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Mechanisms of Acute Asthma Exacerbations Through Molecular Analysis of Airway Secretions and Tissues (MAST-X)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00603629
First Posted: January 29, 2008
Last Update Posted: September 21, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
John V. Fahy, University of California, San Francisco
January 16, 2008
January 29, 2008
September 21, 2011
January 2008
September 2009   (Final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00603629 on ClinicalTrials.gov Archive Site
gene expression in acute airway secretions and tissues [ Time Frame: 30 days ]
Same as current
Not Provided
Not Provided
 
Mechanisms of Acute Asthma Exacerbations Through Molecular Analysis of Airway Secretions and Tissues
A Pilot Study Determining Mechanisms of Acute Asthma Exacerbations Through Detailed Molecular Analysis of Airway Secretions and Tissues
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.

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. "

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
whole blood, DNA, RNA, sputum, nasopharyngeal swab
Non-Probability Sample
People with acute asthma who seek treatment in the Emergency Department or who require admission to the hospital for their asthma
Asthma
Not Provided
I
People with acute asthma in the Emergency department or inpatient settings
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
23
September 2009
September 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Male and female subjects aged 18 - 70 years
  2. Medical history of asthma
  3. Currently experiencing an acute exacerbation of asthma
  4. Ability to provide informed consent or have a surrogate provide consent.
  5. Ability to provide sputum.

Exclusion Criteria:

  1. Cigarette smoking: Subjects must be non-smokers. Non-smokers are defined as subjects who have never smoked or who have not smoked for 1 year and have a total pack-year smoking history < 10 packs.
  2. Pregnant women.
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00603629
H6788-31516-01
No
Not Provided
Not Provided
John V. Fahy, University of California, San Francisco
University of California, San Francisco
Genentech, Inc.
Principal Investigator: John V Fahy, M.D., M.Sc. University of California, San Francisco
University of California, San Francisco
September 2011