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Neural Mechanisms in Asthma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01155843
First Posted: July 2, 2010
Last Update Posted: October 2, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Wisconsin, Madison
  Purpose
Asthma is a chronic disease that affects nearly 13% of adults in the U.S., causing substantial impairment that is reflected in the tens of millions of missed days of work, and doctors' and emergency room visits it leads to annually. Those who have asthma are twice as likely to develop depression and anxiety, which are associated with more frequent and severe asthma symptoms, especially in those under chronic stress. The project proposed here seeks to understand the role of the brain in these associations and to evaluate the neural mechanisms through which a safe, low-cost intervention, that influences the function of body via the mind, may diminish the expression of asthma symptoms.

Condition
Asthma

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Neural Mechanisms by Which Chronic Stress Regulates Inflammation in Asthma

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Neural activity in response to stress [ Time Frame: duration of stress (30 minutes) ]
    positron emission tomography

  • inflammation [ Time Frame: 24 hours ]
    infiltration of eosinophils into lung sputum, percentage of blood eosinophils, exhaled nitric oxide, glucocorticoid sensitivity of peripheral blood leukocytes

  • lung function [ Time Frame: 24 hours ]
    peak expiratory volume in 1 sec effort

  • peripheral acute stress reactivity [ Time Frame: 60 minutes ]
    salivary cortisol and alpha amylase in response to acute stressor


Enrollment: 31
Study Start Date: October 2011
Study Completion Date: November 2014
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Asthmatic, chronic stress
Asthmatic, non-stress

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Community sample
Criteria

Inclusion Criteria:

  • Asthmatics:

    • Physician diagnosed asthma with previous use of asthma medication
  • Controls:

    • negative skin-prick test to cat dander or house dust mite and have no history of asthma
  • Chronic Stress:

    • score 3 or above on any subscale of the UCLA (University of California Los Angeles) chronic stress interview

No chronic stress:

score 1.5 or below on all subscales of the UCLA chronic stress interview

Exclusion Criteria:

  • Individuals with severe asthma, or those whom currently require the use of corticosteroids
  • Individuals with significant medical problems
  • Individuals who smoke cigarettes
  • Individuals a previous adverse reaction to corticosteroids, a recent (< 1 month) viral illness, a history of severe asthma or anaphylaxis.
  • Breastfeeding women or women who are, suspect they might be or are trying to become pregnant
  Contacts and Locations
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): NCT01155843


Locations
United States, Wisconsin
University of Wisconsin-Madison
Madison, Wisconsin, United States, 53715
Sponsors and Collaborators
University of Wisconsin, Madison
  More Information

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01155843     History of Changes
Other Study ID Numbers: K01AT006202 ( U.S. NIH Grant/Contract )
First Submitted: June 30, 2010
First Posted: July 2, 2010
Last Update Posted: October 2, 2015
Last Verified: December 2014

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