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

NCT00890136 | Completed DMC

• 1 other identifier: NA_00017777
• Study Type: observational
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Chronic Obstructive Pulmonary Disease (COPD)

Outcome Measures

Primary Outcomes (1)

• statistical analysis

  one year

Eligibility Criteria

• Age: 40 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Both Male and Female 40 years and older

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute of Environmental Health Sciences (NIEHS): collaborator

Study Sites (1)

Karina Romero

Baltimore, Maryland, 21231, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood, sputum

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Nadia Hansel, MD, MPH

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2009
• First Posted: April 29, 2009
• Study Start: July 1, 2008
• Primary Completion: March 1, 2014
• Study Completion: November 1, 2014
• Last Updated: June 25, 2019

Record last verified: 2019-06

Locations

US (1)