Examining the Link Between Obesity, Inflammation, and Response to Asthma Medications

Completed

• Conditions: Obesity; Asthma
• Interventions: Drug: Tiotropium bromide; Drug: Beclomethasone dipropionate HFA; Drug: Salmeterol xinafoate

• Registration Number: NCT00557180
• Lead Sponsor: National Jewish Health

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2007-11-09
• Study First Submitted QC: 2007-11-09
• Study First Posted: 2007-11-12
• Primary Completion: 2011-02
• Study Completion: 2011-02
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-19
• Last Update Posted: 2020-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
TALC	Salmeterol xinafoate	Participants in the ACRN TALC study
TALC	Tiotropium bromide	Participants in the ACRN TALC study
BASALT	Beclomethasone dipropionate HFA	Participants in the ACRN BASALT study

Primary Outcome Measures

Name	Time	Method
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	Measured at Week 36 for BASALT participants and Week 46 for TALC participants

Trial Locations

Locations (10)

University of California, San Diego; 🇺🇸 San Diego, California, United States

Columbia University Medical Center; 🇺🇸 New York, New York, United States

University of California, San Francisco; 🇺🇸 San Francisco, California, United States

National Jewish Medical & Research Center; 🇺🇸 Denver, Colorado, United States

Wake Forest University Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States

Brigham & Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

Washington University; 🇺🇸 Saint Louis, Missouri, United States

University of Wisconsin; 🇺🇸 Madison, Wisconsin, United States

University of Texas Medical Branch; 🇺🇸 Galveston, Texas, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States