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Asthma clinical trials

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NCT ID: NCT00342030 Completed - Asthma Clinical Trials

Dietary and Genetic Factors in Asthma & Chronic Bronchitis in a Cohort of Chinese Singaporeans

Start date: November 1, 2002
Phase: N/A
Study type: Observational

There is suggestive evidence for a role of dietary in the etiology of asthma and chronic bronchitis. However, there are few prospective data. We propose to expand our collaboration with the Singapore Chinese Health Study to examine dietary, environmental, and genetic factors, along with their interactions, in relation to the risk of developing asthma and chronic bronchitis. The Singapore Chinese Health Study is a cohort of 63,257 men and women of Chinese ethnicity in Singapore who were aged 45-74 years at enrollment from 1993 to 1998. Telephone follow-up of the cohort to update and outcome information began in 1999 and is ongoing. We expect to identify 538 cases of incident asthma and 672 cases of incident chronic bronchitis when the current follow-up questionnaire cycle is complete in 2004. In this proposal, we would validate self-reports of incident asthma, obtain follow-up data from the entire cohort to perform analyses of dietary and smoking in relation to these outcomes, and analyze genetic material on cases of incident asthma and chronic bronchitis and controls from the cohort. In this proposal we will examine the following hypotheses: 1. Higher intake of fruits and/or antioxidant micronutrients decreases the risk of developing asthma and chronic bronchitis. a. Effects if fruit and/or antioxidant micronutrients may differ by smoking history. 2. Common polymorphisms in genes involved in the response to oxidative stress influence the risk of asthma and chronic Bronchitis. We initially propose to examine polymorphisms in three genes--glutathione S-tranferase M1, glutahione S-transferase P1, and matrix metalloproteinase-1. However, we plan to examine additional relevant polymorphisms in the future, especially taking advantage of high throughput screens of candidate genes for asthma and chronic bronchitis. It is possible that by 2004 when the sample set will be available that more compelling candidates and high throughput screens may be available to us at a low cost. Thus we will re-evaluate our choice when the samples are available. 3. Polymorphisms in these and other genes interact with fruit/antioxidant intake and/or smoking to influence the risk of asthma and chronic bronchitis.

NCT ID: NCT00341653 Completed - Asthma Clinical Trials

A Cohort Study of Smoking Prevention and Health Promotion for Middle School Students in Wuhan, China

Start date: December 1, 1998
Phase:
Study type: Observational

We propose to add a collection of buccal cells to a school-based cohort of 7th graders in Wuhan, a large industrial city in China. The cohort study is being conducted by the Wuhan Public Health and Anti-Epidemic Station (Li Yan MD, director and principal investigator). The cohort study is designed to look at several outcomes. One is initiation of smoking. The second is respiratory health in relation to active and passive smoking and other environmental exposures that are prevalent in Wuhan. The respiratory outcomes include changes in pulmonary function, asthma and other respiratory symptoms. Collection of buccal cells is a noninvasive method of obtaining DNA. The addition of a genetic sample will enable us to examine candidate gene associations for asthma and childhood respiratory illness within an interesting and well-characterized Chinese population. In addition, it provides the capability to examine gene environment interaction with respect to common environmental exposures in Wuhan. The ability to examine gene-environment interaction can help to identify relatively subtle effects of pollutants such as environmental tobacco smoke which is becoming a very common exposure due to the major increase in smoking among Chinese men. Other exposures of interest in Wuhan are indoor coal burning and high ambient exposures to particules, ozone and nitrogen oxides. The proposed study has been approved by the human subjects committee of the Wuhan Public Health and Anti-Epidemic Station....

