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

COpd and Domestic Endotoxin (CODE)

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.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease

• Study Type: Observational
• Enrollment (Actual): 84

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21231
      • Karina Romero

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Both Male and Female 40 years and older

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
statistical analysis	one year

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: National Institute of Environmental Health Sciences (NIEHS)
• Investigators: Principal Investigator: Nadia Hansel, MD, MPH, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2008
• Primary Completion (Actual): March 1, 2014
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: April 27, 2009
• First Submitted That Met QC Criteria: April 28, 2009
• First Posted (Estimate): April 29, 2009

Study Record Updates

• Last Update Posted (Actual): June 25, 2019
• Last Update Submitted That Met QC Criteria: June 21, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: Chronic Obstructive Pulmonary Disease (COPD)
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: NA_00017777