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Allergy clinical trials

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NCT ID: NCT01734265 Completed - Allergy Clinical Trials

Safety Clinical Trial With Depigopid 50% Grasses/50% Olea Europaea(2000DPP/ml) or Depigoid 50% Grasses/50% Parietaria Judaica(2000DPP/ml).

Start date: November 2012
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to evaluate the safety and tolerance of a rush build up administration of Depigoid forte pollen and the first maintenance dose administered 4 weeks later.

NCT ID: NCT01728519 Terminated - Allergic Rhinitis Clinical Trials

Phase I/IIa Clinical Evaluation of AllerT vs Placebo in Subjects Allergic to Birch Pollen

AN003
Start date: August 2008
Phase: Phase 1/Phase 2
Study type: Interventional

Birch pollen allergic patients are currently treated by subcutaneous injections of pollen extracts either by standard allergen specific immunotherapy (SIT) or ultra-rush immunotherapy. Such treatment is prone to side effects and has to be performed in a hospital environment due to the risk of potential anaphylactic reactions. The aim of this study is to test the new product AllerT expected to show widely reduced side effects. AllerT will be injected via two different routes, subcutaneous versus intradermal. The primary endpoint of the study is the local and systemic safety of repeated injections of the product. Since AllerT should provide patients with a pre-seasonal treatment to decrease seasonal allergic symptoms, we will also evaluate the potential efficacy of the approach using a nasal provocation test (NPT) with birch pollen

NCT ID: NCT01727115 Completed - Allergy Clinical Trials

Althera® Versus Nutramigen / Cow's Milk Intolerance

Start date: April 2008
Phase: N/A
Study type: Interventional

The primary objective of this study is to demonstrate that ALTHERA® is equal or superior in efficacy than NUTRAMIGEN®

NCT ID: NCT01715675 Completed - Asthma Clinical Trials

Effects of Plant Stanols on Immune Function in Asthma Patients

Start date: October 2010
Phase: N/A
Study type: Interventional

Rationale: Plant stanols are well known for their effects on lowering intestinal cholesterol absorption ultimately resulting in 10-15% reduced serum LDL cholesterol concentrations in humans. In addition we have also shown that serum triacylglycerol (TG) concentrations may be lowered in subjects with elevated baseline concentrations. Till now, there is little evidence for plant stanol effects other than improving lipid profiles. However, we have very recently found strong indications in ex vivo models using isolated human peripheral mononuclear blood cells (PBMCs) from healthy volunteers that plant stanols have the capacity to improve immune function. More into detail, plant stanols shifted the differentiation of naive T-cells into the Th1 direction by activating a specific receptor present on the Antigen presenting cells (APCs) and T-cells. This effect might ultimately be helpful in situations in which the Th1/Th2 cell balance is disturbed into a Th2 over-responsiveness. By activating the Th1 response, the disturbed balance may be restored. This is for example a possibility in the treatment or prevention of asthma, food allergies or HIV in susceptible subjects. In addition, very recently (MEC 08-3-051) in a pilot study we also showed these ex vivo Th1 stimulating effects of plant stanols specifically in PBMCs isolated from asthma patients, as said, a condition characterized by a Th2 dominant immune response. Objective: The major research objective is to prove that the consumption of plant stanol ester enriched yogurts can improve immune function in vivo in asthma patients. Study design: A double-blind randomized placebo-controlled human intervention study in which 90 patients with clinically proven asthma will participate: 45 in the intervention group receiving plant stanol yoghurt and 45 in the control group receiving a control yoghurt without added plant stanols. At the end of the run-in period as well as at the end of the experimental period blood will be sampled to isolate PBMCs. These cells are used to evaluate effects on cytokine production, phagocytic capacity of neutrophils, and the activity of NK cells. In addition, the golden standard to show improvements in immune function is by showing an elevated Immunoglobulin response to a vaccine. Therefore, during the experimental period all subjects receive a vaccination against Hepatitis A Virus. After 1, 2, 3, and 4 weeks blood will be sampled to monitor specific immunoglobulin titers to HAV. Study population: 90 people with clinically proven asthma, who are not carrier of hepatitis A, B or C and have not been vaccinated against hepatitis A in the past. Also, these participants do not have any other immune-related pathology Main study parameters/endpoints: primary: Specific anti-HAV antibody titers after vaccination; secondary: Phagocytic capacity of neutrophils; NK-cell activity; Th1 and Th2 cytokine production profiles by PHA stimulated PMBCs. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: During the study, 9 blood samples (each 20 or 50 mL) will be taken. Total time investment for the subjects will be 160 min. Occasionally, a heamatoma or bruise can occur during venipuncture. After the vaccination a heamatoma or a sore arm can occur. These side effects should disappear within 4-5 days. Other common side effects related to the vaccination are headache, loss of appetite, and fatigue, which usually will disappear within 24 hours. The results of this study will show whether consumption of plant stanol enriched yogurts is able to restore the disturbed th1/Th2 balance in asthma patients. Ultimately, this is expected to reduce asthmatic exacerbations, as the Th2 dominant immune response seems causal to asthmatic symptoms, however these clinical improvements are not verified in this relatively short term intervention study.

