Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT00557180 |
| Other study ID # |
1423 |
| Secondary ID |
R01HL090982 |
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
October 2007 |
| Est. completion date |
February 2011 |
Study information
| Verified date |
October 2020 |
| Source |
National Jewish Health |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Asthma is a common, long-term disease that is caused by inflammation of the airways.
Inflammation also plays a role in obesity and may affect the way a person responds to asthma
medication. This study will examine the relationship between obesity and inflammation and the
effect they have on response to corticosteroid asthma medications.
Description:
Asthma affects 20 million people in the United States. It can be caused by many factors,
including exposure to tobacco smoke, infections, and other allergens. Recent research
suggests that there may be a relationship between obesity and asthma. It is not fully
understood how these two conditions are linked, but inflammation may play a role.
Obesity-related inflammation may increase the risk of airway inflammation, thereby elevating
the risk of developing asthma. Increased inflammation related to obesity may also reduce the
effectiveness of inhaled steroid asthma medications, including glucocorticoids. Compared with
people of normal weight, people who are overweight or obese may have a higher risk of
developing glucocorticoid insensitivity, resulting in intolerance to glucocorticoid
medications. The purpose of this study is to examine the effect that obesity has on
glucocorticoid insensitivity and inflammation. This study will also examine differences in
the response to asthma steroid medications between people who are overweight or obese and
those who are not.
This study will use previously collected data from participants in two clinical trials of the
NHLBI-funded Asthma Clinical Research Network (ACRN): the Best Adjustment Strategy for Asthma
in Long Term (BASALT) study (NCT00495157) and the Tiotropium Bromide as an Alternative to
Increased Inhaled Corticosteroid in Patients Inadequately Controlled on a Lower Dose of
Inhaled Corticosteroid (TALC) study. There will be no additional study visits specifically
for this study. Researchers will examine blood samples collected at participants' first
BASALT or TALC study visit to analyze levels of inflammation biomarkers (including tumor
necrosis factor-alpha [TNF-α], interleukin-6 [IL-6], and leptin) and proinflammatory
cytokines levels, which influence glucocorticoid insensitivity. Additional BASALT and TALC
study data, including lung function, asthma symptoms, and asthma exacerbations, will also be
analyzed.
