Examining the Link Between Obesity, Inflammation, and Response to Asthma Medications
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
|
Asthma Obesity |
Drug: Beclomethasone dipropionate HFA Drug: Tiotropium bromide Drug: Salmeterol xinafoate |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Obesity, Inflammation and Response to Therapy in Asthma - Ancillary to Asthma Clinical Research Network (ACRN) Trials |
- 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 ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
Plasma Serum
| Estimated Enrollment: | 544 |
| Study Start Date: | October 2007 |
| Study Completion Date: | February 2011 |
| Primary Completion Date: | February 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
BASALT
Participants in the ACRN BASALT study
|
Drug: Beclomethasone dipropionate HFA
Participants will receive the BASALT and TALC study drugs as determined in those protocols NCT00495157, NCT00565266. This study is ancillary to those trials and observational only and does not have any control over study drug allocation
Other Name: QVAR® 40 mcg or QVAR® 80 mcg
|
|
TALC
Participants in the ACRN TALC study
|
Drug: Tiotropium bromide
Participants will receive the BASALT and TALC study drugs as determined in those protocols NCT00495157, NCT00565266. This study is ancillary to those trials and observational only and does not have any control over study drug allocation
Other Name: Spiriva®
Drug: Salmeterol xinafoate
Participants will receive the BASALT and TALC study drugs as determined in those protocols NCT00495157, NCT00565266. This study is ancillary to those trials and observational only and does not have any control over study drug allocation
Other Name: Serevent®
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Participants in the BASALT and TALC studies. 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
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.
Contacts and Locations| United States, California | |
| University of California, San Diego | |
| San Diego, California, United States, 92093 | |
| University of California, San Francisco | |
| San Francisco, California, United States, 94143 | |
| United States, Colorado | |
| National Jewish Medical & Research Center | |
| Denver, Colorado, United States, 80206 | |
| United States, Massachusetts | |
| Brigham & Women's Hospital | |
| Boston, Massachusetts, United States, 02115 | |
| United States, Missouri | |
| Washington University | |
| St Louis, Missouri, United States, 63130 | |
| United States, New York | |
| Columbia University Medical Center | |
| New York, New York, United States, 10032 | |
| United States, North Carolina | |
| Duke University Medical Center | |
| Durham, North Carolina, United States, 27710 | |
| Wake Forest University Health Sciences | |
| Winston-Salem, North Carolina, United States, 27157 | |
| United States, Texas | |
| University of Texas Medical Branch | |
| Galveston, Texas, United States, 77555 | |
| United States, Wisconsin | |
| University of Wisconsin | |
| Madison, Wisconsin, United States, 53706 | |
| Principal Investigator: | E. R. Sutherland, MD, MPH | National Jewish Medical & Research Center |
More Information
Additional Information:
No publications provided by National Jewish Health
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | E Rand Sutherland, Associate Professor of Medicine, National Jewish Health |
| ClinicalTrials.gov Identifier: | NCT00557180 History of Changes |
| Other Study ID Numbers: | 1423, R01HL090982, R01 HL090982 |
| Study First Received: | November 9, 2007 |
| Last Updated: | November 3, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Jewish Health:
|
Steroid Resistance Inflammation |
Additional relevant MeSH terms:
|
Asthma Inflammation Obesity Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Pathologic Processes Overnutrition Nutrition Disorders Overweight |
Body Weight Signs and Symptoms Beclomethasone Salmeterol Albuterol Tiotropium Bromides Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Anti-Asthmatic Agents |
ClinicalTrials.gov processed this record on May 22, 2013