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Asthma clinical trials

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NCT ID: NCT00584636 Withdrawn - Asthma Clinical Trials

Pulmicort Respules on Relapse Rates After Treatment in the ED

Budesonide
Start date: October 2007
Phase: Phase 4
Study type: Interventional

The purpose of this study is to see if the addition of budesonide to oral corticosteroids will result in a decrease in relapse rates compared to oral corticosteroids alone in children who are discharged from the ED after an asthma exacerbation. Secondly, that there will be an improvement in lung function, a decrease in beta-2 agonist use and an improvement in health-related quality of life compared to placebo.

NCT ID: NCT00584441 Completed - Asthma Clinical Trials

Menstrual Differences in Airway Inflammation in Asthma

Start date: September 2007
Phase: N/A
Study type: Observational

Asthma is a chronic inflammatory lung disease characterized by airway hyper-responsiveness and reversible airway obstruction. Over the last decade, the prevalence of asthma is on the rise and it disproportionately affects more women than men. As much as 40% of women with asthma are known to have worsening of asthma symptoms and lung function prior to menstruation. This syndrome is being increasingly recognized as premenstrual asthma (PMA). The pathologic differences in female asthmatics with and without this syndrome are not known. The evidence regarding the role of sex hormones has been contradicting. We propose an observational cohort study to examine the changes in airway inflammation in women with asthma in relation to their menstrual cycle and their association with sex hormone levels. In addition we will include women on oral contraceptives to determine their effect on airway inflammation and asthma symptoms. We hypothesis that: - Women with premenstrual asthma will show increased indices of airway inflammation in various phases the monthly menstrual cycle. - In women with premenstrual asthma, a change in serum estradiol/progesterone ratio during the late luteal phase is associated with worsening of airway inflammation, air flow limitation and asthma symptoms. - The use of oral contraceptives is associated with suppression of the cyclical changes in airway inflammation due to lack of fluctuations in estradiol and progesterone levels. Recruited subjects will be asked to record asthma symptom scores, morning Peak Expiratory Flow Rate (m-PEFR) and rescue asthma medication (β2-agonist) used daily during the one month screening period to identify women with and without pre-menstrual asthma. Asthmatic women with regular menstrual cycles will be evaluated in their follicular phase (days 5-8) and luteal phase (days 21-24) and women on oral contraceptive pills (OCP) will be evaluated on days 9-12 of their OCP cycle and during the days 25-28, off of OCP consecutively for a 2-month period.

NCT ID: NCT00584051 Terminated - Asthma Clinical Trials

Examination of the Role of Atrial Natriuretic Peptide Polymorphisms in Allergic Rhinitis and Asthma Severity

Start date: October 2007
Phase:
Study type: Observational

Asthma is an inflammatory condition of the airways in the lungs that results in obstruction of airflow in those with the condition. The disease continues to be a major worldwide health care problem and its prevalence continues to increase annually. In 2005, 20 million people were diagnosed with asthma. The disease causes significant morbidity and accounts for 5,000 deaths annually. Between 1980 and 1994 the prevalence of asthma increased 74% in the United States and, in children under age 5, the prevalence increased by 160%. The allergic etiology of airway inflammation associated with asthma is established. Bronchial washings of asthmatic subjects are most often characterized by eosinophils, mast cells, and cytokines that are associated with the Th2 (allergic) phenotype. Similarly, IgE plays a pivotal role in airway inflammation of asthmatic subjects when allergens that cross-link IgE bound to mast cells in the airways cause the release of histamine and other inflammatory mediators. The association of asthma and the IgE mediated allergic phenotype is well established and up to 70% of asthmatics also suffer from allergic disease. Adequately treated asthma often has minimal impact of quality of life but diagnosis and proper treatment is often delayed, resulting in increased missed school days, emergency room visits, and otherwise preventable degradation in quality of life. It would therefore be highly useful to identify a biomarker that can be used to assist in the diagnosis of asthma or to identify subjects at higher risk of developing allergic disease or asthma in the future. Efforts at identifying a genetic marker for the early diagnosis of asthma have been unsuccessful, mainly due to the complexity of the pathogenesis of the disease. Atrial natriuretic factor is a pro-hormone precursor for 4 natriuretic peptide hormones including atrial natriuretic peptide (ANP). ANP's effects on the cardiovascular system are well characterized. Less well understood is the role these hormones play in immune regulation. Recent studies have demonstrated a role for ANP in the regulation of immune function: ANP induces release of histamine from mast cells and macrophages, stimulates migration of neutrophils, enhances the cytotoxic activity of natural killer (NK) cells, and stimulates TNF-β production. Human dendritic cells express ANP receptors (GC-a) which polarize CD4+ cells towards a Th2 phenotype. Since allergic rhinitis and asthma are associated with a Th2 phenotype, it is possible that elevated levels of ANP can be used to predict asthma severity or to predict future predilection to atopic disease. There are a number of ANP gene polymorphisms that have been studied and found to be associated with renal disease, heart disease, hypertension and diabetes. Several studies have investigated the potential role of these polymorphisms in cardiovascular disease and have found association between polymorphisms of the ANP gene and left ventricular remodeling, hypertension, renal disease, diabetes, and increased risk of ischemic stroke. To our knowledge, no studies evaluating the role of ANP polymorphisms in allergic disease have been performed. The goal of this research proposal is to evaluate whether ANP levels can be utilized to assist in diagnosis of asthma and in the prediction of asthma severity. Additionally, we will investigate the potential effect of polymorphisms in the ANP gene on asthma severity and thus serve as a useful genetic marker to predict future risk of atopy and asthma.

