An observational study in Asthma and Pulmonary Disease, Chronic Obstructive, sponsored by Brigham and Women's Hospital. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-10-19.
Sponsored by Brigham and Women's Hospital · Observational
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.
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; NCT00318708) and the Antileukotriene Therapy for COPD Exacerbations (KIA; NCT01097694). Biological samples will undergo fatty acid mediator analysis and RNA isolation. There will be no study visits for this study.
3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.
This study's enrollment of 43 is below the median of 150 across 970 observational studies indexed under Asthma.
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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.
Exclusion Criteria:
Participants from the MIA trial who are polymerase chain reaction (PCR) negative and have received treatment with placebo
Participants from the MIA trial who are PCR negative and have received treatment with the antibiotic clarithromycin
Participants from the MIA trial who are PCR positive and have received treatment with placebo
Participants from the MIA trial who are PCR positive and have received treatment with the antibiotic clarithromycin
Participants from the LEUKO trial who have received treatment with placebo
Participants from the LEUKO trial who have received treatment with zileuton
8-isoprostane Levels as Biochemical Markers for Nonenzymatic Oxidative Stress in Asthma
8-isoprostane levels in sputum
Time frame: Measured at completion of sample analysis
| Milestone | MIA 1 | KIA 1 |
|---|---|---|
| Started | 24 | 19 |
| Completed | 24 | 19 |
| Not completed | 0 | 0 |
8-isoprostane levels in sputum
| pg/ml | MIA 1 | KIA 1 |
|---|---|---|
| 8-isoprostane Levels as Biochemical Markers for Nonenzymatic Oxidative Stress in Asthma | 292.4 ± 51.0 | 421.8 ± 195.4 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| MIA 1 | — | 0/24 (0%) | 0/24 (0%) |
| KIA 1 | — | 0/19 (0%) | 0/19 (0%) |
| Age, Continuous(years) | MIA 1 | KIA 1 | Total |
|---|---|---|---|
| Mean | 37 ± 10 | 40 ± 11 | 38 ± 10 |
| Sex: Female, Male(Participants) | MIA 1 | KIA 1 | Total |
|---|---|---|---|
| Female | 17 | 9 | 26 |
| Male | 7 | 10 | 17 |
| Ethnicity (NIH/OMB)(Participants) | MIA 1 | KIA 1 | Total |
|---|---|---|---|
| Hispanic or Latino | 5 | 3 | 8 |
| Not Hispanic or Latino | 19 | 16 | 35 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | MIA 1 | KIA 1 | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 15 | 8 | 23 |
| White | 9 | 11 | 20 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | MIA 1 | KIA 1 | Total |
|---|---|---|---|
| United States | 24 | 19 | 43 |
This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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