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Sponsors and Collaborators: |
University of California, San Francisco Genentech |
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Information provided by: | University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT00603629 |
The purpose of this study is to investigate mechanisms which cause acute asthma exacerbations by examining blood and airway secretions during an acute onset (sputum or tracheal aspirates). This pilot study is intended to uncover new mechanisms of asthma exacerbation and to generate hypotheses for future study. By collaborating with Genentech, we (scientists at UCSF) plan to incorporate the latest scientific findings into our work to discover and develop new treatments for asthma.
Condition |
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Asthma |
Study Type: | Observational |
Study Design: | Case-Only, Prospective |
Official Title: | A Pilot Study Determining Mechanisms of Acute Asthma Exacerbations Through Detailed Molecular Analysis of Airway Secretions and Tissues |
whole blood, DNA, RNA, sputum, nasopharyngeal swab
Estimated Enrollment: | 40 |
Study Start Date: | January 2008 |
Estimated Study Completion Date: | September 2009 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
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I
People with acute asthma in the Emergency department or inpatient settings
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Asthma is a common airway disease with persistent unmet needs in terms of treatment. Although many asthmatics enjoy good control of their disease by using regularly scheduled corticosteroid treatment, a significant minority do not achieve optimal control with steroids and suffer asthma exacerbations which can be severe and even fatal. Asthma pathophysiology is complex and involves multiple cell types and multiple signaling mechanisms. One approach to this complexity has been to study responses of isolated airway cells to experimental conditions which model asthmatic inflammation; another has been genetic manipulations of candidate mediators of asthma in inbred mice. These studies have yielded important insights about possible mechanisms of asthma in humans, but the relevance of these mechanisms to human disease has not always been proven, and it is possible that unsuspected mechanisms have not yet been revealed by these approaches.
In the current study, we propose to collect samples of airway secretions and blood from asthmatic subjects when their asthma is uncontrolled and they are being treated in the hospital or emergency room. Our goal will be to identify abnormal gene expression profiles and protein concentration abnormalities in these biological fluids. We will then study them again 6-10 weeks later when their asthma is controlled. This study design will allow us to compare airway and blood biomarkers of asthma exacerbation during acute asthma and recovery. "
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
People with acute asthma who seek treatment in the Emergency Department or who require admission to the hospital for their asthma
Inclusion Criteria:
Exclusion Criteria:
Contact: Natalie Yuan, RN | 415-502-8791 | natalie.yuan@ucsf.edu |
United States, California | |
UCSF Airway Clinical Research Center | Recruiting |
San Francisco, California, United States, 94143 | |
Contact: Kimberly S Okamoto, BS 415-514-1539 kimberly.okamoto@ucsf.edu |
Principal Investigator: | John V Fahy, M.D., M.Sc. | University of California, San Francisco |
Responsible Party: | University of California, San Francisco ( John V. Fahy, M.D., M.Sc. ) |
Study ID Numbers: | H6788-31516-01 |
Study First Received: | January 16, 2008 |
Last Updated: | June 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00603629 |
Health Authority: | United States: Institutional Review Board |
Acute Asthma |
Hypersensitivity Lung Diseases, Obstructive Respiratory Tract Diseases Lung Diseases |
Hypersensitivity, Immediate Asthma Respiratory Hypersensitivity |
Immune System Diseases Bronchial Diseases |