NCT ID: NCT00583986 Completed - Asthma Clinical Trials

Reliability of a Top Mount Actuation Indicator With Levalbuterol MDI in Adult and Pediatric Subjects With Asthma or COPD

Start date: September 2005
Phase: Phase 3
Study type: Interventional

This is a study to investigate the reliability, ruggedness and safety of the top mounted actuation indicator (TMAI) when used with Levalbuterol HFA MDI.

NCT ID: NCT00583947 Completed - Asthma Clinical Trials

A Safety and Tolerability Study of Arformoterol Tartrate Inhalation Solution in Pediatric Subjects

Start date: January 2008
Phase: Phase 2
Study type: Interventional

To determine the safety and tolerability of Arformoterol Tartrate in children with asthma

NCT ID: NCT00583778 Completed - Asthma Clinical Trials

A Comparison of Levalbuterol Plus Ipratropium With Levalbuterol Alone in the Treatment of Acute Asthma Exacerbation

Start date: August 2004
Phase: N/A
Study type: Interventional

This is a double blind, controlled clinical trail testing whether three doses of 1.25 mg of nebulized levalbuterol in combination with three doses of 0.5mg of nebulized ipratropium will lead to greater bronchodilation than that achieved by three doses of nebulized 1.25 mg of levalbuterol alone every 20 minutes. The primary hypothesis of this study is that three doses of 1.25 mg of nebulized levalbuterol in combination with three doses of 0.5mg of nebulized ipratropium will lead to greater bronchodilation than that achieved by three doses of nebulized 1.25 mg of levalbuterol alone every 20 minutes. The secondary hypothesis is that the treatment combination of levalbuterol and ipratropium will lead to fewer hospitalizations than levalbuterol alone in patients with acute asthma exacerbation. Other secondary objectives include (1) evaluating the relationship between baseline (S)- albuterol levels and (R)- albuterol levels on presentation and FEV1, (2) the relationship between baseline (S)- albuterol levels and (R)- albuterol levels on presentation and change in FEV1,(3) time to event analysis for an improvement of 15%, 20%, 30%, 40%, and 50% in FEV1 from initial presentation value, (4) analysis of FEV1 at discharge.

NCT ID: NCT00581048 Completed - Allergic Asthma Clinical Trials

Study on the Role of Treatment With Vitamin E on Asthmatic Responses in Allergic Asthmatics

Start date: December 2006
Phase: N/A
Study type: Interventional

Asthma is a common respiratory disease of unknown etiology which currently affects approximately 7.5 % of the adult population ( ). Asthma is an inflammatory disorder of the airways. Airway inflammation is evident not only in patients with fatal asthma but also in mild asthmatics ( ). Oxidant stress, defined as inadequately controlled generation of toxic reactive oxygen species (ROS) in the cells or tissues is a common feature of inflammation, and has also been documented in asthma ( , ). However, the current understanding of the relationship between the inflammation and the oxidant stress in asthmatic airways is poor. Does oxidant stress contribute to the expression of asthmatic phenotypes independently of inflammation? If so, could asthmatics benefit from supplementation of antioxidants? These questions have been nagging us since our laboratory provided credible evidence of oxidant injury in the airways of allergic asthmatics ( ). The purpose of our study is to more precisely determine 1/ the pathophysiologic role of oxidative stress, and 2/ usefulness of antioxidant therapy using vitamin E in allergic asthma.

NCT ID: NCT00577733 Completed - Obesity Clinical Trials

Study of the Physiology of the Asthma of the Obese Subjects. Breathing Obesity Asthma Study (BOA)

BOA
Start date: January 2008
Phase: N/A
Study type: Observational

Asthma is more frequent in obese women, but the mechanisms underlying the causes of this increased frequency are unknown and are different from usual asthma pathophysiology (associated with allergy). Obesity is known to influence ventilation; our hypothesis is that the normal variability of ventilation is decreased in obese patients, and that this decrease is responsible for an increased reactivity of their airway to non specific stimuli. In this observational study, breathing variability will be studied using polygraphy (an investigation that is made in these women to detect nocturnal apneas), and airway reactivity is studied between pulmonary function tests that are made before bariatric surgery.

NCT ID: NCT00577655 Completed - Asthma Clinical Trials

Albuterol HFA MDI in Pediatric Participants With Asthma

Start date: August 2007
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to evaluate the chronic-dose and efficacy of Albuterol-HFA-MDI relative to placebo in pediatric asthmatics.

NCT ID: NCT00577265 Completed - Asthma Clinical Trials

An Observational Study to Investigate How Patients Experience the Ability to Adjust Their Asthma Maintenance Medication

INVOLVE
Start date: November 2004
Phase: N/A
Study type: Observational

An observational study to investigate how patients experience the ability to adjust their asthma maintenance medication according to instructions received from their physician. The primary aim is to create an insight in the perception of the patient when he has the ability to adjust his own maintenance treatment and how the patient exercises this in the daily practice.