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Mechanisms of Exacerbation of Asthma (MECA)

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ClinicalTrials.gov Identifier: NCT00594750
Recruitment Status : Recruiting
First Posted : January 16, 2008
Last Update Posted : June 2, 2016
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of California, San Francisco

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease
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 Design
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Study Type : Observational
Estimated Enrollment : 115 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Mechanisms of Exacerbation of Asthma
Study Start Date : May 2006
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

Groups and Cohorts
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Group/Cohort
Asthma
People who have been diagnosed with Asthma


Outcome Measures
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Primary Outcome Measures :
  1. rheological measurements (viscosity and elasticity) in sputum from patients with acute severe asthma [ Time Frame: 1-2 years ]

Biospecimen Retention:   Samples Without DNA
Sputum, whole blood

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00594750


Contacts
Contact: Ariana Baum 415-514-1539 ariana.baum@ucsf.edu

Locations
United States, California
UCSF Airway Clinical Research Center Recruiting
San Francisco, California, United States, 94143
Contact: Ariana Baum    415-514-1539    ariana.baum@ucsf.edu   
Sponsors and Collaborators
University of California, San Francisco
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: John V Fahy, M.D., M.Sc. University of California, San Francisco
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
UCSF Airway Clinical Research Center website  This link exits the ClinicalTrials.gov site

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00594750     History of Changes
Other Study ID Numbers: 10-01329
5R01HL080414-08 ( U.S. NIH Grant/Contract )
First Posted: January 16, 2008    Key Record Dates
Last Update Posted: June 2, 2016
Last Verified: June 2016

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