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NCT00594750 Clinical Trial

Mechanisms of Exacerbation of Asthma

Asthma Clinical Trial

— MECA  

Official title:
Mechanisms of Exacerbation of Asthma

Clinical Trial Details — Status: Suspended

Administrative data
NCT number NCT00594750
Other study ID # 10-01329
Secondary ID 5R01HL080414-08
Status Suspended
Phase
First received
Last updated
Start date May 2006
Est. completion date December 2025

Study information
Verified date February 2023
Source University of California, San Francisco
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Suspended
Enrollment 115
Est. completion date December 2025
Est. primary completion date September 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Related Conditions & MeSH terms

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 National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary rheological measurements (viscosity and elasticity) in sputum from patients with acute severe asthma 1-2 years
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