Mechanisms of Exacerbation of Asthma

Suspended

• Conditions: Asthma

• Registration Number: NCT00594750
• Lead Sponsor: University of California, San Francisco

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2006-05
• Study First Submitted: 2008-01-02
• Study First Submitted QC: 2008-01-15
• Study First Posted: 2008-01-16
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-16
• Last Update Posted: 2023-02-21
• Primary Completion: 2025-09
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 115

Inclusion Criteria

1. Male and female subjects with a history of asthma between the ages of 18 to 75 years.
2. Physician diagnosis of asthma.
3. Currently experiencing an acute exacerbation of asthma. This exacerbation may be severe necessitating treatment in the emergency room, ICU, or hospital ward.
4. Ability to provide informed consent.

Exclusion Criteria

1. Lung disease other than asthma.
2. Females who are lactating or who are pregnant.
3. Use of recreational drugs in the 1 month preceding the study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
rheological measurements (viscosity and elasticity) in sputum from patients with acute severe asthma	1-2 years

Trial Locations

Locations (1)

UCSF Airway Clinical Research Center; 🇺🇸 San Francisco, California, United States