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

NCT00595114 | Completed Results DMC

• 3 other identifiers: 1421R01HL090927HL090927
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Asthma; Pulmonary Disease, Chronic Obstructive

Keywords

COPD; Airway; Inflammation; Infection; Lipid Mediators; Oxidative Stress

Outcome Measures

Primary Outcomes (1)

• 8-isoprostane Levels as Biochemical Markers for Nonenzymatic Oxidative Stress in Asthma

  8-isoprostane levels in sputum

  Measured at completion of sample analysis

Study Arms (6)

MIA 1

Participants from the MIA trial who are polymerase chain reaction (PCR) negative and have received treatment with placebo

MIA 2

Participants from the MIA trial who are PCR negative and have received treatment with the antibiotic clarithromycin

MIA 3

Participants from the MIA trial who are PCR positive and have received treatment with placebo

MIA 4

Participants from the MIA trial who are PCR positive and have received treatment with the antibiotic clarithromycin

LEUKO 1

Participants from the LEUKO trial who have received treatment with placebo

LEUKO 2

Participants from the LEUKO trial who have received treatment with zileuton

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

This ancillary study will use data and specimens previously collected in the Macrolides in Asthma (MIA) and the Antileukotriene Therapy for COPD Exacerbations (LEUKO) trials.

You may qualify if:

• No change from the MIA and LEUKO trials

You may not qualify if:

• No change from the MIA and LEUKO trials

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

• Ono E, Dutile S, Kazani S, Wechsler ME, Yang J, Hammock BD, Douda DN, Tabet Y, Khaddaj-Mallat R, Sirois M, Sirois C, Rizcallah E, Rousseau E, Martin R, Sutherland ER, Castro M, Jarjour NN, Israel E, Levy BD; National Heart, Lung, and Blood Institute's Asthma Clinical Research Network. Lipoxin generation is related to soluble epoxide hydrolase activity in severe asthma. Am J Respir Crit Care Med. 2014 Oct 15;190(8):886-97. doi: 10.1164/rccm.201403-0544OC.

  PMID: 25162465 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood and sputum samples with DNA

MeSH Terms

Conditions

Asthma; Pulmonary Disease, Chronic Obstructive; Inflammation; Infections

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Bruce D. Levy
• Organization: Brigham and Women's Hospital

blevy@partners.org

617-525-5407

Study Officials

• Bruce D. Levy, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 7, 2008
• First Posted: January 16, 2008
• Study Start: December 1, 2007
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: October 19, 2016
• Results First Posted: July 6, 2016

Record last verified: 2016-09

Locations

US (1)