Mechanisms of Exacerbation of Asthma
The purpose of this study is to identify the causes of asthma that were not previously suspected, to better understand the effects of inhaled steroids on asthma and to identify new way to treat asthma. In order to take advantage of the most current scientific expertise, we (scientists at UCSF) plan to work together with Genentech Inc. We believe that working with Genentech will provide the best chance of developing new treatments for asthma.
Description
In this study, we will explore mechanisms of exacerbation in asthma by careful characterization studies in asthmatics presenting in acute severe exacerbation. Specifically, we will determine the frequency of secretor status in these subjects by blood and saliva testing, and we will also perform a detailed cellular and biochemical analysis of their airway secretions. We will collect airway secretions using two methods. One method will be to have subjects cough sputum into a clean plastic container. The other method only applies to asthmatics with near-fatal asthma requiring intubation and mechanical ventilation. In these asthmatics, we will collect airway secretions by tracheal aspirate using methods normally applied in their clinical care. As control subjects, we will enroll subjects who are intubated for elective, non-pulmonary, surgery. All asthmatic and healthy controls enrolled in the study will be characterized by questionnaire and by analysis of blood and DNA.
Status: Recruiting (N/A). Started on May 1st, 2006.
Enrollment: 75 subjects
Study Type: Observational
Study Design:
- Observational Model: Case Control
- Time Perspective: Cross-Sectional
Conditions:
Interventions:
Eligibility
Inclusion Criteria: Asthmatics
Male and female subjects with a history of asthma between the ages of 18 to 75 years.
Physician diagnosis of asthma.
Currently experiencing an acute exacerbation of asthma. This exacerbation may be severe necessitating treatment in the emergency room, ICU, or hospital ward.
Ability to provide informed consent. Controls
Male and female subjects without a history of asthma or other pulmonary diseases between the ages of 18 to 75.
Subjects must be non-smokers (patients who have never smoked or patients who have not smoked for 1 year and have a total pack-year smoking history < 10 packs.
Scheduled to be intubated for elective non-pulmonary surgery. Ability to give informed consent. Exclusion Criteria: Exclusion Criteria Asthmatics
Lung disease other than asthma.
Females who are lactating or who are pregnant.
Use of recreational drugs in the 1 month preceding the study.
Exclusion Criteria Controls
History or physician diagnosis of asthma or other pulmonary diseases.
Females who are lactating or pregnant.
Use of recreational drugs in the 1 month preceding the study.
- Gender
Both
- Mininum Age
18 Years
- Maximum Age
75 Years
- Healthy Volunteers
Accepts Healthy Volunteers
Resources
Source: University of California, San Francisco
Authority: United States: Institutional Review Board
Locations
-
UCSF Airway Clinical Research Center
San Francisco
California
94143
United States
Officials
John V Fahy, M.D., M.Sc. (Principal Investigator, University of California, San Francisco)
Sponsors
University of California, San Francisco (Lead Sponsor)
References
None.
Links
- Date Verified
- February 1st, 2009
- First Received
- May 25th, 2010
- Last Changed
- May 25th, 2010
Information obtained from ClinicalTrials.gov on June 09, 2011. Link to the current ClinicalTrials.gov record.
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