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

NCT00557180 | Completed DMC

• 2 other identifiers: 1423R01HL090982
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 10

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.

Conditions

Asthma; Obesity

Keywords

Steroid Resistance; Inflammation

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

BASALT

Participants in the ACRN BASALT study

Drug: Beclomethasone dipropionate HFA

TALC

Participants in the ACRN TALC study

Drug: Tiotropium bromide; Drug: Salmeterol xinafoate

Interventions

Beclomethasone dipropionate HFA DRUG

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

Also known as: QVAR® 40 mcg or QVAR® 80 mcg

BASALT

Tiotropium bromide DRUG

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

Also known as: Spiriva®

TALC

Salmeterol xinafoate DRUG

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

Also known as: Serevent®

TALC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

Sponsors & Collaborators

• National Jewish Health: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (10)

University of California, San Diego

San Diego, California, 92093, United States

Location

University of California, San Francisco

San Francisco, California, 94143, United States

Location

National Jewish Medical & Research Center

Denver, Colorado, 80206, United States

Location

Brigham & Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Washington University

St Louis, Missouri, 63130, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

University of Texas Medical Branch

Galveston, Texas, 77555, United States

Location

University of Wisconsin

Madison, Wisconsin, 53706, United States

Location

Related Publications (1)

• 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.

  PMID: 20075384 DERIVED

Related Links

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

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma Serum

MeSH Terms

Conditions

Asthma; Obesity; Inflammation

Interventions

Beclomethasone; Tiotropium Bromide; Salmeterol Xinafoate

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Chlorinated; Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Albuterol; Ethanolamines; Amino Alcohols; Alcohols; Amines; Phenethylamines; Ethylamines

Study Officials

• E. R. Sutherland, MD, MPH

  National Jewish Medical & Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2007
• First Posted: November 12, 2007
• Study Start: October 1, 2007
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: October 22, 2020

Record last verified: 2020-10

Locations

US (10)