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

This study has been completed.
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
John V. Fahy, University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00603629
First received: January 16, 2008
Last updated: September 20, 2011
Last verified: September 2011
  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

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: 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

whole blood, DNA, RNA, sputum, nasopharyngeal swab


Enrollment: 23
Study Start Date: January 2008
Study Completion Date: September 2009
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, California
UCSF Airway Clinical Research Center
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Genentech, Inc.
Investigators
Principal Investigator: John V Fahy, M.D., M.Sc. University of California, San Francisco
  More Information

Additional Information:
No publications provided

Responsible Party: John V. Fahy, Professor in Residence, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00603629     History of Changes
Other Study ID Numbers: H6788-31516-01
Study First Received: January 16, 2008
Last Updated: September 20, 2011
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 29, 2014