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

Chronic Obstructive Pulmonary Disease Clinical Trial

— CODE  

Official title:

COpd and Domestic Endotoxin (CODE)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00890136
• Other study ID #: NA_00017777
• Status: Completed
• Start date: July 2008
• Est. completion date: November 2014

Study information

• Verified date: June 2019
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: November 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
United States	Karina Romero	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute of Environmental Health Sciences (NIEHS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	statistical analysis		one year