Association Between Increased Oxidative Stress, Anti-Inflammatory Fatty Acid Formation, and Airway Infection in People With Asthma and Chronic Obstructive Pulmonary Disease

Asthma Clinical Trial

Official title:

Ancillary Study of Oxidative Stress and Anti-Inflammatory Lipids in Airway Disease in the MIA (ACRN) and LEUKO (CCRN) Trials

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00595114
• Other study ID #: 1421
• Secondary ID: R01HL090927HL090
• Status: Completed
• Phase: Phase 0
• First received: January 7, 2008
• Last updated: May 14, 2012
• Start date: December 2007
• Est. completion date: August 2009

Study information

• Verified date: May 2012
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

Chronic obstructive pulmonary disease (COPD) and asthma are common respiratory diseases in which people experience long-term inflammation of the lungs. Exacerbations, or prolonged worsening of symptoms, of asthma and COPD are often life-threatening and can lead to frequent need for hospitalization. Even with the proper use of bronchodilators, corticosteroids, and other currently available medications, clinical responses among people with COPD and asthma are variable. There remains a significant unmet clinical need for new therapeutic approaches and insights, including the identification of biomarkers to accurately assess the presence of airway infection and intensity of airway inflammation. This study will investigate potential natural biological causes and new biomarkers for increased susceptibility to persistent airway infection in asthma and COPD.

Description:

COPD and asthma are chronic lung diseases that result in impaired air flow in the lungs, often causing coughing, wheezing, and shortness of breath. In uncontrolled COPD and asthma, people may experience a rapid worsening of symptoms, which may include fever, difficulty breathing, and chest pain. These exacerbations are the most serious expression of asthma and COPD and are usually caused by lung infections or air allergens. However, the biological basis for susceptibility to airway infection and inflammation is not well understood. Increased oxidative stress within the airways has been linked to several airway diseases. This increase in oxidative stress may reduce production of key fatty acid anti-inflammatory mediators. In turn, this may disrupt the airway's natural immune response mechanisms, making the airways more vulnerable to infection or inflammation during COPD and asthma exacerbations. This ancillary study will determine whether susceptibility to persistent airway infection in asthma and COPD stems from increased oxidative stress that impairs the natural formation of protective fatty acid mediators.

This ancillary study will use data biological samples, including blood and sputum, from participants currently enrolled in the Macrolides in Asthma (MIA) and the Antileukotriene Therapy for COPD Exacerbations (LEUKO) trials. Biological samples will undergo fatty acid mediator analysis and RNA isolation. There will be no study visits for this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• No change from the MIA and LEUKO trials

Exclusion Criteria:

• No change from the MIA and LEUKO trials

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Asthma
• Chronic Disease
• Lung Diseases
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mono-oxygenation events for C20:4, C20:5, and C22:6 as biochemical markers for enzymatic and nonenzymatic activities in asthma and COPD		Measured at completion of sample analysis	No
Secondary	Impact of 5-lipoxygenase inhibition on the in vivo formation of counter-regulatory lipid mediators		Measured at completion of sample analysis	No
Secondary	Kinetics for the formation of C20:4, C20:5, and C22:6 based counter-regulatory lipid mediators in COPD exacerbation and resolution		Measured at completion of sample analysis	No
Secondary	Relationship between the formation of C20:4, C20:5, and C22:6 based counter-regulatory lipid mediators and airway infection in asthma		Measured at completion of sample analysis	No