48-week follow-up.
Asthma is a disease of rapidly increasing incidence that already affects more than 17 million people in the United States alone. It has long been known that areas of severely reduced airflow occur in asthma and contribute significantly to the impairment of gas exchange in this disease. However, the extent to which local blood flow changes during an asthmatic attack is unclear. The purpose of this study is using Positron Emission Tomography - Computed Tomography imaging to evaluate how the blood flow changes in the lungs during an asthma attack induced by allergens.
The study was designed to collect data about inadequately controlled moderate to severe allergic asthma in subjects 6 to \< 12 years of age, managed in a real-world setting.
This study will evaluate whether exhaled nitric oxide levels are affected by allergen immunotherapy ("allergy shots"). The investigators' hypothesis is that successful allergen immunotherapy may be accompanied by decreased exhaled nitric oxide levels.
This study will evaluate the effect of omalizumab on markers of impairment in patients with inadequately controlled persistent allergic asthma on Step 4 or above therapy as defined in the 2007 National Heart, Lung, and Blood Institute (NHBLI) Guidelines
This will be a single center, open label study comparing baseline characteristics of recovered sputum cells (collected on screening day) to those of cells recovered 6 hours after inhalational challenge with 20,000 EU Clinical Center Reference Endotoxin (CCRE, a component of air pollution)) within each group as well as cross group comparisons between individuals with allergic asthma (AA's)and normal volunteers (NV's). The primary objective of this study is to test the hypothesis that persons with allergic asthma will have an increased neutrophil response to challenge with 20,000 EU CCRE compared to normal volunteers. Secondary objectives include post CCRE comparison between AA's and NV's with regard to changes in airway cells and blood as well as changes in mucociliary clearance (MCC) in response to inhalation of 20,000 EU CCRE.
Purpose: This is a non-masked study with a primary endpoint of in vitro basophil activation by the allergen D. farinae, comparing basophil activation before and after seven days of supplementation. Secondary endpoints will include circulating antioxidant levels (tocopherols and metabolites), in vitro basophil activation to IgG anti-IgE and to N-formyl-methionyl-leucyl-phenylalanine (f-met-leu-phe), and monocyte and basophil responsiveness to in vitro endotoxin challenge. Participants: Twenty allergic asthmatic volunteers Procedures (methods): Volunteers will be given 1200 mg of a gamma tocopherol enriched supplement, a commercially available supplement form of vitamin E. Study participants will undergo assessment of general health, lung function assessment, symptom scoring, and epicutaneous skin test to allergens at baseline and after supplementation. Blood samples will be collected at baseline and after 7 days of gamma-T treatment.
A single center pilot study to determine the protective effects of RhuMAB-E25 on airway physiology and biology in allergic asthmatics that undergo bronchoprovocation with methacholine. The primary study objective determines the protective impact of RhuMAB-E25 on airway inflammation as reflected in exhaled nitric oxide (NO) levels in allergic asthmatics. The secondary objective determines the protective effect of rhuMAB E25 against airway bronchoconstriction as reflected in the Provocative Concentration of methacholine to cause a 20% fall in FEV1(PC20) with methacholine challenge testing.