NCT01155843

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 30, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 2, 2010

Completed
1.2 years until next milestone

Study Start

First participant enrolled

October 1, 2011

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

October 2, 2015

Status Verified

December 1, 2014

Enrollment Period

3.1 years

First QC Date

June 30, 2010

Last Update Submit

September 30, 2015

Conditions

Outcome Measures

Primary Outcomes (4)

  • Neural activity in response to stress

    positron emission tomography

    duration of stress (30 minutes)

  • inflammation

    infiltration of eosinophils into lung sputum, percentage of blood eosinophils, exhaled nitric oxide, glucocorticoid sensitivity of peripheral blood leukocytes

    24 hours

  • lung function

    peak expiratory volume in 1 sec effort

    24 hours

  • peripheral acute stress reactivity

    salivary cortisol and alpha amylase in response to acute stressor

    60 minutes

Study Arms (2)

Asthmatic, chronic stress

Asthmatic, non-stress

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Community sample

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin-Madison

Madison, Wisconsin, 53715, United States

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2010

First Posted

July 2, 2010

Study Start

October 1, 2011

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

October 2, 2015

Record last verified: 2014-12

Locations