NCT ID: NCT00341237 Recruiting - Asthma Clinical Trials

Personalized Environment and Genes Study

Start date: May 26, 2010
Phase:
Study type: Observational

Despite the overwhelming focus on genetic and genomic causes of human disease over the past two decades, it has been estimated that genetics is currently known to explain only 20% and 40% of the etiology of common disease. Thus, it is becoming increasingly apparent that human disease is a consequence of both genetic susceptibility and environmental exposures. Importantly, while individuals cannot change their genetic composition, we do have the ability both personally and as a society, to influence our environment, promoting health and decreasing the risk of disease. The Personalized Environment and Genes Study (PEGS) aims to determine how the environment and gene-environment interactions can inform our understanding of human health and disease. As science has evolved, so too has the science of this project. This evolution was reflected in a change in the title of this project from the Environmental Polymorphisms Registry (EPR) to the Personalized Environment and Genes Study (PEGS) to more accurately reflect the science that can be conducted. PEGS is a unique resource because of the depth of environmental phenotyping which includes extensive information from exposome surveys, as well as whole genome sequencing on a significant number of participants in the cohort. While it is small relative to genomic cohorts, none of these have the extensive environmental data that is present in PEGS. In addition, other cohorts with deep environmental data lack the depth of genomic data that is present in PEGS. Importantly, PEGS has already provided important analytic advances that are of great interest to and can be confirmed in larger cohorts such as All of Us. The Personalized Environment and Genes Study (PEGS) aims to provide a resource for environmental health translational research by examining gene-environment interactions in health and disease. PEGS is an extension of two previous efforts where it began as a pilot study, the Environmental Polymorphisms Study (EPS; IRB# 02E9004) and was approved subsequently as a full protocol titled the Environmental Polymorphisms Registry (EPR) (IRB #04-E-N0053 and transitioned to its current ID# 04-E-0053). The EPR was envisioned as a phenotype-by-genotype registry of participants who had donated DNA samples, and who had agreed to be contacted for follow-up clinical translational studies based on their DNA genotypes. At the time, the only information available was a participant s age, sex, race, and ethnicity. Further phenotyping of a participant and/or any biospecimens obtained were investigated during a follow-up translational clinical study on participants recruited based on their genotype (hence phenotype-by-genotype) and the PEGS was the first recruit-by- genotype study at the NIH. Following a period focused on recruiting approximately 15,000 participants to enable genotyping of rare (approximately 1% minor allele frequency) single nucleotide polymorphisms (SNPs), the PEGS Consortium Project was undertaken in 2010- 2011 to examine, using the DNA of nearly 4,000 participants, approximately 700 SNPs in approximately 80 environmental response genes that work in concert with environmental exposures to elicit a phenotype. Several clinical follow-up studies, genotype-phenotype association studies, and publications have resulted from the PEGS Consortium Project. To expand phenotype information available to researchers, the Health and Exposure Questionnaire was administered between 2013-2014. In 2017, a more detailed Exposome Questionnaire which includes questions relating to the external and internal exposome was administered. This was an important resource through which to integrate exposures with genotype-phenotype association studies. Whole genome sequencing has now been performed on approximately 4700 participants who were reconsented for this purpose, as indicated above. Questionnaire data was fully adjudicated and combined in a robust and searchable database. With the increased power of the data available, the project was renamed as the Personalized Environment and Genes Study (PEGS) and rolled out in Sept. 2021.

NCT ID: NCT00339872 Completed - Asthma Clinical Trials

Study Evaluating IMA-638 in Asthma

Start date: February 2006
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety of, and blood drug levels for, single, ascending doses of IMA-638 in mild to moderate asthma subjects.

NCT ID: NCT00339703 Completed - Asthma Clinical Trials

Levels of Serum Resistin in Asthmatics as a Potential Marker of Systemic Inflammation and Disease State.

Start date: November 2004
Phase:
Study type: Observational

The purpose of this study is to determine whether serum resistin levels in asthmatics are elevated. We will recruit subjects from the allergy/immunology clinic with a prior diagnosis of moderate to severe persistent asthma in addition to subjects being seen for evaluation of drug allergies. Based on the inclusion and exclusion criteria below, subjects will be placed into a control and asthma group. Each subject will undergo one blood draw in the main lab at WHMC, and return a lavender top tube to the allergy/immunology clinic for the EIA resistin assay. The patient will then have a brief encounter with a physician to determine an up to date history of asthma symptoms prior to participating in the exhaled NO test. The entire subject encounter will take place with one clinic visit, and requires no follow up visits as part of the study. The greatest risk to each subject will be the blood draw, as the exhaled NO is a completely non-invasive test. Plasma from each subject will be stored in a -70° freezer for no more than one month. Samples will be analyzed for resistin levels using an EIA assay run monthly. Mean values from serum CRP, serum glucose, serum resistin, and exhaled NO will be compared using a students T-test.

