Chronic Obstructive Pulmonary Disease (COPD) and Domestic Endotoxin (CODE)

COpd and Domestic Endotoxin (CODE)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00890136

Acronym

CODE

Enrollment

Registered

2009-04-29

Start date

2008-07-31

Completion date

2014-11-30

Last updated

2019-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Chronic Obstructive Pulmonary Disease (COPD)

Brief summary

This project aims to characterize the independent effect of domestic endotoxin exposure on health status, as well as pulmonary and systemic inflammation, in former smokers with COPD. Positive findings from this study would be clinically relevant, as they would provide evidence to support aggressive reduction of ongoing endotoxin exposure in patients with COPD. The investigators also hope to make a methodological advance in the field of endotoxin exposure assessment by elucidating whether settled dust and/or airborne endotoxin measurements are the more relevant exposure of interest in epidemiological studies of respiratory disease. To fulfill the specific aims, the investigators will conduct a longitudinal study, including 75 former smokers with COPD. All subjects will have indoor air monitoring, in-home settled dust collections, home inspections as well as assessments of health status, quality of life (QOL), lung function and pulmonary and systemic inflammation.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

40 Years to 100 Years

Healthy volunteers

Inclusion criteria

* Patient reported physician diagnosis of COPD/Chronic Bronchitis/Emphysema * Cigarette Smoking \> 10 pack-years * Age \> 40 years * Has not smoked \> 1 year * Post BD FEV1/FVC ≤ 70% * Post BD FEV1 (% predicted) 30-80% * Ability and willingness to provide consent

Exclusion criteria

* Non- English speaking * Planning to move or live away from the home during the study period * Co-morbid illnesses such as: * Current physician diagnosis of Asthma * Other pulmonary diseases * Systemic disease requiring treatment with immunosuppressive agents * Known alpha-1 antitrypsin deficiency * Occupational exposure with high endotoxin exposure * Within the last 6 months Use of oral corticosteroids

Design outcomes

Primary

Measure	Time frame
statistical analysis	one year

Countries

United States

Outcome results