Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Neural Mechanisms in Asthma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by University of Wisconsin, Madison.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01155843
First received: June 30, 2010
Last updated: July 1, 2010
Last verified: June 2010
  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

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) ] [ Designated as safety issue: No ]
    positron emission tomography

  • inflammation [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    peak expiratory volume in 1 sec effort

  • peripheral acute stress reactivity [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]
    salivary cortisol and alpha amylase in response to acute stressor


Estimated Enrollment: 72
Study Start Date: February 2011
Groups/Cohorts
Asthmatic, chronic stress
Asthmatic, non-stress
Healthy control, chronic stress
Healthy control, no stress

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
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 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
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: NCT01155843

Contacts
Contact: Melissa Rosenkranz, PhD 608-262-5050 marosenk@wisc.edu

Locations
United States, Wisconsin
University of Wisconsin-Madison Not yet recruiting
Madison, Wisconsin, United States, 53715
Principal Investigator: Melissa Rosenkranz, PhD         
Sponsors and Collaborators
University of Wisconsin, Madison
  More Information

No publications provided

Responsible Party: Melissa Rosenkranz, University of Wisconsin
ClinicalTrials.gov Identifier: NCT01155843     History of Changes
Other Study ID Numbers: K01AT006202
Study First Received: June 30, 2010
Last Updated: July 1, 2010
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on November 25, 2014