NCT ID: NCT01647399 Completed - Asthma Clinical Trials

Vitamin D, Steroids, and Asthma in African American Youth

AsthMaP2
Start date: July 2012
Phase:
Study type: Observational

Asthma has become considerably more prevalent and severe in the U.S. during the last 40 years, particularly affecting youth in urban areas, yet the reasons for this are not clear. There is increasing evidence that vitamin D insufficiency contributes to more severe asthma through increased risk of respiratory infections and decreased sensitivity to glucocorticoids. Indeed, low vitamin D levels are linked with the need for exogenous glucocorticoids and increased asthma severity. Particularly relevant to health disparities, we showed a strong association between vitamin D insufficiency and asthma in urban African American (AA) youth. Importantly, AA youth in ours and other studies had lower vitamin D levels than non-AA participants. Because AA youth residing in urban Washington, DC have markedly worse asthma than other racial/ethnic groups (e.g. prevalence rate 20% higher than the national rate 15 and emergency department utilization rates up to 5 times the national rates and nearly 10 times the Healthy People 2010 target rate), we will utilize our access to this population at the extreme of asthma disparities to examine the contribution of vitamin D to disparities in the chronic control and acute severity of asthma. The overall goal of this study is to provide critical epidemiological/molecular information that will inform the interpretation of ongoing and impending randomized clinical trials of vitamin D supplementation in asthma, especially with regard to urban AA youth with asthma. We hypothesize that low serum 25-hydroxyvitamin D [25(OH)D] levels are associated with poor chronic asthma control, worse acute asthma severity, and glucocorticoid insensitivity. The knowledge generated by the experiments in this application will be crucial to translation of this inexpensive, easily-accessible, and thereby potentially disparity-reducing prospective therapy for asthma.

NCT ID: NCT01634516 Completed - Allergy Clinical Trials

Effectiveness of Mediterranean Diet Intervention in Pregnant Women

Start date: May 2012
Phase: N/A
Study type: Interventional

There has been an increase in asthma and allergic disease prevalence, especially in children. Given the high prevalence, and the associated high disease burden and costs, there is an urgent need to identify effective strategies for the primary prevention of asthma and allergy. A systematic review of the literature has found strong supportive epidemiological evidence of a protective role for the Mediterranean Diet (MD). The investigators aim is to undertake a pilot trial in a sample of pregnant women to establish recruitment, retention, a measurable change to a dietary intervention encouraging greater adherence to a MD during pregnancy, and acceptability of the dietary advice and diet modifications. This pilot study will be a 2-arm randomised controlled trial (RCT) in a sample population of around 50 Scottish pregnant women. This work ultimately aims to contribute to improving health outcomes through seeking to reduce the incidence of asthma and allergic problems. This pilot trial will prove invaluable in informing the subsequent planned definitive parallel group RCT.

NCT ID: NCT01633840 Completed - Allergy Clinical Trials

New Validated Recipes for Double-blind Placebo-controlled Low Dose Food Challenges

Start date: September 2008
Phase: N/A
Study type: Interventional

This study aimed to validate new recipes for cow's milk, hen's egg, soy, cod and wheat, to be used in blinded low-dose food challenges.

NCT ID: NCT01618318 Completed - Asthma Clinical Trials

Glasgow Asthma and Allergy Study

GLAAS
Start date: June 2012
Phase: N/A
Study type: Observational

In the past, doctors separated people with asthma into two groups, those with "allergic asthma" (about 2/3rds of people) and those with "non-allergic asthma". These labels are not much used now as the treatments for all people with asthma don't depend on this classification. However, new treatments for asthma may become available and the classification may again become important. It could be useful for clinicians to know how to identify which patients are likely to benefit from particular treatments. Additionally, some new blood tests are becoming available and some of these might help to categorise the type of asthma people have. What the study hopes to do is to identify patient features which make a diagnosis of "allergic asthma" more likely and to see which new blood tests are most likely to be helpful in confirming this diagnosis.

NCT ID: NCT01611636 Completed - Allergy Clinical Trials

Clinical Characteristics of Allergy, Autoimmune and Rheumatic Diseases: A Ten Year Retrospective Study

Start date: January 1, 2012
Phase:
Study type: Observational

The incidence and prevalence of the allergic, autoimmune and rheumatic diseases are different all over the world. The relative impact of gene and environment on diseases can be revealed by studies from different populations. National Health Insurance database in Taiwan provides a wealth of epidemiology study, which can contribute to the understanding of these diseases. However, national health care database did not contain test results and clinical details. The database of the hospital records can provide complimentary clinical details. Via the comparison of databases of the National health Institutes and the investigators hospital, the investigators hope that the characteristics and outcomes of these patients can be better understood.

NCT ID: NCT01601847 Completed - Allergy Clinical Trials

Wheezing in Black Preterm Infants: Impact of Vitamin D Supplementation Strategy

D-Wheeze
Start date: January 2013
Phase: Phase 4
Study type: Interventional

The goal of this study is to identify a vitamin D supplementation strategy that best promotes the lung, immune, and overall health of black infants born preterm (28-36 weeks gestational age). This is a high risk population that seems to have unique vitamin D needs, and inappropriate supplementation may promote wheezing or allergy. The results of this study will help form nutritional recommendations for the approximately 100,000 black infants born at 30-36 weeks gestational age in the U.S. every year.