NCT ID: NCT00339573 Completed - Asthma Clinical Trials

National Survey of Lead and Allergen Hazards in Housing

Start date: June 30, 1998
Phase:
Study type: Observational

We propose to conduct a scientifically valid, descriptive survey to measure the prevalence and levels of lead in dust, soil, and paint, and the prevalence and levels of various indoor allergens in floor and bedding dust in the nation's housing stock. The survey strategy is a population-based, multi-stage area probability sample designed to represent all 50 states. The survey will include approximately 1000 homes in at least 100 primary sampling units (PSU, a metropolitan area or cluster of counties). Residents of candidate participant housing units (HUs) will initially be contacted by a letter to introduce and provide a brief explanation of the study. A field interviewer will then visit each candidate HU to screen and recruit eligible units into the study. A short Screening Questionnaire will be administered to an adult HU resident and an invitation will be extended to those HUs that are eligible to participate in the study. A field data collection visit will be scheduled for the following week, at the resident's convenience. The collection visit will be conducted by two member team (including the same field interviewer that will conduct the screening/recruiting visit) and will consist of administration of an informed consent form and Data Collection Questionnaire, completion of home observation forms, collection of interior dust and exterior soil samples, and conduct of nondestructive paint lead analysis on both interior and exterior walls. Soil and dust samples will be shipped to analytical laboratories for lead and allergen analysis. Extensive survey design, procedure, and reporting details are provided in the National Survey Lead Hazards and Allergens in Housing: Protocol and Sample Design Report (Attachment A). It is anticipated that this study will provide allergen-specific data regarding: 1) housing conditions, demographic factors, and climate to facilitate evaluation of regional, ethnic, socioeconomic, and housing characteristic differences in the indoor allergen burden; 2) an estimate of indoor allergen exposure in the U.S. population; 3) baseline data that can be used to stimulate future studies which attempt to correlate allergen exposure to disease outcome. The study will yield lead hazard data to: 1) estimate the number and percent of homes with dust and soil lead levels above selected thresholds; 2) identify sources of lead in dust in housing; 3) permit future analysis of lead hazard control strategies an costs, including associated policy and regulatory guidelines.

NCT ID: NCT00339521 Completed - Asthma Clinical Trials

Genetic Susceptibility to Childhood Respiratory IIlness in Mexico City

Start date: May 15, 1999
Phase:
Study type: Observational

We propose to add a collection of genetic material to a clinical trial of anti-oxidant supplementation for the amelioration of asthma in 7-12 year olds being conducted at a public pediatric hospital in Mexico City. The anti-oxidant study has been approved by the Institutional Review Board of the National Institute of Public Health in Mexico City and is scheduled to begin in September 1998. The purpose of this add-on study is to examine genetic polymorphisms that may be related to asthma. Asthma cases will be compared with their parents as controls. In partaicular, we will save the buffy coat from the blood collection being done on the asthmatic child for measurements of plasma micronutrients in the anti-oxidant trial for extraction of DNA. This part of the sample would otherwise be discarded. In addition, we will enroll the parents of the asthmatic child as controls for the child. From the parents, either a 10 ml blood sample or if they prefer, a sample of buccal cells will be collected. Although our current plan is to compare the asthmatic child to the parents using statistical methods based on the "transmission disequilibrium test" because research into various family designs for candidate gene studies is rapidly evolving and various sibling control sample strategies have been discussed, we would also like to collect a genetic sample on as many of the child's siblings as possible with priority given to those closest in age. This will enhance the future usefulness of the samples. We anticipate enrolling approximately 200 families....

NCT ID: NCT00339027 Completed - Obesity Clinical Trials

HealthSpark: Health Access for Children in Federally-Subsidized Child Care

Start date: May 2004
Phase:
Study type: Observational

HealthSpark is a community-based research network of childcare centers designed to improve the health of children in Miami-Dade County. HealthSpark is the health component of SPARK (Supporting Partnerships to Assure Ready Kids), a community coalition led by the Early Childhood Initiative Foundation to improve school readiness in Allapattah/Model City and Homestead/Florida City, two underserved Miami-Dade County communities. The goal of HealthSpark I is to identify the health and healthcare needs of preschool children, then help translate evidence-based intervention into community programs.

NCT ID: NCT00337675 Completed - Asthma Clinical Trials

Intermittent and Daily Dosing for Episodic (Periodic) Asthma (0476-302)(COMPLETED)

Start date: October 2006
Phase: Phase 3
Study type: Interventional

This is a year-long study evaluating the efficacy of both daily and intermittent treatment of asthma in children who experience symptoms episodically (i.e., seasonally, usually in the context of upper respiratory tract infection).

NCT ID: NCT00336050 Active, not recruiting - Asthma Clinical Trials

Effect of Air Pollution on Long-Term Asthma Severity and Lung Function in Children

FACES
Start date: November 2000
Phase: N/A
Study type: Observational

Asthma can be caused by many factors, including mold, pollen, and other airborne pollutants. The purpose of this study is to evaluate the effect that air pollution has on the long-term severity of asthma symptoms and lung function in children.