Asthma Exacerbation Study
|ClinicalTrials.gov Identifier: NCT00853411|
Recruitment Status : Withdrawn (Terminated by Investigator due to lack of eligible subjects.)
First Posted : March 2, 2009
Last Update Posted : March 22, 2016
Asthma is a clinical syndrome that is well recognized by health care practitioners, yet asthma pathogenesis still remains poorly understood. Asthma affects approximately 20 million Americans, who suffer around 5,000 deaths annually. More than 70% of people with asthma also suffer from allergies. Although many advances in understanding the pathophysiology of asthma have been made in the past few decades, more studies are necessary to achieve a more thorough understanding of asthma at the cellular and molecular level.
The majority of murine models suggest asthma and "allergic" responses involve activation of Th2 cytokine pathways, including IL-4 and -13. Similarly in humans, several lines of evidence support a large role for Th2 adaptive immunity. These include the large majority of asthmatic patients with atopy; the measurement of increased amounts of Th2 cytokines, including IL-4 and IL-13 in the airways and sputum of mild asthma; and most recently, the observed efficacy of anti-IgE therapy in "allergic" asthma. However, other data, including the large numbers of subjects with atopy and no asthma, suggest Th2 adaptive responses are insufficient to explain many aspects of asthma. Whether and how innate and adaptive immune pathways interact in human asthma is not clear, with few studies beginning to address these interactions in vitro and in vivo.
For this reason, the investigators of this study would like to prospectively enroll patients with known asthma and follow them through an asthma exacerbation, while treating them with a standardized protocol. Over six week's duration, the investigators would like to study patients by collecting physiologic data such as spirometry, and biologic material in the form of sputum, nasal scraping, venous blood, exhaled breath and sputum. It is our aim to fully characterize the impact of the prostaglandin/cycloygenase/eicosanoid pathway as it relates to asthma exacerbation and recovery.
Completion of this study in human asthma may provide new mechanistic insights into how relationships between innate and adaptive immune responses influence the course of an asthma exacerbation. The information obtained from this research and the corresponding studies may lead to innovative medical therapies and insight into the role of the epithelium and its interactions with both innate and adaptive immunity.
|Condition or disease||Intervention/treatment|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Th2 Effects on Eicosanoid Pathways: Implications for Altered Innate Responses in Asthma|
|Study Start Date :||December 2008|
|Primary Completion Date :||February 2011|
|Study Completion Date :||February 2011|
- We will determine whether there is evidence for both adaptive and innate factors/responses in vivo at the time of an asthma exacerbation, as well as the relationship to infection.Our primary outcome will be differences in 15S HETE, PGE2 and their ratio in sputum of asthmatics with worsening disease (exacerbations), as compared to their stable state (resolution).