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Asthma Exacerbation Study

NCT00853411 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2016-03-22

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

prednisone

Druing asthma exacerbation, subjects will be dosed to prednisone.

Sponsors & Collaborators

  • University of Pittsburgh

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2011-02-28
Completion
2011-02-28

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00853411 on ClinicalTrials.gov