Mechanisms of Exacerbation of Asthma (MECA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by University of California, San Francisco
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00594750
First received: January 2, 2008
Last updated: January 21, 2014
Last verified: January 2014
  Purpose

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.


Condition
Asthma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Mechanisms of Exacerbation of Asthma

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • rheological measurements (viscosity and elasticity) in sputum from patients with acute severe asthma [ Time Frame: 1-2 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Sputum, whole blood


Estimated Enrollment: 115
Study Start Date: May 2006
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Asthma
People who have been diagnosed with 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.

  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

emergency deparment, admitted patients in the ICU and inpatient wards

Criteria

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.
  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: NCT00594750

Contacts
Contact: Kelly McGrath, RN 415-476-8494 kelly.wong@nursing.ucsf.edu

Locations
United States, California
UCSF Airway Clinical Research Center Recruiting
San Francisco, California, United States, 94143
Contact: Kelly McGrath, RN    415-476-8494    kelly.wong@nursing.ucsf.edu   
Contact: Kelly Norsworthy, BA    415-502-8791    kelly.norsworthy@ucsf.edu   
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: John V Fahy, M.D., M.Sc. University of California, San Francisco
  More Information

Additional Information:
No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00594750     History of Changes
Other Study ID Numbers: 10-01329
Study First Received: January 2, 2008
Last Updated: January 21, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 29, 2014