Mechanisms of Acute Asthma Exacerbations Through Molecular Analysis of Airway Secretions and Tissues

Asthma Clinical Trial

— MAST-X  

Official title:

A Pilot Study Determining Mechanisms of Acute Asthma Exacerbations Through Detailed Molecular Analysis of Airway Secretions and Tissues

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00603629
• Other study ID #: H6788-31516-01
• Status: Completed
• Phase: N/A
• First received: January 16, 2008
• Last updated: September 20, 2011
• Start date: January 2008
• Est. completion date: September 2009

Study information

• Verified date: September 2011
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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. "

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Asthma

Locations

Country	Name	City	State
United States	UCSF Airway Clinical Research Center	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Secondary	gene expression in acute airway secretions and tissues		30 days	No

External Links

•   UCSF Airway Clinical Research Center website