Trial record 2 of 23 for:    ccrn

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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Bruce D. Levy, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00595114
First received: January 7, 2008
Last updated: May 14, 2012
Last verified: May 2012
  Purpose

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.


Condition Phase
Asthma
Pulmonary Disease, Chronic Obstructive
Phase 0

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Ancillary Study of Oxidative Stress and Anti-Inflammatory Lipids in Airway Disease in the MIA (ACRN) and LEUKO (CCRN) Trials

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Mono-oxygenation events for C20:4, C20:5, and C22:6 as biochemical markers for enzymatic and nonenzymatic activities in asthma and COPD [ Time Frame: Measured at completion of sample analysis ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Impact of 5-lipoxygenase inhibition on the in vivo formation of counter-regulatory lipid mediators [ Time Frame: Measured at completion of sample analysis ] [ Designated as safety issue: No ]
  • Kinetics for the formation of C20:4, C20:5, and C22:6 based counter-regulatory lipid mediators in COPD exacerbation and resolution [ Time Frame: Measured at completion of sample analysis ] [ Designated as safety issue: No ]
  • Relationship between the formation of C20:4, C20:5, and C22:6 based counter-regulatory lipid mediators and airway infection in asthma [ Time Frame: Measured at completion of sample analysis ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Blood and sputum samples with DNA


Enrollment: 52
Study Start Date: December 2007
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

Inclusion Criteria:

  • No change from the MIA and LEUKO trials

Exclusion Criteria:

  • No change from the MIA and LEUKO trials
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00595114

Locations
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
Principal Investigator: Bruce D. Levy, MD Brigham and Women's Hospital
  More Information

No publications provided

Responsible Party: Bruce D. Levy, Principal Investigator, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00595114     History of Changes
Other Study ID Numbers: 1421, R01HL090927, HL090927
Study First Received: January 7, 2008
Last Updated: May 14, 2012
Health Authority: United States: Federal Government

Keywords provided by Brigham and Women's Hospital:
COPD
Airway
Inflammation
Infection
Lipid Mediators
Oxidative Stress

Additional relevant MeSH terms:
Asthma
Chronic Disease
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Bronchial Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Disease Attributes
Pathologic Processes
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 22, 2014