Neural Mechanisms in Asthma

Asthma Clinical Trial

Official title:

Neural Mechanisms by Which Chronic Stress Regulates Inflammation in Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01155843
• Other study ID #: K01AT006202
• Status: Completed
• Phase: N/A
• First received: June 30, 2010
• Last updated: September 30, 2015
• Start date: October 2011
• Est. completion date: November 2014

Study information

• Verified date: December 2014
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Asthma

Locations

Country	Name	City	State
United States	University of Wisconsin-Madison	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neural activity in response to stress	positron emission tomography	duration of stress (30 minutes)	No
Primary	inflammation	infiltration of eosinophils into lung sputum, percentage of blood eosinophils, exhaled nitric oxide, glucocorticoid sensitivity of peripheral blood leukocytes	24 hours	No
Primary	lung function	peak expiratory volume in 1 sec effort	24 hours	No
Primary	peripheral acute stress reactivity	salivary cortisol and alpha amylase in response to acute stressor	60 minutes	No