Official Title: “Obesity, Inflammation and Response to Therapy in Asthma - Ancillary to Asthma Clinical Research Network (ACRN) Trials”

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.

Study Type: Observational

Study Design: Cohort, Prospective

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.

Intervention(s) in this Clinical Trial

• Drug: Beclomethasone dipropionate HFA
  • Participants will receive the BASALT and TALC study drugs as determined in those protocols NCT00495157, NCT00565266. This study is ancilary to those trials and observational only and does not have any control over study drug allocation
• Drug: Tiotropium bromide
  • Participants will receive the BASALT and TALC study drugs as determined in those protocols NCT00495157, NCT00565266. This study is ancilary to those trials and observational only and does not have any control over study drug allocation
• Drug: Salmeterol xinafoate
  • Participants will receive the BASALT and TALC study drugs as determined in those protocols NCT00495157, NCT00565266. This study is ancilary to those trials and observational only and does not have any control over study drug allocation

Arms, Groups and Cohorts in this Clinical Trial

• : BASALT
  • Participants in the ACRN BASALT study
• : TALC
  • Participants in the ACRN TALC study

Primary Measures

• Measures of lung function; asthma symptoms and exacerbations; quality of life; rescue medication usage; inflammation and oxidative stress biomarkers; and the effect these factors have on glucocorticoid insensitivity
  • Time Frame: Measured at Week 36 for BASALT participants and Week 46 for TALC participants
    Safety Issue?: No

Inclusion Criteria:

• Participation in either the BASALT or TALC studies of the Asthma Clinical Research Network.
• Inclusion and exclusion criteria are as determined by those studies, NCT00495157, NCT00565266.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

Overall Clinical Trial Officials and Contacts

E. R. Sutherland, MD, MPH Principal Investigator National Jewish Medical & Research Center  

Overall Contact: E. R. Sutherland, MD, MPH 303-398-1443 martinlab@njc.org

Information obtained from ClinicalTrials.gov on January 08, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00557180

Study ID Number: 1423

ClinicalTrials.gov Identifier: NCT00557180

Health Authority: United States: Federal Government

Click here for the Asthma Clinical Research Network (ACRN) Web site.