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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
E Rand Sutherland, National Jewish Health
ClinicalTrials.gov Identifier:
NCT00557180
First received: November 9, 2007
Last updated: November 3, 2011
Last verified: November 2011

November 9, 2007
November 3, 2011
October 2007
February 2011   (final data collection date for primary outcome measure)
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 ]
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 ]
Complete list of historical versions of study NCT00557180 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Examining the Link Between Obesity, Inflammation, and Response to Asthma Medications
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Plasma Serum

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

  • Asthma
  • Obesity
  • 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
  • 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®
  • BASALT
    Participants in the ACRN BASALT study
    Intervention: Drug: Beclomethasone dipropionate HFA
  • TALC
    Participants in the ACRN TALC study
    Interventions:
    • Drug: Tiotropium bromide
    • Drug: Salmeterol xinafoate
Sutherland ER, Goleva E, Jackson LP, Stevens AD, Leung DY. Vitamin D levels, lung function, and steroid response in adult asthma. Am J Respir Crit Care Med. 2010 Apr 1;181(7):699-704. doi: 10.1164/rccm.200911-1710OC. Epub 2010 Jan 14.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
544
February 2011
February 2011   (final data collection date for primary outcome measure)

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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00557180
1423, R01HL090982, R01 HL090982
Yes
E Rand Sutherland, National Jewish Health
National Jewish Health
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: E. R. Sutherland, MD, MPH National Jewish Medical & Research Center
National Jewish Health
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP