AsthmaNCT00006498
Chronic Life Stress and Incident Asthma in Adult Women
An observational study of Asthma and Lung Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To prospectively examine the association between a specific chronic life stressor (i.e., intimate violence exposure) and adult asthma in women. Read more about this study
- Who is it for?
- Ages Up to 100 years, women only
- Conditions the study is for
- Asthma, Lung Diseases
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Sep 2000to Aug 2005
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 100 years
- Women only
- No healthy volunteers
- Child, Adult, Older adult
No eligibility criteria
About this study
To prospectively examine the association between a specific chronic life stressor (i.e., intimate violence exposure) and adult asthma in women.
Read the detailed description
BACKGROUND:
Etiologies of the rising prevalence and morbidity of asthma are not well understood. Knowledge gaps are particularly significant with respect to adult-onset asthma. The role of stress in the expression of asthma is largely unexplored in large-scale, prospective, epidemiologic studies and such investigation has been identified as a priority by a recent NHLBI expert panel.
DESIGN NARRATIVE:
The study prospectively examines the association between a specific chronic life stressor (i.e., intimate violence exposure) and adult asthma in women participating in the Nurses' Health Study II cohort. Emerging epidemiologic data suggest that exposure to intimate violence is a pervasive chronic life stressor associated with adverse impact on womens' psychological and physical health. Traumatic stress such as that related to intimate violence exposure has been associated with neuroendocrine changes known to cause alterations in neuroendocrine and immune functions important to the pathophysiology of inflammatory diseases including asthma. The investigators are testing the hypothesis that women exposed to high-level chronic stress (violence) will be at greater risk for asthma development than women with low-level stress (violence) exposure. The influence of chronic stress on neuroendocrine and immune function as reflected in morning cortisol expression, for the former, and cytokine profiles and IgE production (T-helper cell polarization), for the latter, will also be examined in a nested case control fashion among these women.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
- Conditions
- Asthma, Lung Diseases
- Medical subject headings
- Asthma, Lung Diseases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2000 (estimated)
- Study startSep 2000
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Rosalind Wright, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006498
- Sponsor's protocol ID
- 939
- Other IDs
- R01HL064108
- Status last verified
- Jan 2006
- First submitted
- 16 Nov 2000
- Last updated
- 16 Mar 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Life Stress and Incident Asthma in Adult Women
- ClinicalTrials.gov ID
- NCT00006498
- Acronym / sponsor ID
- 939
- Conditions
- Asthma, Lung Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Sep 2000
- Study completion
- Aug 2005 (actual)
- First posted
- 17 Nov 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To prospectively examine the association between a specific chronic life stressor (i.e., intimate violence exposure) and adult asthma in women.
Detailed description
BACKGROUND:
Etiologies of the rising prevalence and morbidity of asthma are not well understood. Knowledge gaps are particularly significant with respect to adult-onset asthma. The role of stress in the expression of asthma is largely unexplored in large-scale, prospective, epidemiologic studies and such investigation has been identified as a priority by a recent NHLBI expert panel.
DESIGN NARRATIVE:
The study prospectively examines the association between a specific chronic life stressor (i.e., intimate violence exposure) and adult asthma in women participating in the Nurses' Health Study II cohort. Emerging epidemiologic data suggest that exposure to intimate violence is a pervasive chronic life stressor associated with adverse impact on womens' psychological and physical health. Traumatic stress such as that related to intimate violence exposure has been associated with neuroendocrine changes known to cause alterations in neuroendocrine and immune functions important to the pathophysiology of inflammatory diseases including asthma. The investigators are testing the hypothesis that women exposed to high-level chronic stress (violence) will be at greater risk for asthma development than women with low-level stress (violence) exposure. The influence of chronic stress on neuroendocrine and immune function as reflected in morning cortisol expression, for the former, and cytokine profiles and IgE production (T-helper cell polarization), for the latter, will also be examined in a nested case control fashion among these women.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
Study design
Who may qualify
- Ages
- Up to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rosalind Wright
Brigham and Women's Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma and Lung Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2016.