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Mechanisms of Acute Asthma Exacerbations Through Molecular Analysis of Airway Secretions and Tissues (MAST-X)
This study is currently recruiting participants.
Verified by University of California, San Francisco, June 2008
Sponsors and Collaborators: University of California, San Francisco
Genentech
Information provided by: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00603629
  Purpose

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
Asthma

MedlinePlus related topics: Asthma
U.S. FDA Resources
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

Further study details as provided by University of California, San Francisco:

Secondary Outcome Measures:
  • gene expression in acute airway secretions and tissues [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Biospecimen Description:

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
I
People with acute asthma in the Emergency department or inpatient settings

Detailed Description:

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. "

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

People with acute asthma who seek treatment in the Emergency Department or who require admission to the hospital for their asthma

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00603629

Contacts
Contact: Natalie Yuan, RN 415-502-8791 natalie.yuan@ucsf.edu

Locations
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    
Sponsors and Collaborators
University of California, San Francisco
Genentech
Investigators
Principal Investigator: John V Fahy, M.D., M.Sc. University of California, San Francisco
  More Information

UCSF Airway Clinical Research Center website  This link exits the ClinicalTrials.gov site

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

Keywords provided by University of California, San Francisco:
Acute Asthma

Study placed in the following topic categories:
Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases
Hypersensitivity, Immediate
Asthma
Respiratory Hypersensitivity

Additional relevant MeSH terms:
Immune System Diseases
Bronchial Diseases

ClinicalTrials.gov processed this record on January 14, 2009